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Week Ending: June 9th , 2007
Alan Franciscus
Editor-in-Chief
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This Issue:
June 4th, 2007
Nexavar significantly extends overall survival by 44 percent in liver cancer patients
http://www.eurekalert.org
First agent ever to demonstrate significant survival benefit in liver cancer
Chicago, IL – June 4, 2007 -- Bayer HealthCare Pharmaceuticals Inc. (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that Nexavar® (sorafenib) tablets significantly extended overall survival in patients with hepatocellular carcinoma (HCC), or primary liver cancer versus those taking placebo by 44% (HR=0.69; p-value=0.0006). Results were presented at the 43rd annual meeting of the American Society of Clinical Oncology (ASCO).
The international, Phase 3, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) Trial randomized and evaluated 602 liver cancer patients who had no prior systemic therapy at sites in the Americas, Europe, and Australia/New Zealand. The primary objective of the study was to compare overall survival in patients administered Nexavar versus those administered placebo. Median overall survival was 10.7 months in Nexavar-treated patients compared to 7.9 months in those taking placebo.
“Because there are no therapies that significantly improve survival for the thousands of patients with liver cancer, these findings demonstrate the compelling study results of Nexavar as the new reference standard of care for the first-line treatment of HCC,” said Dr. Josep M. Llovet, co-principal investigator and Professor of Research, Barcelona Clinic Liver Cancer (BCLC) Group, IDIBAPS, Liver Unit, Hospital Clinic Barcelona; Director of Research, HCC Program, Associate Professor of Medicine, Mount Sinai School of Medicine, New York.
Bayer and Onyx halted the SHARP trial in February 2007 when an independent data monitoring committee determined in a pre-scheduled analysis that the overall survival endpoint had been met. There were no significant differences in serious adverse event rates between the Nexavar and placebo-treated groups, with the most commonly observed serious adverse events in patients receiving Nexavar being diarrhea and hand-foot-skin reaction. Based on the strength of the data, the companies are now in the process of preparing applications to the U.S. Food and Drug Administration (FDA) and European health authorities for a supplemental indication for Nexavar in treatment of patients with liver cancer.
“Although much progress has been made in cancer research, the number of lives lost to liver cancer is increasing,” said Dr. Jordi Bruix, co-principal investigator and Director of the Barcelona Clinic Liver Cancer (BCLC) Group; Senior Consultant, Liver Unit, Hospital Clinic of Barcelona. “For that reason, these results represent an unprecedented achievement and Nexavar could become the first widely-approved new therapy for this difficult to treat cancer.”
Hepatocellular carcinoma is the most common form of liver cancer and is responsible for about 90 percent of the primary malignant liver tumors in adults.1, 2 It is the fifth most common cancer in the world3 and the third leading cause of cancer-related deaths globally.4 Over 600,000 new cases of HCC are diagnosed globally each year4 (19,000 in the United States5 and 32,000 in the European Union6), and in 2002 approximately 600,000 people (about 13,000 Americans and 57,000 Europeans) died of HCC.7 Although overall cancer incidence and mortality are decreasing in the United States, both the incidence and mortality of liver cancer are increasing.8
Nexavar’s Differentiated Mechanism
Nexavar targets both the tumor cell and tumor vasculature and is the only oral multi-kinase inhibitor that does not require patients to interrupt their treatment schedule.
In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET. Preclinical models have also demonstrated that the Raf/MEK/ERK pathway has a role in HCC; therefore blocking signaling through Raf-1 may offer therapeutic benefits in HCC.
Nexavar is currently approved in more than 50 countries, including the United States and those in the European Union, for the treatment of patients with advanced kidney cancer. In Europe, Nexavar is approved for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
Nexavar is also being evaluated by the companies, international study groups, government agencies and/or individual investigators as a single agent or combination treatment in a wide range of other cancers, including adjuvant therapy for kidney cancer, metastatic melanoma, breast cancer and non-small cell lung cancer (NSCLC). The Phase 3 ESCAPE (Evaluation of sorafenib, carboplatin, and paclitaxel efficacy in NSCLC) trial recently completed enrollment of more than 900 previously untreated patients with NSCLC of all histologies.
“HCC is the second tumor type in which Nexavar has demonstrated a clinical benefit. We intend to move swiftly with our partner Onyx to file these data for health authority review,” said Susan Kelley, MD, Vice President, Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals. “Our strategy of leveraging the unique attributes of Nexavar, the only approved orally administered anti-angiogenic that targets the Raf pathway, has led to a robust ongoing clinical program that could bring the potent cancer fighting properties of this oral multi-kinase inhibitor to an even broader number of patients in the coming years.”
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Important Safety Considerations for U.S. Patients Taking Nexavar
Based on the currently approved package insert for the treatment of patients with advanced kidney cancer, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. Incidence of bleeding regardless of causality was 15% for Nexavar vs. 8% for placebo and the incidence of treatment-emergent cardiac ischemia/infarction was 2.9% for Nexavar vs. 0.4% for placebo. Most common treatment-emergent adverse events with Nexavar were diarrhea, rash/desquamation, fatigue, hand-foot skin reaction, alopecia, and nausea. Grade 3/4 adverse events were 38% for Nexavar vs. 28% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.
For U.S. Nexavar prescribing information, visit www.nexavar.com or call 1.866.NEXAVAR (1.866.639.2827).
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company developing innovative therapies that target the molecular mechanisms that cause cancer. The company is developing Nexavar®, a small molecule drug, with Bayer Pharmaceuticals Corporation. Nexavar has been approved for the treatment of advanced kidney cancer. For more information about Onyx's pipeline and activities, visit the company's web site at:
www.onyx-pharm.com.
About Bayer HealthCare
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world’s leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the United States, Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
About Bayer Schering Pharma AG, Germany
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve quality of life.
Forward Looking Statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including its Form 20-F). Bayer assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
This news release also contains “forward-looking statements” of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the timing, progress and results of the clinical development, regulatory processes, and commercialization efforts of Nexavar. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Onyx’s Annual Report on Form 10-K for the year ended December 31, 2005, filed with the Securities and Exchange Commission under the heading “Risk Factors” and Onyx’s Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law. Nexavar® (sorafenib) tablets is a registered trademark of Bayer Pharmaceuticals Corporation.
Contacts:
Mark Bennett
Bayer HealthCare Pharmaceuticals
+ 1 203 314 5556
Julie Wood
Onyx Pharmaceuticals, Inc.
+ 1 510 597 6505
Jost Reinhard
Bayer Schering Pharma
+ 49 30 468 15062
Alicia Samuels
(media contact)
GCI Group
+ 1 914-720-4635
Geoff Curtis
(media contact)
WeissComm Partners
+ 1 312-550-8138
References
- World Health Organization. Hepatitis B. Available at: http://www.who.int/csr/disease/hepatitis/
whocdscsrlyo20022/en/ . Accessed April 10, 2007
- Penn State Milton S. Hershey Medical Center College of Medicine. Malignant Hepatoma. Available at: http://www.hmc.psu.edu/healthinfo/m/
malignanthepatoma.htm . Accessed April 10, 2007.
- World Health Organization. Estimates by WHO Region: Incidence. Available at: http://www.who.int/healthinfo/statistics/
gbdwhoregionincidence2002.xls . Accessed April 10, 2007.
- International Agency for Cancer Research. GLOBOCAN 2002. Available at: http://www dep.iarc.fr . Accessed April 23, 2007.
- Jemal A et al. CA Cancer J Clin. 2007;57:43-66.
- International Agency for Cancer Research. EUCAN 1998. Available at: http://www-dep.iarc.fr/eucan/eucan.htm. Accessed April 26, 2007.
- Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004. Available at: http://www-dep.iarc.fr. Accessed April 10, 2007.
- Ries LAG, Melbert D, Krapcho M, Mariotto A, Miller BA, Feuer EJ, Clegg L, Horner MJ, Howlader N, Eisner MP, Reichman M, Edwards BK (eds). SEER Cancer Statistics Review, 1975-2004, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2004/ , based on November 2006 SEER data submission, posted to the SEER web site, 2007.
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California to Fund Needle Exchange Programs for the First Time
www.harmreduction.org
Governor Passage of Legislation Still Needed to Purchase Syringes
SACRAMENTO -- For the first time, the state of California will fund some needle exchange programs. On June 1, the HIV Education and Prevention Services Branch of the Office of AIDS announced awards totaling $2.25 million of direct state funding to Syringe Exchange Programs (SEPs). Ten syringe exchange programs were awarded for $75,000 a year each for three years. Community-based organizations that operate SEPs and local health jurisdictions in areas where SEPs are approved for operation were awarded the grants.
Because of a California law that denies the use of state funds to purchase syringes themselves, this funding will be dedicated to improving access to sterile syringes by increasing SEP operating hours, purchasing non-syringe operating materials, expanding syringe exchange to new locations, adding staff or improving compensation for existing staff as well as adding outreach workers, to encouraging clients of SEPs to test for HIV and HCV and link clients to medical care when appropriate. Funds may also be used to add services, such as wound care, that improve overall health and wellness for injection drug users.
Assemblymember John Laird is sponsoring a bill, AB 110, to change the state law that denies the use of state HIV prevention funds for the purchase of syringes for clean needle and syringe exchange projects. The same bill was passed by a strong majority in the California legislature last year, but was pulled when Governor Schwarzenegger threatened a veto. Proponents are hopeful that this funding from the Office of AIDS will demonstrate the need for state commitment to such programs.
"This funding represents a positive sea change in terms of support for needle exchange in California, said Hilary McQuie of the Harm Reduction Coalition, "But there are over 30 other programs in CA that don't get any state funding and survive on a shoestring, while courageously serving as a bridge between active injection drug users and medical and social services, reducing the spread of HIV and other blood borne diseases, and reducing the number of syringes discarded in public places. The governor should follow the lead of the Office of AIDS, and let local communities use their prevention dollars as they see fit."
According to the Center for Disease Control, over a third of adult AIDS cases are associated directly or indirectly with injection drug use. In California, sharing contaminated injection equipment accounts for 20 percent of new AIDS cases. State data also suggests that more than 1500 new HIV infections occur annually due to syringe sharing. Seventy-five percent of HIV infections among women and children are related to sharing of injection equipment, and communities of color are hit especially hard. In addition to the human toll, the cost of medical treatment ranges from $200,000 to $600,000 over the lifetime of one HIV patient.
# # # #
The Harm Reduction Coalition is a national advocacy and capacity-building organization that promotes the health and dignity of individuals and communities impacted by drug use. For more information, see www.harmreduction.org
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FDA Warns on Chinese-Manufactured Toothpaste
http://firstwatch.jwatch.org
The FDA is warning consumers to throw out any Chinese toothpaste after it found a component of antifreeze in several products.
Because diethylene glycol (DEG) is not always listed in the ingredients on the package, the FDA says people should examine their toothpaste and discard any imported from China. So far there have been no reports of injuries from DEG-contaminated toothpaste, but there have been deaths in several countries from DEG-contaminated products like cough syrup. The FDA is concerned about chronic exposure to DEG, particularly to vulnerable populations like children and people with kidney or liver disease.
The following brands are affected by the advisory: Cooldent Fluoride, Cooldent Spearmint, Cooldent ICE, Dr. Cool, Everfresh, Superdent, Clean Rite, Oralmax Extreme, Oral Bright Fresh Spearmint Flavor, Bright Max Peppermint Flavor, ShiR Fresh Mint Fluoride Paste, DentaPro, DentaKleen, and DentaKleen Junior.
Link: FDA advisory (Free)
Published in Physician's First Watch June 4, 2007
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June 5th, 2007
Launch of Several Novel Therapies Will Drive Dramatic Near-Term Growth in the Hepatitis C Virus Drug Market
http://www.prnewswire.com
However, Market Will Contract After 2011, According to a New Report from Decision Resources
WALTHAM, Mass., June 5 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the drug market to treat the hepatitis C virus will experience dramatic growth through 2011 as the launch of several novel therapies, beginning in 2009, significantly alters the standard of care. However, the market will contract after 2011 as the treatment-eligible pool of hepatitis C virus-infected patients declines in the United States, France, Germany, Italy, Spain, the United Kingdom, and
Japan.
The new Pharmacor report Emerging Hepatitis C Virus Therapies finds that the most highly anticipated drugs in development are the hepatitis C virus- specific protease and polymerase inhibitors. The uptake of protease inhibitors, such as Vertex/Johnson & Johnson/Mitsubishi's Telaprevir, Schering-Plough's Boceprevir, and InterMune/Roche's ITMN-191, will be driven by their impressive efficacy rates, safety, and oral formulation.
Furthermore, leading gastroenterologists and hepatologists believe that polymerase inhibitors such as Idenix/Novartis's valopicitabine, Wyeth/ViroPharma's HCV 796, Roche's R1626, Abbott's A-837093, and Merck's MK 0608 will also drive significant growth in the market to treat the hepatitis C virus.
"Physicians and thought leaders expect that the novel protease and polymerase inhibitors will be used in combination with long-acting interferon- alpha such as Roche's Pegasys, Schering-Plough's Peg-Intron, and Novartis/Human Genome Sciences' Albuferon-alpha," said Aaron Woolsey, Ph.D., analyst at Decision Resources, Inc. "As a result, the introduction of novel second- and third-line therapies will invigorate sales of long-acting interferon-alpha agents and contribute to overall market growth. Paradoxically, because we project that hepatitis C virus incidence will not keep pace with mortality and treatment-cure rates after 2016, the improved efficacy of novel therapies will improve cure rates, resulting in a decline in the number of treatment-eligible patients."
About Pharmacor from Decision Resources
Pharmacor is a unique family of studies that assesses a host of market-impacting factors and analyzes the commercial outlook for drugs in research and development.
About Decision Resources
Decision Resources (http://www.decisionresources.com ) is a world leader in market research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets.
All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.
For more information, contact:
Elizabeth Marshall
Decision Resources, Inc.
781-296-2563
emarshall@dresources.com
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Teen drugged with hepatitis C syringe, violated, court told
http://www.stuff.co.nz
By KATHY WEBB - The Dominion Post
A 14-year-old girl was drugged, sexually violated and given hepatitis C by a builder working at her home, the High Court at Napier was told yesterday.
Sean Lesley Riley, 28, who had hepatitis C when he is alleged to have injected the girl five times in her hand, is on trial on three counts of sexual violation by unlawful connection, injuring the girl by infecting her with a disease with reckless disregard for her safety, and threatening to kill her and her family if she told anyone.
Crown prosecutor Clayton Walker told the court that the girl was home alone during school holidays in December, 2005, while her mother was at work and her young sister was being looked after elsewhere.
Riley was renovating a porch at the home.
In court yesterday, Riley sat in the dock behind a screen as the girl wept during her description of an afternoon in which she was allegedly stupefied, repeatedly injected and subjected to a sexual ordeal.
She told the court that Riley had offered her a drink of water while she was sitting in the lounge.
She accepted and drank about half of it before starting to feel dizzy and not being able to hear properly.
The girl said she saw Riley go out to his truck and put a cigarette lighter beneath a spoon, then put its contents into a syringe he had taken from the glovebox.
He got his 15-year-old nephew to hold the girl's wrist tightly while he put the syringe into the top of her hand.
The girl said she tried to resist but felt too weak.
Riley told her he was giving her Ritalin, which would make her "do things", she said.
She was then taken out to Riley's truck and driven, first to Riley's wife's home, then to a shed at the back of an unknown property.
There, he again heated up something in a spoon and injected it into her hand before forcing her to give him oral sex.
Riley allegedly gave her three more injections, and violated her twice more before she blacked out.
At one stage she woke and found him violating her.
Eventually, Riley asked the girl what time her mother finished work.
He put her back into the truck and told her not to say a word to anyone about what had happened "or me and my family would be dead".
Riley told the girl's mother that the three of them had been out getting quotes for building work.
The girl, still feeling ill, told her mother she did not want dinner.
She went straight to her bedroom and tried to sleep, but stayed awake all night.
The next day, terrified of being alone at the house with Riley again, she sent a text message to a friend, asking her to visit.
She told the friend what had happened, but swore her to secrecy.
It was not till six months later, unable to keep it to herself any longer, that she told her mother, who called police.
Blood tests revealed she had hepatitis C.
Mr Walker told the court that Riley had been diagnosed with hepatitis C about six months before the alleged attack on the girl.
At the time, he was on a methadone programme.
He said Riley denied everything the girl alleged.
The trial is before Justice Denis Clifford and a jury of six men and six women.
Riley's lawyer is to cross-examine the girl today.
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Liver Cancer Patients With High Serum Levels Of Hepatitis B Virus Face Poorer Outcomes
http://www.medicalnewstoday.com
In the June issue of Hepatology, a journal published by John Wiley & Sons on behalf of the American Association for the Study of Liver Diseases (AASLD), researchers report their findings from the first-ever study examining the prognostic value of serum HBV DNA levels for patients with liver cancer undergoing chemotherapy. They found that patients with high pre-chemotherapy levels of HBV DNA had a significantly increased incidence of severe hepatitis which was associated with the worst survival. The article is also available online at Wiley Interscience (http://www.interscience.wiley.com/
journal/hepatology).
HBV is associated with a more than 200-fold increase in risk of liver cancer. In areas where HBV is endemic, like China and the Far East, the great majority of cases of hepatocellular carcinoma (HCC) occur in individuals with the virus. For most patients whose cancer is inoperable, chemotherapy is one of the main treatment options, and still the prognosis is dismal. Survival is often measured in months.
Researchers, led by Winnie Yeo of the Chinese University of Hong Kong, examined the significance of pre-chemotherapy HBV DNA levels in the blood on the survival of HCC patients. They studied 188 patients participating in a phase III randomized controlled trial comparing two different chemotherapy regimens. One hundred and seventy patients (92 percent) had evidence of HBV infection. Of these, 125 had sera available to determine HBV DNA levels and were included in the study.
For each patient, the researchers measured the level of HBV DNA in the blood before the start of chemotherapy. They also gathered other potentially important prognostic information, like age, sex, total bilirubin and presence of cirrhosis. Over the course of each patient's treatment, the researchers monitored blood counts, renal and liver function and clinical signs and symptoms. They then performed statistical analysis to assess which factors might have influenced patient outcomes.
The median survival of all patients was 6.83 months. Patients with high pre-treatment HBV DNA had a significantly higher incidence of developing severe hepatitis during chemotherapy and had poorer survival. Other factors significantly affecting survival were high total bilirubin and HCV infection.
"The present study has shown that a pre-chemotherapy viral load higher than 10(5.65) copies per milliliter is associated with poorer survival in HCC patients with chronic HBV infection, and this association is independent of an individual's hepatic reserve, tumor and clinical factors," the authors report.
Though the study was limited by a small patient cohort, and the fact that all had advanced disease, the authors concluded, "Based on the present findings, the incorporation of anti-viral therapies to reduce HBV viral load should be considered as part of management for HCC patients undergoing chemotherapy."
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Article: "Hepatitis B Viral Load Predicts Survival of HCC Patients Undergoing Systemic Chemotherapy," Yeo, Winnie; Mo, Frankie; Chan, Stephen; Leung, Nancy; Hui, Pun; Lam, WY; Mok, Tony; Lam, Kwok; Ho, Wing; Koh, Jane; Tang, Julian; Chan, Anthony; Chan, Paul. Hepatology; June 2007; (DOI: 10.1002/hep.21572).
Contact: Amy Molnar
John Wiley & Sons, Inc.
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June 6th, 2007
New hepatitis C virus prevention findings from National Institute of Genetics described
http://www.therapeuticsdaily.com
Hepatitis Weekly
Current study results from the report, "A reduction in selective immune pressure during the course of chronic hepatitis C correlates with diminished biochemical evidence of hepatic inflammation," have been published. "It is considered that selection pressure exerted by the host immune response during early HCV infection might influence the outcome of that infection particularly as it relates to persistence or clearance of the agent. However, it is unclear whether positive selection pressure plays a role in determining the severity of hepatitis C during the course of persistent HCV infection," investigators in Mishima, Japan report.
"To address the evolutionary mechanism by which HCV escapes from the host immune response and to assess the relationship between viral evolution and hepatic inflammation, we determined 57 sequences (3-5 serial samples per patient) from 5 individuals with persistent HCV infection of genotype 1a who were under long-term follow-up ranging from 15.6 to 21.6 years. We applied a novel method to estimate serial alternations of selective pressure against the HCV enveloped region and compared this to fluctuation in transaminase level over time. Positive selection pressure was reduced over time postinfection, as evidenced by a reduction in nonsynonymous substitutions in the later phase of infection. Furthermore, serum transaminase, as a measure of inflammatory necrosis of hepatocytes, was reduced in parallel with decreased positive selection pressure. These results suggest that during persistent HCV infection, the virus faces diminished immune pressure over time, either from mutation to an immune resistant sequence or from immunologic exhaustion, and that this diminished immune attack is reflected in diminished inflammatory activity," wrote K. Hanada and colleagues, National Institute of Genetics.
The researchers concluded: "This observation may be applicable to other viruses characterized by a slow rate of disease progression."
Hanada and colleagues published their study in Virology (A reduction in selective immune pressure during the course of chronic hepatitis C correlates with diminished biochemical evidence of hepatic inflammation. Virology, 2007;361(1):27-33).
For additional information, contact K. Hanada, National Institute of Genetics, Yata 1111, Mishima, Shizuoka, Japan.
The publisher of the journal Virology can be contacted at: Academic Press Inc. Elsevier Science, 525 B St., Ste. 1900, San Diego, CA 92101-4495, USA.
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XTL Suspends Development of Hepatitis C Drug
http://pharmalive.com
XTL Provides Update on Phase I Clinical Trial of XTL-2125
VALLEY COTTAGE, New York, June 06, 2007 /PRNewswire-FirstCall/ -- XTL Biopharmaceuticals Ltd. announced today that it has completed the analysis of results from a Phase I clinical trial with XTL-2125 in patients with chronic Hepatitis C. This Phase I trial was a placebo controlled, randomized, dose escalating study, which evaluated the safety, tolerability and antiviral activity of single and multiple doses of XTL-2125. The study enrolled 56 patients into seven cohorts comprised of eight patients each (of which two are placebo patients). Each patient received a single dose, followed by a 14-day multi-dosing regimen commencing one week after the single dose administration. The highest daily multi-dose regimen that was evaluated in the trial was 1800mg per day (600mg three times per day).
The analysis of the data indicates that XTL-2125 was generally well tolerated. However, HCV-RNA viral load reductions in patients treated with XTL-2125 were not significantly different from those observed in the placebo group. Based on these results, XTL has decided to suspend further development of XTL-2125.
XTL's CEO, Ron Bentsur, commented: "The completion of this Phase I trial concludes our research on the XTL legacy compounds that we inherited. Through an aggressive business development effort, XTL's new management team has successfully reinvented the company's product portfolio - with Bicifadine as a lead product in late stage clinical development, and the XTL-DOS program, which is emerging as a very promising program in Hepatitis C. We look forward to an exciting rest of 2007, with the initiation of a late-stage clinical trial with Bicifadine in chronic neuropathic pain, and the initiation of IND-enabling studies with a novel hepatitis C inhibitor from the XTL-DOS program. We will also continue to opportunistically seek to broaden our portfolio through the in-licensing and acquisitions of additional clinical stage products."
ABOUT XTL BIOPHARMACEUTICALS LTD.
XTL Biopharmaceuticals Ltd. ("XTL") is engaged in the acquisition, development and commercialization of therapeutics for the treatment of neuropathic pain and hepatitis C. XTL is developing Bicifadine, a serotonin and norepinephrine reuptake inhibitor, for the treatment of neuropathic pain. XTL is also developing several novel pre-clinical hepatitis C small molecule inhibitors. XTL also has an active in-licensing and acquisition program designed to identify and acquire additional drug candidates. XTL is publicly traded on the NASDAQ, London, and Tel-Aviv Stock Exchanges .
Contact:
Ron Bentsur, Chief Executive Officer
Tel: +1-(845)-267-0707 ext. 225
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future performance, clinical and business prospects for our clinical compound for neuropathic pain, Bicifadine, and for our pre-clinical compounds for hepatitis C from our XTL-DOS program, growth and operating strategies and similar matters, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to start a clinical trial with Bicifadine in 2007; our ability to successfully complete cost-effective clinical trials for the drug candidates in our pipeline which would affect our ability to continue to fund our operations with our available cash reserves, our ability to meet anticipated development timelines for the drug candidates in our pipeline due to recruitment, clinical trial results, manufacturing capabilities or other factors; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission and the London Stock Exchange, including our annual report on Form 20-F filed with the Securities and Exchange Commission on March 23, 2007. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.xtlbio.com . The information in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.
CONTACT: Contact: Ron Bentsur, Chief Executive Officer, Tel:+1-(845)-267-0707 ext. 225
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North Dakota Tackles Hepatitis C in Prisons
http://www.npr.org/
by Cheryl Corley
Morning Edition, June 6, 2007 · Hepatitis C is a growing problem in U.S. prisons, and a number of facilities are being sued for failure to treat inmates. As part of a public health initiative in North Dakota, all new prisoners are screened for the disease, among other measures.
You can listen to this story on NPR radio here: http://www.npr.org/templates/story
/story.php?storyId=10758143
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FierceBiotech Names Intarcia Therapeutics as One of the 'Fierce 15' Biotech Companies of 2007
http://www.sys-con.com
Intarcia Therapeutics selected based on innovative Hepatitis C drug candidate and expanding therapeutics pipeline
EMERYVILLE, Calif., June 6 /PRNewswire/ -- Intarcia Therapeutics, Inc. announced today that it has been named to the annual FierceBiotech "Fierce 15" list, designating it as one of the top biotech companies of 2007. The editors of FierceBiotech evaluated hundreds of privately-held firms based on company vision, revenue potential, quality of deals, strength of technology, partnerships, and competitive market position. Intarcia Therapeutics was determined to be one of the "fiercest," proven by their creativity and innovations in the industry.
An internationally recognized daily newsletter reaching more than 56,000 biotech and pharma industry professionals, FierceBiotech provides subscribers with a quick authoritative briefing on the day's top stories, with a special focus on drug discovery and clinical trials.
Intarcia Therapeutics is a biopharmaceutical company developing therapeutics for patients with chronic diseases in which there are significant unmet medical needs. Intarcia's lead clinical program, Omega DUROS(R) therapy, is being developed to improve the treatment of HCV by offering a more convenient and potentially safer and more effective treatment. Omega DUROS therapy is designed to deliver a continuous and consistent dose of omega interferon for three months via the implantable DUROS device, a drug delivery technology developed by ALZA Corporation, and licensed to Intarcia for use in certain broad fields.
In the first quarter of 2007, Intarcia completed a transaction to raise $50 million to support the development of its lead therapeutic candidates for the treatment of hepatitis C and type 2 diabetes. Recently, Intarcia reported successful results of a phase 2 study of Omega interferon in the treatment of HCV at two major hepatology conferences in Europe and the US. The next phase of development of the HCV program involves evaluation of continuous delivery of omega interferon with the implantable DUROS device. The first clinical study of Omega DUROS therapy is expected to begin this month.
"An innovative approach to treating hepatitis C has delivered supporting data in a series of clinical trials and could help spawn new programs related to sustained delivery of therapeutics," said John Carroll, Editor of FierceBiotech.
Intarcia's drug development expertise and competitive edge are complemented by its ability to stabilize macromolecules and to deliver them in a constant and consistent manner with the proprietary DUROS drug delivery platform. In addition to the clinical stage hepatitis C program, Intarcia is also leveraging the DUROS technology in evaluating other drug development opportunities. The most advanced of these are a type 2 diabetes program focused on the delivery of GLP-1 analogs and mimetics with the DUROS device, and a novel therapy for the treatment of multiple sclerosis.
"FierceBiotech is renowned for its advanced understanding of biotechnology companies and the industry as a whole," said Alice Leung, President and CEO of Intarcia. "Being selected as a member of the 'Fierce 15' is an honor that highlights Intarcia's significant progress over the last twelve months and our potential to make a significant impact in a growing number of therapeutic fields."
The Fierce 15 celebrates the spirit of being "fierce" -- championing innovation and creativity, even in the face of intense competition. The complete list of 'Fierce 15' companies is available in today's issue of FierceBiotech and on the FierceBiotech Web site at http://www.fiercebiotech.com/ .
About Omega DUROS Therapy
Omega DUROS therapy is being developed to improve the treatment of HCV by offering a more convenient and potentially safer and more effective treatment. Omega DUROS therapy is designed to deliver a continuous and consistent dose of omega interferon for three months via the implantable DUROS device, a drug delivery technology developed by ALZA Corporation, and licensed to Intarcia for use in certain broad fields. Another product incorporating the DUROS technology has already been approved by the FDA for the palliative treatment of prostate cancer. Intarcia is also leveraging the DUROS technology in evaluating other drug development opportunities. The most advanced of these is focused on the delivery of GLP-1 and GLP-1 analogs with the DUROS device for the treatment of type 2 diabetes.
About Intarcia
Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapeutics for patients with chronic diseases in which there are significant unmet medical needs. Intarcia's drug development expertise and competitive edge are complemented by its ability to stabilize macromolecules and to deliver them in a constant and consistent manner via the proprietary DUROS drug delivery platform. The initial programs that Intarcia is pursuing are in hepatitis C and type 2 diabetes.
About Hepatitis C
Hepatitis C is a major global public health problem. According to the World Health Organization, more than 170 million people worldwide are chronically infected with HCV, and three to four million new HCV infections occur annually. The U.S. Centers for Disease Control and Prevention has estimated that in the United States approximately 3.2 million people are chronically infected with HCV and approximately 25,000 new patients are infected each year. It is estimated that 10,000 to 12,000 patients die annually in the United States from complications resulting from HCV infection. The current standard of care for treating chronic hepatitis C is combination therapy consisting of pegylated alpha interferon and ribavirin.
About Diabetes
Diabetes affects more than 20 million in the United States and an estimated 194 million adults worldwide. Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the United States. According to the U.S. Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve target hemoglobin A1C levels with their current treatment regimen.
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, unpredictable and potentially disabling disease of the central nervous system. According to the National Institutes of Health, there are approximately 250,000 to 350,000 people in the United States diagnosed with MS. Most people experience their first symptoms of MS between the ages of 20 and 40. Initial symptom of MS often include vision problems. As the disease progresses, it is characterized by symptoms such as loss of balance, numbness, difficulty walking and even complete paralysis.
DUROS is a registered trademark of ALZA Corporation (Mountain View, CA) licensed to Intarcia Therapeutics, Inc. Intarcia and its logo are trademarks of Intarcia Therapeutics, Inc. (Emeryville, CA).
About FierceMarkets
FierceMarkets is a digital business media company serving vertical markets with email newsletters, web sites, and live events. Based in Washington, DC, FierceMarkets publications reach more than 450,000 executives in over 100 countries every business day.
Intarcia Therapeutics, Inc.
CONTACT: James Ahlers of Intarcia Therapeutics, Inc., +1-510-652-2600,
james.ahlers@intarcia.com ; or Heather Cox of FierceMarkets, Inc.,
+1-202-628-8778, x13, heather@fiercemarkets.com
Web site: http://www.intarcia.com/
http://www.fiercebiotech.com/
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Hepatitis progresses in HIV patients
http://www.upi.com
CINCINNATI, June 6 (UPI) -- U.S. HIV patients are living longer, but those who are also infected with hepatitis B or C are experiencing the progression of liver disease.
Because of shared modes of transmission, HIV and viral hepatitis infections often coexist, but while therapies have made HIV a manageable condition, hepatologists are seeing more infected patients with complex liver issues.
In treating HIV/hepatitis C co-infected patients, studies have shown that pegylated interferon with ribavirin is better than interferon-only regimens. Although combination therapy is routine, drug resistance remains a troubling issue, according to the findings of an international forum convened in Jackson Hole, Wyo., last year.
Until recently, liver transplants were not an option for patients with HIV, but it is important not to wait until the patient is moribund, researchers at the forum said.
The forum topics were summarized by Dr. Kenneth Sherman, of the University of Cincinnati, and published in the current issue of Hepatology.
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Hepatitis C fears see women tested
http://www.channel4.com
Thousands of women who were treated by health workers suffering from hepatitis C are being offered screening amid fears they may have been infected with the disease.
The Health Protection Agency (HPA) said around 3,000 patients were being contacted following a review of case notes from 23 hospitals in England and five in Scotland.
The women have been sent a letter by their health trusts or boards asking them to take a blood test for the virus, which can cause liver disease.
The scare involves the separate cases of two infected health workers who were employed in the obstetric and gynaecology departments of UK hospitals.
The review is an extension of two previous patient reviews which were recommended by the UK Advisory Panel for Health Care Workers Infected with Blood-borne Viruses (UKAP). These were ordered in February and April 2005, after it emerged that the workers were suffering from the disease.
More than 2,000 women who underwent high-risk treatment such as Caesareans and hysterectomies were offered screening. Five patients were later found to have contracted hepatitis C.
A further review was then undertaken to assess the risk posed to female patients who had lower-risk procedures carried out at the hospitals concerned. This has now been completed and UKAP has advised the NHS that these women - around 3,000 - are screened.
NHS Ayrshire and Arran, one of the affected Scottish health boards, has sent letters to 236 former patients. One of the infected healthcare workers was employed at its two hospitals between May 1990 and June 1991.
Dr Maida Smellie, a consultant in public health medicine, said: "I understand that this news may cause anxiety to some people, but I want to emphasise that the risk is very small, and that we are offering screening purely as a precaution."
Hepatitis C is a virus which can lead to inflammation of the liver. Symptoms include feeling sick and suffering abdominal pain and jaundice.
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Inovio Biomedical Highlights Enhanced DNA Vaccine Potency with Electroporation DNA Delivery Technology and New Devices at Gene Therapy Meeting
http://www.pharmalive.com/
SAN DIEGO--(BUSINESS WIRE)--Jun 6, 2007 - Inovio Biomedical Corporation (AMEX:INO), focused on the development of DNA vaccines for cancers and infectious diseases and a novel alternative to surgery to treat localized cancers, announced today the company delivered multiple presentations on preclinical study results and new device innovations relating to its electroporation-mediated DNA delivery technology at the 10th Annual Meeting of the American Society of Gene Therapy (ASGT). Inovio's DNA delivery systems are designed to enhance the potency of DNA-based immunotherapies and vaccines against infectious diseases and cancers.
Three presentations reported preclinical data regarding immune responses to DNA vaccines directed against major infectious diseases including malaria, HIV, and hepatitis C, respectively. In all cases, Inovio's electroporation technology was well tolerated and significantly enhanced both humoral (antibody) and cellular (T-cell) immune responses when compared with traditional vaccine delivery methods.
A study conducted in collaboration with the Naval Medical Research Center showed that electroporation-augmented immunization with a DNA vaccine against a malaria parasite-specific antigen not only enhanced humoral and cellular immune responses, but more importantly caused a significant reduction of parasite burden compared to non-immunized control animals.
A study conducted in partnership with Wyeth tested a multi-antigenic DNA vaccine against HIV. Using only one-fifth the dose used without electroporation, antibody responses were increased several hundred-fold by electroporation. The cellular immune response was enhanced 10 to 40-fold, translating into a 50 to 200-fold increase (8 weeks and 22 weeks, respectively) in vaccine potency.
A third study conducted in partnership with the Karolinska Institute, Sweden, supported the safety of electroporation in detailed experiments and demonstrated that the electroporation-enhanced immune responses to a hepatitis C DNA vaccine were capable of eliminating all liver cells that produced a model hepatitis C virus gene, simulating a potential cure of hepatitis C infection. Vaccination by methods not employing Inovio's technology were less or not effective.
Two other Inovio presentations reported electroporation device innovations including the Elgen 1000 system and a single-needle device. The Elgen 1000 system, which recently received CE marking, consists of an advanced pulse generator and a two-needle DNA injector that delivers the genes and electroporation pulses in a single step. The pulse generator allows flexible programming of pulse and injection parameters via a flash card operated personal computer, as well as comprehensive recording and storage of electroporation and patient data. The single needle device, in early development, allows injection of the DNA and electroporation with a single needle resembling a normal injection needle and applies pulses of lower voltage than those delivered by presently used devices, thus reducing the electrical sensation experienced by the patient.
"We are pleased with the performance of our DNA delivery technology in advanced preclinical studies. Together with our continuing innovations in electroporation devices, our technology may be able to make critical contributions to the development of novel, effective vaccines for the treatment or prevention of major life-threatening infectious diseases," said Dr. Avtar Dhillon, Inovio's president and CEO.
About Inovio's Immunotherapy Products
DNA-based immunotherapy products have the potential to by-pass inherent scientific obstacles of conventional vaccines that prevent their development for cancer and chronic infectious diseases such as HIV and hepatitis C. Pre-clinical data has indicated the potential ability of Inovio's technologies to safely and effectively deliver and significantly enhance the potency of such immunotherapies.
Inovio's DNA-based immunotherapy products consist of DNA plasmids and the Elgen and MedPulser DNA delivery systems. DNA plasmids are designed to express antigens that can induce an immune response specific to a cancer or infectious disease-causing organism. These plasmids are created synthetically and readily manufactured using well-established bacterial fermentation and purification technology. After a plasmid is delivered into muscle or tumor cells, production of the desired antigens may then induce a preventive or therapeutic immune response against the targeted disease. Inovio's advanced electroporation devices facilitate delivery and expression of these plasmid DNA-based immunotherapeutics and have been shown in primate studies and interim Phase I data to significantly enhance antibody and T-cell immune responses over plasmid DNA delivered by other methods, suggesting the potential to provide a better protective or therapeutic effect against complex infectious diseases as well as cancers.
Inovio is poised to deliver advanced DNA-based immunotherapies, devices and know-how in this rapidly advancing field. The company is actively licensing its technology to pharmaceutical and biotechnology companies and supporting early stage clinical studies arising from its own research efforts or through academic collaborations.
About Inovio Biomedical Corporation
Inovio Biomedical (AMEX:INO) is focused on developing multiple DNA-based immunotherapies and commercializing its Selective Electrochemical Tumor Ablation (SECTA) therapy. Inovio is a leader in developing human applications of electroporation, which uses brief, controlled electrical pulses to increase cellular uptake of a useful biopharmaceutical. In the case of DNA vaccines, Inovio's technology has shown it can significantly increase levels of gene expression and immune response. Inovio's immunotherapy partners include Merck, Wyeth, Vical, University of Southampton, Moffitt Cancer Center, and the U.S. Army, with four DNA-based immunotherapies in Phase I clinical studies. The SECTA therapy for locally treating solid tumors is designed to selectively kill cancerous cells and minimize cosmetic or functional detriments often caused by surgical removal of predominantly healthy tissue typically treated around a tumor. Inovio's technology is protected by an extensive patent portfolio covering in vivo electroporation. More information is available at www.inovio.com.
This press release contains certain forward-looking statements relating to our plans to develop our electroporation drug and gene delivery technology. Actual events or results may differ from our expectations as a result of a number of factors, including the uncertainties inherent in clinical trials and product development programs (including, but not limited to, the fact that pre-clinical results referenced in this release may not be indicative of results achievable from testing in humans and that results from one study may necessarily not be reflected or supported by the results of other similar studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of Inovio's technology as a delivery mechanism, the availability or potential availability of alternative therapies or treatments for the conditions targeted by Inovio or its collaborators , including alternatives that may be more efficacious or cost-effective than any therapy or treatment that Inovio and its collaborators hope to develop, evaluation of potential opportunities, issues involving patents and whether they or licenses to them will provide Inovio with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether Inovio can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2006, our 10-Q for the three months ending March 31, 2007, and other regulatory filings. There can be no assurance that any product in our product pipeline will be successfully developed or manufactured, or that final results of clinical studies will be supportive of regulatory approvals required to market licensed products.
Contact
Inovio Biomedical Corporation
Bernie Hertel (Investor Relations), 858-410-3101
or
Jeff Richardson (Media Relations), 805-491-8313
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Phase III Study Evaluating Gilead's Viread(R) for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint
http://biz.yahoo.com
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq:GILD - News) today announced that Study 102, a Phase III clinical trial evaluating the company's once-daily anti-HIV drug Viread® (tenofovir disoproxil fumarate or tenofovir DF) 300 mg as a potential treatment for chronic hepatitis B virus (HBV) infection, met its primary efficacy endpoint. The study shows that Viread is non-inferior to the company's once-daily antiviral drug Hepsera® (adefovir dipivoxil) among patients with HBeAg-negative/anti-HBe positive (presumed pre-core mutant) chronic HBV infection. The primary efficacy endpoint, the proportion of patients with a complete response at week 48, was defined by serum HBV DNA levels below 400 copies/mL and histologic improvement characterized by at least a two point reduction in the Knodell necroinflammatory score (a measure of necro-inflammation - an inflammatory process in the liver including or leading to death of liver cells) with no concurrent worsening of fibrosis (scarring of liver tissue).
At 48 weeks, 70.8 percent of patients in the Viread arm (n=250) had a complete response compared to 48.8 percent in the Hepsera arm (n=125; p less than 0.001). The most commonly observed treatment-emergent adverse events of moderate intensity or higher were abdominal pain, back pain, headache, respiratory infections, creatinine phosphokinase and transaminase elevations. The incidence of these events was comparable between the Viread and Hepsera arms of the study. In addition, the incidence of grade 3 or 4 laboratory abnormalities was comparable between the two arms. Full study results will be submitted for presentation at an upcoming scientific meeting.
"Chronic hepatitis B remains a serious disease that impacts more than one million people in the United States and an estimated 400 million people worldwide," said Franck Rousseau, MD, Vice President, Clinical Research, Gilead Sciences. "We believe Viread has the potential to be an important treatment option for patients with chronic hepatitis B and look forward to sharing detailed data from this study at a scientific conference later this year."
Study 102 is one of two Phase III pivotal studies evaluating the efficacy, safety and tolerability of Viread for the treatment of chronic hepatitis B. The second study (Study 103), a 48-week trial among patients with hepatitis B "e" antigen (HBeAg)-positive chronic hepatitis B, is expected to be complete later this year.
The active ingredient in Viread, tenofovir DF, is currently the most prescribed molecule in the United States for combination HIV therapy. Viread received approval as an anti-HIV medication from the U.S. Food and Drug Administration (FDA) in October 2001 and from the European Commission in February 2002. Viread is not approved as a treatment for chronic hepatitis B, and data from this analysis have not been reviewed by the FDA.
Study Design
Study 102 is a multi-center, randomized, double-blind Phase III clinical trial that compares the efficacy, safety and tolerability of Viread and Hepsera over 48-weeks among patients with HBeAg-negative/anti-HBe positive (presumed pre-core mutant) chronic hepatitis B. Three hundred and seventy-five patients were randomized in a 2:1 ratio to receive either tenofovir DF (300 mg once daily; n=250) or Hepsera (10 mg once daily; n=125).
About Viread (tenofovir disoproxil fumarate)
In the United States, Viread is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Viread should not be used in combination with the fixed-dose combination products Truvada® or Atripla(TM) because they already contain Viread.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals. Viread is not approved for the treatment of chronic hepatitis B and the safety and efficacy of Viread have not been established in patients coinfected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Viread. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are co-infected with HIV and HBV and discontinue Viread. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported in association with the use of Viread. It is recommended that creatinine clearance be calculated in all patients prior to initiating therapy with Viread and as clinically appropriate during therapy. Coadministration of Viread and didanosine should be undertaken with caution. Patients should be monitored closely for didanosine-associated adverse events, and didanosine should be discontinued if these occur. Patients on atazanavir and lopinavir/ritonavir plus Viread should be monitored for Viread-associated adverse events, and Viread should be discontinued if these occur. When co-administered with Viread, it is recommended that atazanavir 300 mg be given with ritonavir 100 mg. Atazanavir without ritonavir should not be co-administered with Viread.
Decreases in bone mineral density (BMD) at the lumbar spine and hip have been seen with the use of Viread. The effects of Viread-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk are unknown. Changes in body fat have been observed in patients taking anti-HIV medicines. The cause and long-term health effect of these changes are unknown. Immune Reconstitution Syndrome has been reported in patients treated with combination therapy, including Viread.
The most common adverse events among patients receiving Viread with other antiretroviral agents in a pivotal clinical study (Study 903) were mild to moderate gastrointestinal events and dizziness. Moderate to severe adverse events occurring in more than 5 percent of patients receiving Viread included rash (rash, pruritis, maculopapular rash, urticaria, vesiculobullous rash and pustular rash), headache, pain, diarrhea, depression, back pain, fever, nausea, abdominal pain, asthenia (weakness) and anxiety. In another pivotal study (Study 907), less than 1 percent of patients discontinued participation because of gastrointestinal events.
It is important for patients to be aware that anti-HIV medicines including Viread do not cure HIV infection or AIDS and do not reduce the risk of transmitting HIV to others. Full prescribing information is available at www.GileadHIV.com.
The parent compound of Viread was discovered through a collaborative research effort between Dr. Antonin Holy, Institute for Organic Chemistry and Biochemistry, Academy of Sciences of the Czech Republic (IOCB) in Prague and Dr. Erik DeClercq, Rega Institute for Medical Research, Katholic University in Leuven, Belgium.
About Hepsera
Hepsera, a nucleotide analogue for the treatment of chronic hepatitis B, works by inhibiting HBV DNA polymerase, an enzyme involved in the replication of the virus in the body.
In the United States, Hepsera is indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
The adverse reactions considered at least possibly related to treatment reported in 3 percent or greater of patients in the first 48 weeks in Hepsera pivotal clinical studies were asthenia, headache, abdominal pain, nausea, flatulence, diarrhea and dyspepsia. With extended treatment, mild to moderate increases in serum creatinine were observed uncommonly in patients with chronic hepatitis B and compensated liver disease treated with Hepsera for a median of 49 weeks up to a maximum of 240 weeks. Changes in serum creatinine were observed very commonly in patients pre- and post-transplantation with lamivudine-resistant liver disease and multiple risk factors for changes in renal function who were treated with Hepsera for up to 129 weeks, with a median time on treatment of 19 and 56 weeks, respectively. Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of treatment with antiviral therapies for hepatitis B, including Hepsera. Special warnings and precautions for use are included in the package insert regarding monitoring of renal function, post-treatment exacerbations of hepatitis, and the occurrence of lactic acidosis and severe hepatomegaly with steatosis. Dosing instructions for patients with underlying renal impairment and for patients co-infected with HIV are also provided in the package insert, which is available for download online at www.hepsera.com .
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia. For more information on Gilead Sciences, please visit the company's website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including risks related to Gilead's ability to successfully commercialize tenofovir DF for chronic hepatitis B. For example, the FDA may not approve tenofovir DF for the treatment of chronic hepatitis B in the United States, and marketing approval, if granted, may have significant limitations on its use. In addition, future discussions with the FDA may impact the amount of data needed and timelines for review, which may differ materially from Gilead's current projections. Further, safety and efficacy data from additional clinical studies may not warrant further development of this compound for the treatment of chronic hepatitis B and completing our clinical studies may take longer or cost more than expected. In addition, feedback from regulatory authorities or results from clinical trials might require modifications or delays in later stage clinical trials or additional trials to be performed. Further, other regulatory authorities may not approve tenofovir DF for the treatment of chronic hepatitis B, and marketing approval, if granted, may have significant limitations on its use and physicians and may not see advantages of tenofovir DF over other treatment options and may therefore be reluctant to prescribe tenofovir DF for chronic hepatitis B. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Annual Report on Form 10-K for the year ended December 31, 2006 and its Quarterly Report on Form 10-Q for the first quarter of 2007, filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
Hepsera and Viread are registered trademarks of Gilead Sciences, Inc.
For more information on Gilead, please call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235) or visit www.gilead.com .
Contact:
Gilead Sciences, Inc.
Susan Hubbard, 650-522-5715 (Investors)
Amy Flood, 650-522-5643 (Media)
Source: Gilead Sciences, Inc.
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June 7th, 2007
Human Genome Sciences Announces Positive Final Results Of Phase 2b Trial of Albuferon
http://www.pharmalive.com
- Albuferon 900-mcg dosed every two weeks achieved an SVR rate at least comparable to Pegasys dosed every week (ITT analysis), with more favorable quality-of-life scores -
ROCKVILLE, Md., June 07, 2007 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. today announced the top-line final results of a Phase 2b clinical trial of Albuferon(R) (albinterferon alfa-2b) in combination with ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C. The Company expects to make a full presentation of the final results at an appropriate scientific meeting later in 2007.
"The final Phase 2b results confirm and extend the findings of several studies, which suggest that Albuferon may offer efficacy at least comparable to peginterferon alfa-2a, with half the injections and possibly less impairment of quality of life," said John McHutchison, M.D., Coordinating Center Principal Investigator for the Phase 2b trial, and Professor of Medicine and Associate Director, Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina. "We are extremely pleased with the high quality of the data that have emerged from the Phase 2b study, and we look forward to continuing the evaluation of the 900-mcg and 1200-mcg doses of Albuferon in larger populations in Phase 3 trials."
The primary efficacy endpoint of the Phase 2b trial of Albuferon was sustained virologic response (SVR), defined as undetectable viral load (HCV RNA<10 IU/mL) at 24 weeks following completion of therapy. The final results demonstrated that Albuferon provided at least comparable efficacy vs. Pegasys (peginterferon alfa-2a), based on an ITT analysis. The treatment group receiving Albuferon 900-mcg doses every two weeks achieved an SVR rate of 58.5%, vs. 57.9% for the group receiving Pegasys once every week (ITT analysis). This Albuferon treatment group also had more favorable health- related quality-of-life scores than the Pegasys treatment group. Among heavier patients (>75 kg) who were treatment-adherent, 71.2% of those in the combined groups receiving Albuferon every two weeks achieved SVR, versus 53.3% for patients receiving Pegasys once a week. The ability to maintain efficacy in heavier patients is of particular importance in certain markets, including the United States, where a large percentage of patients weigh more than 75 kg.
Top-Line Final Results by Treatment Group
The top-line final results of the Phase 2b trial at Week 24 following the completion of therapy include the following SVR rates and other findings:
Albuferon 900-mcg Every Two Weeks (Albuferon 900 Q2w)
- Based on an intention-to-treat (ITT) analysis, 58.5% of patients in the Albuferon 900 Q2w treatment group achieved SVR, vs. 57.9% for Pegasys administered every week.
- In heavier patients (>75 kg) who were treatment-adherent, 74.2% of those in the Albuferon 900 Q2w treatment group achieved SVR, versus 53.3% for Pegasys.
- Among all treatment-adherent patients in the Albuferon 900 Q2w treatment group, 72.3% achieved SVR, versus 66.7% for Pegasys.
- Based on the SF-36 Health Survey, patients in the Albuferon 900 Q2w treatment group reported less impairment of health-related quality of life, compared with patients in the Pegasys treatment group, as measured by both physical component and mental component SF-36 summary measures at all time-points throughout the 48-week treatment period.
- Fewer working patients in the Albuferon 900 Q2w treatment group reported missing 7 days or more of work during the month prior to their visits at Weeks 12 and 24, vs. the Pegasys group (Week 12: 3.0% for Albuferon 900 Q2w vs. 19.2% for Pegasys; Week 24: 5.8% for Albuferon 900 Q2w, vs. 22.4% for Pegasys).
- The rate of discontinuations due to adverse events was 9.3% in the Albuferon 900 Q2w treatment group, vs. 6.1% in the Pegasys group.
"The 900-mcg Albuferon dose has the potential to offer patients an attractive therapeutic option, requiring half as many injections as Pegasys, with more favorable quality of life effects and favorable sustained virologic response data," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS.
Albuferon 1200-mcg Every Two Weeks (Albuferon 1200 Q2w)
- ITT analysis shows that 55.5% of patients in the Albuferon 1200 Q2w treatment group achieved SVR, vs. 57.9% for Pegasys administered every week.
- In heavier patients (>75 kg) who were treatment-adherent, 67.9% of those in the Albuferon 1200 Q2w treatment group achieved SVR, versus 53.3% for Pegasys every week.
- Among all treatment-adherent patients in the Albuferon 1200 Q2w treatment group, 70.6% achieved SVR, versus 66.7% for Pegasys.
- ITT analysis shows that the Albuferon 1200 Q2w treatment group exhibited a robust early antiviral response (reduction in hepatitis C RNA viral load to below the level of quantitation): 74.5% for Albuferon 1200 Q2w at Week 12, vs. 65.8% for Pegasys. The Albuferon 1200 Q2w treatment group also had the most rapid time to HCV RNA negativity.
- The rate of discontinuations due to adverse events was 18.2% in the Albuferon 1200 Q2w treatment group, vs. 6.1% in the Pegasys group. Adverse events observed were those typically expected with interferon therapy. Dose reductions were attempted in only 30.0% of Albuferon subjects prior to discontinuation, versus 42.9% for Pegasys.
"In the Albuferon Phase 3 trials, we will strongly encourage titration of dose where necessary to ensure tolerability, reduce the rate of discontinuations, and maximize the therapeutic benefit of the robust early antiviral response offered by the 1200-microgram dose on a two-week administration schedule," said Dr. Stump.
Albuferon 1200-mcg Monthly (Albuferon 1200 Q4w)
- ITT analysis shows that 50.9% of patients in the Albuferon 1200 Q4w treatment group achieved SVR, vs. 57.9% for Pegasys administered every week.
- In heavier patients (>75 kg) who were treatment-adherent, 61.0% of those in the Albuferon 1200 Q4w treatment group achieved SVR, versus 53.3% for Pegasys administered once every week.
- Among all treatment-adherent patients in the Albuferon 1200 Q4w treatment group, 62.0% achieved SVR, versus 66.7% for Pegasys.
- The rate of discontinuations due to adverse events was 12.1% in the Albuferon 1200 Q4w treatment group, vs. 6.1% in the Pegasys group.
- The number of patients experiencing severe hematologic adverse events was significantly lower in the Albuferon 1200 Q4w treatment group (10.3%, vs. 23.7% for Pegasys, p=0.006).
"We are encouraged that more than half of the patients achieved sustained virologic response in the treatment group receiving Albuferon 1200-mcg once every month," said Dr. Stump. "These data, along with emerging Phase 2 data for a monthly 1500-mcg dose, provide an excellent rationale for the study that we and our collaborator, Novartis, are currently planning to evaluate higher doses of Albuferon administered monthly."
The top-line final Phase 2b results include data through Week 24 following completion of 48 weeks of therapy. The open-label, multi-center, active- controlled, dose-ranging trial enrolled and randomized 458 patients with genotype 1 chronic hepatitis C. Patients were randomized into four treatment groups, three of which received subcutaneously administered Albuferon (900 mcg every two weeks, 1200 mcg every two weeks, and 1200 mcg every four weeks). The fourth treatment group served as the active control group and received 180 mcg of subcutaneously administered peginterferon alfa-2a (Pegasys) once a week. All patients received weight-based oral ribavirin daily. The study was conducted in Australia, Canada, Czech Republic, France, Germany, Israel, Poland and Romania.
About Albuferon
Albuferon is a novel long-acting form of interferon alpha created by HGS using its proprietary albumin fusion technology. Albuferon results from the genetic fusion of human albumin and interferon alpha. Human albumin is the most prevalent naturally occurring blood protein in the human circulatory system, persisting in circulation in the body for over twenty days. Research has shown that genetic fusion of therapeutic proteins to human albumin decreases clearance and prolongs the half-life of the proteins. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers.
Albuferon is being developed by HGS and Novartis under an exclusive worldwide development and commercialization agreement entered into in June 2006. Under the agreement, HGS and Novartis will co-commercialize Albuferon in the United States, and will share clinical development costs, U.S. commercialization costs and U.S. profits equally. Novartis will be responsible for commercialization in the rest of the world and will pay HGS a royalty on those sales. Clinical development, commercial milestone and other payments to HGS could total as much as $507.5 million, including $92.5 million received to date.
About Hepatitis C
Hepatitis C is an inflammation of the liver caused by the hepatitis C virus. It is estimated that as many as 170 million people worldwide are infected with hepatitis C virus. This includes nearly four million people in the United States. When detectable levels of the hepatitis C virus in the blood persist for at least six months, a person is diagnosed as having chronic hepatitis C. The hepatitis C virus can cause serious liver disease in a significant proportion of infected individuals, leading to cirrhosis, primary liver cancer, and even death.
About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.
The HGS clinical development pipeline includes novel drugs to treat hepatitis C, lupus, anthrax disease, cancer, rheumatoid arthritis and HIV/AIDS. The Company's primary focus is rapid progress toward the commercialization of its two lead compounds, Albuferon(R) for hepatitis C, and LymphoStat-B(R) for lupus. Phase 3 clinical trials of both compounds are now underway.
In June 2006, HGS announced that the U.S. Government exercised its option under an existing contract to purchase 20,000 doses of ABthrax(TM) for the treatment of anthrax disease. Other HGS drugs in clinical development include two TRAIL receptor antibodies for the treatment of hematopoietic and solid malignancies, in addition to an antibody to the CCR5 receptor for the treatment of HIV/AIDS.
For more information about HGS, please visit the Company's web site at www.hgsi.com. For more information about Albuferon, please visit http://www.hgsi.com/products/albuferon.html. Health professionals or patients interested in Albuferon clinical trials or other studies involving HGS products may inquire via the Contact Us section of the Company's web site, www.hgsi.com/products/request.html, or by calling us at (301) 610-5790, extension 3550.
HGS, Human Genome Sciences, ABthrax, Albuferon and LymphoStat-B are trademarks of Human Genome Sciences, Inc.
SafeHarbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences' current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company's unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company's ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with facilities and clinical trials, intense competition, the uncertainty of patent and intellectual property protection, the Company's dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the Company will continue to face risks related to animal and human testing, to the manufacture of ABthrax and to FDA concurrence that ABthrax meets the requirements of the ABthrax contract. If the Company is unable to meet the product requirements associated with the ABthrax contract, the U.S. Government will not be required to reimburse the Company for the costs incurred or to purchase any ABthrax doses. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
CONTACT: Jerry Parrott, Vice President, Corporate Communications,+1-301-315-2777, Kate de Santis, Director, Investor Relations,+1-301-251-6003, both of Human Genome Sciences, Inc.
Web site: http://www.hgsi.com/
Company News On-Call: http://www.prnewswire.com/comp/121115.html/
Ticker Symbol: (NASDAQ-NMS:HGSI)
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Clinical Trials Update: June 7, 2007
Hepatitis C; Chronic
For a listing of ongoing and new Clinical Trials for hepatitis C, Please see http://www.centerwatch.com/patient/studies
/cat670.html.
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Hepatitis C deserves the attention
http://seattlepi.nwsource.com
MICHAEL NINBURG
"We stand at the precipice of a grave threat to our public health ... it affects people from all walks of life, in every state, in every country. And unless we do something about it soon, it will kill more people than AIDS." Those words were spoken more than seven years ago by former Surgeon General C. Everett Koop and many people will be surprised to learn he was speaking about hepatitis C.
Here in Washington we are finally beginning to heed Koop's advice. Last week, coinciding with the end of Viral Hepatitis Awareness Month, the Washington State Department of Health convened its second statewide hepatitis C conference. Public health workers, advocates and medical professionals from around the state met in Seattle to discuss ways to better address this looming public health threat.
Hepatitis C is transmitted by blood-to-blood contact and is the most common blood-borne infection in the U.S. About 5 million Americans have been infected with the hepatitis C virus, or almost 2 percent of the population. Most of those with hepatitis C are unaware of their infection because they often remain asymptomatic for decades. And most of those people will also live normal, relatively healthy lives and die from causes unrelated to their hepatitis C. Unfortunately, about 20 percent to 30 percent eventually will develop cirrhosis of the liver and some of those will die from end-stage liver disease.
The good news is that much of the disease burden from hepatitis C is preventable. Early diagnosis allows people to take action that can slow disease progression. Avoiding alcohol and getting vaccinated against hepatitis A and B are two relatively simple actions that can improve medical outcomes.
Better news, though, is that for many people, hepatitis C is curable. In about half the people who undergo treatment for hepatitis C, the virus becomes undetectable. And the most recent research shows that for those who are treated successfully, the virus stays undetectable.
For people to be treated for hepatitis C, however, they have to be diagnosed. National prevalence data suggest that about 110,000 Washingtonians are living with hepatitis C. Of those, about 70,000 are unaware of their infection. Those people can transmit the virus to others unwittingly and unknowingly do things to exacerbate their own liver damage.
Our challenge is twofold: We must get those undiagnosed individuals tested and we must make sure that everyone with hepatitis C has access to proper medical care.
We are encouraged by recent developments in this state and in our nation's capital. This past session, the Washington Legislature appropriated $400,000 to the state Department of Health to begin implementation of our state Hepatitis C Strategic Plan, which includes testing, education and prevention efforts.
And two weeks ago, U.S. Sens. Ted Kennedy, D-Mass., and Kay Bailey Hutchison, R-Texas, re-introduced the Hepatitis C Epidemic Control and Prevention Act, a bill that mirrors much of what our state plan would do, but on a national level. A bipartisan companion bill was reintroduced in the House of Representatives.
Those developments and the heightened awareness among public health professionals and the general public give us hope that we are on the right path to finally giving hepatitis C the attention it deserves.
Michael Ninburg is executive director of the Hepatitis Education Project based in Seattle.
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Tim Harmon 5K Event is June 16
http://www.connectionnewspapers.com
By Bonnie Hobbs
Tim Harmon was just 51 when he died in 1999 as a result of hepatitis C. But he lives on in the memories of those who knew him and through the work he did in substance-abuse treatment.
HE'S ALSO honored via a race in his name, and this year's Eighth Annual Tim Harmon Memorial 5K Run/Walk is Saturday, June 16. It's at 8:30 a.m., rain or shine, at the Fairfax County Government Center.
Cost is $20, and participants may register at www.racepacket.com , even on race day. For more information, call 703-934-8756, e-mail peggy.cook@fairfaxcounty.gov or see www.timharmon5k.org.
"It's really become a race that people look forward to," said race director Tom Cook of Chantilly's Armfield Farms community. "We get lots of people who've done it six or seven years in a row."
A Sterling resident, Harmon worked 20 years for Fairfax County and was Director of Residential Services for Alcohol and Drug Services. He also founded a substance-abuse treatment program for teen-agers.
Because of his efforts, seven new residential treatment programs were opened. He also helped expand those at A New Beginning and Fairfax Detox in Chantilly, New Generations in Vienna, plus Crossroads and Sunrise House.
THE RACE is held to remember Harmon and to raise awareness of hepatitis C. Proceeds go to charities including the Hepatitis Foundation, the American Liver Foundation and local drug-treatment centers, including Sunrise in Fair Oaks.
And this year, a special contribution will also go to the family of MPO Vinnie DarConte, 47. The Sully District Station police officer died May 26 after a motorcycle/deer collision, leaving a wife and 12-year-old son.
Prizes in the 5K are awarded to the top three, male and female overall finishers, plus the top three finishers in 14 age groups in five-year increments. There are four race divisions: Runners/walkers, Fairfax County employees, baby joggers and public safety. Fire and police personnel will compete against each other for team and individual trophies.
The course is mostly flat and fast, beginning and ending in front of the Government Center and going out to West Ox Road and Monument Drive. Registered participants receive custom T-shirts designed by Kay Rankin. They're purple, yellow and white and feature the event's name and a winged running shoe.
Major sponsors include Sports Plus and Battlefield Screen, CASSADAY Inc. and the West Group. And more than 100 trophies, plaques and medals will be presented. Lots of doorprizes from local restaurants and merchants will be awarded, including gift certificates and coupons.
For example, the Blue Iguana is donating a dinner for two, and there's a $100 gift card from The Wharf restaurant in Old Town Alexandria, plus gift certificates from Potomac River Running.
Always a hit, the silent auction is chock full of sports memorabilia and signed collectibles, including a basketball autographed by the Washington Wizards team, a hockey puck signed by Washington Capitals' star Alexander Ovechkin, Washington Redskin Clinton Portis' autographed helmet and a football signed by Hall-of-Famer Bob Griese and his son Brian, now with the Chicago Bears.
"And unique this year, we've got an original script from the TV show, 'Las Vegas,'" said Cook. "It's signed by actors James Caan and Josh Duhamel."
ADDING TO THE FUN will be a live, classic-rock band, The Sock Monkeys, who will entertain before, during and after the race. And post-race refreshments such as bagels, juice and soda will be available.
"Last year, we raised $17,000 and had 650 participants," said Cook. "People like the party atmosphere, the band and the fact that we give out so many awards."
Literature in the race packets also helps educate people about hepatitis C. Harmon's disease was discovered through a routine blood test but, unfortunately, there's no vaccine for this silent killer.
And it has no symptoms, so people don't realize they have it until they're diagnosed. But by then, their livers may be irreparably damaged — and that's what happened to Harmon. (For more information, call 1-800-891-0707 or see www.hepfi.org).
Harmon's wife of 22 years, Becky, is a mental-health therapist in Sterling. Their daughters, Cara and Rachael, are now 25 and 20, respectively.
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June 8th, 2007
Hepatitis now overtakes AIDS
http://www.dailynews-tsn.com/
DAILY NEWS Reporter
HEPATITIS B, a fatal viral infection of the liver, has been found to have higher prevalence among blood donors than even the dreaded HIV/AIDS killer disease.
The Programme Manager of the National Blood Transfusion Service (NBTS), Blood Safety Programme, Dr Faustine Ndugulile, told media editors in Dar es Salaam yesterday that researchers at the Muhimbili National Hospital (MNH) were shocked to find that the disease had the highest infection rate among voluntary blood donors.
According to results of a research carried out from April 2004 to May 2005, Hepatitis B, which has a vaccine but no cure, was found to be present in nearly nine out of every 100 blood donors compared to only four in every 100 donors for HIV/AIDS.
Hepatitis C, a more virulent strain of the disease, was found in about two donors out of every 100. Syphilis, long considered no longer a major menace, was also seen resurfacing infecting nearly five donors out of every 100.
In early stages, syphilis can be treated using antibiotics. Many penicillin formulations are still a potent cure against the disease but some of its advanced stage complications and physical malformations may never be reversed.
More worrisome was that all the diseases were sexually transmitted, leading to fears that there was a lot of unsafe sex going on. Data was collected from five zonal centres of Dar es Salaam, Moshi, Mwanza, Mbeya and Zanzibar.
Previous blood screening had focused on detecting HIV/AIDS and syphilis but the results have awakened them to look at Transfusion Transmissible Infections (TTIs)in general and efforts would be made to send kits to hospitals.
Hepatitis B causes flu-like symptoms, stomach upset and pains, fever, loss of appetite and diarrhoea. The virus could hibernate in the human body for up to ten years before infection signs appeared.
World Blood Donor Day is marked every June 14 and celebrations this year are being held in Mtwara under the theme: 'Safe Blood for Safe Mothers.' Two blood screening centres would be inaugurated in the region and Tabora while another in Dodoma would be complete by the end of the year.
Eastern Zone Blood Transfusion Centre Manager, Dr Efesper Nkya said that 500,000 mothers died annually worldwide either during pregnancy or child birth. Over 99 per cent of the cases occurred in developing countries.
Dr Nkya said that 44 per cent of the deaths South of the Sahara were a result of excessive bleeding when giving birth. He added that 25 per cent of those deaths could be avoided with the availability of safe blood at the right time.
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Super-Size Mice—Fast Food Hurts Rodents
http://www.sciencenews.org
Janet Raloff
Three years ago, in a documentary that was equal parts witty and disturbing, Morgan Spurlock took viewers along on his month-long McDonald's binge. For 30 days, every food or beverage that entered his mouth came from the fast-food franchise. And every time a clerk asked if he wanted to super-size—bump up the size of the fries and drink in his order—he did. This gave rise to the feature's title: Super Size Me.
The film was intended to explore the economic and health ramifications of the nation's love affair with fast food. And Spurlock sandwiched in plenty of facts and mini-interviews with physicians, nutritionists, and economists between video segments of him biting into burgers, fries, and more.
However, the initially trim and healthy Spurlock paid a big personal price to make this riveting picture: He gained about a pound a day, and in just 3 weeks exhibited symptoms of fatty liver disease, a condition that can ultimately kill. At the start of the film, doctors had given Spurlock—and his liver—a clean bill of health.
Hyperbole?
Admittedly, most people don't subsist on a diet of fast food alone. However, much of the nation does partake of such sweet, high-salt, and high-fat fare on a regular basis. So, it's possible that Spurlock's self-experimentation just compressed into 1 month what many people experience gradually over the decades. At a minimum, Spurlock's film raised a host of troubling questions about the potential risks of fast food and its relationship to the nation's collective waistline—one that just keeps getting fatter and fatter.
In reviewing Super Size Me, Chicago Sun-Times movie critic Richard Roeper said: "Whether you're a fast-food junkie or a vegan, this movie provides a bounty of food for thought."
It certainly provided food for thought to Brent Tetri. Indeed, he told Science News Online, Spurlock's film—and apparent flirtation with diet-induced fatty-liver disease—"inspired" Tetri to investigate just how potent a liver poison fast-food meals might be.
Tetri, a gastroenterologist and liver specialist at St. Louis University, undertook a 16-week study of such diets in mice and, on May 22, unveiled his findings at Digestive Disease Week 2007, a research conference, in Washington, D.C.
Those data indicate that when offered the rodent equivalent of McDonald's fast food, mice fare at least as poorly as people do. Fat accumulations nearly doubled the size of the animals' livers. And within just 2 weeks of beginning their new diets, mice on the fast-food-like fare exhibited signs of incipient diabetes.
"It was a surprise to see how soon this developed—and very disturbing," Tetri says.
He emphasizes that all animals were free to eat or drink until sated, much as people do in real life. While mice getting a standard rodent diet stayed trim, those offered high-fat chow and a sweetened beverage voluntarily "over-ate to the point of getting sick."
Moreover, the pattern of fat accumulation in their livers was similar to what occurs in children with fatty liver disease. That, too, Tetri finds disturbing, since a study in Pediatrics last year pointed out that the incidence of this disease is quite high in youngsters—especially those who are obese (SN: 3/3/07, p. 136). And with U.S. children experiencing an obesity epidemic, the share of youngsters with potentially dangerous liver disease could be poised to skyrocket.
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