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Week Ending: November 24th , 2007
Alan Franciscus
Editor-in-Chief
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This Issue:
November 17th, 2007
Spitzer: State response 'unacceptably slow' in LI needle case
http://www.newsday.com/
NEW YORK - Gov. Eliot Spitzer said state officials took too long to notify the public that a Long Island doctor's needle technique may have spread hepatitis, calling the nearly three-year delay "deeply troubling."
Spitzer called Friday for an investigation into what he called the state Health Department's "unacceptably slow" response to the case, which predated his administration.
"The Department of Health has no more important objective than the safety of the public, and clearly its response was not what it should have been," the governor said. Meanwhile, State Senate Health Committee Chairman Kemp Hannon said he would hold hearings next month on the state's response in the case.
Health Department spokeswoman Claudia Hutton said, "The process should have moved faster, and there are issues we are going to address."
The agency became aware of the problem nearly three years before urging more than 600 of Dr. Harvey Finkelstein's patients last week to get tested for hepatitis and the HIV virus.
Health officials say Finkelstein sometimes would use a syringe multiple times on the same patient, possibly contaminating vials of medicines into which the syringes were reinserted. Other patients' medicines may later have been drawn from those vials.
Health officials say the practice infected at least two patients with hepatitis C, a potentially fatal liver disease. Finkelstein, an anesthesiologist who works at a Plainview pain management clinic, has said he stopped reusing syringes after health authorities noted the problem.
Finkelstein's license has remained in effect throughout. The 52-year-old physician said Friday that he had built a reputation as a dedicated caregiver during his more than 20 years in practice.
"I believe that throughout my medical career, I have been there for my patients and their families when they needed me," he said in a statement that also urged his patients to get the recommended tests.
The Health Department has said it took several years of negotiations before Finkelstein turned over his patient list. The agency can issue subpoenas but rarely does, Hutton said.
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November 19th, 2007
Regulus Therapeutics Announces Allowance of Key Patent on microRNA Therapeutics for the Treatment of Hepatitis C Virus Infection
http://www.ad-hoc-news.de/CorporateNews/en/
Regulus Therapeutics Announces Allowance of Key Patent on microRNA Therapeutics for the Treatment of Hepatitis C Virus InfectionCAMBRIDGE, Mass. & CARLSBAD, Calif.MA-REGULUS-THERAPEUTICS
Regulus Therapeutics, a joint venture between Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) and Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) formed to discover, develop, and commercialize microRNA therapeutics, announced today that the United States Patent and Trademark Office (USPTO) recently issued a “Notice of Allowance” for the “Sarnow” patent (U.S. patent application 11/122,328). The allowed claims cover methods for targeting a specific microRNA to inhibit Hepatitis C virus (HCV) replication. The Sarnow patent, a Stanford University patent to which Regulus has exclusive rights, relates to the discovery and development of therapeutic products for HCV infection by inhibiting a liver-specific microRNA known as miR-122. Regulus is developing a microRNA therapeutic targeting miR-122 for the treatment of HCV infection as its most advanced therapeutic program.
“The opportunity to selectively antagonize microRNAs involved in the cause or pathway of human disease represents an exciting new frontier for pharmaceutical research. The recent formation of Regulus unites the scientific leadership and intellectual property estates of both Isis and Alnylam to build what we believe is the leading microRNA therapeutics company, and this new U.S. patent allowance represents an early proof point of our value creation strategy,” said John Maraganore, Ph.D., Chairman of Regulus, and President and Chief Executive Officer of Alnylam. “HCV is a serious infectious disease representing a major public health concern affecting 170 million people worldwide. Most current and emerging anti-HCV therapies target viral genes and are therefore prone to the emergence of resistance. By targeting a host factor required for viral replication, a microRNA therapeutic targeting miR-122 is an attractive and differentiated approach for the possible treatment of HCV.”
“miR-122, one of over 500 microRNAs expressed in human cells, has been shown to be an important host factor for HCV replication and a promising target for microRNA-based therapeutics,” commented C. Frank Bennett, Ph.D., Senior Vice President of Research of Isis. “We are pleased to announce this patent allowance, as we feel that the Sarnow patent will provide Regulus with broad protection for its most advanced therapeutic program, which targets miR-122.”
Data published in 2005 by the Sarnow lab in the journal Science [Jopling et al. Science 309, 1577 (2005)] demonstrated that miR-122, which is specifically and abundantly expressed in the human liver, is required for HCV proliferation. In these studies, miR-122 was found to interact directly with a specific part of the HCV genome leading to increased expression of viral components. Sequestration of miR-122 using antisense oligonucleotides resulted in a dramatic inhibition of HCV reproduction in cultured human liver cells. This links the endogenous expression of a specific microRNA with a major infectious disease, and suggests that antagonism of miR-122 may comprise a novel therapeutic strategy against HCV.
Following a Notice of Allowance, the process resulting in final issuance of a patent involves several administrative steps that are typically completed within a year.
About microRNAs
microRNAs are a recently discovered class of genetically encoded small RNAs, approximately 20 nucleotides in length, and are believed to regulate the expression of a large number of human genes. microRNA therapeutics represent a new approach for the treatment of a broad range of human disease. When inappropriately encoded, microRNAs represent potential disease targets whose selective antagonism can result in the correction of an entire disease pathway in a manner unachievable by today’s medicines. In fact, the inappropriate absence or presence of specific microRNA molecules in various cells has been shown to be associated with specific human diseases including cancer, viral infection, and metabolic disorders.
About Regulus
Regulus Therapeutics LLC is a biopharmaceutical company formed to discover, develop and commercialize microRNA therapeutics. The company was created as a joint venture between Alnylam Pharmaceuticals, a leader in RNAi therapeutics, and Isis Pharmaceuticals, a leader in antisense technologies and therapeutics. Isis and Alnylam scientists and collaborators were the first to discover microRNA antagonist strategies that work in vivo in animal studies (Krutzfeldt et al. Nature 438, 685-689 (2005); Esau et al. Cell Metab., 3, 87-98 (2006)). Isis and Alnylam have also created and consolidated key intellectual property believed by the companies to be required for development and commercialization of microRNA therapeutics. The company, founded in 2007, maintains facilities in Carlsbad, California. For more information, visit www.regulusrx.com.
About Alnylam Pharmaceuticals
Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi. The company is applying its therapeutic expertise in RNAi to address significant medical needs, many of which cannot effectively be addressed with small molecules or antibodies, the current major classes of drugs. Alnylam is leading the translation of RNAi as a new class of innovative medicines with peer-reviewed research efforts published in the world’s top scientific journals including Nature, Nature Medicine, and Cell. The company is leveraging these capabilities to build a broad pipeline of RNAi therapeutics; its most advanced program is in Phase II human clinical trials for the treatment of respiratory syncytial virus (RSV) infection. In addition, the company is developing RNAi therapeutics for the treatment of influenza, hypercholesterolemia, and liver cancers, among other diseases. The company’s leadership position in fundamental patents, technology, and know-how relating to RNAi has enabled it to form major alliances with leading companies including Medtronic, Novartis, Biogen Idec, and Roche. The company, founded in 2002, maintains headquarters in Cambridge, Massachusetts. For more information, visit www.alnylam.com.
About Isis Pharmaceuticals
Isis is exploiting its expertise in RNA to discover and develop novel drugs for its product pipeline and for its partners. The Company has successfully commercialized the world’s first antisense drug and has 18 drugs in development. Isis’ drug development programs are focused on treating cardiovascular and metabolic diseases. Isis’ partners are developing drugs for a wide variety of diseases. Ibis Biosciences, Inc., Isis’ wholly owned subsidiary, is developing and commercializing the Ibis T5000 Biosensor System, a revolutionary system to identify infectious organisms. Isis is a joint owner of Regulus Therapeutics LLC, a joint venture focused on the discovery, development and commercialization of microRNA therapeutics. As an innovator in RNA-based drug discovery and development, Isis is the owner or exclusive licensee of over 1,500 issued patents worldwide. Additional information about Isis is available at www.isispharm.com.
Alnylam Forward-Looking Statements
Various statements in this release concerning Alnylam’s Future expectations, plans and prospects, including statements concerning the potential of microRNA therapeutics and the importance of Alnylam’s intellectual property, know-how, and other technology in the discovery, development and commercialization of microRNA therapeutics, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: Alnylam’s approach to discover and develop novel drugs, which is unproven and may never lead to marketable products; obtaining, maintaining and protecting intellectual property; Alnylam’s ability to enforce its patents against infringers and to defend its patent Portfolio against challenges from third parties; Alnylam’s ability to obtain additional funding to support its business activities; Alnylam’s dependence on third parties for development, manufacture, marketing, sales and distribution of products; obtaining regulatory approval for products; competition from others using technology similar to Alnylam’s and others developing products for similar uses; Alnylam’s dependence on collaborators; and Alnylam’s Short operating history; as well as those risks more fully discussed in the ‘Risk Factors’ section of its most recent quarterly report on Form 10-Q on file with the Securities and Exchange Commission. In addition, any forward-looking statements represent Alnylam’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam does not assume any obligation to update any forward-looking statements.
Isis Forward Looking Statements
This press release includes forward-looking statements regarding the future therapeutic and commercial potential of Isis’ technologies and intellectual property related to microRNA therapeutics being discovered and developed by Regulus. Any statement describing Isis’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement, including those statements that are described as Isis’ goals. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such products. Isis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Isis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Isis’ programs are described in additional detail in Isis’ annual report on Form 10-K for the year ended December 31, 2006, and its quarterly report on Form 10-Q for the quarter ended September 30, 2007, which are on file with the SEC. Copies of these and other documents are available from the Company.
Isis Pharmaceuticals is a registered trademark of Isis Pharmaceuticals, Inc. Ibis Biosciences and Ibis T5000 are trademarks of Ibis Biosciences, Inc. Regulus Therapeutics is a trademark of Regulus Therapeutics LLC.
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Inhibitex Obtains License To HCV Polymerase Inhibitors
http://biz.yahoo.com
Potent Nucleoside Analogues Augment Company's Hepatitis C Program
ATLANTA--(BUSINESS WIRE)--Inhibitex, Inc. (Nasdaq: INHX - News) announced today that it has entered into an exclusive worldwide license agreement with Cardiff University in Wales, United Kingdom and Katholieke Universiteit in Leuven, Belgium for intellectual property covering a series of highly potent hepatitis C virus (HCV) polymerase inhibitors in exchange for an upfront license fee, future milestone payments and royalties on future net sales. Additional financial details of the transaction were not disclosed.
The licensed compounds include a series of nucleoside analogs that inhibit NS5b, an RNA-dependent RNA polymerase that is a critical enzyme in the lifecycle of HCV. In vitro studies using a HCV genotype 1b subgenomic replicon system demonstrate that these nucleoside analogues are among the most potent HCV polymerase inhibitors in development. The compounds were discovered in the laboratories of Professor Chris McGuigan, Chairman of Departmental Research Committee and Director of Research, Head of Medicinal Chemistry at Cardiff University and Professor Johan Neyts of the Laboratory of Virology and Chemotherapy of the Rega Institute for Medical Research of the Katholieke Universiteit, Leuven.
“The addition of these highly potent nucleoside polymerase inhibitors complement those we recently in-licensed from the University of Georgia and fully establishes a HCV program at Inhibitex,” stated Dr. Joseph M. Patti, Chief Scientific Officer. “Further, this exclusive license expands our collaborative relationships with two leaders in the field of antiviral research, Cardiff University and the Rega Institute. We are very pleased with the addition of these compounds to our pipeline, which includes a number of promising infectious disease development programs with the potential to provide meaningful benefits to large patient populations.”
About Hepatitis C
Hepatitis C is a chronic liver disease caused by infection with hepatitis C virus (HCV), which is transmitted primarily through blood or blood products. According to the World Health Organization, approximately 170 million people worldwide are infected with HCV, four million of which are in the United States. HCV is a leading cause of cirrhosis, liver cancer and liver failure.
About Inhibitex
Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company focused on the development of products that can treat, prevent or diagnose serious infections. In addition to its emerging antiviral pipeline that includes FV-100 to treat shingles (herpes zoster), HIV integrase inhibitors, HCV polymerase inhibitors and nucleoside analogues with antiviral activity against cytomegalovirus (CMV), the Company has several programs and collaborations based upon its proprietary MSCRAMM® protein platform. These include Aurexis®, a humanized monoclonal antibody being developed for the treatment, in combination with antibiotics, of serious Staphylococcus aureus bloodstream infections, including those caused by MRSA, as well as license agreements with Wyeth for the development of staphylococcal vaccines and 3M for the development of diagnostic products.
For additional information about Inhibitex, please visit www.inhibitex.com.
SafeHarbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts included in this press release, including statements regarding the potential for programs in the Company’s pipeline to provide benefits to large patient populations, are forward-looking statements. These plans, intentions, expectations or estimates may not actually be achieved and various important factors could cause actual results or events to differ materially from the forward-looking statements that the Company makes, including risks related to the continued successful development and the results of future studies of the Company’s development programs; expanding, maintaining and protecting the intellectual property incorporated into and supporting the Company’s development programs and other cautionary statements contained elsewhere herein and in its Annual Report on Form 10-K for the year ended December 31, 2006, as filed with the Securities and Exchange Commission, or SEC, on March 16, 2007, and its Quarterly Report on Form 10-Q for March 31, 2007, as filed with the SEC on May 10, 2007, for June 30, 2007 as filed on August 9, 2007, and for September 30, 2007 as filed on November 9, 2007. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release.
There may be events in the future that the Company is unable to predict accurately, or over which it has no control. The Company's business, financial condition, results of operations, and prospects may change. The Company may not update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the Federal securities laws to update and disclose material developments related to previously disclosed information. The Company qualifies all of the information contained in this press release, and particularly its forward-looking statements, by these cautionary statements.
Inhibitex®, MSCRAMM® and Aurexis® are registered trademarks of Inhibitex, Inc.
Contact:
Inhibitex, Inc.
Russell H. Plumb
Chief Executive Officer
678-746-1136
rplumb@inhibitex.com
or
Stern Investor Relations, Inc.
Laura Perry (Investors)
212-362-1200
laura@sternir.com
Source: Inhibitex, Inc.
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Feds To Investigate Illinois HIV-Organ Transplant Case
http://www.turks.us
Federal officials are investigating what three hospitals knew and told four organ transplant patients about a high-risk donor who infected them with HIV and hepatitis.
The investigation's new phase involves the federal Centers for Medicare and Medicaid Services, which oversees organ procurement programs and hospitals nationwide. The case disclosed this week is the first known instance of HIV transmission through organ transplants since 1986, and the first time HIV and hepatitis have been spread simultaneously from one donor to transplant recipients, public health officials say.
While Medicare officials generally contract with local authorities to investigate hospitals, this time the agency has sent officials to Chicago to assist investigators from Illinois' Department of Public Health, said Jan Tarantino, director of the agency's division of continuing care providers.
"We're taking some extra steps ... because this is potentially a very serious situation," she said Thursday. Hospital and public health officials have called the case a tragedy, but emphasize that the risk of getting any disease from transplanted organs is less than 0.01 percent.
Tarantino said officials from her agency last week visited the Elmhurst group that procured the organs, Gift of Hope Organ & Tissue Donor Network. This week they started questioning authorities at the three hospitals, Northwestern Memorial Hospital, Rush University Medical Center and the University of Chicago Medical Center.
"We're looking at the circumstances surrounding the donor and the four recipients and checking to make sure that all the notifications" took place, Tarantino said. None of the hospitals has said publicly what patients were told, citing doctor-patient confidentiality. They also have declined to identify the donor, the patients and what organs they received, citing privacy concerns.
Vanessa Arellano Doctor
http://www.turks.us
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Nexavar First FDA-Approved Drug Therapy for Liver Cancer
http://www.therapeuticsdaily.com
Only Systemic Therapy Proven to Significantly Improve Overall Survival in Patients with Liver Cancer
WAYNE, N.J. and EMERYVILLE, Calif., November 19, 2007 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for Nexavar(R) (sorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC), or liver cancer. Nexavar, an oral anticancer drug, is the first approved systemic therapy for liver cancer and the only one shown to significantly improve overall survival in patients with the disease. In 2005 Nexavar became the first new treatment in more than a decade for advanced kidney cancer, and is currently approved in more than 60 countries for this indication.
"The approval of Nexavar in liver cancer marks the second time in two years that this novel kinase inhibitor has been granted FDA approval on a Priority Review basis, making it rapidly available to patients who previously had limited treatment options," said Arthur Higgins, chairman of the Executive Committee of Bayer HealthCare. "This milestone will likely establish Nexavar as the standard systemic therapy for the treatment of liver cancer, and is a turning point in improving treatment outcomes in patients facing the devastating impact of this disease."
"Liver cancer is one of the cancers in which the number of related deaths continues to increase," said Hollings C. Renton, chairman, president and chief executive officer of Onyx Pharmaceuticals, Inc. "This second approval for Nexavar demonstrates our commitment to expediting the clinical development of this innovative therapy to treat today's unmet needs in cancer. We are grateful to the patients, families and investigators who make this important research possible."
HCC, the most common form of liver cancer, is responsible for about 90 percent of the primary malignant liver tumors in adults.(1,2) Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally.(3) More than 600,000 cases of liver cancer are diagnosed worldwide each year(3) (about 19,000 in the United States,(4) 54,000(5) in Europe,(6) and 390,000 in China, Korea and Japan(6)) and incidence is increasing.(7) In 2002 approximately 600,000 people died of liver cancer including 13,000 in the United States, 57,000(5) in Europe and approximately 360,000 in China, Korea and Japan.(6) Currently, the 5-year survival rate for liver cancer patients in the United States is 11 percent.(8)
"The American Liver Foundation (ALF) is always pleased when new therapies prove effective for those affected by liver disease. Researchers worldwide, including those supported by ALF, have spent decades studying liver cancer," said James L. Boyer, M.D., chairman, board of directors, American Liver Foundation. "This new treatment provides a valuable option for liver cancer patients and will enable ALF to further promote the treatment of liver disease through our education and advocacy efforts."
The companies also announced that an innovative patient support program - Resources for Expert Assistance and Care Helpline (REACH(R)) - is available to answer questions about Nexavar treatment, reimbursement, and patient support. For more information, healthcare providers and patients may contact the REACH program at 1.866.NEXAVAR (1.866.639.2827).
Phase 3 Data Summary
The FDA approval was based on positive data from the international Phase 3 placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial which demonstrated that Nexavar improved overall survival by 44 percent in patients with HCC (HR=0.69; p=0.0006) versus placebo. In the study, median overall survival was 10.7 months in Nexavar-treated patients compared to 7.9 months in those taking placebo. No indication of imbalances was observed in serious adverse events between the Nexavar and placebo-treated groups with the most commonly observed adverse events in patients receiving Nexavar being diarrhea and hand-foot skin reaction. Based on these data, the European Commission granted marketing authorization to Nexavar for the treatment of patients with hepatocellular carcinoma on October 29, 2007.
Nexavar's Differentiated Mechanism
Nexavar targets both the tumor cell and tumor vasculature. 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 Raf/MEK/ERK has a role in HCC; therefore, blocking signaling through Raf-1 may offer therapeutic benefits in HCC.
Important Safety Considerations for U.S. Patients Taking Nexavar
Based on the currently approved package insert for the treatment of patients with unresectable hepatocellular carcinoma, 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. Bleeding with a fatal outcome from any site was reported in 2.4% for Nexavar vs. 4% in placebo. The incidence of treatment-emergent cardiac ischemia/infarction was 2.7% for Nexavar vs. 1.3% for placebo. Most common adverse events reported with Nexavar in patients with unresectable HCC were diarrhea, fatigue, weight loss, anorexia, nausea and hand-foot skin reaction. Grade 3/4 adverse events were 45% for Nexavar vs. 32% 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 information about Nexavar including 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(R), a small molecule drug, with Bayer HealthCare Pharmaceuticals Inc. Nexavar is approved for the treatment of advanced kidney cancer in more than 60 countries. For more information about Onyx's pipeline and activities, visit the company's web site at: www.onyx-pharm.com.
About Bayer HealthCare Pharmaceuticals Inc.
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 U.S., 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.
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 our annual and interim reports filed with the Frankfurt Stock Exchange. The company 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, 2006, 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(R) (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals Inc.
References
(1) World Health Organization. Hepatitis B. Available at:
http://www.who.int/csr/disease/hepatitis
/whocdscsrlyo20022/en/. Accessed April 10, 2007
(2) 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.
(3) International Agency for Cancer Research. GLOBOCAN 2002. Available at:
http://www-dep.iarc.fr. Accessed April 23, 2007.
(4) Jemal A et al. CA Cancer J Clin. 2007;57:43-66.
(5) The reported mortality of HCC in Europe is higher than the incidence of HCC in Europe. This is due to the overestimation of mortality by occasional counting of metastatic cancers that have spread to the liver, and underestimation of incidence as a result of a lack of technology for early detection and diagnosis of HCC. Source: International Agency for Research on Cancer.
(6) 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.
(7) 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.
(8) American Cancer Society. Cancer Facts & Figures 2007. Atlanta: American Cancer Society: 2007.
CONTACT: Mark Bennett, Bayer HealthCare Pharmaceuticals, +1-203-314-5556;Julie Wood, Onyx Pharmaceuticals, Inc., +1-510-597-6505; Catey Laube, GCIGroup, +1-212-537-8247; or Hala Mirza, WeissComm Partners, +1-212-301-7205
Web site: http://www.nexavar.com http://www.onyx-pharm.com/
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Pharmexa Provides Update on the HeptoVax Trial of GV1001 In Liver Cancer
http://www.therapeuticsdaily.com
Summary: Pharmexa updates on preliminary results of the HeptoVax trial after the first 21 patients. Final data is still expected before the end of the second quarter of 2008.
HORSOLM, Denmark, Nov. 19, 2007-As stipulated in the clinical trial protocol, the clinical investigators and Pharmexa reviewed the interim safety and efficacy data from the first 21 patients enrolled in the HeptoVax trial, an uncontrolled Phase II trial in which GV1001 (a telomerase peptide vaccine administered with GM-CSF) was given to patients suffering from advanced hepatocellular carcinoma (HCC or liver cancer). As previously announced, Pharmexa provides an update of the trial at this point in time.
Enrollment of patients to the trial, which takes place in three centers in Spain, France and Germany, has been completed. Currently, 14 patients are still on treatment with GV1001. According to plan, the final trial results will include an analysis of safety, immunogenicity, tumor response, time-to-progression and survival of all 40 patients enrolled. As planned, these data are expected to be available before the end of the second quarter of 2008.
In the first 21 patients, all 6 vaccine doses were well tolerated and no vaccine-attributable serious adverse effects were observed. No measurable tumor responses were observed in the first 21 patients. Important T-cell immune response data and overall survival data are not yet available. The observed lack of an objective tumor response as measured by CT scans in this small cohort of patients with advanced liver cancer was not surprising and does not exclude that patients will experience other treatment benefits. For example, a recently concluded placebo-controlled controlled Phase III trial of the new cancer drug sorafenib (Nexavar®) demonstrated partial tumor responses in only 7 out of 299 treated patients (2.3%), but still gave significant improvements in time-to-progression and survival.
Achim Kaufhold, Pharmexa's CSO and CMO says: "The HeptoVax trial is progressing according to plan and will deliver conclusive results within the time frame we originally announced. We are looking forward to the in-depth analysis of the final data set concerning, safety, immunogenicity, objective tumor responses, time-to-progression and survival, which will determine whether or not we proceed to further development in this particular indication."
HeptoVax trial design outline In the open, uncontrolled trial, 40 patients with advanced stage liver cancer will receive a single pre-treatment dose of the chemotherapeutic drug cyclophosphamide three days prior to the start of immunotherapy, followed by doses of GV1001 plus GM-CSF three times in the first week, and once weekly in week 2, 3, 4 and 6. Thereafter, GV1001 plus GM-CSF will be given once a month. All patients will be treated for a minimum of 6 months unless they show symptomatic progression, in which case patients will be discontinued from the trial.
The primary outcome variable of the trial is to assess tumor efficacy, measured by objective tumor response. Other endpoints include the safety and immunogenecity of the vaccine. Approximately half of the patients with advance stage liver cancer are expected to die within a year, hence other efficacy parameters such as time-to-progression and overall survival will also be measured.
Liver cancer represents a large unmet need Hepatocellular carcinoma is the fifth most common cancer in the world. More than 600,000 new cases of HCC occur worldwide each year with almost as many deaths. In Europe alone, more than 50,000 new cases occur each year. The incidence of HCC, however, varies greatly between different countries and regions, and HCC occurs significantly more often in Japan than in Europe. Moreover, accumulating evidence indicates that the incidence of liver cancer is rising. HCC is twice as common in men as in women and has a strong association with hepatitis B and hepatitis C infection as well as with cirrhosis.
The GV1001 vaccine GV1001 is a so called peptide vaccine that activates the patients' immune system - primarily the T-cells - to recognize and kill cancer cells. GV1001 differs from most other peptide vaccines by containing epitopes that can stimulate both the immune system's T-helper cells, which coordinate the immune response and killer T-cells which selectively attack cancer cells. GV1001 is targeted towards an enzyme called telomerase. Telomerase is rarely found in normal cells, but is overexpressed in most cancer cells, which makes telomerase a good target for a cancer vaccine. In addition, telomerase activity is a key factor in the process wherein cancer cells lose their normal mortality, which is a common feature for all cancers. GV1001 therefore has the potential to be a universal cancer vaccine and Pharmexa's broad development strategy for GV1001 reflects this. More details can be found on Pharmexa's homepage.
Hørsholm, November 19, 2007
Jakob Schmidt Chief Executive Officer
Additional information: Jakob Schmidt, Chief Executive Officer, telephone +45 4516 2525 Claude Mikkelsen, Vice President, Corporate Affairs and Communication, telephone +45 4516 2525 or +45 4060 2558
Note to editors: Pharmexa A/S is a leading company in the field of active immunotherapy and vaccines for the treatment of cancer, serious chronic and infectious diseases. Pharmexa's proprietary technology platforms are broadly applicable, allowing the company to address critical targets in cancer and chronic diseases, as well as serious infectious diseases such as HIV, influenza, hepatitis and malaria. Its leading programs are GV1001, a peptide vaccine that has entered phase III trials in pancreatic cancer and phase II trials in liver cancer, and HIV and hepatitis vaccines in phase I/II. Collaborative agreements include H. Lundbeck, Innogenetics, IDM Pharma and Bavarian Nordic. With operations in Denmark, Norway and USA, Pharmexa employs approximately 105 people and is listed on the Copenhagen Stock Exchange under the trading symbol PHARMX.
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November 20th, 2007
Call for wider vaccination as hepatitis B cases nearly double in UK
http://www.guardian.co.uk
Sarah Boseley, health editor The Guardian
The number of people with chronic hepatitis B infection in the UK has nearly doubled in the past five years, leading to calls for widespread vaccination programmes.
A report today from the Hepatitis B Foundation says the sharp increase, to 320,000 cases from 180,000 at the last Department of Health estimate in 2002, is linked to increasing migration. Traditionally, hepatitis B levels have been low in the UK, but rising numbers of people are coming to live here from countries where it is endemic.
The virus - more infectious than HIV or hepatitis C - can cause death from cirrhosis of the liver or liver cancer. It passes from mother to child and can be transmitted from one child to another through cuts and grazes in the playground.
However, government policy is to immunise only at-risk groups - such as injecting drug users, prisoners and those who attend clinics for sexually transmitted infections - in spite of 1991 World Health Organisation recommendations to introduce universal vaccination.
"There is a serious risk that in the future, while chronic HBV infection declines in countries which have implemented universal vaccination, the UK, that great pioneer of public health, will continue to harbour an ever-increasing pool of chronic HBV infection," says the report, which is backed by a group dominated by influential doctors including Arie Zuckerman, emeritus professor of medical microbiology at University College London.
The report shows there are high infection levels among people from Africa (where prevalence reaches 14.3% in Nigeria) and Asia (8.65% in China). Levels are also higher elsewhere in Europe (1.5% in Poland and 2.45% in Italy).
"I think inevitably we will end up with universal vaccination at some stage in this country," said Dr David Mutimer, a foundation trustee and consultant hepatologist at Queen Elizabeth hospital, Birmingham. At the moment, hepatitis B is concentrated in Britain's minority ethnic communities in big cities, who are not the population vaccination is aimed at. "Hepatitis B will inevitably spill over ino the indigenous community," said Mutimer.
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Patient Of Accused LI Doctor Tests Positive For Hepatitis B
http://www.wnbc.com/
NEW YORK -- Long Island health officials report a positive test for hepatitis among the patients of a physician whose needle technique put hundreds of people at risk.
Officials said they will not know if the patient contracted hepatitis B in the doctor's office for several weeks.
Nassau County Health Department spokeswoman Cynthia Brown says the patient would be retested.
Authorities have also widened their probe to include more of Dr. Harvey Finkelstein's patients.
The physician has defended his reputation as a dedicated caregiver during his more than 20 years in practice.
Health officials became aware of the problem nearly three years before urging more than 600 of Finkelstein's patients to get tested for hepatitis and the HIV virus.
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Change in Liver Transplant Criteria Reduced Waiting List Deaths
http://www.medpagetoday.com
By Peggy Peck, Executive Editor, MedPage Today
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine.
NASHVILLE, Tenn., Nov. 19 -- Allocating donor livers based on disease severity rather than time on a waiting list shortened time to transplant and decreased waiting list mortality, researchers here reported.
And the immediate impact of the change in United Network for Organ Sharing (UNOS) policy was an increase in waiting-list mortality from about 11 deaths per 1,000 registrants per month to 13 (95% CI: 1.1 to 3.4, P=0.001), they wrote.
But that brief spike "was followed by a modest post-intervention decline by 0.09 deaths per 1,000 registrants per month," they wrote, which was, however, significant (95% CI: -0.16 to -0.03, P<0.001).
The most likely explanation for the initial increase in mortality, the authors said, was the repopulation of the list that occurred when UNOS changed its rules in February 2002. Before that time, they said, less ill patients were placed on the waiting list in order to "bank time," since waiting time was a key criteria for allocation of donor livers.
When UNOS implemented the MELD-based system, patients "banking time" were bumped and the list was repopulated with more seriously ill patients, as well as patients with early-stage hepatocellular carcinoma (who often had well-compensated liver disease, but received a priority MELD score in order to prevent disease progression).
Implementation of MELD also had the immediate effect of decreasing waiting time by more than a month (from approximately 294 days to 250 days; -44.4 days, 95% CI: -77.1 to -11.7, P<0.001).
The findings emerged from an analysis of UNOS waiting list time and mortality from March 1, 1999 through July 30, 2004, using the date of MELD implementation as a nominal inception point -- data from 60,392 registrants.
In addition to waiting list time and mortality before and after the criteria change, the authors assessed changes in registration pre- and post-implementation.
They found that using MELD as the criteria had no difference in registration, nor was it associated with three- or six-month post-transplantation survival, but the analysis did review marked seasonal variation in list registration, "with peaks in the summer and troughs in the winter."
The authors noted a number of limitations including the ecologic study design, which they wrote was "best served when an outcome is caused by a single factor," whereas the UNOS policy change was "one of many possible variables that may affect waiting list mortality."
Another limitation was selection bias, which may have occurred because the implementation of MELD changed the waiting list population, making it possible that "the reduction in waiting list mortality is diluted by the differential listing of new candidates."
In an invited critique that accompanied the study, Benjamin Philosophe, M.D., Ph.D., and Stephen T. Bartlett, M.D., of the University of Maryland, noted that the increase in hepatocellular carcinoma patients -- from 5.8% of liver transplant patients in 1999 to 14.1% in 2004, may skew the outcome data because those patients "typically have lower calculated MELD scores and hence better outcomes."
Drs. Philosophe and Bartlett conclude that the impact of MELD on survival "remains a controversial subject, and the better outcomes in patients with hepatocellular carcinoma may be balanced by reported negative correlations with higher MELD scores, especially in patients with hepatitis C virus."
The study was supported by the Health Resources and Services Administration. Drs. Pinson, Philosophe, and Bartlett reported that they had no disclosures.
Primary source:
Austin MT, et al "Model for End-stage Liver Disease: Did the New Liver Allocation Policy Affect Waiting List Mortality?" Arch Surg 2007; 142: 1079-1085.
Additional source:
Philosophe B, Bartlett ST, "Model for End-stage Liver Disease: Did the New Liver Allocation Policy Affect Waiting List Mortality? -- Invited Critique" Arch Surg 2007; 142: 1086.
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Medivir: Initiation of a Phase IIa Clinical Trial with Investigational Hepatitis C Protease Inhibitor TMC435350
http://biz.yahoo.com
STOCKHOLM, Sweden--(BUSINESS WIRE)--Regulatory News: Medivir (STO:MVIRB) announced today that, following the successful completion of a phase I study in both healthy volunteers and patients chronically infected with hepatitis C virus (HCV), the phase IIa study, TMC435350-C201, of the investigational hepatitis C (HCV) protease inhibitor TMC435350. The study will start shortly in Europe by Tibotec Pharmaceuticals Ltd., who are collaborating with Medivir on the development of TMC435350.
TMC435350-C201 is a phase IIa proof-of-concept, blinded, randomized, placebo-controlled trial to assess the effectiveness, safety, tolerability, and pharmacokinetics of four different dose regimens of TMC435350 (25 mg daily, 75mg daily, 200mg daily, 400mg daily). 96 treatment-naïve and 24 treatment-experienced patients with chronic genotype-1 HCV infection will be enrolled in the trial which will be conducted at more than 20 sites in Europe. Patients will receive either TMC435350 or placebo once daily (qd) for 28-days. Standard of Care (SoC) treatment, peginterferon alpha-2a (Pegasys®) and ribavirin (Copegus®), will be provided for 48 weeks or, optionally, for 24 weeks for those patients with an undetectable HCV viral load at Week 4 and who remain undetectable at Week 20. Patients will be followed-up for 24 weeks after the end of SoC to allow evaluation of sustained virologic response (SVR).
In the phase I study TMC435350 was administrated at 200 mg qd for five days to patients chronically infected with genotype-1 hepatitis C virus (HCV). The viral load reductions met the target set for the trial. These results will be submitted for presentation at the Annual Meeting of the European Association for the Study of the Liver in Milan in April 2008
The earlier phase I study results were reported at the AASLD Liver Meeting in Boston, November 2-6 2007. They showed that in this study TMC435350 was generally well-tolerated when given to HCV-negative healthy volunteers at single oral doses up to 600 mg, and at 5 days of oral doses up to 400 mg. The plasma levels of TMC435350 24 hours after day 5 dosing at 200 mg qd were more than 250-fold in excess of the HCV replicon EC50 value.
For more information about the phase IIa study, visit www.clinicaltrials.gov
For further information on Medivir, please see our website: www.medivir.se
This information was brought to you by Cision http://newsroom.cision.com
Contact:
Medivir AB
Rein Piir, CFO & Vice President, Investor Relations, +46 8 5468 3123 or +46 708 53 72 92
Source: Medivir
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November 21st, 2007
Hepatitis C sufferer credits clinical trial at SLU for her recovery from disease
http://www.thevitalvoice.com
by Rebecca Perlow
Rhoda Hutchings certainly doesn’t look like a chronically ill woman. Smiling broadly, the West County native’s gold hoop earrings wave slightly as she runs her fingers through short, graying hair.
“My hair got really thin [after the treatment]. I used to have really long, very straight hair. After I cut it, as it grew back it had body to it and it’s wavy without me having to curl it,” Hutchings said. Later she laughed, “There’s two good things about this treatment: I lost weight and got great hair!”
Hutchings, 57, was diagnosed with Hepatitis C in 2001. After enrolling as a research patient at Saint Louis University, she was declared virus free by her doctors last May.
Hepatitis C is a blood borne, highly infectious viral disease that is caused by a hepatotropic virus. As it progresses, the virus causes cirrhosis, liver cancer and eventually, death. The virus is spread by blood-to-blood contact with an infected person.
“It’s a very insidious disease,” Hutchings said. “You could be walking down the beach barefoot, step on a piece of glass that someone who has the disease handled and if there’s dried blood on it, you could contract the disease.”
According to the American Gastroenterological Association journal Clinical Gastroenterology and Hepatology, approximately 70 to 80 percent of persons infected will develop chronic hepatitis. Chronic Hepatitis C is defined as infection with the Hepatitis C virus (HCV) persisting for more than six months. It is often asymptomatic and it is mostly discovered many years after infection.
“I’d had it for about 20 years before it was picked up,” Hutchings said.
Because Hepatitis C attacks the liver, the consumption of alcohol for an infected person is the equivalent of pouring gasoline on a flame. “My saving grace, according to my doctor, was that I never really drank,” she remembered. “I had just developed a taste for wine when I was diagnosed so I was not happy.”
Hutchings, a nurse at St. John’s Mercy since 1982, began work at the hospital in 1976. St. John’s paid for her hospital-based nursing training at Missouri Baptist. It’s believed she contracted the virus through her work at the hospital.
“It’s the luck of the draw. You know when you go into the medical profession what the risks are,” Hutchings said. “The cards are on the table and not just for nurses.”
St. John’s Mercy does not conduct liver research, but Saint Louis University does. Shortly after her diagnosis, Hutchings called the university to see if any clinical trials were going on for treating HCV.
“I thought ‘well, if I’m going to die, I’m going to help some people before I’m dead.’ That’s one of the scariest thing I’ve ever done — to leave a hospital and an environment where you’re familiar and go into the unknown.”
Hutchings first participated in a year-long clinical trial of pegalated Interferon for treatment of chronic Hepatitis C. Interferon, an immunomodulator made by the body, is administered in doses higher than what the body makes, rearranging the immune system slightly in order to fight HCV. During the first trial, Hutchings participated in administered pegalated Interferon once a week but was unresponsive to treatment.
“I didn’t have the real funky side effects some people have [with Interferon],” Hutchings said. “I know people on the pegalated Interferon that take their shot and are in bed for days.”
This recent trial administered Infergen, or Consensus Interferon, in a daily injection with two ribavirin pills. Ribavirin is an anti-viral medication shown to be effective in enhancing response to Interferon in patients with Hepatitis C.
“If you look at the data of Interferon alone versus Interferon plus ribavirin, you see an enhanced response in the ribavirin. So the two work together,” Dr. Bruce Bacon, Director of Gastroenterology and Hepatology at SLU, said.
Bacon served as the principal investigator for both the St. Louis and national research site. The national study enrolled 450 patients, approximately 30 of them at SLU, all diagnosed with chronic Hepatitis C. In the clinical trial, 10 percent of chronic Hepatitis patients who previously hadn’t responded to treatment responded to the combined use of Infergen and ribavirin. There was a 30 to 40 percent response among patients with milder liver disease who’d shown some sensitivity to Interferon in prior treatment.
The results of the three-year trial are being presented at the American Association for the Study of Liver Diseases in Boston next month.
There are some side effects to the treatment. Hutchings has had problems with her eyesight and lost feeling in the outside of her legs. Interferon has also destroyed her thyroid, so she takes Synthroid to restore it. Still, she remains enthusiastic about her recovery and is determined to make people aware of the treatment available for the virus.
“I think this is a drug that people could use and work and keep going on with their life. I love the drug because it cured me and I have a second chance at life.
You can e-mail Rebecca Perlow at ladyjane52983@hotmail.com.
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Non-invasive screening for liver fibrosis in HIV/HCV coinfected patients
www.aidsmap.com
Derek Thaczuk
A research team from the University of Barcelona has found that serum levels of hyaluronic acid (HA) and a specific tissue inhibitor of metalloproteinase (TIMP-1) are predictive of higher stages of hepatic fibrosis in patients coinfected with HIV and hepatitis C virus.
These markers may serve as non-invasive alternatives to liver biopsy for determining the stage of liver fibrosis in coinfected patients. The results were published in the November 1st edition of the Journal of Acquired Immune Deficiency Syndromes.
Liver disease such as hepatitis C virus (HCV) infection generally leads, over the long term, to liver tissue damage including fibrosis and cirrhosis. Liver biopsy, an invasive procedure requiring hospitalisation, is still the standard means of assessing the extent of hepatic (liver) tissue damage. Research efforts have been investigating other, non-invasive means of quantifying hepatic tissue damage without resorting to biopsy. The two main approaches are newer scanning technologies such as Fibroscan and the development of indices based on various metabolic markers in the blood serum. (See, for instance, the reports on aidsmap.com here, here and here.
Several such markers are already being studied in people with chronic hepatitis C infection: procollagen type III–N-terminal peptide (PIIINP) and hyaluronic acid (HA) have been extensively studied as markers of fibrosis. The metalloproteinase's and tissue inhibitors of metalloproteinases - markers of cellular changes in connective tissue – have shown a correlation with cirrhosis in people with chronic hepatitis C but have been little studied in people coinfected with HIV.
This study chose to assess the predictive value of five of these potential markers: metalloproteinases MMP-1 and MMP-2, specific tissue inhibitor of metalloproteinase TIMP-1, procollagen type III–N-terminal peptide (PIIINP), and hyaluronic acid (HA). (Other markers have also been investigated in the coinfected population – see this aidsmap.com report here).
The study population consisted of 119 HIV/HCV-coinfected patients at the clinic who consented to a liver biopsy as part of the study. All were on stable antiretroviral treatment for HIV, with HIV viral loads below 200 copies/ml and CD4 cell counts ≥ 250 cells/mm3; none had received any treatment for HCV. Patients were excluded for liver disease other than hepatitis C, autoimmune disease, or any other symptomatic infection, decompensated cirrhosis, cardiovascular disease, or pregnancy.
Median age was 39 years; 66% of the participants were male, and 77% had a history of injection drug use. Median length of HIV infection was twelve years and, of HCV infection, 19 years. Median CD4 count was 515 cells/mm3. Fibrosis stage, as determined by biopsy, was F0 in 22 participants (19%), F1 in 36 (30%), F2 in 24 (20%), F3 (bridging fibrosis) in 19 (16%), and F4 (compensated cirrhosis) in 18 (15%).
Various statistical models were used to evaluate the predictive value of the serum markers. Individually, all but MMP-1 were found to correlate positively and significantly with degree of fibrosis. Correlations were as follows, as measured by r-value (Sperman's correlation): TIMP-1, r = 0.6 (p < 0.001); MMP-2, r = 0.2 (p = 0.044); PIIINP, r = 0.4 (p < 0.001); HA, r = 0.5 (p < 0.001). Although MMP-1 levels were not themselves significantly correlated with fibrosis, the TIMP-1/MMP-1 ratio (r = 0.5, p< 0.001) was, as was TIMP-1/MMP-2 (r = 0.3, p < 0.001).
Investigators then analysed the ability of each marker to discriminate fibrosis stages of moderate or greater (F2 to F4) – the point at which therapy for HCV is generally recommended – from the lowest stages, F0 and F1.
TIMP-1 and HA levels proved moderately predictive of stage F2 or higher fibrosis. TIMP-1 was the best marker: TIMP-1 levels of 908.5 ng/ml or higher predicted moderate-or-higher fibrosis with a sensitivity of 65% and a specificity of 85%. HA levels were the next most useful predictor: a cutoff level of 39 µg/ml yielded a sensitivity of 60% and specificity of 88%. By multivariate analysis, both markers remained independently predictive of stage F2 or higher fibrosis – TIMP-1 with an odds ratio (OR) of 1.004 (95% confidence interval [CI] 1.002 to 1.006; p = 0.001), and HA>95 µg/mL, with an OR of 6.041 (95% CI, 1.184 to 30.816; p = 0.031).
A combined TIMP-1 and HA score was able to identify cases of F2 or higher fibrosis with a sensitivity of 72.9% and specificity of 83.1%. The predictive ability of the combined score compared favourably to that of other non-invasive predictors studied in the literature.
In summary, the researchers suggest that "an index of serum markers, including TIMP-1 [tissue inhibitor of matrix metalloproteinase-1] and HA [hyaluronic acid], may be clinically useful for detecting fibrosis in HIV/HCV-coinfected individuals. The combination serum levels of TIMP-1 and HA results were well correlated with the stages of liver fibrosis [and] could be used for establishing priorities in the management of HCV."
References
Larrousse M et al. Noninvasive diagnosis of hepatic fibrosis in HIV/HCV-coinfected patients. J Acquir Immun Defic Syndr 46 (3) :304-311, 2007.
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GNI Announces IND Approval in China for Novel Liver Disease Drug F351
http://www.pr-inside.com
- GNI Ltd (TOKYO:2160), a leading biopharmaceutical company in Japan and China, is pleased to announce that the State Food and Drug Administration of China has approved its Investigational New Drug application (IND) for the clinical development of one of its lead drug candidates, F351, for the treatment of liver fibrosis/cirrhosis. GNI's China-based affiliate, Shanghai Genomics, is in the process of preparing its Phase I clinical trial.
The principal causes of liver fibrosis/cirrhosis in Japan and China are viral infection by the Hepatitis B virus or Hepatitis C virus. Alcohol abuse and fatty liver may also lead to liver fibrosis. Fibrosis is a complicated disease process during which liver cells are replaced with scar tissue and gradually damages liver function. Inflammation is usually the first step of this process. In China alone, it is estimated that 130 million people are infected with and carrying the HBV virus. A significant percentage of them will develop liver fibrosis/cirrhosis, frequently resulting in mortality.
Liver fibrosis has a very large patient population in Japan, China, and many other Asian countries. Liver disease is also called a "National Disease" in China. "F351 may provide a breakthrough therapy for liver fibrosis patients at risk of developing cirrhosis complication," stated Ying Luo, Ph.D., Chief Executive Officer of GNI, Ltd. and Shanghai Genomics, Inc. "This will be our second product in clinical trials, which represents a major milestone and expands our product portfolio. The IND approval demonstrates our R&D and regulatory team's capability and our determination to develop new drugs for diseases prevalent in Asia, especially in Japan and China," continued Dr. Luo.
"The initiation of this clinical study follows years of our research on key inflammatory signaling pathways in human cells and in animals," added Jun Wu, Ph.D., Chief Scientific Officer of GNI, Ltd. and Shanghai Genomics, Inc. "We have shown that F351 specifically inhibits over-production of collagen by liver fibroblasts following inflammatory insults. The possibility to intervene in such inflammatory process has enormous relevance to the treatment of fibrotic diseases in humans."
About GNI
Founded in 2001, GNI is a clinical-stage international drug development company with its headquarter in Japan and major operation in China. GNI has successfully mapped gene regulatory networks via a complex process of reverse-engineering. Furthermore, GNI has developed the technology required to apply this data to drug development and discovery. In June 2005, GNI acquired Shanghai Genomics, which operates an integrated drug discovery and development platform in Shanghai, China. The combined strength of GNI and Shanghai Genomics has resulted in research collaborations with major international pharmaceutical companies. In August 2007 GNI was listed on the Mothers market of the Tokyo Stock Exchange (ticker symbol: 2160). For further information, please visit www.gene-networks.com and www.shanghaigenomics.com.
This press release contains "forward-looking" statements, including statements related to GNI's plans to pursue development of product candidates and the timing thereof. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "continue," "could," "may," and similar expressions are intended to identify these forward-looking statements. There are a number of important factors that could cause GNI's results to differ materially from those indicated by these forward-looking statements, including risks associated with the timing and success of clinical trials and the commercialization of product candidates. GNI does not undertake any obligation to update forward-looking statements.
GNI Ltd
Tetsuya Yoshikawa, +81 (03) 3580-0751 (Japan)
Ying Luo, +86 1381-769-8961 (China)
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November 22nd, 2007
Stokes' patient records seized
http://www.mlive.com/
Pat Shellenbarger
The Grand Rapids Press
GRAND RAPIDS -- Kent County authorities plan to seek a warrant Monday allowing them to download patients' records from computers seized during a raid Wednesday at the office of Dr. Robert W. Stokes, a Grand Rapids dermatologist whose alleged unsanitary practices may have exposed patients to hepatitis and HIV.
Those computers, as well as a van-load of paper records seized Wednesday, contain thousands of patients' names, Kent County Health Department officials believe, in addition to the more than 4,500 already identified through insurance records. As soon as those additional patients can be identified, the health department will begin sending out letters, urging them to be tested for possible exposure to blood-borne diseases, said Bill Anstey, the department's deputy director.
Although the paper records might contain the patients' names, county officials believe the computers could help identify at-risk people sooner, but that will require a separate warrant signed by a judge, said Sherry Batzer, Kent County's corporate counsel.
"There were patient records scattered throughout," Batzer said, emerging from Stokes' office nearly three hours after the search began. "I wouldn't call it organized."
"There's a lot more in there than we thought," she said as the search began. "This looks like it's going to take quite some time."
Stokes, who lives in East Grand Rapids, apparently was unaware the search was under way, she said. County authorities had considered searching Stokes' home on Reeds Lake, but decided against it after seizing the records at his office.
Sheriff's deputies, armed with a search warrant signed by a 61st District Court magistrate, carried out dozens of boxes filled with records from the office at 1815 Breton Ave. SE and loaded them into a red Ford van.
Health officials say Stokes' alleged practice of reusing surgical instruments and materials intended for use on only one patient may have exposed as many as 10,000 patients to harm.
Several patients had hepatitis
In the affidavit requesting the administrative search warrant, a health department official said Medicare records showed several of Stokes' patients already have hepatitis C, raising the possibility it could have been transmitted to other patients.
More than 4,500 of Stokes' former patients already have been notified of their possible exposure, and 348 were tested at the Kent County Health Department on Tuesday. Another 57 patients, most of them from Stokes' Greenville office, made appointments to be tested at the Mid Michigan Health Department in Montcalm County. Stokes also is believed to have treated patients at an Ionia office.
Possibly 5,000 more at-risk
In the past week, the Kent County Health Department has received calls from 2,045 of Stokes' former patients, mostly from Michigan, but also from 11 other states as far away as California.
Most of his former patients likely are seeking the blood tests from their primary care doctors, health department officials believe, but a large number of them may be unaware of their possible exposure, which is why the health department sought the search warrant.
The names of 2,050 patients were gleaned from Medicare records and 2,530 from Blue Cross Blue Shield records as part of an insurance fraud investigation of Stokes. Kent County Medical Director Dr. Mark Hall suspects Stokes' records may contain the names of as many as 5,000 additional patients who were uninsured or covered by other insurance companies.
"The only way the Kent County Health Department may fulfill its statutory duty to notify all known individuals suspected to be at risk of exposure by Dr. Stokes to three serious communicable diseases is to obtain the remaining names and addresses from Dr. Stokes' patient records," Kent County Administrative Health Officer Cathy Raevsky said in an affidavit seeking the search warrant.
Three of Stokes' former employees told federal investigators he commonly reused sutures, syringes, hypodermic needles, scalpels and gloves without properly sterilizing them.
Stokes was convicted April 26 in federal court on 31 counts of health care fraud. He is scheduled to be sentenced Dec. 13.
Send e-mail to the author: pshellenbarger@grpress.com
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Hearing To Address Hepatitis Infections
http://www.gcnews.com/
Senator Kemp Hannon (R-Garden City), Chair of the Senate Health Committee, today announced a public hearing on the case surrounding a Nassau County physician infecting patients with Hepatitis C by improper sterilization procedures.
The recent recommendation by the New York State Department of Health, based on findings of improper needle sterilization, that hundreds of patients of a certain physician should be tested for Hepatitis B, Hepatitis C and HIV have sparked widespread alarm and questions into the adequacy of measures to ensure the quality and safety of health care in Nassau, specifically focused on infection control procedures.
"The time lags involved in all aspects of this situation...from the point of confirming actual transmission to the initial notification of a smaller group of infected patients to the just revealed recommendations to all 630 patients treated between 2000 and 2005 underscores the need for a thorough review of this process," said Senator Hannon.
The State Health Department has key resources involved in physician practice oversight: the Board for Professional Medical Conduct, the Office of Professional Medical Conduct and the State Patient Safety Center.
The Board's mission is to protect the public from medical negligence, incompetence, and illegal or unethical practices by physicians. It has been in operation for over 30 years. The Office of Professional Medical Conduct provides the staff to the Board and is charged with protecting the public through its investigative powers. It "strives to deter medical misconduct and promote and preserve the highest standards of medical practice." ( Board for Professional Conduct 2005 Annual Report)
The State Health Department also has the "Patient Safety Center," established in 2000, as a potential arm to address maximizing patient safety, improve the quality of health care by identifying systemic problems in healthcare leading to medical errors, or impairing patient safety and to reduce medical errors.
"The missions of these entities and their ability to carry out their objectives will be scrutinized," said Senator Hannon. " The public hearing process will be the opportunity to collect the facts for possible legislative steps to strengthen and restore confidence in this oversight system."
"As head of the Senate Health Committee, I have an obligation to do my part to ensure the quality of our public health system. It is unacceptable this has happened, let alone that it took so long to notify patients. I cannot change the past, but am going to work to make sure this doesn't happen again," concluded Senator Hannon.
The hearing will take place on Thursday, December 6th at 11:00 a.m. at:
Roosevelt Hall, Little Theater
Farmingdale State College, State University of New York
2350 Broadhollow Road
Farmingdale, New York 11735
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Health Canada licenses Qiagen's hepatitis B test
http://www.pharmaceutical-business-review.com
Qiagen has announced that its newly released hepatitis B virus assay kit, known as artus HBV LC PCR Kit, is in compliance with Health Canada's medical device requirements.
The kit, which monitors the viral load of infected patients, is now available to doctors in Canada to help them determine the success of a treatment.
The ready-to-use molecular diagnostic detection kit for the quantitation of hepatitis B viral (HBV) DNA from plasma helps to monitor on-going drug therapy treatments for those people chronically infected with hepatitis B. The kit utilizes the polymerase chain reaction amplification technology and is configured for the widely available LightCycler Instrument.
The kit provides all necessary reagents optimized for reliable HBV DNA detection and quantitation, including of the HBV genotypes A to G. This spectrum of genotypes is representative of strains of the virus which can be found globally, ensuring highest sensitivity in monitoring of treatments, the company said.
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Report: about 38 mln Chinese carry hepatitis C virus
http://news.xinhuanet.com
BEIJING, Nov. 22 (Xinhua) -- About 38 million Chinese are carrying the hepatitis C virus (HCV), but public understanding of the disease is low, said the China Foundation for Hepatitis Prevention and Control (CFHPC) here on Thursday.
The incidence of hepatitis C has surged in the past few years, said a CFHPC report.
The disease was identified in 1989, and research found that a majority of its infections became chronic and led to liver disorders, including cancer.
The Ministry of Health said early this month that hepatitis C was one of China's top five deadly epidemics.
But the public is not well informed about the disease, the CFHPC said, citing its latest survey that indicated only 1 percent of the respondents were aware of how HCV spreads and how to prevent it. Only 5 percent have had a test for HCV.
No HCV vaccine is available, yet 80 percent of those surveyed believed that they could be protected against hepatitis C by a vaccine, the report said.
Although the virus can be eradicated or controlled in the early stages of the disease through proper therapy, about 30 percent of those surveyed said there was no cure for hepatitis C.
Many also confused hepatitis C with hepatitis B, the CFHPC report said.
Clinical research in China and abroad showed that 70 percent of the HVC carriers could be cured if diagnosed at an early stage, the report said. "The whole society should work to improve the public awareness of HCV so that the carriers could be diagnosed and treated as early as possible."
The CFHPC suggested that the government tighten controls on blood products and expand HVC testing.
HCV usually spreads through contact with infected blood, sex with an infected person or from mother to baby during childbirth.
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