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Week Ending: January 12th, 2008
Alan Franciscus
Editor-in-Chief
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This Issue:
January 5th, 2007
Hepatitis patient sues, blames dental implants
http://www.suntimes.com
A woman who underwent dental implant surgery at a Chicago office is suing the makers of products used in the surgery, after she learned the products had been recalled and she had contracted Hepatitis C.
After undergoing a dental implant procedure at the University of Chicago that utilized bone allograft products, Donna A. Drew was told about the recall and was advised to undergo medical testing, according to a suit filed in Cook County Circuit Court Friday.
After undergoing the testing, Drew was diagnosed with Hepatitis C.
The seven-count suit names Tutogen Medical, Inc., Biomedical Tissue Services, Ltd., Zimmer Dental, Inc. and Apptec, Inc. - medical companies that were involved in the making of the products.
Drew accuses the companies of failing to include adequate and sufficient instructions and warnings to patients that the product could be contaminated. The companies also inadequately designed, manufactured and tested the product, allowing for contamination, the suit said.
The suit seeks an amount in excess of the jurisdiction limits, as well as court fees.
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January 7th, 2007
Vertex Pharmaceuticals Reports Progress in Development of Investigational HCV Drug Telaprevir and Provides Business Update
http://investors.vrtx.com/
- Formal European scientific advice obtained for telaprevir development program - - Meeting scheduled with FDA for January 2008 on Phase 3 trial design and recent data - - Next-generation HCV protease inhibitor and two investigational compounds for cystic fibrosis in clinical development -
CAMBRIDGE, Mass., Jan 07, 2008 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced its key business objectives for 2008 and provided an overview of recent developments, including highlights from research and development programs, in conjunction with the 26th Annual JPMorgan Healthcare Conference in San Francisco. At the conference, Joshua Boger, Ph.D., President and Chief Executive Officer, and Kurt Graves, Executive Vice President, Chief Commercial Officer and Head, Strategic Development, will today review Vertex's HCV product development and commercialization strategy. A live webcast of this presentation will be available on Vertex's website, www.vrtx.com, today at 2:00 p.m. PST (5:00 p.m. EST).
"As we enter 2008, Vertex is focused on initiating a Phase 3 clinical program for telaprevir, our lead investigational hepatitis C protease inhibitor," stated Dr. Boger. "Clinical data generated in 2007 has provided a platform for constructive dialogue with U.S. and E.U. regulatory authorities, and in early 2008 we look forward to completing these discussions and advancing telaprevir into pivotal clinical development."
Dr. Boger continued, "As we advance toward the initiation of a Phase 3 development program for telaprevir, and with the expansion of our investigational HCV portfolio to include next-generation protease inhibitors, we believe we will be well-positioned to establish leadership in the HCV treatment landscape."
Telaprevir Regulatory Update for Treatment-Naive Genotype 1 Patients
- In collaboration with Vertex, Tibotec is developing and commercializing telaprevir in Europe, South America, Australia, the Middle East and other countries. Tibotec has obtained formal scientific advice from European regulatory authorities on the telaprevir development program. Following receipt of this formal scientific advice, Vertex has submitted a Phase 3 protocol to the U.S. Food and Drug Administration (FDA) for review. The submitted Phase 3 trial design includes a 48-week control arm and both 8 and 12 weeks of telaprevir treatment as part of 24-week combination treatment regimens. The Company plans to use rapid viral response (RVR) criteria to determine which patients stop all treatment at 24 weeks.
- Vertex plans to review this Phase 3 clinical trial design, as well as recently submitted clinical data, at a scheduled meeting with the FDA in January 2008. Tibotec is also in the process of finalizing Phase 3 development plans in Europe. Vertex expects to provide an update on its discussions with the FDA no later than February 11, 2008, the planned date of its year-end financial results conference call.
Telaprevir Clinical Development Plans for Treatment-Failure Genotype 1 Patients
- Vertex is conducting PROVE 3, a Phase 2b clinical trial of telaprevir-based combination therapy in patients with genotype 1 HCV who have not achieved a sustained viral response (SVR) with a previous pegylated interferon-based treatment. Vertex plans to discuss with regulatory authorities in mid-2008 the next steps in the telaprevir development program for treatment-failure HCV patients after the first interim clinical data are available from the PROVE 3 clinical trial.
Tibotec Leading Two Clinical Trials of Telaprevir in Europe
- Tibotec initiated in late 2007 a Phase 2 clinical study in Europe to evaluate 8-hourly and 12-hourly dosing of telaprevir in combination with pegylated interferon (Pegasys(R) or Pegintron(R)) and ribavirin. Patients are currently being dosed in this trial. Interim 12-week on-treatment data are expected to be available in the second half of 2008.
- Tibotec is also conducting a Phase 2 viral kinetics study in Europe to evaluate telaprevir in patients infected with genotype 2/3 HCV. Patients are currently being screened in this trial, and interim on-treatment data are expected to be available in late 2008.
Additional Telaprevir Research Conducted in 2008
- Also in 2008, Vertex intends to initiate clinical exploration of telaprevir in combination with other investigational HCV therapies.
Next-Generation HCV Protease Inhibitor Program
- Vertex has initiated dosing in a Phase 1a clinical trial of VX-500, a second-generation investigational HCV protease inhibitor. The trial will evaluate single, escalating doses of VX-500 in healthy volunteers.
- Pending results from the Phase 1a trial, Vertex expects to initiate in mid-2008 a Phase 1b trial of VX-500 in HCV patients.
- Vertex expects at least one additional next-generation investigational HCV protease inhibitor to advance from research and enter clinical development in 2008.
"In addition to investigational therapies aimed at hepatitis C, Vertex is also pursuing development of multiple novel compounds for the treatment of other serious diseases," continued Dr. Boger. "Two novel compounds targeting the underlying mechanisms of cystic fibrosis are currently being studied in clinical trials, and we are seeking to advance additional molecules for the treatment of cancer, autoimmune disorders and other significant diseases."
Broad Program Targeting Cystic Fibrosis (CF)
- Vertex is conducting a randomized, double-blind, placebo-controlled Phase 2a trial of VX-770, an investigational potentiator compound for the treatment of CF. In the trial, VX-770 is being dosed as an oral therapy in patients with CF. Pending results from the Phase 2a trial, Vertex plans to advance VX-770 into a larger Phase 2b trial.
- Vertex has also initiated dosing in a Phase 1a trial for VX-809, an investigational corrector compound for the treatment of CF. The trial will evaluate single and multiple doses of VX-809 in healthy volunteers. Pending results from the Phase 1a trial, Vertex expects to initiate a subsequent Phase 1b trial in patients with CF in mid-2008.
Productivity in Research
- Vertex has commenced preclinical activities for a number of additional investigational compounds that are advancing from research and may enter clinical development in 2008.
Vertex will report full-year 2007 financial results and financial guidance for 2008 on February 11, 2008.
Webcast:
Vertex Pharmaceuticals will webcast its corporate presentation at the 26th Annual JPMorgan Healthcare Conference on January 7, 2008 at 2:00 p.m. PST (5:00 p.m. EST). A link to the live webcast will be available via Vertex's website, www.vrtx.com, in the Events & Presentations section. An archived webcast of the presentation will be available on Vertex's website through January 21, 2008.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, inflammation, autoimmune diseases, cancer, pain and bacterial infection. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Lexiva is a registered trademark of the GlaxoSmithKline group of companies.
SafeHarbor Statement
This press release may contain forward-looking statements, including statements that (i) we look forward to completing U.S. and E.U. regulatory discussions and advancing telaprevir into pivotal clinical development in early 2008; (ii) with our planned initiation of a Phase 3 program for telaprevir and expansion of our investigational portfolio with next-generation HCV protease inhibitors, we believe we are well-positioned to establish leadership in the HCV treatment landscape; (iii) we plan to review a proposed Phase 3 clinical trial design with the FDA in January 2008 and provide an update on those discussions no later than February 11, 2008; (iv) we plan to discuss with regulatory authorities in mid-2008 the next steps in the development program for telaprevir in treatment-failure patients after the first interim data from the PROVE 3 clinical trial are available; (v) we expect that interim data will be available in the second half of 2008 from a Phase 2 BID clinical trial being conducted by Tibotec, and that interim data will be available in late 2008 from a genotype 2/3 trial of telaprevir being conducted by Tibotec; (vi) we intend to initiate clinical exploration of telaprevir in combination with other investigational HCV therapies in 2008; (vii) we expect to initiate a Phase 1b trial of VX-500 in mid-2008, depending on results from an ongoing Phase 1a trial, and we expect that we will bring at least one additional second-generation HCV protease inhibitor into clinical development in 2008; and (viii) we expect to initiate a Phase 1b trial of VX-809 in CF patients in mid-2008, depending on results from the ongoing Phase 1a trial. While management makes its best efforts to be accurate in making forward-looking statements, such statements are subject to risks and uncertainties that could cause the actual results of studies to vary materially. Those risks and uncertainties include, among other things, the risk that the FDA or other regulatory authorities will not endorse our proposed clinical trial designs, will require substantially altered trial designs or will require more clinical or nonclinical studies before permitting our proposed studies to continue toward regulatory submission and approval, that observed outcomes in clinical investigations of smaller numbers of patients will not be reflected in future clinical trials involving larger numbers of patients, that unexpected and adverse outcomes in ongoing clinical and nonclinical studies will occur and could result in substantial program delays or program terminations, that delays in planning, patient enrollment, drug supply, data collection or analysis or other activities will delay the availability of data from ongoing or planned studies, that planned meetings or discussions with the FDA or other regulatory authorities will be delayed due to scheduling issues, data availability or for other reasons outside the control of the company; that unexpected adverse results from an ongoing clinical trial will adversely impact the occurrence or timing of other planned studies or activities; and other risks listed under Risk Factors in Vertex's Form 10-K filed with the Securities and Exchange Commission on March 1, 2007. Vertex disclaims any obligation to update the information contained in this press release as new data become available.
(VRTX-GEN)
SOURCE: Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Michael Partridge, 617-444-6108
Senior Director, Strategic Communications
or
Lora Pike, 617-444-6755
Manager, Investor Relations
or
Zachry Barber, 617-444-6470
Senior Media Relations Specialist
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Pharmasset Up on Hepatitis C Data
http://biz.yahoo.com
Pharmasset Shares Spike to New High As Hepatitis C Drug Performs Strongly in Early Trial
PRINCETON, N.J. (AP) -- Shares of Pharmasset Inc. reached a new all-time high Monday after the company said 85 percent of patients dosed with 1500 milligrams of its experimental drug R7128, in combination with Pegasys and Copegus, achieved undetectable levels of Hepatitis C virus after just four weeks.
The early-stage study of both 500 milligram and 1500 milligram doses evaluated 50 patients who had never before received Hepatitis C treatment. Pharmasset said both dose levels were safe and well-tolerated compared with placebo.
Patients received twice-daily oral doses of R7128 with once-weekly injections of Pegasys (pegylated interferon) plus Copegus (ribivarin). Thirty percent of those receiving the 500 milligram dose achieved undetectable virus levels.
No serious adverse events were reported during the four-week treatment period.
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3 percent of the world's population, are infected with hepatitis C virus. The CDC has reported that almost four million people in the United States have been infected with HCV, of whom 2.7 million are chronically infected.
Shares rose $2.09, or 15 percent, to $16.08 in morning trading, having hit a new all-time high of $16.97 earlier in the session.
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The Impact Of Hepatitis B On Quality Of Life
http://www.medicalnewstoday.com
With over 350 million people affected worldwide, infection with the chronic hepatitis B virus causes considerable distress to individuals and results in substantial global economic loss through costs of treatment and indirectly, through lost productivity. However, the impact on the quality of life of patients is not well studied and despite the availability of new treatment options, little information is available on how infected and uninfected persons value the impact of health states arising from the hepatitis B virus.
The objective of this study was to estimate preference-based "utility weights", for six increasingly severe health states that occur with chronic infection with the hepatitis B virus. This information was elicited from respondents living in six jurisdictions, in North America, Europe and Asia, that ranged from low to high prevalence of chronic hepatitis B infection.
The authors interviewed 534 chronic hepatitis B-infected patients and 600 uninfected respondents making this one of the largest valuations of health states ever published, for any disease. The results show that the chronic hepatitis B and compensated cirrhosis health states have a moderate impact on health related quality of life, and there is a large detrimental effect on quality of life associated with decompensated cirrhosis and hepatocellular carcinoma. There were geographic differences in the impact of the different health states. A greater impact on quality of life was observed in Hong Kong and mainland China which are jurisdictions with high prevalence of disease. The authors speculate that finding be due to greater fear of the social consequences of infection. A practical implication of the inter-country differences is that economic evaluations may benefit from country-specific utility estimates.
The study represents a successful collaboration of outcomes researchers from Bristol-Myers Squibb Uchenna Iloeje, Eskinder Tafesse and Jayanti Mukherjee, academic liver specialists Kris Kowdley, Robert Gish and Natalie Bzowej, and academic health services researchers Adrian Levy and Andrew Briggs.
The original study, "The Impact of Chronic Hepatitis B on Quality Of Life: A Multi-National Study of Utilities from Infected and Uninfected Persons," is to be published in Value in Health.
Value in Health is the official journal of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR).
Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research and help health care leaders to make decisions that are solidly evidence-based. The journal is published bi-monthly and has a regular readership of over 3,000 clinicians, decision-makers, and researchers worldwide.
ISPOR is a nonprofit, international organization that strives to translate pharmacoeconomics and outcomes research into practice to ensure that society allocates scarce health care resources wisely, fairly, and efficiently.
Source: Value in Health Volume 11 Issue 5
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Tacere Therapeutics Enters Collaboration and License Agreement With Pfizer To Develop and Commercialize RNAi Hepatitis C Drug
http://biz.yahoo.com
SAN JOSE, Calif., Jan. 7 /PRNewswire/ -- [Benitec's San Francisco-based license company,] Tacere Therapeutics, Inc., an RNA interference (RNAi)-based therapeutics developer, announced today that it has entered into a collaboration and license agreement with Pfizer Inc. to develop and commercialize its Hepatitis C virus (HCV) compound, TT-033. The collaboration will focus on completing all necessary studies for submission of an investigational new drug application (IND), as well as clinical development and commercialization of TT-033.
"We are very pleased about forming a collaborative relationship with Pfizer, and are excited about being first in the industry to partner an expressed RNAi drug," said Sara M. Hall, Chief Executive Officer of Tacere. "We have made excellent progress in the research and preclinical development of TT-033, and are very happy to be joined by Pfizer at an important time in the program's development. Pfizer recognizes the potential of this first-in- class approach to provide a novel treatment option for HCV patients and we look forward to working with the team at Pfizer to advance TT-033."
Mike Catelani, Chairman, President and CFO of Tacere, stated, "We look forward to combining Pfizer's and Tacere's complementary capabilities to take TT-033 into the clinic. We are pleased that Pfizer has chosen to work with us in developing this potential single administration RNAi drug to aid in the fight against the global healthcare crisis of HCV."
Under the terms of the agreement, Tacere and Pfizer will form a joint steering committee to oversee preclinical research and development efforts for TT-033. Pfizer will fund all aspects of the collaboration, including the preclinical development work and will have exclusive worldwide rights, excluding all Asian countries, to commercialize products that result from the collaboration.
During the initial phase of the collaboration, Pfizer will provide Tacere with funding in order to complete the necessary IND-enabling studies for TT-033. In addition, Tacere will be eligible to receive milestone payments through successful achievement of development, approval, and commercialization milestones resulting in total potential payments to Tacere of over $145 million. Upon commercialization of TT-033 Tacere would be entitled to receive royalties on net sales by Pfizer.
About TT-033
TT-033 is a novel therapeutic product containing three separate RNAi elements targeted against the Hepatitis C virus itself and entrapped in an AAV protein coat. AAV delivery methods have demonstrated clinical safety, and preclinical studies with TT-033 have shown the ability to penetrate hepatocytes (the site of HCV replication) at high levels following a single intravenous administration. In preclinical animal studies, this "cocktail in one drug" monotherapy targeted and cleaved the Hepatitis C virus itself at three different sites simultaneously without toxicity.
About Tacere Therapeutics, Inc.
Tacere is an innovative biotechnology company focused on developing therapeutics to treat serious infectious diseases using its proprietary knowledge in the development of RNAi therapeutics. Tacere is located in San Jose, California, USA and obtained its founding capital from Hokkaido Venture Capital of Sapporo, Japan. Its lead therapeutic compound is TT-033, an RNAi drug for the treatment of Hepatitis C. For additional information, please visit www.tacerebio.com.
CONTACTS:
TACERE THERAPEUTICS, INC.
Mike Catelani
Chairman, President & CFO
+1 408 839-1818
info@tacerebio.com
MEDIA CONTACT:
Gregory Tiberend
Richard Lewis Communications, Inc.
+1 212 827-0020 or 917 406-1880
gtiberend@rlcinc.com
Source: Tacere Therapeutics, Inc.
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Idenix Pharmaceuticals Provides Update on Hepatitis C Pipeline at JP Morgan Healthcare Conference
http://www.examiner.com/
SAN FRANCISCO, Jan. 7 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases, today announced an update on the company's HCV pipeline, including promising second-generation polymerase and protease inhibitor compounds for the treatment of hepatitis C. This update will be presented on Tuesday, January 8, at 2:30 p.m. PT at the JP Morgan Healthcare Conference in San Francisco, CA.
Second-Generation Nucleoside Polymerase Inhibitor Program
Idenix's preclinical HCV nucleoside polymerase inhibitor program comprises two novel nucleotide prodrugs, IDX184 and IDX102. This program is based on Idenix's proprietary liver-targeting technology, which delivers high levels of nucleoside triphosphate in the liver, potentially maximizing drug efficacy and limiting systemic side effects.
In preclinical studies using an HCV replicon assay, IDX184 exhibited 10 times greater potency than nucleosides currently in clinical development. In a 7-day preclinical toxicology study of IDX184, no toxicities, including gastrointestinal or hematological, were observed in monkeys at doses greater than or equal to 600 mg/kg/day. In HCV genotype-1 infected chimpanzees, once- daily oral administration of 10 mg/kg of either nucleotide prodrug produced a rapid and potent inhibition of HCV replication with mean viral load reductions ranging from 1.5 log(10) with IDX102 to 2.5-4.0 log(10) with IDX184 after 4 days of dosing. IDX184 has been selected as the company's lead candidate from this program and clinical data are expected in 2008.
Novel Macrocyclic Protease Inhibitor Program
Idenix is evaluating multiple scaffolds in its protease inhibitor discovery program. Compounds from two of these scaffolds have demonstrated potent and selective antiviral activity in in vitro preclinical studies to date. Several compounds have demonstrated subnanomolar potency against the HCV NS3 protease target, single nanomolar potency in the HCV replicon, and no inhibition of 8 human cellular proteases. Initial preclinical pharmacokinetic evaluation of these compounds suggests the potential for once-daily or twice- daily dosing. Clinical candidates from this program have been selected and IND-enabling toxicology studies are ongoing.
"Our second-generation HCV drug candidates could offer improvements over direct-acting compounds currently in clinical development," said Jean-Pierre Sommadossi, Idenix's chairman and chief executive officer. "For example, in preclinical studies our second-generation polymerase inhibitor, IDX184, delivered multi-log viral load reductions in HCV genotype-1 infected chimpanzees in just 4 days -- on par with the antiviral activity reported to date from protease inhibitors currently in development."
Sommadossi continued, "In 2008, we look forward to advancing our nucleotide prodrug and macrocyclic protease inhibitor programs into the clinic to determine whether the promising preclinical data generated to date bears out in HCV-infected patients. If successful, the combination of our second- generation polymerase and protease inhibitors could lead to very exciting changes in the HCV treatment paradigm."
2007 Financial Guidance
Idenix today reaffirmed prior 2007 financial guidance of ending 2007 with between $100 million and $110 million of cash, cash equivalents and marketable securities. The company's 2007 financial results have not yet been finalized or audited.
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis C virus and HIV. For further information about Idenix, please refer to www.idenix.com .
Forward-looking Statements
This press release contains "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward- looking statements can be identified by the use of forward-looking terminology such as "could," "may," "plans," "will," or similar expressions, or by express or implied statements with respect to the company's clinical development programs in hepatitis C, or any potential pipeline candidates for the treatment of hepatitis C. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantees that the company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization. In particular, management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, pre-clinical studies and/or clinical trials, including additional data relating to the ongoing pre-clinical studies and/or clinical trials evaluating its product candidates; the company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the company's dependence on its collaboration with Novartis Pharma AG; changes in the company's business plan or objectives; the ability of the company to attract and retain qualified personnel; competition in general; and the company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" in the company's annual report on Form 10-K for the year ended December 31, 2006 and the Quarterly Report on Form 10-Q for the quarter ended September 30, 2007, each as filed with the Securities and Exchange Commission (SEC) and other filings that the company makes with the SEC.
All forward-looking statements reflect the company's expectations only as of the date of this release and should not be relied upon as reflecting the company's views, expectations or beliefs at any date subsequent to the date of this release. Idenix anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
Idenix Pharmaceuticals' Contact:
Teri Dahlman (617) 995-9905
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Chronic Marijuana Use May Increase Fibrosis for Hep C Patients
http://bbsnews.net
Edited by: Michael Hess
Daily cannabis use increases the risk of liver fibrosis in patients with hepatitis C
BBSNews 2008-01-06 -- (IACM) According to research at the University of California at San Francisco daily cannabis use was associated with moderate to severe liver fibrosis in 204 patients with hepatitis C. Between 2001 and 2004, participants underwent interviews to assess demographic data, risk factors for HCV, and use of cannabis and alcohol. In addition, virologic testing and liver biopsy was performed.
The median age of the group was 46.8 years, 69 per cent were male, 49 per cent were white. Cannabis use frequency within prior 12 months was daily in 13.7 per cent, occasional in 45.1 per cent, and never in 41.2 per cent. There was no fibrosis in 27.5 per cent, mild fibrosis in 55.4 per cent and moderate to severe fibrosis in 17.2 per cent of subjects.
Current daily cannabis use increased the odds of moderate to severe fibrosis by nearly 7-fold. There was no association between current daily cannabis use and mild fibrosis. A major limitation of the study is the method, since only one examination was performed, which limits the ability to establish a temporal relationship between cannabis use and fibrosis stage.
However, the study confirms an earlier French study of 2004, in which daily cannabis use was also associated with an increased risk for liver fibrosis. Authors conclude that "HCV-infected individuals should be counseled to reduce or abstain from cannabis use."
(Source: Ishida JH, Peters MG, Jin C, Louie K, Tan V, Bacchetti P, Terrault NA. Influence of cannabis use on severity of hepatitis C disease. Clin Gastroenterol Hepatol 2008;6(1):69- 75)
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January 8th, 2007
Social workers urged to improve Hepatitis C awareness
http://www.communitycare.co.uk
Sally Gillen
The Scottish government is urging social workers to improve their knowledge of hepatitis C as part of a national awareness campaign.
It is estimated that around 50,000 people carry the liver disease, which is commonly contracted by drug users, but two-thirds are undiagnosed.
Hazel Robertson, who is a member of the Association of Directors of Social Work and sits on the hepatitis C national action plan co-ordinating group, said it was likely that many of those infected would come into contact with social services.
“Social work can play a key role in helping to tackle this issue through offering a wide range of support to people with hepatitis C. It is important to help identify those with hepatitis C from an early stage and encourage individuals to seek treatment, particularly as many will lead chaotic lifestyles,” she added.
Professionals can access information online on the testing, referral and treatment of the virus.
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January 9th, 2007
Safety Monitoring Committee Recommends That Emergent BioSolutions Continue Its Hepatitis B Immunotherapy Phase II Trial
http://www.centredaily.com
ROCKVILLE, Md. — Emergent BioSolutions Inc. (NYSE: EBS) announced today that based upon recommendations from an independent Safety Monitoring Committee (SMC) the company is progressing into the next stage of the enrollment of patients in its study of a hepatitis B immunotherapy. In this study, a total of 45 patients with chronic hepatitis B virus (HBV) infection are being randomized within three separate groups to receive immunotherapy or placebo. The immunotherapy utilizes the company's proprietary spi-VEC delivery system to deliver the hepatitis B core antigen, in order to induce an immune response to the hepatitis B virus.
"We are pleased by the Safety Monitoring Committee's recommendation and look forward to advancing this critical study of our hepatitis B candidate. Hepatitis B is the tenth leading cause of death worldwide and our commitment to the development of this therapeutic vaccine is squarely in line with our mission - to protect life," said Daniel Abdun-Nabi, president of Emergent BioSolutions Inc.
The SMC reviewed the safety data from the first group of patients that have completed day 70 in the study. On the basis of the available data, the SMC recommended that the company continue to progress the study into the two remaining groups. The company anticipates preliminary top line safety and efficacy data from this study will be available at the end of 2008 and complete study results will be available in the first half of 2009.
About The Hepatitis B Therapeutic Vaccine Candidate
Although current treatment options are safe and effective in the majority of patients, the majority of hepatitis B patients are unable to clear the viral infection resulting in the need for long-term therapy. The company's HBV immunotherapeutic is designed to direct the immune system against virus infected cells in the liver. Following oral administration, the hepatitis B core antigen protein is produced by the spi-VEC Salmonella vector, within gut macrophages. The macrophages "present" portions of the HBV core antigen to the immune system, inducing antigen specific T-cells responsible for cell-mediated immunity. Through the targeted immune response, the company's hepatitis B immunotherapy is anticipated to benefit patients by increasing the potential to clear the virus therefore minimizing the risk of liver damage and eliminating the need for long-term antiviral therapy.
About Hepatitis B
The World Health Organization (WHO) estimates that up to 2 billion people (one-third of the world's population) have been infected with HBV and that between 350 and 400 million people are chronically infected. Globally, chronic HBV is one of the leading causes of advanced liver cancer. During their lifetime, 10-40% of chronic HBV patients will develop serious sequelae, such as hepatocellular carcinoma, cirrhosis and decompensated liver disease. Hepatitis B virus affects all countries and geographic areas throughout the world.
The hepatitis B market size is estimated to be currently valued at $500 million and is expected to double to over $1 billion by 2010. The strong market growth is attributed to an increase in the awareness and diagnosis of hepatitis B, as well as the increasing use of drug combination therapy.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a profitable, multinational biopharmaceutical company dedicated to one simple mission--to protect life. We develop, manufacture and commercialize immunobiotics, consisting of vaccines and therapeutics, that assist the body's immune system to prevent or treat disease. Our products target infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. Our marketed product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. More information on the company is available at www.emergentbiosolutions.com .
SafeHarbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, prospects, plans and objectives of management, including clinical trial results and development plans, and any other statements containing the words "believes", "expects", "anticipates", "plans", "estimates" and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements, including the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs, preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
Emergent BioSolutions Inc.
Investors: Robert G. Burrows, 301-795-1877 Vice President, Investor Relations BurrowsR@ebsi.com or Media Contact: Tracey Schmitt, 301-795-1847 Director, Corporate Communications SchmittT@ebsi.com.
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Palisades Expert Warns about Liver Disease
http://www.palisadespost.com/
The liver is not the most glamorous of organs and is rarely mentioned in song or prose. Yet liver disease is on the rise among 40- to 60-year-olds in the United States, which means this overlooked body part deserves a spotlight.
The Centers for Disease Control estimate that one in every 55 people in Los Angeles County have hepatitis C, the most common blood-borne illness in America. Alarmingly, two-thirds of these people are not aware they have the disease.
'It is getting worse and worse,' said Pacific Palisades resident Dr. Sammy Saab, an internationally known liver expert. 'People often contract the virus when they are in high school and college, but it takes two to three decades before the disease becomes full-blown.'
In fact, 'some 80 percent of the people in the beginning stages of liver disease have no symptoms,' Saab said. 'It's like high blood pressure--a silent killer.'
Saab explained that people afflicted with hepatitis C today might have experimented with needles or drugs decades ago, and one or two times may have been enough for them to contract the virus. Other major risk factors include blood transfusions that were done before 1992 and having kidney dialysis.
The only way doctors can diagnose early-stage liver disease is through blood tests, but if the disease is detected early, it's treatable.
'If you catch liver disease at an early stage, you can halt it or even reverse it,' Saab said. There are injections and pills for hepatitis C.
Many people are not concerned about hepatitis C because they thought they were immunized. Unfortunately, existing immunizations are only for the other two hepatitis viruses: A and B.
Hepatitis A is most commonly transmitted by the fecal-oral route, such as contaminated food. It does not cause permanent liver damage, but can make you sick for as long as four to six weeks.
The vaccine for hepatitis A is most commonly recommended if you travel outside of the country to areas where there is a high prevalence of the disease.
Hepatitis B is spread through blood and sex and for the most part people recover, but in some it can linger on and cause chronic liver disease. A vaccination for B is recommended for adults at increased risk of infections and all infants.
According to Saab, the liver is soft and mushy like tofu, but if one has untreated hepatitis or alcoholism, the liver becomes diseased and tissue is replaced with scar tissue, which makes it hard, leading to cirrhosis.
If cirrhosis goes unchecked, varicose veins develop in the esophagus (called esophageal varices) and the disease can progress to cancer of the liver. Those cancer patients need to be screened every six months.
'If we can catch liver cancer early, we can cure someone,' Saab said. 'And anyone with liver cancer should be considered for a liver transplant.'
Doctors are able to do a blood test that predicts how long a patient with liver disease can live, which is called a M.E.L.D. score (Model for End-Stage Liver Disease), which ranges from 6 to 40; the latter reflects more serious disease. The M.E.L.D. score determines the order for receiving liver transplants.
'Half of all liver transplants today are a result of hepatitis C,' Saab said.
Fatty liver may replace hepatitis C as a major problem in the future and is a result of lifestyle choices, Saab said. Those patients usually are overweight and have diabetes and/or high cholesterol.
'A fast-food diet gets converted to fat in our livers,' said Saab, who noted the alarming fact that '20 percent of California kids are obese.'
Fatty liver takes the same route as hepatitis C: liver damage that results in scarring and eventually produces cirrhosis, which can cause cancer or liver failure.
Saab's advice for preventing fatty liver is, 'Eat healthy, avoid fatty and sweet foods, exercise, and limit alcohol intake to one or two drinks a day.'
Saab, an associate professor of medicine and surgery at UCLA, is traveling to China in February to talk about hepatitis B and C, and liver transplants. In May he'll be featured at a conference in Canada and in July he'll lecture on liver transplants in Paris.
He and his wife Peggy have four children: Kenny, 10, Clara 9, Elena 7 (all of whom attend Corpus Christi School), and Adelaide, 4.
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http://lfpress.ca
John Miner, Sun Media
New Health Canada regulations that restrict the transplant of organs from sexually active gay men and injection drug users are reasonable precautions, a leading transplant doctor said yesterday.
"The intent of the guidelines is to prevent communicable disease being transmitted from a potential donor to potential organ recipients," said Bill Wall, head of the multi-organ transplant program at London Health Sciences Centre.
Viral and other diseases have been spread through organ donations in the past, he said.
Wall said the new regulations, which took effect in December, are aimed at risky behaviour, not individuals. They are similar to the restrictions for donating blood.
"As a blanket statement, the sexual orientation of a potential donor is irrelevant if that individual is healthy and has no communicable disease," he said.
The difficulty for medical officials is that if an individual has just been infected with a disease such as Hepatitis C or HIV, it can take three to six months before tests will show it, Wall said.
But the director of the multi-organ transplant program for the University Health Network in Toronto criticizes the new rules for zeroing in on gay men.
"In the past, the gay community was considered a high-risk community because of a perception of high-risk behaviour," Gary Levy said.
"We now know it's not a homogeneous community. The fact is, if someone has 62 partners, whether its heterosexual or homosexual, there still is a risk."
The London transplant program was consulted on the changes that also restrict the use of organs from individuals who have had recent tattoos or engaged in sex for money, Wall said.
Included in the regulations is the ability to transplant organs from higher-risk individuals such as sexually active gay men if, in the judgment of physicians and transplant surgeons, the risk of disease transmission is low.
The recipient also has to be informed of the risk.
A case could be an individual who is dying of liver failure and the only donor available is an individual with an element of risky behaviour, Wall said.
"Perhaps the individual is known to be monogamous and his sexual partner is normal and healthy and has no communicable disease," Wall said.
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http://www.wnbc.com
NEW YORK -- A liver transplant patient has sued New York University Medical Center for $2 million, claiming the hospital's pharmacy gave him medicine for HIV, the virus that causes AIDS, when he tried to fill a prescription for hepatitis C.
Gregory Rossini, 56, says in court papers that taking the wrong medication caused his hepatitis condition to worsen. Besides chills, dizziness, fever and loss of appetite and weight, his eyes and skin turned yellow, the lawsuit says.
Rossini, who got his transplanted liver in 1996, said an employee in the NYU Medical Center pharmacy made the error on Jan. 18, 2005, when the patient asked for a medication called Rebetol for hepatitis C. The unidentified pharmacist instead gave him Reyataz, an HIV medication, court papers say.
The NYU Medical Center did not immediately return a telephone call seeking comment Wednesday.
Rossini's court papers, filed in Manhattan's state Supreme Court, say he noticed that the pills he received were different from those he usually got but he did not challenge the pharmacist.
The lawsuit says Rossini received a letter two months later dated March 8, 2005, and signed by Dr. Max M. Cohen, admitting that the patient had been given medication from a mislabeled bottle.
Cohen's letter, appended to the lawsuit as an exhibit, said a "robotic malfunction" resulted in the pharmacists having to dispense medications manually.
Rossini's lawyer, William Bird, said Wednesday he was unsure what Cohen meant by "robotic malfunction."
Bird said Rossini, married and a retired former employee of the medical center, worked in the facility's real estate department.
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UK Soldiers May Have Been Given Contaminated Blood
http://uk.news.yahoo.com/
Sky News
British troops and civilian workers may have been given blood that had not been properly screened for infections like HIV and Hepatitis.
Eighteen soldiers received emergency transfusions while in Afghanistan and Iraq.
The health protection agency confirmed that a further six civilian contractors may also have been exposed to the blood, which came from the US military.
The Americans admitted failing to follow their own testing procedures.
The soldiers were seriously injured in Iraq or Afghanistan and given transfusions using batches of blood sourced from the American military as part of their emergency treatment.
The blood may not have been properly screened and "certified" after it was donated, leaving a risk that it could have been contaminated with infections such as HIV, hepatitis or syphilis.
However, the US military says the American donors who provided the blood had subsequently tested negative for hepatitis and HIV.
Defence Minister Derek Twigg said: "The procedures weren't followed in terms of retrospective testing by the Americans."
He said the risk of infection was "low" but stressed the matter was being taken "extremely seriously".
Both the British and the US military have now reviewed their procedures.
It is believed that all 18 soldiers have been found and informed of the risk of infection.
James Arbuthnot, chairman of the Commons defence select committee, told Sky News: "The benefits of getting blood of any sort when you've been wounded far outweigh the risks that that blood might have been contaminated.
"It's important to remember that the Americans gave their blood to our troops to save their lives and it did the trick."
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January 11th, 2007
Japan to compensate patients in hepatitis scandal
http://www.reuters.com
Japan passed a law on Friday to compensate patients who contracted hepatitis C through tainted blood products, as Prime Minister Yasuo Fukuda apologised again for the government's role in the scandal.
The ruling coalition proposed the compensation plan after Fukuda's delay in helping the victims eroded his public support ratings, adding to voter anger over mishandled pension records and a bribery case involving a former defence official.
At least 10,000 people are estimated to have contracted Hepatitis C through tainted products from around 1970 to the early 1990s. A group of patients sued the government and drug makers including Mitsubishi Tanabe Pharma Corp (4508.T: Quote, Profile, Research).
"Finally, our five-year battle has been rewarded," said Michiko Yamaguchi, one of the patients, after the new law was passed in an unanimous vote in parliament's upper house.
The group had been unhappy with a previous government aid proposal that sought to compensate only some victims under different conditions.
A public outcry forced Fukuda to order his ruling coalition to draft a new bill, under which an estimated 1,000 patients will be compensated under equal conditions.
The compensation will be funded by the government and drug companies.
Fukuda apologised to the patients and their families.
"The government must honestly admit to its responsibility for the enormous suffering brought about to the victims of the infection and for its inability to prevent it from spreading," he said in a statement.
In October, patients were outraged after Health Ministry officials admitted to having data that would have helped identify or warn hundreds of patients before their illnesses worsened.
Most cases have been linked to fibrinogen, a coagulant used to stop haemorrhaging during surgery or childbirth and sold in Japan even after it was withdrawn in the United States in 1977.
Hepatitis C can develop into chronic liver infection and cirrhosis. About 1 percent to 5 percent of people with the disease eventually die from long-term infection, the U.S. Centers for Disease Control and Prevention says.
Fukuda's decision to draft the bill in December came a week after public opinion polls found ratings for his cabinet had plunged to just over 30 percent, a level analysts say could threaten his ability to stay in power. (Reporting by Chisa Fujioka; editing by Sophie Hardach)
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Nucleonics Initiates Hepatitis B Clinical Trial With Expressed Interfering RNA Therapeutic
http://www.centredaily.com
First Patient Treated With Systemically Delivered Gene Silencing Therapeutic Designed to Reduce Both Viral Titer and Destructive HBV Antigen Load
HORSHAM, Pa. — Nucleonics, Inc., a privately held biotechnology company focused on the development of novel RNA interference (RNAi)-based therapeutics, announced today that the company has begun treating patients in a Phase 1 human safety study of its experimental treatment for chronic Hepatitis B virus (HBV) infection, NUC B1000.
NUC B1000 (http://www.nucleonicsinc.com
/products/hepb.html) is an expressed interfering RNA (eiRNA)-based product consisting of a plasmid DNA construct designed to produce four short interfering RNA (siRNA) molecules, formulated with a proprietary cationic-lipid delivery system. Each of the four siRNAs targets a different sequence of the HBV genome, collectively leading to the potential destruction or elimination of all RNA species produced by HBV within an infected cell. The result is a potent antiviral effect designed for efficacy against all HBV genotypes, including drug resistant strains. Additionally, unlike currently available HBV therapeutics, NUC B1000 is designed to specifically reduce viral antigen load in addition to viral titer, thereby reducing the destructive effects of hepatitis and increasing the potential for resolution of viral infection.
"Despite the widespread availability of multiple prophylactic vaccines against HBV, chronic HBV infection remains a public health problem around the world that can lead to such serious diseases as cirrhosis, fibrosis and liver cancer in up to one-third of patients," said Principal Investigator, Robert G. Gish, M.D., Medical Director, Liver Transplant Program and Chief, Division of Hepatology and Complex GI, California Pacific Medical Center, San Francisco. "Current anti-HBV drug therapies are of limited effectiveness and are not often used in patients with mild to moderate disease due to risks of developing drug resistance. Thus there is significant need for new treatments that can improve patient response rates to therapy and prevent the emerging drug resistance associated with the use of conventional antiviral therapeutics, enabling more patients to benefit from treatment."
Nucleonics plans to enroll a total of 15 patients infected with HBV with mild to moderate disease and no evidence of cirrhosis at three U.S. clinical sites and two sites in Eastern Europe. The patients are being organized into five escalating dose groups of three patients per group. Primary endpoints are safety-related, with secondary endpoints tracking biological markers of efficacy, including HBV viral levels in the blood and circulating HBV surface antigen (HBsAg) levels. An independent safety monitor as well as a data safety monitoring board (DSMB) will oversee the trial. There is a planned stop and interim safety analysis after completion of the third dose group before proceeding to the fourth and fifth cohorts.
"We are very pleased to initiate this clinical study, which represents one of the first systemic administrations of any RNAi-based therapeutic and is the first RNAi treatment directed against HBV," said Robert Towarnicki, President and Chief Executive Officer of Nucleonics, Inc. "We believe Nucleonics' eiRNA approach offers several major advantages over other RNAi approaches. Each eiRNA molecule entering the nucleus of a targeted cell produces thousands of copies of siRNA, and allows for a sustained therapeutic response versus the repeat administration expected to be required for synthetically created RNAi drugs. Moreover, one eiRNA drug molecule has the potential to encode four or more different siRNAs, enabling the attack of multiple targets using a single therapeutic, thereby decreasing the chances of developing drug resistance. Moreover, plasmid DNA is non-immunogenic and a stable drug format that benefits from well-characterized manufacturing methods, storage techniques, regulatory requirements and the likelihood of a favorable safety profile based on earlier DNA vaccine clinical trials."
For additional information about clinical studies with NUC B1000, please visit our web site at http://www.nucleonicsinc.com/clinical/index.html. If you have further questions, please email clinicaltrials@nucleonicsionc.com .
About Nucleonics, Inc.
Nucleonics, founded in January 2001, is an emerging biotechnology company focused on the development of novel RNA interference-based therapeutics for viral and other diseases. Privately owned, Nucleonics is headquartered in Horsham, Pennsylvania. For more information on the company, please visit the Nucleonics website at http://www.nucleonicsinc.com.
Nucleonics, Inc. Robert Towarnicki, CEO, 267-518-0101 rtowarnicki@nucleonicsinc.com or Kureczka/Martin Associates Joan Kureczka, 415-821-2413 (Media) Jkureczka@comcast.net
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