Healthcare Industry News: Novartis Pharma AG
News Release - October 27, 2006
Idenix Announces New 24-Week Data From A Phase IIb Clinical Trial Of Valopicitabine Plus Pegylated Interferon in Treatment Naive Genotype-1 Hepatitis C PatientsBOSTON, Oct. 27 (HSMN NewsFeed) -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX ) today announced interim results of the phase IIb clinical trial of its hepatitis C investigational therapy, valopicitabine, dosed in combination with pegylated interferon. In this study, 200 mg/day of valopicitabine, combined with pegylated interferon, resulted in favorable viral suppression with a low rate of side effects in treatment naive patients with genotype-1 HCV infection after 24 weeks of treatment. The results will be presented at the 57th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, Massachusetts.
"We are very excited about these preliminary results at Idenix because they further validate our valopicitabine development program in treatment naive patients," said Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix Pharmaceuticals. "The observed synergistic activity demonstrated in this trial between valopicitabine and pegylated interferon has reinforced our belief that valopicitabine has potential to be a part of HCV combination treatments. We have initiated a drug-drug interaction study with ribavirin and, if successful, will possibly evaluate double and triple combination regimens in phase III trials."
At 24 weeks, the 200 mg/day dose of valopicitabine in combination with pegylated interferon achieved marked HCV RNA reductions in treatment naive patients with genotype-1 infection. A mean 4.24 log10 reduction in viral load was achieved among patients being treated with 200 mg/day of valopicitabine, in combination with pegylated interferon. Approximately 68 percent (23/34) of patients receiving this combination regimen achieved viral clearance at week 24, utilizing the TaqMan® assay's lower limit of quantification of 20 IU/mL.
"These data are very encouraging because they demonstrated that the combination of valopicitabine and pegylated interferon cleared viral load in many patients at six months," said Douglas Dieterich, M.D., Professor of Medicine at the Mt. Sinai School of Medicine, New York and an investigator in the study. "Direct-acting antivirals are likely to be the key components of HCV combination treatments in the future. As the most advanced polymerase inhibitor in clinical development, valopicitabine could have a potential role in these future combination therapies."
About the Phase IIb Study Design
The 24-week analysis from this ongoing 48-week phase IIb clinical trial in treatment-naive HCV patients included data from the following five randomized treatment arms, all involving dosing regimens of valopicitabine, administered once-daily, in combination with pegylated interferon alfa-2a (Pegasys®) 180 ug per week: (A, n=34) pegylated interferon beginning on day 8 plus valopicitabine ramping from 400 mg to 800 mg beginning at day 29-32, followed by dosing at 800 mg; (B, n=34) valopicitabine 200 mg beginning on day 1 plus pegylated interferon beginning on day 8; (C, n=34) valopicitabine ramping from 400 mg to 800 mg from day 1-6, followed by dosing at 800 mg plus pegylated interferon beginning on day 8; (D, n=36) valopicitabine 800 mg beginning on day 1 plus pegylated interferon beginning on day 8; and (E, n=35) valopicitabine 800 mg plus pegylated interferon, both beginning on day 1.
Seventy-one percent of patients in both the valopicitabine 200 mg/day arm and the pooled valopicitabine 800 mg/day (n=105) attained HCV RNA below the limit of quantification for the Amplicor® assay (<600 IU/mL) at week 24. Sixty-eight percent of patients in the valopicitabine 200 mg/day arm reached undetectable virus levels, compared to 58 percent in the pooled valopicitabine 800 mg/day arms after 24 weeks according to the TaqMan® assay's lower limit of detection of 20 IU/mL. Mean reductions of HCV RNA of 4.24 log10 after 24 weeks of treatment were achieved among patients in both the 200 mg/day dose group and the pooled 800 mg/day dosing groups.
In March 2006, the protocol for this ongoing phase IIb 48-week clinical trial in treatment naive patients was amended after GI side effects related primarily to the higher dose arms (800 mg/day) of valopicitabine were observed. The amendment required that patients in the 800 mg/day dose arms who had virus levels below 600 IU/mL, be randomized to continue study treatment with either valopicitabine 200 mg/day plus pegylated interferon or valopicitabine 400 mg/day plus pegylated interferon. Twelve percent of the treatment-naive patients did not meet the criteria and were discontinued from the trial. Patients originally receiving the 200 mg/day dose have continued on that treatment regimen. The 24-week data discussed herein include data post protocol modifications.
Through 24 weeks of treatment, 29 out of a total of 173 patients discontinued from the trial for adverse events (AEs), mostly gastrointestinal (GI) related; of these, 3 patients were from the 200 mg/day arm. Five serious adverse events (SAEs) were assessed as attributable to either valopicitabine or valopicitabine and pegylated interferon during the first 24 weeks of treatment. Most of these were GI related and four occurred in patients in an 800 mg arm. Since the dose reduction in March 2006, no valopicitabine-related GI SAEs have occurred at 200 or 400 mg arms.
About Hepatitis C
HCV infection is the most common chronic blood-borne infection in the United States.(1) The Centers for Disease Control and Prevention estimates that 4 million Americans have been infected with HCV, and 2.7 million of these carry chronic HCV infections.(2) Hepatitis C related liver failure is the most common indication for liver transplantation in the United States.(2) As the prevalence of severe liver disease attributable to hepatitis C rises, deaths due to complications from hepatitis C infection, currently 8,000 to 10,000 per year in the United States, are increasing and are expected to triple by 2010.(3)
Idenix is co-promoting its hepatitis B product and developing its hepatitis B and hepatitis C product candidates, in collaboration with Novartis Pharma AG. Under this agreement, Novartis and Idenix will co-promote TYZEKA, and if successfully developed, valtorcitabine and valopicitabine, in the United States, France, Germany, Italy, Spain and the United Kingdom. Novartis has the exclusive right to commercialize licensed approved products in the rest of the world.
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery, development and commercialization 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 B virus, hepatitis C virus and human immunodeficiency virus (HIV). For further information about Idenix, please refer to http://www.idenix.com.
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 "is encouraging", "believe", "may", "planning", or similar expressions or by express or implied discussions regarding the ongoing and planned clinical trial development of valopicitabine, regarding potential future marketing approvals for valopicitabine or potential future sales of valopicitabine. 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 valopicitabine will successfully complete Phase IIb clinical evaluation in both or either patient population in which it is currently being evaluated or that valopicitabine will proceed to Phase III clinical trials in any patient population. Neither can there be any guarantees that valopicitabine will be approved by regulatory authorities in any markets, or that the company will earn any revenues from valopicitabine. In particular, management's expectations may be affected by the results of clinical trials, including additional data relating to the ongoing Phase IIb clinical trial evaluating valopicitabine; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the ability of the company to attract and retain qualified personnel; competition in general; government, industry and general public pricing pressures; and the company's ability to obtain, maintain and enforce patent and other intellectual property protection for valopicitabine. 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, 2005 and filed with the Securities and Exchange Commission and other filings that the company makes with the Securities and Exchange Commission.
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.
Pegasys®, Amplicor®, are registered trademarks of Hoffmann-La Roche, Inc.
TaqMan® is a registered trademark of Roche Molecular Systems, Inc.
(1) Center For Disease Control National Prevention Strategy
(2) Center for Disease Control. Hepatitis C Fact Sheet accessed online at http://www.cdc.gov/ncidod/diseases/hepatitis/c/fact.htm
(3) Davis, G. et al., Projecting Future Complications of Chronic Hepatitis C in the United States. Liver Transplantation, April 2003
Source: Idenix Pharmaceuticals
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