Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
PRNewswire - November 10, 2004
"M184V is one of the most prevalent viral mutations resulting from both Epivir and Emtriva HIV therapies," noted Dr. Michael J. Otto, Pharmasset's Executive Vice President of Pharmaceutical Research. "If this study demonstrates that Racivir is more effective than Epivir in reducing the viral load of patients carrying virus strains with the M184V mutation, Racivir could become an alternative to Epivir in the treatment of drug-resistant HIV."
RCV-201, is a randomized, double-blind, placebo-controlled, multicenter study in the US, Argentina, Mexico, and Panama, designed to include 60 patients. The study entry criteria requires participants to have been receiving lamivudine as part of their antiretroviral therapy for the previous 60 days, to carry the M184V mutation, and to have an HIV RNA viral load of greater than or equal to 2,000 copies/mL. The study has a blinded treatment period of up to 28 days, followed by an open label treatment period of up to 20 weeks. Patients will be subsequently followed for an additional four weeks after the conclusion of the study treatment periods. For more information about RCV-201, patients and physicians can contact Pharmasset's clinical operations at clinical@pharmasset.com.
"Drug resistance continues to be a significant problem in HIV therapy," stated Schaefer Price, Pharmasset's President and CEO. "Pharmasset is committed to the development of HIV drugs that address emerging viral resistance."
Racivir is a nucleoside analog that is being developed at Pharmasset under a US FDA IND for the treatment of HIV-1 and hepatitis B (HBV). A Phase I single-dose, oral pharmacokinetic study in healthy volunteers demonstrated that Racivir was safe and well-tolerated at all doses studied. In a Phase Ia/IIb 14-day study, plasma HIV RNA levels dropped two logs by day 14 in HIV- infected treatment-naove patients receiving a triple drug combination of Racivir, Zerit(R) (D4T, stavudine), and Sustiva(R) (efavirenz).
* Epivir is a registered trademark of GlaxoSmithKline. Emtriva is a registered trademark of Gilead Sciences. Zerit and Sustiva are registered trademarks of Bristol-Myers Squibb.
Pharmasset, Inc., is an emerging pharmaceutical company committed to the discovery, development, and commercialization of novel antiviral drugs. The company leverages its expertise in nucleoside chemistry to develop therapeutics to combat infections caused by drug-resistant human immunodeficiency virus (HIV) and hepatitis viruses. Pharmasset has two drugs in Phase 2 clinical trials, Reverset(TM) and Racivir(R), and several other antiviral compounds in advanced preclinical studies.
In September 2003, Pharmasset entered into a collaborative licensing agreement with Incyte Corporation for the development and commercialization of Reverset in certain territories. In October 2004, Pharmasset entered into a collaboration agreement with Hoffmann-La Roche for the development and commercialization of PSI-6130 in certain territories for the treatment of Hepatitis C. Pharmasset retains proprietary development and commercialization rights to the balance of its clinical and preclinical pipeline.
Pharmasset's expanding portfolio of antiviral therapeutics aims to improve the lives of individuals around the world.
STATEMENTS IN THIS COMPANY PRESS RELEASE MAY CONSTITUTE FORWARD-LOOKING STATEMENTS AND ARE SUBJECT TO NUMEROUS RISKS AND UNCERTAINTIES, INCLUDING THE FAILURE OF PHARMASSET'S TECHNOLOGY TO PERFORM AS EXPECTED, THE COMPANY'S FUTURE CAPITAL NEEDS, THE COMPANY'S ABILITY TO OBTAIN ADDITIONAL FUNDING AND REQUIRED REGULATORY APPROVALS, THE DEVELOPMENT OF COMPETITIVE PRODUCTS BY OTHERS, THE EXISTENCE OF THIRD-PARTY PATENT RIGHTS, AND OTHER RISKS INHERENT IN A DISCOVERY AND DEVELOPMENT STAGE BIOTECHNOLOGY COMPANY. THE ACTUAL RESULTS MAY DIFFER MATERIALLY FROM THOSE ANTICIPATED IN THIS COMPANY PRESS RELEASE. THE COMPANY DISCLAIMS ANY OBLIGATION TO UPDATE THE STATEMENTS CONTAINED IN THIS COMPANY PRESS RELEASE.
Contact: Alan Roemer
(678) 395-0035 - aroemer@pharmasset.com
SOURCE Pharmasset, Inc.
Web Site: http://www.pharmasset.com
041110
PR041117
Copyright © 2004 - PRNewswire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through PRNewswire, Permissions, 810 Seventh Ave., 32nd Floor, New York, NY 10019 http://www.prnewswire.com.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, the National Library of Medicine, Pacific Life Foundation and donations from users like you.
Always watch for outdated information. This article first appeared in 2004. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 2004. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .