Navigation Links
Roche and Pharmasset To Present the R7128 Monotherapy Resistance Profile
Date:2/6/2008

-- Study concludes there was no evidence of the development of viral resistance to R7128 after 2 weeks of monotherapy in hepatitis C patients --

PRINCETON, N.J., Feb. 6 /PRNewswire-FirstCall/ -- Pharmasset (Nasdaq: VRUS) and Roche will present the R7128 monotherapy resistance profile at the EASL-AASLD-APASL-ALEH-IASL Conference on Hepatitis B & C Virus Resistance to Antiviral Therapies being held in Paris, France from February 14-16, 2008. The scientific abstract for poster board no. 36, entitled "Lack of Viral Resistance after 14-day Monotherapy Treatment with R7128 in Treatment-experienced Patients Infected with HCV Genotype 1," is currently available on the conference website at http://www.easl.ch/hepatitis-conference/program/session1.asp. The poster presentation will be available for download in PDF format after it is presented on February 14, 2008 in the "Events & Presentations" section of Pharmasset's website at http://investor.pharmasset.com/events.cfm.

About R7128

R7128 is being developed for the treatment of chronic HCV infection through Pharmasset's collaboration with Roche. R7128 is a prodrug of PSI-6130, a nucleoside analog inhibitor of HCV RNA polymerase. A prodrug is a chemically modified form of a molecule designed to enhance the absorption, distribution and metabolic properties of that molecule.

In a Phase 1 clinical trial, R7128 demonstrated potent, dose-dependent antiviral activity across four patient cohorts (n=40) receiving 750mg or 1500mg administered either once-daily or twice-daily for 2 weeks as monotherapy. The greatest mean decrease in HCV RNA from baseline was observed in the patient cohort that received 1500mg twice-daily, the highest dose of R7128 administered in the study. These patients experienced a mean 2.7 log10 IU/mL (>99%) decrease in HCV RNA. There was no evidence of the selection of PSI-6130 resistant virus in any dose cohort during the 2 weeks of dosing.

The preliminary results of a 4 week Phase 1 clinical trial to evaluate two oral dose levels of R7128 in combination with Pegasys(R) (pegylated interferon) plus Copegus(R) (ribavirin) in 50 treatment-naive patients chronically infected with HCV genotype 1 demonstrated potent short-term antiviral activity. Eighty-five (85%) of patients receiving R7128 1500mg and Pegasys plus Copegus (n=20) achieved undetectable HCV RNA levels following 4 weeks of treatment, or rapid virologic response. The R7128 combination cohorts demonstrated safety and tolerability comparable to placebo with Pegasys plus Copegus.

About Pharmasset

Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).

Pharmasset is currently developing three product candidates. Clevudine, for the treatment of chronic HBV infection, is enrolling Phase 3 clinical trials for registration in North, Central and South America and Europe. Clevudine is already approved for HBV in South Korea and marketed by Bukwang Pharmaceuticals in South Korea under the brand name Levovir. R7128, an oral treatment for chronic HCV infection, is in a 4-week Phase 1 clinical trial in combination with Pegasys plus Copegus through a strategic collaboration with Roche. Racivir, which is being developed for the treatment of HIV in combination with other approved HIV drugs, has completed a Phase 2 clinical trial.

Pegasys(R) and Copegus(R) are registered trademarks of Roche.

Forward-Looking Statements

Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding our business that are not historical facts are "forward-looking statements" that involve risks and uncertainties, including without limitation the risk that we will fail to present the monotherapy resistance profile of R7128, the risk that we will fail to release final safety and efficacy data from a Phase 1, Part 3 combination study of R7128 with Pegasys plus Copegus or that such final data will not corroborate our preliminary results, the risk that adverse events could cause the cessation of clinical studies and/or the development of any of our product candidates, the risk that our collaboration with Roche will not continue or will not be successful and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of these risks and uncertainties, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section of our Annual Report on Form 10-K for the fiscal year ended September 30, 2007 filed with the Securities and Exchange Commission entitled "Risk Factors" and discussions of potential risks and uncertainties in our subsequent filings with the Securities and Exchange Commission.

Contact

Alan Roemer, Vice President

Investor Relations & Corporate Communications

alan.roemer@pharmasset.com

Office: (609) 613-4125


'/>"/>
SOURCE Pharmasset, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Roche responds to announcement of IDEAL hepatitis C trial results
2. Roche Submits Application for FDA Approval of ACTEMRA(R) for the Treatment of Rheumatoid Arthritis
3. Two Pivotal Phase III Studies for Roches ACTEMRA(TM) (tocilizumab) Demonstrate Significant Improvement in Rheumatoid Arthritis Symptoms
4. Roches Investigational Polymerase Inhibitor, Combined with PEGASYS(R) and COPEGUS(TM), Shows Potent Antiviral Activity in Treatment of Chronic Hepatitis C at Four Weeks
5. Roche Diagnostics HIV Viral Load Test Used in Clinical Trials for Isentress, a New Class of HIV Drug
6. Roche Announces Positive Results in Solid Tumors Using Human Monoclonal Antibody Against IGF-1R (R1507)
7. MacroChem Acquires Rights to Pexiganan, a Novel Topical Anti-Infective for Treatment of Diabetic Foot Infections, From Genaera
8. Rochester Medical Anti-Infection Foley Catheter Demonstrates Effectiveness in Randomized Trial
9. Researchers Identify Virus Possibly Responsible for Declining Honeybee Population Using 454 Sequencing Technology from Roche
10. Wyeths Torisel and Roche/Genentechs Avastin Will Challenge Pfizers Sutent to Become the Clinical Gold Standard for Treatment of Metastatic Renal Cell Carcinoma
11. Pharmasset Announces R7128 Achieves 85% Rapid Virologic Response in a 4-week Combination Study for the Treatment of Chronic Hepatitis C
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/27/2017)... STUTTGART, Germany , March 27, 2017 /PRNewswire/ ... provide over 7,000 attendees and more than 600 ... learn, and discover opportunities and solutions that will ... - 6 April 2017 at the Messe Stuttgart, ... is the preeminent medical technology platform showcasing the ...
(Date:3/27/2017)... British Columbia, March 27, 2017  Sophiris Bio ... or "Sophiris"), a clinical late-stage biopharmaceutical company developing ... urological diseases, today reported fourth quarter and full ... Key Corporate Highlights: ... Localized Prostate Cancer. During 2016, the Company reported ...
(Date:3/27/2017)... 27, 2017 /PRNewswire/ - INVICTUS MD STRATEGIES CORP. ("Invictus ... Invictus MD is pleased to announce it has received ... on the TSX Venture Exchange.  Receiving ... year of significant achievements for Invictus-MD. Some of which ... at AB Laboratories Inc. ("AB Labs"), a Licensed Producer ...
Breaking Medicine Technology:
(Date:3/28/2017)... ... March 28, 2017 , ... Columbus OH. Dr. Justin Harper, Founder ... few medical professionals in the country to sit on the 2017 National Advisory Board ... just 2 years Dr. Harper helped propel the clinic from a small start-up to ...
(Date:3/28/2017)... , ... March 28, 2017 , ... Public relations pros ... across a variety of business channels. , While many results are clear, much of ... relations program. , When it comes to measurement, firms should always take an ...
(Date:3/28/2017)... ... , ... Oily skin is a common and unwelcomed occurrence in people of all ages, genders ... offer to the discussion of dealing with excess skin oil. “Oily skin is a challenge ... that can help remove the oily shine while keeping the skin fresh and clean,” says ...
(Date:3/28/2017)... California (PRWEB) , ... March 28, 2017 , ... Bacteria and fungi are probably not ... microorganisms are bad. In fact, including the right microorganisms in your diet can actually improve ... favorite foods. , This is the topic of a new peer-reviewed paper ...
(Date:3/27/2017)... ... 2017 , ... New patients who want to experience the benefits of ... them placed by Dr. Manju Kejriwal, with or without a referral. Dr. Kejriwal is ... accuracy of each dental implant placement. The i-CAT CBCT system captures the shapes of ...
Breaking Medicine News(10 mins):