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:1/23/2017)... , Jan 23, 2017 NeuroVive ... NeuroVive has signed a preclinical collaboration agreement with the Children,s ... Marni J. Falk , M.D., a US key opinion leader ... ... CHOP will evaluate compounds from NeuroVive,s research program, NVP015, in ...
(Date:1/22/2017)... Switzerland and ABU DHABI , Saudi ... from the US ... , Hospital of the Future , at the ... the hospital of the future will be driven by big data and powered ... according to the panel of experts that discussed the ,Hospital of the Future, ...
(Date:1/21/2017)... PUNE, India , January 20, 2017 ... by Type (Descriptive, Prescriptive), Application (Marketing, R&D, Compliance, SCM), Component (Software, ... CRO) - Forecasts to 2021" published by MarketsandMarkets, the market is ... Billion in 2016, at a CAGR of 13.3% during the forecast ... ...
Breaking Medicine Technology:
(Date:1/23/2017)... ... January 23, 2017 , ... ... Living (IHCA/INCAL), will serve as a healthcare industry expert at the 2017 Sector ... discussion, moderated by Inside Indiana Business host Gerry Dick, will feature an employer ...
(Date:1/23/2017)... Greifensee, Switzerland (PRWEB) , ... January 23, 2017 ... ... many lab and production applications. However, choosing the right method is paramount to ... may occur more often in situations where multiple persons use the same equipment. ...
(Date:1/23/2017)... ... 23, 2017 , ... "ProRandom is a set of camera tools that allow video editors to ... Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. , With ... with video footage. ProRandom works by using a virtual camera to create the illusion ...
(Date:1/23/2017)... (PRWEB) , ... January 23, ... ... Education Foundation (OREF), in partnership with the American Society of Anesthesiologists® (ASA®), ... Foundation (APSF), the American Academy of Orthopaedic Surgeons (AAOS) and the Cigna ...
(Date:1/23/2017)... , ... January 23, 2017 , ... “The Inn at the Mill”: a story ... fears in her quest to become happy and content. , “The Inn at the ... has also lived in Germany and Vermont and is now living in Berks County on ...
Breaking Medicine News(10 mins):