Navigation Links
All-Oral Combination Study with PSI-7977 for HCV Genotypes 1, 2 and 3 Initiated
Date:5/26/2011

PRINCETON, N.J., May 26, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today the initiation of a Phase 2a trial investigating the combination of Pharmasset's PSI-7977, a nucleotide polymerase inhibitor, and BMS-790052, Bristol-Myers Squibb Company's (NYSE: BMY) NS5A replication complex inhibitor, for the treatment of chronic hepatitis C (HCV).  This trial is the result of a clinical collaboration agreement between Pharmasset and Bristol-Myers Squibb announced in January 2011.

"We are happy to announce the initiation of this important combination trial," stated William Symonds, Pharmasset's Senior Vice President of Clinical Pharmacology and Translational Medicine. "Recent data from Bristol-Myers Squibb's combination study demonstrated that individuals with HCV can be cured without the traditional interferon and ribavirin, but only if two potent DAAs are used and drug resistance is avoided. We believe Pharmasset's nucleotide analogs have demonstrated potent antiviral activity and a high barrier to resistance and therefore have the potential to be the future backbone of interferon-free treatment."

About the Trial

This Phase 2a trial is planned to enroll approximately 84 patients with chronic HCV genotypes 1, 2 or 3 who have not been treated previously. The primary endpoint of the trial is sustained virologic response (SVR). The trial will be conducted in the U.S. Subjects will be randomized equally across each of the following arms:

  • PSI-7977 400mg QD for 7 days, then add BMS-790052 60mg QD for further 23 weeks in genotype 1 subjects;
  • PSI-7977 400mg QD for 7 days, then add BMS-790052 60mg QD for further 23 weeks in genotype 2 or 3 subjects;
  • PSI-7977 400mg QD and BMS-790052 60mg QD for 24 weeks in genotype 1 subjects;
  • PSI-7977 400mg QD and BMS-790052 60mg QD for 24 weeks in genotype 2 or 3 subjects;
  • PSI-7977 400mg QD, BMS-790052 60mg QD and ribavirin for 24 weeks in genotype 1 subjects;
  • PSI-7977 400mg QD, BMS-790052 60mg QD and ribavirin for 24 weeks in genotype 2 or 3 subjects.

Additional details can be found at www.clinicaltrials.gov.

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 development of oral therapeutics for the treatment of hepatitis C virus (HCV) infection. Our research and development efforts are focused on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have three clinical-stage product candidates advancing in trials in various populations. Our pyrimidine, PSI-7977, an unpartnered uracil nucleotide analog, is currently under study in three Phase 2b trials in patients with HCV genotypes 1 through 6, including abbreviated duration interferon and interferon-free regimens. Our purine, PSI-938, an unpartnered guanosine nucleotide analog, recently reported safety and efficacy data from 14-days of monotherapy as well as 14 days in combination with the pyrimidine, PSI-7977. An SVR-endpoint study of the purine-pyrimidine combination is anticipated to begin third quarter 2011. Mericitabine (RG7128) continues in two Phase 2b trials and one interferon-free trial conducted through a strategic collaboration with Roche.

Contact
Richard E. T. Smith, Ph.D.
VP, Investor Relations and Corporate Communications
Office: +1 (609) 865-0693

Forward-Looking Statements

Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release that are not historical facts are "forward-looking statements," that involve risks, uncertainties, and other important factors, including, without limitation, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving 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 risks, uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended September 30, 2010 and our Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission.


'/>"/>
SOURCE Pharmasset, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Ground-Breaking Combination of All-Oral Agents Demonstrates Potential as Hepatitis C Treatment Regimen
2. Ardea Biosciences Provides Additional Results From a Phase 2b Study of Lesinurad in Combination With Allopurinol at the Annual European Congress of Rheumatology
3. Nexavar in Combination with Chemotherapy Improves Progression-Free Survival in Patients with Advanced Breast Cancer in Phase 2 Study
4. ViroPharma and Halozyme Announce Collaboration for Combination of Recombinant Human Hyaluronidase Enzyme (rHuPH20) Technology with C1 Esterase Inhibitor
5. Pearl Therapeutics Highlights Its Porous Particle Cosuspension Platform, Demonstrating Universal Applicability Across Multiple Drug Classes and Combination Products
6. Particle Sciences and Celanese EVA Performance Polymers Collaborate to Accelerate Drug-Eluting Device Combinations
7. Jennerex and Green Cross Announce Publication of Positive Clinical Data of JX-594 in Combination With Sorafenib in Advanced Liver Cancer
8. Merrimack Pharmaceuticals Announces that Recruitment is Open in a Phase 1 Combination Study of MM-111 with Multiple Treatment Regimens in HER2 Positive Patients
9. New Interim Data About Combination Oral Contraceptives
10. Syndax Announces Start of NCI Sponsored Phase 2 Study of Entinostat in Combination in Triple Negative Breast Cancer
11. Bayer and Onyx Begin Enrollment in Phase 3 Trial of Nexavar in Combination With Chemotherapy Agent Capecitabine for Patients With Advanced Breast Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016  Collagen Matrix, Inc., ... development and manufacturing of collagen and mineral based ... today that Bill Messer has joined ... to further leverage the growing portfolio of oral ... Bill joins the Collagen Matrix executive ...
(Date:6/24/2016)... , June 24, 2016   Bay ... Rehabilitation Network,s Dean Center for Tick Borne ... Medicine and Rehabilitation, MIT Hacking Medicine, University of ... Innovation, today announced the five finalists of ... Lyme disease.  More than 100 scientists, clinicians, researchers, ...
(Date:6/24/2016)... June 24, 2016 Research ... "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural Health ... Structural electronics involves electronic and/or electrical ... structures, replacing dumb structures such as vehicle bodies ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating in cancer ... they remain in the eye of the beholder, according to experts who offered insights ... American Journal of Managed Care. For the full issue, click here . , ...
(Date:6/26/2016)... ... ... Kasmer, a legally blind and certified personal trainer is helping to develop a weight loss ... plans to fix the two major problems leading the fitness industry today:, ... , They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... ... ... closing of Bruton Memorial Library on June 21 due to a possible lice infestation, as ... of head lice: the parasite’s ability to live away from a human host, and to ... one in the event that lice have simply gotten out of control. , As lice ...
(Date:6/25/2016)... Oklahoma City, Oklahoma (PRWEB) , ... June 25, ... ... to helping both athletes and non-athletes recover from injury. Recently, he has implemented ... for the Oklahoma City area —Johnson is one of the first doctors to ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may ... to unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To ... for healthy coping following a traumatic event. , Trauma sufferers tend to feel a ...
Breaking Medicine News(10 mins):