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PSI-938 Receives Fast Track Designation from the FDA for the Treatment of Chronic Hepatitis C Infection
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EASL: ONCE DAILY DUAL-NUCLEOTIDE COMBINATION OF PSI-938 AND PSI-7977 PROVIDES 94% HCV RNA < LOD AT DAY 14: FIRST PURINE/PYRIMIDINE CLINICAL COMBINATION DATA (THE NUCLEAR STUDY) - (03/31/11)
PSI-352938, A Novel Purine Nucleotide Analog, Exhibits Potent Antiviral Activity and No Evidence of Resistance in Patients with HCV Genotype 1 Over 7 Days - (04/06/11)
PRINCETON, N.J., Aug. 24, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) has received fast track designation from the U.S. Food and Drug Administration (FDA) for PSI-938 for the treatment of chronic hepatitis C virus (HCV) infection. PSI-938 is an oral guanosine nucleotide analog polymerase inhibitor of HCV.
In March 2011, Pharmasset presented data from the NUCLEAR study demonstrating that PSI-938 has potent antiviral activity and is generally safe and well tolerated, both as monotherapy and in combination with Pharmasset's lead nucleotide analog, PSI-7977. The NUCLEAR study was conducted in treatment naive subjects with genotype 1 HCV who were treated for 14 days with either PSI-938 or a combination of PSI-938 and PSI-7977 with 92% achieving HCV RNA <15IU/mL, the limit of detection, in the combination arms. Pharmasset plans to initiate QUANTUM, an interferon-free combination trial with PSI-938 and PSI-7977 in the third quarter of 2011.
Under the FDA Modernization Act of 1997, fast track designation may facilitate the development and expedite the review of a drug candidate that is intended for the treatment of a serious and life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition. PSI-938 was granted the fast track designation primarily due to the need for HCV treatments with improved tolerability, safety and efficacy over the existing standard of care for both treatment-naive and treatment-experienced patients.
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 the 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 four 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 in the third quarter of 2011. Mericitabine (RG7128) continues in three Phase 2b trials and one interferon-free trial being conducted through a strategic collaboration with Roche.
Contact
Richard E. T. Smith, Ph.D.
VP, Investor Relations and Corporate Communications
richard.smith@pharmasset.com
Office: +1 (609) 613-4181
SOURCE Pharmasset, Inc.
Here is a link to the HCV section on the NATAP website where you can find all planned studies and results from studies reported and all the drugs in development. You can use the NATAP search engine to locate anything http://www.natap.org
Hep C Articles...
NEW Drugs in Development for HCV - (06/06/11)
Dizzying Array of HCV Drug Development
from Jules: There are many studies ongoing & planned to examine various combinations of the numerous oral HCV drugs in development. Several companies are using PSI-7977 in combination with other classes of oral HCV drugs they have developed including BMS using PSI-7977 in combination with their potent NS5A inhibitor and Tibotec very recently announcing they inked a deal with Pharmasset to study PSI-7977 in combination with their HCV protease inhibitor TMC-435 currently in a large global phase 3 study. And, ongoing studies are examining therapy without peginterferon+ribavirin or retaining ribavirin in therapy but eliminating peginterferon. There was a proof of concept study reported in the Spring 2011 from BMS which found 4 of 11 null non-responders, the hardest to treat patients, were cured without peginterferon/ribavirin, with only the 2 oral BMS HCV drugs, their HCV protease BMS-650032 + their NS5A inhibitor BMS-650032. Thus, at least some patients can be cured without peg/rbv. More recently, Vertex announced early results showing proof of concept that 12 weeks of therapy could cure a significant number of patients in this study where patients received the Vertex NNRTI polymerase inhibitor VX222 + their Protease Telaprevir & ribavirin. In addition ongoing study by many other companies who are dedicating major funded new oral HCV drug development programs including Roche/Genentech, Merck and Gilead are studying combinations of their own newly developed multiple oral HCV drugs in various combinations with and without peginterferon/ribavirin. If for some patients peginterferon and ribavirin cannot be eliminated & are required for a cure there are several potential substitute therapies in development including the BMS lambda interferon which in study results was potent and had much fewer side effects than standard peginterferon. I could go on but clearly the array of developments in HCV drug development is dizzying promising that everyone who is treatable can eventually be cured.
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