Navigation Links
Pharmasset Initiates First Time in Human Study of PSI-7851 for the Treatment of Hepatitis C (HCV)
Date:3/31/2009

PRINCETON, N.J., March 31 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today that dosing has started in a phase 1, single ascending dose (SAD) study in healthy volunteers with PSI-7851, a second generation nucleotide analog polymerase inhibitor of hepatitis C virus (HCV). Pharmasset filed an Investigational New Drug Application (IND) with the Food and Drug Administration (FDA) earlier this quarter.

"This is a significant milestone for Pharmasset. PSI-7851 is a wholly owned, second generation nucleotide analog that was discovered by Pharmasset scientists" stated Dr. Michelle Berrey, Pharmasset's Chief Medical Officer. "We continue to see nucleos(t)ide inhibitors as having the potential to be the cornerstone of future HCV treatment, given their higher barrier to resistance and antiviral activity across multiple HCV genotypes, characteristics that set them apart from other HCV drug classes. We look forward to reporting the first antiviral data with PSI-7851 in the second half of 2009."

About PSI-7851

PSI-7851 is a uridine nucleoside analog currently in developed for the treatment of chronic HCV infection. PSI-7851 has demonstrated in vitro anti-HCV activity with EC(50) values of 90 +/- 60 nM, which is approximately 15- to 20-fold more potent than the active metabolite of Pharmasset's first generation nucleoside polymerase inhibitor, R7128. In vitro studies of PSI-7851 have not shown evidence of any mitochondrial or other cellular toxicities that may be associated with some nucleoside analogs. The half-life of the triphosphate in primary human hepatocytes is approximately 38 hours, which suggests the possibility for once-daily dosing. Like R7128, PSI-7851 has demonstrated in vitro activity against all of the most common HCV genotypes.

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, Europe, Japan and Taiwan. Clevudine is already approved for HBV in South Korea and the Philippines. It is marketed in Korea by Bukwang Pharmaceuticals under the brand name Levovir. R7128, an oral treatment for chronic HCV infection, has completed a 4-week clinical trial in combination with Pegasys(R) plus Copegus(R) through a strategic collaboration with Roche, and is initiating a Phase 2b trial. 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.

    Contact
    Richard E. T. Smith, Ph.D.
    VP, Investor Relations and Corporate Communications
    richard.smith@pharmasset.com
    Office: +1 (609) 613-4181

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 adverse events could cause the 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 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, 2008 and our Quarterly Report on Form 10-Q for the period ended December 31, 2008 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.


'/>"/>
SOURCE Pharmasset, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Pharmasset Reports Fiscal Year End 2008 Financial Results
2. Roche, InterMune and Pharmasset Announce Initiation of INFORM-1, the First Dual-Combination Clinical Trial with Oral Antivirals in Hepatitis C
3. Richard E.T. Smith, Ph.D. Joins Pharmasset as Vice President of Investor Relations and Corporate Communications
4. Pharmasset to Present at the UBS Global Life Sciences Conference on Wednesday, September 24th
5. Pharmasset Reports Financial Results for Quarter Ended June 30, 2008
6. Pharmasset Reports Preliminary Results of a 4-week Combination Study of R7128 for the Treatment of Chronic Hepatitis C
7. Pharmasset Announces Initiation of Combination Study of Clevudine and Viread(R) for HBV by French National Agency for Research on AIDS and Viral Hepatitis (ANRS)
8. Pharmasset Receives Notice of Allowance
9. Pharmasset Nominates PSI-7851 as a Lead Development Candidate for the Treatment of Chronic Hepatitis C
10. Pharmasset Commences Dosing R7128 Cohorts 3 and 4 for the Treatment of Chronic Hepatitis C
11. Pharmasset Presents Results of 4-Week Combination Study of R7128 for the Treatment of Chronic Hepatitis C
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/9/2016)... Corporation ("Unilife" or "Company") (NASDAQ: UNIS ; ASX: UNS), ... its financial results for the second quarter of fiscal 2016 (three ... Financial Results for the Second Quarter of ... Revenue for the second quarter of fiscal 2016 was $4.5 ... Cash receipts from customers for the second quarter of fiscal 2016 ...
(Date:2/9/2016)... February 9, 2016 ... heute den Abschluss eines Kooperationsvertrags mit 10x ... Lösungen in den Bereichen Next-Generation-Sequencing (NGS), Single-Cell-Biology ... ; Frankfurt Prime Standard: QIA) gab heute ... für die Entwicklung und Förderung umfassender Lösungen ...
(Date:2/9/2016)... February 9, 2016 QGEN ... collaboration with 10x Genomics to develop and promote ... and bioinformatics. --> QGEN ; Frankfurt ... 10x Genomics to develop and promote comprehensive solutions ... --> QIAGEN N.V. (NASDAQ: QGEN ...
Breaking Medicine Technology:
(Date:2/10/2016)... ... February 10, 2016 , ... AxoGen, Inc. (NASDAQ: AXGN), a leading ... the fourth quarter and full year ended December 31, 2015 on Monday, February 29, ... webcast for the investment community following the release at 4:30 PM ET. Investors interested ...
(Date:2/10/2016)... Carefree, AZ (PRWEB) , ... February 10, 2016 , ... ... coach in new book , Pioneering book "Better with Age: The Ultimate Guide to ... neuroplasticity can improve memory. The book’s publication date is March 16, 2016. ...
(Date:2/10/2016)... MA (PRWEB) , ... February 10, 2016 , ... ... their revolutionary, biocompatible columns and accessories. These PEEK-lined stainless steel (PLS) columns combine ... provide a solution that ensures the integrity of biological samples while operating at ...
(Date:2/10/2016)... ... February 10, 2016 , ... The recreational use of marijuana has been ... still face a lot of restrictions as to where they can smoke pot. ... use” and that cannabis “may not be consumed openly or publicly.” , Given the ...
(Date:2/10/2016)... ... February 09, 2016 , ... ... Face and Body Specialists are delighted to welcome a new addition to their ... Face and Body Specialists as a nurse practitioner performing cosmetic procedures ...
Breaking Medicine News(10 mins):