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Pharmasset Nominates PSI-7851 as a Lead Development Candidate for the Treatment of Chronic Hepatitis C
Monday May 19, 7:05 am ET
- IND or foreign regulatory equivalent filing anticipated in 1Q 2009 -
PRINCETON, N.J., May 19 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News) has nominated PSI-7851 as a lead development candidate for the treatment of chronic hepatitis C virus (HCV). PSI-7851 is a proprietary nucleotide analogue polymerase inhibitor of HCV that is being advanced into Good Laboratory Practice (GLP) animal toxicity studies required for submission of an Investigational New Drug (IND) application with the FDA or an equivalent foreign regulatory filing. PSI-7851 has demonstrated in vitro potency that is approximately 15- to 20-fold greater than the in vitro potency of R7128, a nucleoside analog polymerase inhibitor of HCV that Pharmasset is developing through its collaboration with Roche.
"Our in-house research team has, once again, discovered a new potential product candidate for the treatment of chronic HCV," stated Dr. Michael Otto, Pharmasset's Chief Scientific Officer. "Our goal continues to be the identification of anti-HCV compounds with improved potency, equivalent or improved safety and oral bioavailability. In addition, we have focused on increasing intrahepatic triphosphate levels, which may lead to a higher level of active drug in the liver. We anticipate completing the required animal toxicity studies and filing an IND in the first quarter of 2009."
Nucleotide analogs have shown the ability to deliver higher levels of the active triphosphate form of the drug into infected cells. PSI-7851 has demonstrated in vitro anti-HCV activity with EC90 values of 0.31 +/- 0.12 uM, which is approximately 15- to 20-fold more potent than the active metabolite of R7128, PSI-6130. 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. Early animal studies indicate that PSI-7851 can achieve concentrations of active triphosphate in the liver of up to 1,000 times higher than PSI-6130 at equivalent doses.
Pharmasset shares up; analysts upbeat on hepatitis candidate
Friday May 16, 5:15 pm ET
Pharmasset shares rise analysts optimistic about hepatitis C drug candidate
NEW YORK (AP) -- Shares of clinical-stage pharmaceutical company Pharmasset Inc. rose Friday after analysts expressed optimism about the company's hepatitis Cdrug candidate in partnership with Roche AG.
Merriman Curhan Ford analyst Brian McCarthy noted that hepatitis candidate, R7128, is slated to enter a midstage study in the fourth quarter of the year. He rates the shares "Buy."
He believes that Pharmasset's current share price doesn't account for positive R7128 data, the company's other programs and partnerships, upcoming clinical milestones, and the potential for generating revenue.
JMP Securities Liisa A. Bayko is also upbeat about Pharmasset. She said that Roche currently has a hepatitis C drug of its own, R1626, but it has been plagued by toxicity concerns. She believes that Roche might put R1626 on the back burner due to the concerns with the drug in favor of R7128.
"In our mind, this could be the biggest catalyst for shares of Pharmasset this year," Bayko said.
She rates Pharmasset shares "Buy" with a $35 price target.
On Thursday, Pharmasset said its first-quarter loss widened on a decrease in collaborative payments and higher costs for its hepatitis B program.
Shares of Pharmasset rose $1.05, or 6.4 percent, to $17.45.
Pharmasset 1Q loss widens on revenue dip, costs
Thursday May 15, 5:59 pm ET
Pharmasset's 1st-quarter loss widens on a dip in partnership revenue and higher costs
PRINCETON, N.J. (AP) -- Pharmasset Inc., a clinical-stage pharmaceutical company, said Thursday its first-quarter loss widened on a dip in collaborative payments and higher costs for its hepatitis B program.
The company lost $12.1 million, or 57 cents per share, compared with a loss of $1.7 million, or 16 cents per share, during the same period a year prior. Revenue plunged to $464,292 from about $5.5 million.
Analysts polled by Thomson Financial expected a loss of 44 cents per share on revenue of $3.3 million.
Revenue fell on lower payments from the company's partnership with Roche on hepatitis drug treatments.
Meanwhile, costs and expenses jumped to $12.8 million from $7.3 million. The increase was primarily due to expenses for the hepatitis B drug candidate clevudine.
Shares of Pharmasset fell 21 cents to $16.19 in after-hours trading after rising 61 cents, or 3.9 percent, to close at $16.40 during the regular trading session.
Pharmasset Commences Dosing R7128 Cohorts 3 and 4 for the Treatment of Chronic Hepatitis C
Wednesday May 14, 7:05 am ET
- Two 4-week cohorts will evaluate R7128 1000mg BID in HCV genotype 1 treatment-naive patients and R7128 1500mg BID in HCV genotypes 2 or 3 treatment-experienced patients -
PRINCETON, N.J., May 14 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News) has commenced dosing two additional cohorts of a 4-week Phase 1 study of R7128 in combination with Pegasys® (peginterferon alfa-2a) plus Copegus® (ribavirin) in both treatment-naive and treatment-experienced patients chronically-infected with hepatitis C virus (HCV) genotypes 1, 2 and 3. R7128, a prodrug of PSI-6130, is a nucleoside analogue polymerase inhibitor of HCV that is being developed through Pharmasset's collaboration with Roche.
The purpose of this 4-week study is to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of R7128 in the clinically-relevant setting of combination therapy for chronic HCV infection. The previously planned Cohort 3 will continue dose-exploration with administration of R7128 1000mg twice-daily (BID) in treatment-naive patients with HCV genotype 1. Cohort 4 will evaluate R7128 1500mg BID administered in combination with Pegasys plus Copegus in treatment-experienced patients with genotypes 2 or 3 who did not achieve a sustained virologic response (SVR) with previous interferon-based therapy.
There will be 25 patients in each dose cohort with 20 patients randomized to receive R7128 and 5 patients randomized to receive placebo. After completing 4 weeks of the triple combination regimen and a follow-up period of 4 weeks of Pegasys plus Copegus, patients will receive an additional 16 to 40 weeks of open-label dosing of Pegasys plus Copegus under a separate protocol to complete the standard of care regimen for each genotype. Preliminary safety and antiviral activity data from the 4-week combination treatment period are anticipated during the third quarter of 2008.
"Based on our pharmacokinetic modeling, we believe that the R7128 1000mg BID combination dosing regimen in Cohort 3 may be able to achieve similar antiviral responses as were demonstrated with R7128 1500mg BID in Cohort 2," stated Dr. Michelle Berrey, Pharmasset's Chief Medical Officer. "Cohort 4 will be the first administration of R7128 in patients with HCV genotypes 2 or 3, and thus will serve as proof-of-concept for this population who we believe represent an area of great unmet medical need. If R7128 shows activity in HCV genotype 2 or 3 patients, this would demonstrate a distinct clinical attribute of nucleoside polymerase inhibitors."
Please see www.clinicaltrials.gov or e-mail clinicaltrials@pharmasset.com for more information.
Pharmasset hepatitis C drug meets safety goal in study
Friday April 25, 2:54 pm ET
Pharmasset hepatitis C drug meets safety goal in early-stage clinical trial
PRINCETON, N.J. (AP) -- Pharmasset Inc., a clinical-stage pharmaceutical company, said Friday its hepatitis C drug candidate R7128 met safety goals in an early-stage study.
The study results were presented at the 43rd annual meeting of the European Association for the Study of the Liver in Milan.
The drug was tested in two oral doses in combination with other hepatitis C treatments over the course of four weeks. The company said the drug candidate also prompted short-term antiviral activity in patients.
The study was not designed to test effectiveness as a main goal. Phase I clinical trials are often too small to measure effectiveness with any accuracy and instead focus on safety.
Shares of Pharmasset fell 29 percent, or 2 percent, to $14.21 in afternoon trading. The stock has traded between $7.54 and $36.44 over the last 52 weeks.
I wonder that myself sometimes, I would always have a shelf offering in place(locked & loaded) for when my stock had a huge spike/run. These guys are better at drug development than they are at finance or predicting their own stock price.
Surf, Instead of these 12% loans, I wonder why they just didn't do a financing when the stock had its big move above $30?
Pharmasset Rises on UBS Upgrade
Wednesday April 2, 7:57 pm ET
UBS Analyst Lifts Pharmasset Rating to "Buy," Citing Low Share Price, Strong Drug Candidates
NEW YORK (AP) -- Shares of Pharmasset Inc. rose Wednesday, as a UBS analyst upgraded the antiviral drugmaker, citing its low share price and strong hepatitis B and C pipeline.
Analyst Annabel Samimy lifted her rating on Princeton, N.J.-based Pharmasset to "Buy" from "Neutral," ahead of the company's hepatitis C data presentation at the European Association for the Study of the Liver (EASL) meeting on April 25.
"Share price has contracted since the promising R7128 (hepatitis C drg candidate) data emerged, and we believe this creates an attractive entry into a company that has two lead programs with best-in-class potential in the hepatitis B and hepatitis C markets," she wrote in a note to clients.
Samimy noted that previous top-line data on drug candidate R7128 highlighted impressive antiviral responses, with few safety or tolerability issues. Samimy said the EASL presentation will likely provide important details about the safety and resistance profile of the drug.
"We expect some volatility around the EASL Meeting, which will likely permeate across the small/mid-cap biotech sector," she wrote. "Beyond EASL, we expect VRUS will have a relatively quiet year, as both its programs progress. We do not expect major stock-moving catalysts for the remainder of the year, but see 2009 as pivotal."
Pharmasset shares rose 85 cents, or 4.5 percent, to $19.94.
Pharmasset Receives $10 Million of Working Capital
Friday March 28, 4:05 pm ET
PRINCETON, N.J., March 28 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News) received a second loan of $10 million from Horizon Technology Finance under an existing working capital loan agreement that was entered into during September 2007. Pharmasset received the first loan of $10 million in October 2007 and, at its option, may receive a third loan of $10 million by November 30, 2008, provided certain conditions are satisfied.
"We believe that our existing cash resources, together with a third loan available under our working capital agreement and anticipated payments under our existing HCV collaboration agreement with Roche, will be sufficient to fund our projected cash requirements for the next 18 months," stated Kurt Leutzinger, Pharmasset's Chief Financial Officer. "In light of the recent stock market volatility, this facility has proved to be valuable in providing flexibility regarding the timing of any future equity financings."
For each $10 million loan funded, Pharmasset will pay interest only for the first 15 months followed by 30 equal monthly installments of principal and accrued interest. The interest rate for the initial loan and the second loan will be 12%. In addition, upon entering into the working capital loan agreement, Pharmasset issued to Horizon a seven-year warrant to purchase up to 149,377 shares of common stock at an exercise price of $12.05 per share. The warrant is currently exercisable for up to 66,390 shares associated with the first loan and up to 49,793 shares associated with the second loan. The remaining 33,194 shares will become exercisable upon the funding of the third loan if it occurs.
About Horizon
Founded in 2003, Horizon Technology Finance, LLC is an independent venture debt finance company that offers senior and subordinated working capital to emerging technology companies in the information technology and life sciences industries. Horizon provides a compelling alternative to the restrictive structures offered by banks and corporate finance companies.
The Horizon management team has provided debt financing for more than 750 companies over the last 15 years representing more than $2.0 billion in commitments. Horizon has offices in Farmington, CT and Pleasant Hill, CA. For additional information, please go to www.HorizonTechFinance.com.
Top 10 Biotech Buzz Stocks for This Year
VRUS
By Adam Feuerstein
Senior Writer
1/14/2008 12:22 PM EST
Click here for more stories by Adam Feuerstein
http://www.thestreet.com/_yahoo/newsanalysis/biotech/10398390.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
Pharmasset Announces R7128 Achieves 85% Rapid Virologic Response in a 4-week Combination Study for the Treatment of Chronic Hepatitis C
Monday January 7, 8:35 am ET
- 85% of patients achieve undetectable HCV RNA levels following 4 weeks of treatment with R7128 1500mg and Pegasys(R) plus Copegus(R) with safety and tolerability comparable to placebo -
- Conference Call Scheduled for 4:00PM ET Today -
PRINCETON, N.J., Jan. 7 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News) announces the preliminary results of a 4-week Phase 1 clinical trial to evaluate two oral dose levels of R7128 in combination with Pegasys (pegylated interferon) plus Copegus (ribavirin) in 50 treatment-naive patients chronically infected with hepatitis C virus (HCV) genotype 1. In this study, R7128 demonstrated potent short-term antiviral activity and was generally safe and well-tolerated. Eighty-five (85%) of patients receiving R7128 1500mg and Pegasys plus Copegus achieved undetectable HCV RNA levels following 4 weeks of treatment with safety and tolerability comparable to placebo. R7128 is a prodrug of PSI-6130, a cytidine nucleoside analogue polymerase inhibitor of HCV that is being developed through Pharmasset's collaboration with Roche.
http://biz.yahoo.com/prnews/080107/clm042.html?.v=101
http://biz.yahoo.com/prnews/071102/clf043.html?.v=99
Pharmasset Presents R7128 14-Day Monotherapy Study Results for the Treatment of Chronic Hepatitis C
Friday November 2, 5:00 am ET
-Nucleoside polymerase inhibitor demonstrates >99% mean decrease in HCV RNA with no serious adverse events-
PRINCETON, N.J., Nov. 2 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News) announces the results of a 14-day Phase 1 multiple ascending dose monotherapy study of R7128 for the treatment of chronic hepatitis C infection. In this study, being presented as a "late-breaker" abstract at the 58th Annual Meeting of the American Association for the Study of Liver Diseases, R7128 demonstrated potent antiviral activity and was generally safe and well-tolerated. R7128 is an orally administered prodrug of PSI-6130, a cytidine nucleoside analogue polymerase inhibitor of hepatitis C virus (HCV) that is being developed through Pharmasset's collaboration with Roche.
"R7128 has provided positive proof-of-concept that a single, direct-acting antiviral can deliver sufficient potency to suppress HCV in an interferon non- responder population," stated Dr. Michelle Berrey, Pharmasset's Vice President, Clinical Development & Chief Medical Officer. "Since robust synergy has been observed with other potent inhibitors when combined with the standard of care for HCV, we hope that these monotherapy results will translate well when R7128 is used with standard of care for longer duration in a treatment-naive population."
Dr. Rajender Reddy, Professor of Medicine and Surgery in the Division of Gastroenterology at the University of Pennsylvania and a clinical investigator in the study, noted "R7128's safety profile is encouraging, with no serious or treatment-limiting adverse events reported even at the highest dose tested. In addition, there were actually a higher number of adverse events reported in the placebo group than in the treated arms of this study. Safety is an important aspect of new HCV therapies, because the current standard of care is not always as well tolerated as desired."
The R7128 scientific presentation will be available for download in PDF format following the conference in the "R7128 Presentations & Publications" section of Pharmasset's website at http://www.pharmasset.com/pipeline/R7128-publications.asp.
R7128 Phase 1 Multiple Ascending Dose Study Overview
The Phase 1 clinical trial is a multiple center, observer-blinded, randomized and placebo-controlled study was conducted in 40 patients chronically-infected with HCV genotype 1 who previously failed interferon therapy. The primary objective was to assess the safety, tolerability and pharmacokinetics of R7128 after once-daily (QD) or twice-daily (BID) dosing for 14 days. The secondary objective was to assess antiviral activity by measuring the change in HCV RNA.
R7128 Safety Summary
R7128 was generally safe and well tolerated, and all patients completed the study. There were no serious adverse events, no adverse events requiring dose modification, no dose-related gastrointestinal adverse events and no clinically significant changes in hematologic or other laboratory parameters. The preliminary data on adverse events (AEs) reported shows the highest incidence of AEs was in the placebo group with 34 events in 7 of 8 patients receiving placebo. During treatment in patients receiving R7128, most of the AEs reported were of mild intensity. Eighteen AEs were reported in 7 of 8 subjects that received 750mg QD, 6 AEs in 3 of 8 subjects receiving 1500mg QD, 13 AEs in 4 of 8 subjects receiving 750mg BID and 14 AEs in 4 of 8 subjects receiving 1500mg BID. The most frequently reported AEs for patients receiving R7128 were headache (13), dry mouth (3), nausea (2), fatigue (2), tiredness (2) and upper respiratory infection (2). In subjects on placebo, the most commonly reported AEs were headache (4) and diarrhea (4).
R7128 Antiviral Activity Summary
R7128 demonstrated potent, dose-dependent antiviral activity across the four patient cohorts (8 active, 2 placebo per cohort) receiving 750 mg or 1500 mg administered either QD or BID for 14 days as monotherapy. Both the greatest mean and maximum decrease in HCV RNA from baseline were demonstrated in the patient cohort that received 1500 mg BID. R7128 demonstrated a mean HCV RNA decrease of -0.9 log10 IU/mL (87.4%), -1.5 log10 IU/mL (96.8%), -2.1 log10 IU/mL (99.2%) and -2.7 log10 IU/mL (99.8%) in patients receiving 750mg QD, 1500mg QD, 750mg BID and 1500 mg BID, respectively. All four dose groups reached nadir values at Day 15. A maximum -4.2 log10 IU/mL (99.9%) HCV RNA decrease was demonstrated in a patient following 14 days of monotherapy with 1500 mg BID of R7128, which was also below the level of detection (<15 IU/ml). There was no clinical evidence of viral rebound in any dose cohort during the 14 days of dosing, which provides early evidence of high genetic barrier for nucleoside inhibitors of NS5b polymerase.
Pharmasset is currently enrolling a 4-week Phase 1 clinical trial to evaluate R7128 in combination with Pegasys® (pegylated interferon) plus Copegus® (ribavirin) in up to 75 treatment-naïve patients chronically infected with hepatitis C virus (HCV) genotype 1. The primary objective is to assess the safety, tolerability and pharmacokinetics of R7128 in combination with Pegasys plus Copegus. The secondary objective is to evaluate the short- term change in HCV RNA. The study will investigate up to three oral dose levels of R7128 (500 mg to 1500 mg) administered twice-daily with Pegasys plus Copegus for 4 weeks. Please see www.clinicaltrials.gov or e-mail clinicaltrials@pharmasset.com for more information.
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 the Americas 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 orally administered treatment for chronic HCV infection, is enrolling a 4-week Phase 1 clinical trial in combination with Pegasys® and 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.
About R7128
R7128 is being developed for the treatment of chronic HCV infection. R7128 is a prodrug of PSI-6130, a pyrimidine 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. Results from an oral single ascending dose study of PSI-6130 in 24 healthy male volunteers showed that PSI-6130 was generally well tolerated with no serious adverse events in doses up to 3000 mg.
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost four million people in the United States have been infected with HCV, of whom 2.7 million are chronically infected.
Contact
Alan Roemer, Vice President
Investor Relations & Corporate Communications
alan.roemer@pharmasset.com
Office: (609) 613-4125
Pegasys® and Copegus® are registered trademarks of Roche.
Pharmasset Enters Antiviral Research Collaboration with the University of Cincinnati's Genome Research Institute
PRINCETON, N.J., Oct. 31 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) entered into a research collaboration and license agreement with the University of Cincinnati (UC) on behalf of its Genome Research Institute (GRI). The purpose of the collaboration between Pharmasset and GRI's drug discovery professionals is to identify active and selective compounds against antiviral targets for hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
According to the terms of the agreement, UC granted Pharmasset access to the GRI Lead Generation Library, which includes over 250,000 compounds. Pharmasset will also gain access to GRI's drug discovery capabilities, including high-throughput screening, computational chemistry and in silico docking expertise, which are led by Ruben Papoian, PhD. UC granted Pharmasset commercial rights for any lead compounds that are identified for HBV, HIV and HCV. Pharmasset will make an annual payment to UC in support of the research collaboration and shall be responsible for all development expenses of products that may result from the collaboration. If a lead compound progresses through clinical development activities and achieves regulatory approval, Pharmasset will make certain milestone payments and pay a royalty on any net sales of the product. The specific financial terms of the research collaboration and license agreement will not be disclosed.
'The University of Cincinnati's Genome Research Institute has resources and expertise that will expand our discovery efforts,' stated Dr. Michael Otto, Executive Vice President, Pharmaceutical Research. 'The GRI compound library, drug discovery platform and biology capabilities provide tremendous leverage for our internal efforts. We are very optimistic about the potential of this collaboration.'
'The research collaboration and license agreement with Pharmasset marks an important step for UC's Genome Research Institute, as we strive not only to discover new drug treatments with the potential to improve health, but also to provide a meaningful fiscal return on our research investment,' stated George Thomas, PhD, Professor of Genome Science and Interim Director of GRI. 'We believe that Pharmasset will be an excellent collaboration partner, as their team is very experienced in the discovery and development of antiviral compounds.'
About the Genome Research Institute
In 2001, the University of Cincinnati (UC) Academic Health Center received a gift of land and a 360,000 square foot facility in Reading, Ohio from Aventis Pharmaceuticals. The gift set in motion a two-year, $44 million renovation of the vacant building to create UC's Genome Research Institute (GRI). Nearly 40 principal investigators and 350 support staff and personnel work at the GRI to advance life science research by combining the talents, creativity and resources of academic and industrial scientists to develop treatments for cancer, metabolic disorders and other diseases. The interdisciplinary research program at GRI features core facilities for drug discovery, proteomics, structural biology, protein production and animal phenotype analysis.
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 the Americas 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 enrolling a 28-day Phase 1 clinical trial in combination with Pegasys(R) and Copegus(R) 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.
Contact
Alan Roemer, Vice President
Investor Relations & Corporate Communications
alan.roemer@pharmasset.com
Thats why I always sell "Fast Track Designation" news releases, the VRUS drug would be 8-10 years out before anything comes from it.
Perfectly timed cover for insiders to dump shares pursuant to the accelerated IPO lockup expiration.
R7128 Receives Fast Track Designation from the FDA for the Treatment of Chronic Hepatitis C Infection
PRINCETON, N.J., Oct. 24 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) has received fast track designation from the U.S. Food and Drug Administration (FDA) for R7128 for the treatment of chronic hepatitis C virus (HCV) infection. R7128 is a prodrug of PSI-6130, an oral cytidine nucleoside analog polymerase inhibitor of HCV that is being developed through Pharmasset's collaboration with Roche. Pharmasset is currently enrolling a 28-day Phase 1 clinical trial to evaluate R7128 in combination with Pegasys(R) (pegylated interferon) plus Copegus(R) (ribavirin) in treatment-naive patients chronically infected with hepatitis C virus (HCV) genotype 1. Please see www.clinicaltrials.gov or e-mail clinicaltrials@pharmasset.com for more information.
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 life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition. R7128 was granted the fast track designation primarily due to the need for HCV treatments with novel mechanisms of action, oral administration, different resistance profiles and improved safety and efficacy over the existing standard of care for both treatment-naive and treatment-experienced patients.
'The FDA's fast track designation for R7128 acknowledges the urgent need for new HCV drugs,' stated Dr. Michelle Berrey, Pharmasset's Vice President, Clinical Development & Chief Medical Officer. 'Currently, there are no HCV polymerase inhibitors approved for the treatment of chronic HCV infection. We continue to work closely with our HCV partner, Roche, and the FDA on the development and regulatory review of R7128, which has demonstrated compelling antiviral activity and has been generally well-tolerated in clinical trials to date.'
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 the Americas 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 enrolling a 28-day Phase 1 clinical trial in combination with Pegasys(R) and Copegus(R) 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.
About R7128
R7128 is being developed for the treatment of chronic HCV infection. R7128 is a prodrug of PSI-6130, a pyrimidine 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. Results from an oral single ascending dose study of PSI-6130 in 24 healthy male volunteers showed that PSI-6130 was generally well tolerated with no serious adverse events in doses up to 3000 mg.
R7128 Phase 1 Study Overview
The Phase 1 clinical trial is a multiple center, observer-blinded, randomized and placebo-controlled study to investigate the pharmacokinetics, pharmacodynamics, safety, tolerability and food effect of R7128 in healthy volunteers and in patients chronically infected with HCV genotype 1. This adaptive Phase 1 study is comprised of three parts:
Part 1 is a single ascending dose study of R7128 conducted in 46 healthy volunteers. The primary objective of Part 1 is to assess the safety, tolerability and pharmacokinetics of R7128 following single ascending doses under fasting conditions. The secondary objective of Part 1 is to explore the effect of food on the pharmacokinetics of R7128. Results from the single ascending dose portion of the study indicated that all doses of R7128 studied (500 mg to 9000 mg) were generally safe and well-tolerated. All patients completed the study, and none experienced gastrointestinal adverse events or serious adverse events during the study. No hematological or laboratory abnormalities of clinical significance were noted.
Part 2 is a multiple ascending dose study of R7128 conducted in 40 patients chronically-infected with HCV genotype 1 who previously failed interferon therapy. The primary objective of Part 2 is to assess the safety, tolerability and pharmacokinetics of R7128 after once-daily (QD) or twice- daily (BID) dosing for 14 days. The secondary objective is to assess antiviral activity by measuring the change in HCV RNA. Preliminary data from the multiple ascending dose portion of the study indicated that R7128 demonstrated potent, dose-dependent antiviral activity in four patient cohorts receiving 750 mg or 1500 mg administered either once-daily or twice-daily for 14 days as monotherapy. Patients receiving 1500 mg BID demonstrated a mean 2.7 log10 IU/mL (>99%) decrease in HCV RNA. There was no evidence of viral rebound in any dose cohort during the 14 days of dosing. R7128 was generally safe and well tolerated. There were no serious adverse events, no adverse events requiring dose modification, no dose-related gastrointestinal adverse events and no clinically significant changes in hematologic or other laboratory parameters.
Part 3 is a multi-center, observer-blinded, within-cohort randomized, placebo-controlled study being conducted in up to 75 treatment-naive patients with genotype 1 hepatitis C virus. The primary objective is to assess the safety, tolerability and pharmacokinetics of R7128 in combination with Pegasys plus Copegus. The secondary objective of Part 3 is to evaluate the short-term change in HCV RNA. The study will include two to three oral doses of R7128 (500 mg to 1500 mg) that are being administered twice-daily with Pegasys plus Copegus for 28 days.
Pegasys(R) and Copegus(R) are registered trademarks of Roche.
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost four million people in the United States have been infected with HCV, of whom 2.7 million are chronically infected.
Contact
Alan Roemer, Vice President
Investor Relations & Corporate Communications
alan.roemer@pharmasset.com
Office: (609) 613-4125
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 the FDA withdraws the R7128 fast track designation, the risk that the FDA does not expedite the review or approval of any application for R7128, the risk that adverse events could cause the cessation of the Phase 1 study and/or our development of R7128, the risk that our collaboration with Roche will not continue or will not be successful, the risk that the on-going or anticipated clinical trials for any one or more of our product candidates will not be successful or will not provide meaningful data 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 Quarterly Report on Form 10-Q for the quarter ended June 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.
SOURCE Pharmasset, Inc.
Source: PR Newswire (October 24, 2007 - 8:35 AM EDT)
News by QuoteMedia
www.quotemedia.com
VRUS is the topic du jour on the Biotech Values board (#board-1418).
Pharmasset Commences Dosing in 28-Day Combination Study of R7128 with Pegasys(R) plus Copegus(R) for Hepatitis C
PRINCETON, N.J., Oct. 3 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) has commenced dosing in a Phase 1 study of R7128 in combination with Pegasys (pegylated interferon) plus Copegus (ribavirin) in up to 75 treatment-naive patients chronically infected with hepatitis C virus (HCV) genotype 1. R7128 is a prodrug of PSI-6130, an oral cytidine nucleoside analog polymerase inhibitor of HCV that is being developed through Pharmasset's collaboration with Roche. The purpose of this study is a preliminary evaluation of safety, tolerability, pharmacokinetics and antiviral activity of R7128 in the clinically-relevant setting of combination therapy with the current standard of care for chronic HCV infection.
The study will include two to three oral doses of R7128 (500 mg to 1500 mg) that will be administered twice-daily with Pegasys plus Copegus for 28 days. There will be 25 patients in each dose cohort with 20 patients randomized to receive R7128 and 5 patients randomized to receive placebo, all administered in combination with the standard of care. After completing 28 days of the triple combination regimen and a follow-up period of 4 weeks of Pegasys plus Copegus, all patients will then receive 40 weeks of open-label standard of care dosing under a separate protocol. Please see www.clinicaltrials.gov or e-mail clinicaltrials@pharmasset.com for more information.
'We are excited about the rapid pace of development of R7128, and the opportunity to evaluate its safety and potency in combination with the standard of care,' stated Dr. Michelle Berrey, Pharmasset's Vice President, Clinical Development & Chief Medical Officer. 'The 28-day endpoint will provide meaningful data on early viral kinetics and the proportion of patients who have undetectable HCV RNA by the end of this treatment period. We look forward to sharing the preliminary results of this combination study in the first quarter of 2008 and making plans for future studies of R7128.'
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, an oral treatment for chronic HBV infection, is in Phase 3 clinical trials for registration in the Americas 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 Phase 1 clinical trial 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.
About R7128
R7128 is being developed for the treatment of chronic HCV infection. R7128 is a prodrug of PSI-6130, a pyrimidine nucleoside analog inhibitor of HCV RNA polymerase. Results from an oral single ascending dose study of PSI-6130 in 24 healthy male volunteers showed that PSI-6130 was generally well tolerated with no serious adverse events in doses up to 3000 mg.
R7128 Phase 1 Study Overview
The Phase 1 clinical trial is a multiple center, observer-blinded, randomized and placebo-controlled study to investigate the pharmacokinetics, pharmacodynamics, safety, tolerability and food effect of R7128 in healthy volunteers and in patients chronically infected with HCV genotype 1. This adaptive Phase 1 study is comprised of three parts:
Part 1 is a single ascending dose study of R7128 conducted in 46 healthy volunteers. The primary objective of Part 1 is to assess the safety, tolerability and pharmacokinetics of R7128 following single ascending doses under fasting conditions. The secondary objective of Part 1 is to explore the effect of food on the pharmacokinetics of R7128. Results from the single ascending dose portion of the study indicated that all doses of R7128 studied (500 mg to 9000 mg) were generally safe and well-tolerated. All patients completed the study, and none experienced gastrointestinal adverse events or serious adverse events during the study. No hematological or laboratory abnormalities of clinical significance were noted.
Part 2 is a multiple ascending dose study of R7128 conducted in 40 patients chronically-infected with HCV genotype 1 who previously failed interferon therapy. The primary objective of Part 2 is to assess the safety, tolerability and pharmacokinetics of R7128 after once-daily (QD) or twice- daily (BID) dosing for 14 days. The secondary objective is to assess antiviral activity by measuring the change in HCV RNA. Preliminary data from the multiple ascending dose portion of the study indicated that R7128 demonstrated potent, dose-dependent antiviral activity in four patient cohorts receiving 750 mg or 1500 mg administered either once-daily or twice-daily for 14 days as monotherapy. Patients receiving 1500 mg BID demonstrated a mean 2.7 log10 IU/mL (>99%) decrease in HCV RNA. There was no evidence of viral rebound in any dose cohort during the 14 days of dosing. R7128 was generally safe and well tolerated. There were no serious adverse events, no adverse events requiring dose modification, no dose-related gastrointestinal adverse events and no clinically significant changes in hematologic or other laboratory parameters.
Part 3 is a multi-center, observer-blinded, within-cohort randomized, placebo-controlled study being conducted in up to 75 treatment-naive patients with genotype 1 hepatitis C virus. The primary objective is to assess the safety, tolerability and pharmacokinetics of R7128 in combination with Pegasys plus Copegus. The secondary objective of Part 3 is to evaluate the short-term change in HCV RNA. The study will include two to three oral doses of R7128 (500 mg to 1500 mg) that are being administered twice-daily with Pegasys plus Copegus for 28 days.
Pegasys and Copegus are registered trademarks of Roche.
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost four million people in the United States have been infected with HCV, of whom 2.7 million are chronically infected.
Differences between US and Korean Clevudine trials:
#msg-21955710.
Score One for Pharmasset
By Brian Lawler September 11, 2007
It's usually pretty easy to tell when a drugmaker announces positive clinical trial results by the rise in its shares after that data is released. Shares of Pharmasset (Nasdaq: VRUS) were up 15% yesterday after it announced the first efficacy data on its hepatitis C virus (HCV) drug candidate R7128.
The first viral load reduction results for R7128 were fairly impressive. Pharmasset tested the drug in eight patients with genotype 1 HCV (the most common subtype in the U.S.) who had previously failed other therapies. [If you're a Fool who revels in detail, more about the study results can be found at the end of this article.]
Based on the results, Pharmasset and partner Roche plan to expedite the development of R7128. Rather than waiting for the second quarter of 2008 -- as previously planned -- to initiate combination studies of R7128 with Roche's Pegasys and Ribavirin, the partners will commence these combo studies in the next couple of weeks. Look for R7128 to perform even better on the efficacy side of things due to the combination treatment with Pegasys, longer 28-day treatment duration, and use in patients who have never been treated with an antiretroviral treatment.
Other potent HCV oral antivirals have been derailed in the past due to problems with their safety. If R7128 can keep away from these safety issues it looks like Pharmasset has a potential hit on its hands.
I recently highlighted Pharmasset as a biotech bet that investors should keep their eyes on due to the potential of R7128 and its other HCV and HIV drugs in development. Investors should watch closely the expanded data set from this phase 1 study that Pharmasset presents at the upcoming American Association for the Study of Liver Diseases medical conference in the first week of November.
As promised, a feast of details
After 14 days of treatment, patients who received the highest dose of R7128 experienced a 2.7 log reduction in the amount of hepatitis C virus in their bloodstream. In comparison, Vertex Pharmaceuticals' (Nasdaq: VRTX) exciting Telaprevir produced a 4.4 log viral load reduction after 14 days in phase 1 testing, and ViroPharma's (Nasdaq: VPHM) non-nucleoside polymerase inhibitor (which ultimately failed due to safety concerns) produced between 2.6 and 3.2 log viral load reductions in combination with pegylated interferon for genotype 1 patients after 14 days of treatment.
R7128 Demonstrates Safety and Potent Antiviral Activity in HCV-Infected Patients
Monday September 10, 7:00 am ET
- Phase 1 Study Results in 2.7 log10 (>99%) Mean HCV RNA Decrease with No Serious Adverse Events -
- Conference Call Scheduled for 8:30AM (ET) Today -
PRINCETON, N.J., Sept. 10 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News) reports preliminary safety and potent antiviral activity with R7128 following 14 days of monotherapy in 40 patients chronically infected with hepatitis C virus (HCV) who have failed prior interferon therapy. R7128 is a prodrug of PSI-6130, an oral cytidine nucleoside analog polymerase inhibitor of HCV that is being developed through Pharmasset's collaboration with Roche. The Phase 1 multiple ascending dose study of R7128 was designed to evaluate safety, tolerability, pharmacokinetics and preliminary antiviral activity.
R7128 demonstrated potent, dose-dependent antiviral activity across the four patient cohorts (n=10; 8 active, 2 placebo) receiving 750 mg or 1500 mg administered either once-daily or twice-daily for 14 days as monotherapy. The greatest mean decrease in HCV RNA from baseline was demonstrated in the patient cohort that received 1500 mg twice-daily, the highest dose of R7128 administered in this study. These patients demonstrated a mean 2.7 log10 IU/mL (>99%) decrease in HCV RNA. There was no evidence of viral rebound in any dose cohort during the 14 days of dosing.
R7128 was generally safe and well tolerated in this Phase 1 multiple ascending dose study. There were no serious adverse events, no adverse events requiring dose modification, no dose-related gastrointestinal adverse events and no clinically significant changes in vital signs, electrocardiograms, hematologic, renal or other laboratory parameters.
Based on the results of this study, Pharmasset and Roche plan to initiate a 28-day study of R7128 in combination with Pegasys (pegylated interferon) plus Copegus (ribavirin) in treatment-naive patients chronically infected with HCV genotype 1. Patient recruitment for this combination study is expected to begin in late September 2007. The purpose of this study is a preliminary evaluation of the safety, tolerability, pharmacokinetics and antiviral activity of R7128 in the clinically-relevant setting of combination therapy with the current standard of care consisting of Pegasys plus Copegus. Please see www.clinicaltrials.gov or e-mail clinicaltrials@pharmasset.com for more information.
In addition, a late breaker abstract for the Phase 1 multiple ascending dose study has been accepted as a presentation at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) being held in Boston, MA from November 2-6, 2007. In accordance with the conference press embargo guidelines, no additional data will be available for this study until the scientific abstracts are published by AASLD on October 1, 2007.
Dr. Rajender Reddy, Professor of Medicine and Surgery in the Division of Gastroenterology at the University of Pennsylvania and a clinical investigator in the R7128 multiple ascending dose study, stated "The R7128 results are exciting based on the combination of potency, safety and tolerability. There were no major organ or other acute toxicities observed during the 14-day dosing period, which is encouraging for future studies with longer exposures to R7128 in combination with the standard of care. Leading clinicians believe that HCV therapy will evolve to include direct-acting antiviral drug combinations, and nucleoside polymerase inhibitors such as R7128 could improve sustained virologic response (SVR) rates for the treatment of chronic HCV."
"R7128 has demonstrated the most potent antiviral activity of any investigational nucleoside HCV polymerase inhibitor to date in doses suitable for progression into future combination studies," stated Dr. Michelle Berrey, Pharmasset's Vice President, Clinical Development & Chief Medical Officer. "Nucleosides are the cornerstone of antiviral therapeutic regimens due to their potency and safety profile. In addition, nucleosides have a significantly higher genetic barrier than non-nucleosides and protease inhibitors, which protects against drug-resistant mutations of HCV. We are pleased to be partnered with Roche for the development and commercialization of R7128. Roche continues to position itself as a company focused on expanding their market-leading HCV franchise to improve the lives of patients chronically infected with hepatitis C."
Conference Call
Pharmasset will host a conference call at 8:30AM (ET) on Monday, September 10, 2007 to discuss the R7128 Phase 1 study results.
Dial-in Information:
Domestic callers: 1 (800) 811-0667 (US/Canada)
International callers: 1 (913) 981-4901 (International)
Live audio of the conference call will be simultaneously broadcast over the internet via a webcast. To access the live webcast, log on to the "Events & Presentations" section of the Investor Center on Pharmasset's corporate website at http://investor.pharmasset.com/events.cfm.
Please connect to the company's website at least ten minutes prior to the start of the presentation to ensure adequate time for a reliable connection and any software download that may be necessary to listen to the webcast. The archived replay of the webcast will be available on the Pharmasset website for two weeks following the conference call.
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 expected to enter Phase 3 clinical trials for registration in the Americas and Europe. Clevudine is already approved for HBV in South Korea and marketed by Bukwang Pharmaceuticals under the brand name Levovir. R7128, an oral treatment for chronic HCV infection, is in a Phase 1 clinical trial 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.
About R7128
R7128 is being developed for the treatment of chronic hepatitis C. R7128 is a prodrug of PSI-6130, which demonstrated potency in preclinical studies. PSI-6130 is a pyrimidine nucleoside analog inhibitor of HCV RNA polymerase, an enzyme that is necessary for hepatitis C viral replication. Results from an oral single ascending dose study of PSI-6130 in 24 healthy male volunteers showed that PSI-6130 was generally well tolerated with no serious adverse events in doses up to 3000 mg.
R7128 Phase 1 Study Overview
The Phase 1 clinical trial is a multiple center, observer-blinded, randomized and placebo-controlled study to investigate the pharmacokinetics, pharmacodynamics, safety, tolerability and food effect of R7128 in healthy volunteers and in patients chronically infected with HCV genotype 1. This Phase 1 study is comprised of two parts:
- Part 1 is a single ascending dose study of R7128 conducted in 46
healthy volunteers. The primary objective of Part 1 is to assess the
safety, tolerability and pharmacokinetics of R7128 following single
ascending doses under fasting conditions. The secondary objective of
Part 1 is to explore the effect of food on the pharmacokinetics of
R7128. Preliminary data from the single ascending dose portion of the
study indicate:
-- All doses of R7128 studied were generally safe and well-tolerated.
-- All patients completed the study, and none experienced
gastrointestinal adverse events or serious adverse events during
the study.
-- No hematological or laboratory abnormalities of clinical
significance were noted.
- Part 2 is a multiple ascending dose study of R7128 conducted in 40
patients chronically infected with HCV genotype 1 who have previously
failed interferon therapy. The primary objective of Part 2 is to
assess the safety, tolerability and pharmacokinetics of R7128 after
once-daily or twice-daily dosing for 14 days. The secondary objective
is to assess antiviral activity by measuring the change in HCV RNA.
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The World Health Organization estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost four million people in the United States have been infected with HCV, of whom 2.7 million are chronically infected.
Contact
Alan Roemer, Vice President
Investor Relations & Corporate Communications
alan.roemer@pharmasset.com
Office: (609) 613-4125
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 there will be a delay in the release of R7128 safety, tolerability, pharmacokinetic and antiviral efficacy data from the Phase 1 multiple ascending dose study, the risk that there will be a delay in the presentation of safety, tolerability, pharmacokinetic and food effect and pharmacokinetic data from the Phase 1 single ascending dose study, the risk that the preliminary R7128 data from the Phase 1 multiple ascending dose study is not accurate or representative, the risk that the data from the R7128 Phase 1 single ascending dose study is not accurate or representative, the risk that our collaboration with Roche will not continue or will not be successful, the risk that the on-going or anticipated clinical trials for any one or more of our product candidates will not be successful, the risk that any one or more of our product candidates will not be successfully developed and commercialized and the risk that HCV therapy will not evolve to include direct-acting antiviral drug combinations, and nucleoside polymerase inhibitors such as R7128. 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 Quarterly Report on Form 10-Q for the quarter ended June 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.
Source: Pharmasset, Inc.
Pharmasset and Roche to Present R7128 Data at the 14th International Symposium on Hepatitis C Virus and Related Viruses
PRINCETON, N.J., Sept. 6 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) and Roche (OTC: RHHBY) announced today that four scientific presentations related to R7128 for the treatment of chronic hepatitis C virus (HCV) will be made at the 14th International Symposium on Hepatitis C Virus and Related Viruses being held from September 9-13, 2007 in Glasgow, Scotland. R7128, a prodrug of PSI-6130, is an oral cytidine nucleoside analog polymerase inhibitor of HCV that is being developed through Pharmasset's collaboration with Roche. In addition, Pharmasset will present data on proprietary phosphoramidate HCV RNA inhibitors. The conference abstract information is listed below, and the poster presentations will be available in the 'Events & Presentations' section of Pharmasset's website at http://www.pharmasset.com on September 10, 2007.
'The presentations at the HCV Symposium represent our growing knowledge about R7128's preclinical properties, clinical safety and pharmacokinetics,' stated Dr. Michael Otto, Pharmasset's Executive Vice President, Pharmaceutical Research. 'In addition, Pharmasset's internal HCV discovery efforts have identified additional proprietary compounds that may have complementary or improved properties. We will carefully evaluate these molecules for potential advancement toward future development.'
Poster presentations at the 14th International Symposium on Hepatitis C Virus and Related Viruses will include:
-- Abstract P-268: Pharmacokinetics, Safety, and Tolerability of R7128, a
Novel Nucleoside Polymerase Inhibitor for HCV Following Single,
Ascending Oral Doses in Healthy Volunteers. Otto MJ, Robson R,
Rodriguez CA, Beard A, Symonds WT, Hill G and Berrey MM (Pharmasset,
Christchurch Clinical Studies Trust and Roche Palo Alto).
-- Abstract P-262: The Mechanism of Action of Beta-D-2'-Deoxy-2'-fluoro-
2'-C-methylcytidine Involves a Second Metabolic Pathway Leading to
Beta-D-2'-Deoxy-2'-fluoro-2'-C-methyluridine 5'-Triphosphate, a Potent
Inhibitor of the HCV RNA-Dependent RNA Polymerase. Murakami E, Niu C,
Bao H, Micolochick Steuer HM, Otto MJ and Furman PA (Pharmasset).
-- Abstract P-265: The Nucleoside Inhibitors R1479, PSI-6130, and NM107
have a Higher Genetic Barrier to Resistance than the Non-nucleoside
Inhibitor HCV-796 and the Protease Inhibitor VX-950. McCown M,
Rajyaguru S, Symons J, Cammack N and Najera I (Roche Palo Alto).
-- Abstract P-263: In Vitro Selection and Characterization of HCV
Replicons Resistant to PSI-6130. Ali S, Leveque V, LePogam S, Ma H,
Philipp F, Najera I, Klumpp K, Symons J, Cammack N and Jiang WR (Roche
Palo Alto).
-- Abstract P-259: Beta-D-2'-Deoxy-2'-fluoro-2'-C-methyluridine
Phosphoramidates: Potent and Selective Inhibitors of HCV RNA
Replication. Sofia MJ, Wang P, Du J, Micolochick Steuer HM, Niu C,
Furman PA and Otto MJ (Pharmasset).
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 expected to enter Phase 3 clinical trials for registration in the Americas and Europe. Clevudine is already approved for HBV in South Korea and marketed by Bukwang Pharmaceuticals under the brand name Levovir. R7128, an oral treatment for chronic HCV infection, is in a Phase 1 clinical trial 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.
About R7128
R7128 is being developed for the treatment of chronic hepatitis C. R7128 is a prodrug of PSI-6130, which demonstrated potency in preclinical studies. PSI-6130 is a pyrimidine nucleoside analog inhibitor of HCV RNA polymerase, an enzyme that is necessary for hepatitis C viral replication. Results from an oral single ascending dose study of PSI-6130 in 24 healthy male volunteers showed that PSI-6130 was generally well tolerated with no serious adverse events in doses up to 3000 mg.
R7128 Phase 1 Study Overview
The Phase 1 clinical trial is a multiple center, observer-blinded, randomized and placebo-controlled study to investigate the pharmacokinetics, pharmacodynamics, safety, tolerability and food effect of R7128 in healthy volunteers and in patients chronically infected with HCV genotype 1. This Phase 1 study is comprised of two parts:
-- Part 1 is a single ascending dose study of R7128 conducted in 46
healthy volunteers. The primary objective of Part 1 is to assess the
safety, tolerability and pharmacokinetics of R7128 following single
ascending doses under fasting conditions. The secondary objective of
Part 1 is to explore the effect of food on the pharmacokinetics of
R7128. Preliminary data from the single ascending dose portion of the
study indicate:
-- All doses of R7128 studied were generally safe and well-tolerated.
-- All patients completed the study, and none experienced
gastrointestinal adverse events or serious adverse events during
the study.
-- No hematological or laboratory abnormalities of clinical
significance were noted.
-- Part 2 is a multiple ascending dose study of R7128 conducted in 40
patients chronically infected with HCV genotype 1 who have previously
failed interferon therapy. The primary objective of Part 2 is to
assess the safety, tolerability and pharmacokinetics of R7128 after
once-daily or twice-daily dosing for 14 days. The secondary objective
is to assess antiviral efficacy by measuring the change in HCV RNA.
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost four million people in the United States have been infected with HCV, of whom 2.7 million are chronically infected.
Contact
Alan Roemer, Vice President
Investor Relations & Corporate Communications
alan.roemer@pharmasset.com
Office: (609) 613-4125
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 there will be a delay in the presentation of R7128 data at upcoming conferences, the risk that the R7128 data to be presented at upcoming conferences is not accurate or representative, the risk that the preliminary data from the R7128 Phase 1 Study is not accurate or representative, the risk that our collaboration with Roche will not continue or will not be successful, the risk that the on-going or anticipated clinical trials for any one or more of our product candidates will not be successful, the risk that any one or more of our product candidates will not be successfully developed and commercialized, and the risk that our proprietary compounds will not be successfully developed into product candidates or 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 Quarterly Report on Form 10-Q for the quarter ended June 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.
SOURCE Pharmasset, Inc.
Source: PR Newswire (September 6, 2007 - 9:03 AM EST)
News by QuoteMedia
www.quotemedia.com
Pharmasset Completes Enrollment of Phase 1 Study of R7128 for HCV
- Anticipate Preliminary 14-day Multiple Ascending Dose Efficacy Data in September 2007 -
PRINCETON, N.J., Aug. 2 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) has completed patient enrollment of the ongoing multiple ascending dose study of R7128 for the treatment of hepatitis C virus (HCV). R7128, a nucleoside polymerase inhibitor of HCV, is currently being evaluated in a Phase 1 clinical trial as part of Pharmasset's collaboration with Roche. The primary objective of the multiple ascending dose study is to assess the safety, tolerability and pharmacokinetics of R7128 after once-daily or twice- daily dosing for 14 days in up to 40 patients chronically infected with HCV genotype 1 who have previously failed interferon therapy. The secondary objective is to assess antiviral efficacy by measuring the change in HCV RNA in these patients.
Pharmasset expects to release preliminary 14-day safety and efficacy treatment data from the multiple ascending dose study in September 2007. Results for the entire Phase 1 single ascending and multiple ascending dose study are expected to be presented at various scientific conferences throughout the remainder of 2007. As recently announced, Roche has initiated long-term chronic toxicology studies in support of the potential advancement of R7128 into Phase 2 clinical trials.
About R7128
R7128 is a polymerase inhibitor being developed for the treatment of chronic hepatitis C. R7128 is a prodrug of PSI-6130, which demonstrated potency in preclinical studies. PSI-6130 is a pyrimidine nucleoside analog inhibitor of HCV RNA polymerase, an enzyme that is necessary for hepatitis C viral replication. Results from an oral single ascending dose study in 24 healthy male volunteers showed that PSI-6130 was generally well tolerated with no serious adverse events in doses up to 3000 mg.
R7128 Phase 1 Study Overview
The Phase 1 clinical trial is a multiple center, observer-blinded, randomized and placebo-controlled study to investigate the pharmacokinetics, pharmacodynamics, safety, tolerability and food effect of R7128 in healthy volunteers and in patients chronically infected with HCV genotype 1. This Phase 1 study is comprised of two parts:
* Part 1 is a single ascending dose study conducted in 38 healthy
volunteers. The primary objective of Part 1 is to assess the safety,
tolerability and pharmacokinetics of R7128 following single ascending
doses under fasting conditions. The secondary objective of Part 1 is
to explore the effect of food on the pharmacokinetics of R7128.
* Preliminary data from the single ascending dose portion of the study
indicate:
-- All doses of R7128 studied were generally well-tolerated.
-- All patients completed the study with no gastrointestinal adverse
events or serious adverse events reported during the study.
-- No hematological or laboratory abnormalities of clinical
significance were noted.
* Part 2 is a multiple ascending dose study being conducted in up to 40
patients chronically infected with HCV genotype 1 who have previously
failed interferon therapy. The primary objective of Part 2 is to
assess the safety, tolerability and pharmacokinetics of R7128 after
once-daily or twice-daily dosing for 14 days. The secondary objective
is to assess antiviral efficacy by measuring the change in HCV RNA.
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Pharmasset, Inc., a clinical-stage pharmaceutical company, engages in the discovery, development, and commercialization of drugs to treat viral infections. It focuses on the development of oral therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). The company focuses on three product candidates: Clevudine, an oral pyrimidine nucleoside analog, for the treatment of HBV, which is entering the United States and European Phase III registration clinical trials, and is approved for HBV in South Korea and marketed by Bukwang Pharm. Co., Ltd. under the brand name Levovir; R7128, an oral pro-drug of PSI-6130 for the treatment of HCV, that is in a Phase 1 clinical trial through a strategic collaboration with F. Hoffmann-La Roche, Ltd. and Hoffmann-La Roche, Inc.; and Racivir for the treatment of HIV in combination with other approved HIV drugs that is in a Phase 2 clinical trial. It also engages in the discovery and development of additional antiviral therapeutics using nucleoside chemistry. Pharmasset was founded in 1998 as Pharmasset, Ltd. and changed its name to Pharmasset, Inc. in 2004. The company is headquartered in Princeton, New Jersey.
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