Navigation Links
R7128 Receives Fast Track Designation from the FDA for the Treatment of Chronic Hepatitis C Infection
Date:10/24/2007

ges 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
'/>"/>

SOURCE Pharmasset, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Sirion Therapeutics Receives Orphan Drug Designation for Ophthalmic Drug to Treat Viral Eye Infection
2. Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD
3. DUSA Pharmaceuticals Receives Orphan Drug Desi gnation for Levulan PDT to Treat Esophage al Dysplasia
4. Gloucester Pharmaceuticals Receives Fast Track Designation for Romidepsin in Peripheral T-Cell Lymphoma
5. Based on Up to 6 Years of Follow-Up, Biovest Announces Favorable Interim Blinded Data for Fast-Tracked Pivotal Phase 3 Clinical Trial of BiovaxID Anti-Cancer Vaccine for Non-Hodgkins Lymphoma
6. Accentia Biopharmaceuticals Announces Favorable Interim Blinded Data on SinuNase in Its Fast-Tracked Pivotal Phase 3 Clinical Trial for Chronic Sinusitis
7. Stanford Researchers Track Human Stem Cells Transplanted Into Rat Brain
8. Pixantrone Granted Fast Track Designation by FDA for Relapsed Indolent NHL Patients
9. Staphylococcus aureus vaccine development on track ? safe and immunogenic in Phase I clinicaltrials
10. Allos Therapeutics PDX Granted Orphan Medicinal Product Designation by the European Commission
11. Point of Care Strep Tests Speed Treatment, Lower Costs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/29/2014)...  Encision Inc. (OTCQB:ECIA), a medical device company owning ... in minimally invasive surgery, today announced financial results for ... The Company posted quarterly net revenue of ... thousand, or $(0.02) per share. These results compare to ... of $311 thousand, or $(0.04) per share, in the ...
(Date:7/29/2014)... , July 29, 2014   ... announced that it has taken an exclusive worldwide licence ... Ltd, a Durham University spin-out ... will pay an upfront fee, development and commercial milestone ... has also taken an option for additional exclusive licences ...
(Date:7/28/2014)... July 28, 2014  Dignity Health St. Mary,s ... the Get With The Guidelines®-Stroke Silver-Plus Quality Achievement ... by the American Heart Association/American Stroke Association for ... number four cause of death and a leading ... United States , according to the American ...
Breaking Medicine Technology:Encision Reports First Quarter Fiscal Year 2015 Results 2Encision Reports First Quarter Fiscal Year 2015 Results 3Encision Reports First Quarter Fiscal Year 2015 Results 4Glide Pharma Takes Exclusive Worldwide Rights to Novel Diagnostic Technology for Prostate Cancer 2Glide Pharma Takes Exclusive Worldwide Rights to Novel Diagnostic Technology for Prostate Cancer 3Dignity Health St. Mary's Medical Center Honored with Quality Achievement Award for Stroke Care 2Dignity Health St. Mary's Medical Center Honored with Quality Achievement Award for Stroke Care 3
(Date:7/29/2014)... Regents Health Resources, a consulting firm ... health care industry veteran Daryl Demonbreun and former St. ... the company’s ambitious plans to grow into a full-service ... moving along at a steady pace for nearly 20 ... notch,” says Bob Maier, founder and chief executive officer ...
(Date:7/29/2014)... Intermedix Corporation is proud to announce the ... The Clinical Data eXchange, or CDX, is an information ... data. , With this solution, state public health agencies, ... NEMSIS 3.0 compliant data from multiple field EMS data ... analyzed, and reported to the national NEMSIS data registry. ...
(Date:7/29/2014)... There is controversy over how best to treat ... Does one wait until the cancer comes back or ... recurrence? Now, a new study from Thomas ... help doctors and patients make a more informed decision. ... same," says first author Robert Den, M.D., Assistant Professor ...
(Date:7/29/2014)... procedure may enable more widespread use of preoperative testing ... with severe sleep apnea, suggests a study in ... and Dr. Jeff E. Mandel of the University of ... control" anesthetic technique for putting patients to sleep briefly-just ... apnea. The simplified technique requires no special expertise and ...
(Date:7/29/2014)... people can handle stressful situations better than others, ... identical twins show differences in how they respond. ... in the brains of genetically identical mice that ... stressful situations. , The findings, published July ... help researchers prevent potential consequences of chronic stress ...
Breaking Medicine News(10 mins):Health News:Sferrella and Demonbruen Join Regents Health Resources 2Health News:Intermedix Releases NEMSIS Compliant EMS Information System 2Health News:Genomic analysis of prostate cancer indicates best course of action after surgery 2Health News:New anesthesia technique helps show cause of obstruction in sleep apnea 2Health News:New anesthesia technique helps show cause of obstruction in sleep apnea 3Health News:A new brain-based marker of stress susceptibility 2
... each developed by Merck and Smith Glaxo Kline has found ... caused by the human papilloma viruses (HPVs). ... reduced infection in about 90% of the subjects. ... immunologic technologies have contributed to the discovery of the link ...
... revealed that having several older brothers increases the chances of ... //weight to the idea of a biological basis for sexual ... in St Catharines, Canada said, "It's likely to be a ... probably a biological basis for homosexuality." ,S Marc ...
... Graham Burton, M.D., SVP, Regulatory Affairs and Pharmacovigilance ... a new oral drug option// to the group ... ,Celgene Corporation (Nasdaq: CELG) announced that the U.S. ... for its Supplemental New Drug Application (sNDA) for ...
... had stated on Friday that the precedent conditions of ... outbreak at Durban's Mahatma Gandhi Memorial Hospital, which had ... Mseleku said, “Nobody needs to communicate these problems. We ... It's (overcrowding and staff shortages) a known fact.” That ...
... by K M Shah Dental College an eye wash and ... admission //process by with a supposed entrance test held by ... for granting admissions. ,The court, had issued a ... admission should continue and has asked the Gujarat University (GU) ...
... Quebec say that chronic job stress can raise blood ... ,The research, appearing in the American Journal of ... deadlines increased blood pressure especially in men. The study ... study supports the hypothesis that job strain, particularly in ...
Cached Medicine News:Health News:Klebsiella Outbreak In Durban Blamed On Staff Shortage & Overcrowding 2Health News:Gujarat High Court Stays PG Admissions In A Private Dental Collage 2
... Aplicare's saturated swabsticks are packaged in ... 4 inch swabstick is saturated with precisely ... The Gel Swabstick is saturated with a ... The gel is also approved for venipuncture ...
... BETADINE® Spray provides 5% ... pump spray. It delivers ... wounds too tender to ... and is indicated whenever ...
... that does not contain Alcohol. ... destroys over 99% of bacteria. ... of minor wounds, burns, cuts, ... personal utensils and tools. Prevents ...
BETADINE® Surgical Scrub is a microbicidal, sudsing cleanser that promptly kills most bacteria, fungi, viruses, protozoa and yeasts. It is indicated for hand hygiene, surgical hand-scrubbing, an...
Medicine Products: