Vertex to start Phase II trial for investigational Oral HCV protease inhibitor, FDA grants Fast Track designation.
Vertex Pharmaceuticals, Inc., Cambridge, MA, announced it has initiated a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
phase II for VX-950, an investigational oral hepatitis C virus
hepatitis C virus
HCV 1 Hepatitis C virus, see there 2. Human coronavirus. See Coronavirus. ) protease inhibitor for the treatment of HCV infection. The company also announced the FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. has granted Fast Track designation to the drug trial. Fast Track designation indicates that the FDA will facilitate the development and may expedite the review of a drug if it is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition.
The 28-day study will evaluate the safety, tolerability and pharmacodynamics pharmacodynamics /phar·ma·co·dy·nam·ics/ (-di-nam´iks) the study of the biochemical and physiological effects of drugs and the mechanisms of their actions, including the correlation of their actions and effects with their chemical of VX-950 when combined with pegylated interferon and ribavirin, two existing approved treatments for HCV infection. Vertex says this is the first clinical study of VX-950 to be initiated under an open investigational new drug (IND) application with the FDA and marks the beginning of a broad Phase II clinical development program planned for the drug that will evaluate the compound in multiple clinical studies in 2006, including a three-month study in more than 200 treatment-naive patients.
Vertex reports it expects to obtain 28-day results from the initial Phase II study in the first quarter of 2006. Following completion of the initial phase, patients will receive the standard of care. In early 2006, the company expects to initiate a three-month Phase II clinical study in more than 200 treatment-naive patients. A major object of the study, in addition to an evaluation of safety, will be to measure HCV RNA RNA: see nucleic acid.
in full ribonucleic acid
One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic at the end of treatment and post-treatment as a measure for sustained viral response, potentially enabling a decision to move to Phase III clinical study of RX-950.
Contact: Lynne Brum, - (617) 444-6414, Web site: www.vrtx.com