Now here's a good example of a small Phase II with a control arm that I think (and hope seeing INCY is now one of my bigger positions and in my charity portfolio to boot) will do good things for the stock. I suspect (can anyone confirm?) that these results are a deal better than those for any marketed NRTI's.
But note that the market would likely have not cared if this hadn't in fact been placebo controlled - if your drug is good enough and it's a well-studied model then nobody's going to hassle you about an early non-randomized Phase II.
Press Release Source: Incyte Corporation
Incyte and Pharmasset Announce Preliminary Findings from Phase II Study of Reverset in HIV-Infected Patients
Saturday February 7, 5:30 pm ET
Once-Daily Dosing Results in Significant Reduction in Viral Load
WILMINGTON, Del. & ATLANTA--(BUSINESS WIRE)--Feb. 7, 2004--Incyte Corporation (Nasdaq:INCY - News) and Pharmasset Inc. announced that preliminary results of a 10-day Phase II dose-escalating, placebo-controlled trial designed to evaluate the anti-viral effects and safety of Reverset(TM) demonstrated a significant reduction in viral load in treatment-naive patients infected with human immunodeficiency virus (HIV). The mean reduction in viral load at the end of the treatment phase ranged from 1.67 log10 copies/mL to 1.77 log10 copies/mL. No serious adverse events were observed. Incyte and Pharmasset will release the full results of the Phase II study on Wednesday, February 11, 2004, following the presentation of the data at a major scientific meeting.
Reverset is currently in Phase II clinical trials for the treatment of HIV infections under an approved United States Food and Drug Administration Investigational New Drug application.
Conference Call Information
Incyte will host a conference call on Wednesday, February 11, 2004, to discuss the final results of this Phase II study with details on time, dial-in numbers and access instructions to follow on Wednesday, February 11.
(Incidentally the single-dose effect they had announced previously was .4 log, which was pretty remarkable). Note they don't give the dosage used in the latest study - so likely given that this was a dose-escalating study the patients didn't get the full dose for the whole ten days.
Peter |
