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Biotech / Medical : Panacos Pharmaceuticals (PANC) -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (38)	10/26/2007 3:25:40 AM
From: idos	Respond to of 53

<So the 300mg cohort results look solid, good> Agreed: There were no serious adverse events, discontinuations, or significant laboratory abnormalities. Two patients had mild adverse events, both of which were GI related, including one transient liver enzyme elevation that resolved with continued dosing (No idea if this patient was on bevirimat since the the study is blinded). Results from phase IIa and phase IIb studies, indicates that plasma concentration and mean viral load reduction correlates. So escalating 350mg could lead to greater antiviral activity. liquid formulation- PANC said that in order to use a solid formulation in the phase III program, only a bridging study in healthy volunteers would be required. Maybe they understood that the development of a solid formulation is essential for bevirimat’s commercial success. It will no doubt prolong its development.

To: tuck who wrote (38)	12/11/2007 3:25:49 AM
From: idos	Read Replies (1) \| Respond to of 53

[PANC: "We believe there is a population of HIV patients that responds very well to bevirimat" But how will they be able to predict the potential responders? This will make pivotal trial design very hard and there's the commercial problem too.] Panacos Announces Results of Bevirimat 350 mg Cohort, Data Support Further Dose Escalation in Phase 2b Study WATERTOWN, Mass.--(BUSINESS WIRE)--Panacos Pharmaceuticals, Inc. (NASDAQ:PANC - News), a biotechnology company dedicated to developing the next generation of antiviral therapeutic products, today announced preliminary results from the 350 mg cohort of a Phase 2b study of bevirimat (PA-457) in patients failing HIV therapy due to drug resistance. In this cohort, nine patients received 350 mg of bevirimat solution once daily and two patients received placebo for 14 days on top of their failing background regimen. A mean viral load reduction of 0.62 log10 was seen in the nine bevirimat-treated patients on day 15, the primary endpoint of the study. Of these patients, three (33%) had greater than a 0.5 log10 reduction, all of which also had greater than a 1.0 log10 reduction. This compared to five of a total of eight patients with greater than a 1.0 log10 reduction in the 300 mg cohort of the trial. Bevirimat continued to be well tolerated in this cohort, consistent with previous clinical experience. All adverse events were mild and there were no clinically relevant lab abnormalities. Pending full analysis and FDA review of the data, the Company intends to initiate a 400 mg cohort in order to ensure it has fully explored the dose/response relationship. Following dosing with 350 mg of bevirimat solution administered on top of patients' failing background regimens, the mean trough plasma concentration of bevirimat at steady state was 43.8 micrograms/ml compared to 48.4 micrograms/ml at steady state in the 300 mg solution cohort. Overall AUC (Area Under the Curve) exposures to bevirimat were comparable in the 300 and 350 mg cohorts. "Based on a preliminary analysis of these and the other cohorts in this study, we believe there is a population of HIV patients that responds very well to bevirimat, with viral load change of greater than 1 log10. There is another population that does not respond as well at current dose levels. We plan to explore this further in the 400mg dose cohort," said Alan W. Dunton, M.D., Panacos' Chief Executive Officer. "We believe we may be at, or close to, the peak of the dose response curve in the population of patients who respond very well and believe that we are on track to move expeditiously into pivotal studies in this group in 2008.” About the Phase 2b Bevirimat Study The objectives of this Phase 2b study of bevirimat are to examine the antiviral efficacy, pharmacokinetics, and safety of bevirimat in combination with a failing regimen of other HIV drugs ("functional monotherapy"). In this 14-day study, patients are dosed with either placebo or bevirimat in combination with their failing antiretroviral therapy. The primary endpoints of the trial are safety, pharmacokinetics, and viral load reduction on day 15. snip biz.yahoo.com