>>Panacos Announces Initiation of Phase 2b Clinical Trial of First-In-Class HIV Maturation Inhibitor, Bevirimat (PA-457)
WATERTOWN, Mass., Jun 12, 2006 (BUSINESS WIRE) -- Panacos Pharmaceuticals, Inc. (Nasdaq:PANC), a biotechnology company dedicated to developing the next generation of antiviral therapeutic products, today announced the initiation of a Phase 2b clinical trial of bevirimat (previously designated PA-457), the Company's lead drug candidate for the treatment of HIV. Institutional Review Board (IRB) and other approvals have been received at initial study sites and the study is now open for enrollment.
"Initiation of the Phase 2b study of bevirimat represents a key milestone for Panacos," said Dr. Samuel K. Ackerman, Panacos' President and CEO. "With the benefit of the results of our Phase 2a study, we have been able to focus on a dose range that we believe will provide maximum antiviral benefit to patients. In the Phase 2b trial, we plan to test these doses of bevirimat in combination with approved HIV drugs as part of an optimized regimen in patients failing treatment due to drug resistance. The goal of this study is to select the most appropriate dose to take into pivotal Phase 3 testing."
Study Design
In the Phase 2b study, HIV-infected patients failing their current antiretroviral therapy will receive oral bevirimat or placebo once daily for three months in combination with background antiretroviral therapy. Initially, twelve patients per dose plus four placebo patients will be enrolled in each of three bevirimat dosage groups (400mg, 500mg and 600mg) in a dose-escalation fashion. For the first two weeks of treatment, patients will receive bevirimat or placebo in addition to their previous background therapy ("functional monotherapy"), following which each patient's background will be optimized and treatment continued for a total of three months. Groups receiving doses higher than 600mg may be enrolled following review of functional monotherapy data from the first three groups by the Company and FDA. Following evaluation of data, the Company also plans to submit a protocol amendment to expand patient numbers to a total of approximately 36 patients receiving bevirimat at each of the selected doses.
Efficacy endpoints of the study will include reduction in viral load after 14 days of functional monotherapy and after three months of dosing. If doses up to 600mg are evaluated and all three dosage groups are expanded, the total number of patients in the trial would be approximately 144, including 108 patients receiving bevirimat and 36 patients receiving placebo. Patients completing three months of therapy would be eligible for a rollover protocol to continue long-term dosing.<<
I don't know how quickly these studies tend to enroll, and it may be too early for them to speculate with much precision, but if they intend to go to pivotal trials in next year, they must be figuring on having the IIb data in hand 1H07. Typically, companies in this space announce viral load reduction data as an interim look, and I would guess we'd see that sometime around November. But I'm just guessing. I haven't looked at PANC for some time, and it sure looks cheap. I gather it is chiefly the cash position and shelf registration that dragged it down 50% over the past year or so: they have cash to last through the first half of next year. If one wanted to gamble on good results this fall, picking up some this summer might be good timing. I would guess they will release the data, then act on that shelf; even if they are in discussions with a partner, they would want some cash so they aren't in a desperate negotiating position. As such, selling on the release of results would probably be a good idea. When they announce the stock sale, there will likely be a knee-jerk sell-off. Once it has been priced in, one could climb back aboard if those results look good.
To their credit, the company has started the trial almost on time. Negotiations with the FDA over the doses -- and they've been given pretty free rein there, it appears -- and the recent death of the CEO may have slowed them down a bit. I have not yet found info on whether or not the company has disclosed a timeline for data release, so until I do (probably will have to listen to a recent CC), the above speculation will have to do.
Cheers, Tuck |
