Message #32 From:
NewsBot Date: December 12, 2007 06:03:01 AM
Panacos Announces Results of Bevirimat 350 mg Cohort, Data Support Further Dose Escalation in Phase 2b Study
Company to Hold a Conference Call at 5:00 p.m. EST Today
Panacos Pharmaceuticals, Inc. (NASDAQ:PANC), 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.
Conference Call
The Company will host a conference call to discuss these results at 5:00
p.m. today (EST). The conference call can be accessed via the web at www.panacos.com
or by dialing 800.638.4930 (domestic) or 617.614.3944 (international),
between 4:45 and 5:00 p.m. and entering the passcode 43718966. A replay
of the conference call will be available from 7:00 p.m. on December 10,
2007 until Wednesday, January 9, 2008, and can be accessed via the web
at www.panacos.com or by dialing
toll-free (888) 286-8010, and outside the U.S. (617) 801-6888 with
passcode 31464797.
About Panacos
Panacos is developing the next generation of anti-infective products
through discovery and development of small molecule oral drugs for the
treatment of HIV and other major human viral diseases. HIV infects
approximately 1.7 million people in North America and Western Europe and
approximately 33 million people worldwide. Approximately 650,000
patients are treated annually for HIV in the United States and Western
Europe. Resistance to currently available drugs is one of the most
pressing problems in HIV therapy and the leading cause of treatment
failure. Panacos' proprietary discovery technologies are designed to
combat resistance by focusing on novel targets in the virus life cycle,
including virus maturation and virus fusion.
Panacos' lead candidate, bevirimat (PA-457), is the first in a new class
of oral HIV therapeutics under development called maturation inhibitors,
discovered by Panacos scientists and their academic collaborators. Based
on its novel mechanism of action, bevirimat is designed to have potent
activity against a broad range of HIV strains, including those that are
resistant to existing classes of drugs. The Company has completed nine
clinical studies of bevirimat in over 400 patients and healthy
volunteers, showing significant reductions in viral load in HIV-infected
patients and a promising safety profile, and is currently in Phase 2b
clinical trials. The Company also has a second-generation program in HIV
maturation inhibition at the clinical testing stage and a research
program to develop oral HIV fusion inhibitors.
Except for the historical information contained herein, statements
made herein, including those relating to bevirimat's clinical
development, the potential results of treatment with bevirimat and
future clinical trials and clinical practice are forward-looking
statements made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. These statements involve risks
as set forth in the Company's filings with the Securities and Exchange
Commission, including, but not limited to, the Company's Annual Report
on Form 10-K for the fiscal year ended December 31, 2006 and its
Quarterly Reports on Form 10-Q for the quarters ended March 31, June 30
and September 30, 2007. These risks and uncertainties could cause actual
results to differ materially from any forward-looking statements made
herein. The Company undertakes no obligation to publicly update
forward-looking statements, whether because of new information, future
events or otherwise, except as required by applicable law.
Panacos Pharmaceuticals, Inc. Jill Smith, Director,
Corporate Communications 240-449-1250 jsmith@panacos.com
