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PANC News Panacos Files IND for Second-Generation Maturation Inhibitor

WATERTOWN, Mass.--(BUSINESS WIRE)--Panacos Pharmaceuticals, Inc. (Nasdaq: PANC), a biotechnology company dedicated to developing the next generation of antiviral therapeutic products, today announced that it has filed an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) for the company's second-generation HIV maturation inhibitor, PA-1050040. Following review by the FDA, the Company intends to begin Phase 1 clinical trials of this new agent in the first quarter of 2007.

Maturation inhibition is a new target discovered by Panacos scientists and their academic collaborators. The first-in-class HIV maturation inhibitor, bevirimat (PA-457), has shown significant anti-HIV activity in HIV patients and is in Phase 2b clinical testing. The Company’s second-generation maturation inhibitor program is designed to identify analogs of bevirimat with different pharmacological properties. Specific goals are to develop second generation compounds that retain activity against HIV strains resistant to bevirimat, should these resistant strains appear in the clinic in the future.

In vitro studies with PA-1050040 have shown that the compound has a lower level of binding to human serum proteins than bevirimat, which may result in greater levels of free drug in patients dosed with the compound and thus the potential ability to inhibit HIV strains that exhibit partial bevirimat resistance. Furthermore, PA-1050040 retains wild-type activity against one of two bevirimat-resistant HIV isolates that represent the most-frequently mutated amino acids found by in vitro resistance-selection experiments performed to date. These amino acids flank the HIV-1 capsid-SP1 cleavage site and the results suggest PA-1050040 may bind differently than bevirimat to this region of the viral Gag protein, which is the target for maturation inhibitor activity.

Graham Allaway, Ph.D., President and Chief Operating Officer of Panacos commented, "Bevirimat, our first-generation maturation inhibitor, has shown the potential clinical value of maturation inhibitors. As the discoverers of this new HIV drug target, we intend to build a franchise in maturation inhibition. PA-1050040 represents one of a large number of second generation maturation inhibitors currently in pre-clinical testing. We believe that maturation inhibitors have the potential to be important agents in the fight against HIV, and are pleased to be able to announce this step forward."

The current IND will allow Panacos to examine the pharmacokinetics of PA-1050040 following single doses in humans. The Company intends to file additional INDs for other second-generation maturation inhibitors during 2007 and then select a candidate based partly on human pharmacokinetics to take into multiple dosing human clinical studies.

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 40 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, including strains that are resistant to existing classes of drugs. The Company has completed seven clinical studies of bevirimat in over 300 subjects, showing significant reductions in viral load in HIV-infected subjects and a promising safety profile, and is in Phase 2b clinical trials. Additional pipeline programs in HIV maturation inhibition and HIV fusion inhibition are currently being tested in preclinical trials.

Except for the historical information contained herein, statements made herein, including those relating to the clinical development of bevirimat and PA-1050040, the potential results of treatment with bevirimat, 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, 2005. 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.