GAITHERSBURG, Md., Feb. 9 /PRNewswire/ -- Panacos Pharmaceuticals, Inc. today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) application to begin human clinical trials of the Company's lead compound, PA-457. PA-457 is the first in a new class of HIV drug candidates called Maturation Inhibitors, with potent activity against HIV strains resistant to currently approved drugs. A Phase 1 clinical study of PA-457, administered orally, will be initiated in the near future.
In recent years the prevalence of drug resistance has risen dramatically, so that today the majority of HIV-infected individuals receiving antiretroviral treatment and an increasing number of individuals newly infected with HIV, harbor viruses resistant to currently approved drugs. This often leads to treatment failure, so there is a critical need for new therapies that are effective against drug resistant HIV strains. One way to achieve this is to discover and develop drugs that target different points in the virus lifecycle than approved drugs. PA-457 blocks viral maturation, a new target for HIV drug discovery that was recently identified by Panacos scientists. Maturation is a key step in viral replication that occurs as new virus particles are released from infected cells. Following PA-457 treatment, the newly formed virus particles have a defective core structure and are non- infectious.
David E. Martin, PharmD, Vice President for Drug Development said: "PA- 457, as the first HIV Maturation Inhibitor, offers a completely novel approach for treating HIV/AIDS. In addition to its activity against drug resistant HIV, the compound has favorable pharmacokinetics in animals and the pre- clinical data suggest it should be possible to achieve therapeutic drug concentrations following oral delivery in humans. The Phase I study will focus on PA-457's safety and pharmacokinetics in uninfected volunteers. If the data are supportive we will rapidly move on to test PA-457's antiviral potency in HIV-infected individuals later this year."
Pre-clinical data on PA-457 support the use of this compound in combination therapy. When combined with currently approved HIV drugs, PA-457 is synergistic in blocking HIV replication. Furthermore, in vitro metabolism studies with the drug candidate predict a low probability for clinically significant drug-drug interactions with other antiretroviral drugs. Panacos scientists have also confirmed the absence of cross-resistance between PA-457 and other classes of HIV drugs.
Panacos Pharmaceuticals is engaged in the discovery and development of small molecule, orally available drugs for the treatment of HIV and other major human viral diseases. The Company's proprietary discovery technologies focus on novel targets in the virus life cycle, including the first and last steps of virus infection, namely virus fusion and maturation.
For more information on Panacos Pharmaceuticals, please visit http://www.panacos.com, or email: info@panacos.com.
Source: Panacos Pharmaceuticals, Inc.
