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Pre-clinical development of the antiretroviral drug candidate PA-344B.

Wild CT, Kilgore NR, Reddick MS, Asfaw YD, Salzwedel KD, Turpin JA, Xie L, Lee KH, Smith PC, Allaway GP, Martin DE; International Conference on AIDS.

Int Conf AIDS. 2002 Jul 7-12; 14: abstract no. TuPeB4435.

Panacos Pharmaceuticals Inc., Gaithersburg, MD, United States

BACKGROUND: The dicamphanoyl khellactone (DCK) compounds potently inhibit replication of HIV-1 by a novel mechanism of action compared to approved drugs. They do not inhibit RNA-dependent DNA polymerase activity of HIV-1 RT, but block the production of double-stranded DNA. Their precise molecular target is the subject of ongoing studies. PA-344B is a new analog in this family with improved solubility and in vivo disposition. Its in vitro and in vivo properties are described in this report. METHODS: PA-344B was analyzed for potency against a panel of primary HIV-1 isolates, including drug resistant strains, propagated in PBMCs. Binding to human plasma proteins was analyzed by a standard filtration method. In vivo disposition was examined in rats and dogs following IV or PO administration at 10-25 mg/kg. In vitro metabolism of the compound was analyzed following incubation with liver microsomes from several species. RESULTS: PA-344B inhibited replication of all primary HIV-1 isolates tested, including AZT-resistant strains, with a mean IC50 of 40nM. Comparison with the mean in vitro cytotoxicity concentration of 50microM gave a selectivity index of >1,000. Binding to human plasma proteins was moderate (80-85% bound). Following IV administration to rats PA-344B had a half-life of approximately 3 hours. Oral bioavailability was around 15% in rats but lower in dogs. This may be explained by a higher rate of first pass metabolism in dogs compared to rats. In vitro metabolism studies using liver microsomes indicated that dogs have a faster rate of metabolism than rats while metabolism by human liver microsomes was the slowest. CONCLUSIONS: PA-344B exhibits in vitro and in vivo properties that support its further development as an HIV drug candidate. Pre-clinical toxicology studies are in progress with the goal of filing an IND and initiating clinical testing during 2002.

Publication Types:
  • Meeting Abstracts
Keywords:
  • Administration, Oral
  • Animals
  • Biological Availability
  • Dogs
  • HIV-1
  • Human Development
  • Humans
  • In Vitro
  • Microsomes, Liver
  • Pharmaceutical Preparations
  • RNA-Directed DNA Polymerase
  • Rats
  • Rats, Sprague-Dawley
  • Solubility
  • Zidovudine
  • growth & development
  • metabolism
  • p-Aminosalicylic Acid
Other ID:
  • GWAIDS0016011
UI: 102253509

From Meeting Abstracts




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