AEGiS-PRn: Sarawak MediChem Pharmaceuticals' (+)-Calanolide A Anti-HIV Compound Meets Phase 1A Trial Endpoints

Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

Sarawak MediChem Pharmaceuticals' (+)-Calanolide A Anti-HIV Compound Meets Phase 1A Trial Endpoints

PR Newswire; Thursday February 5, 2:00 pm EST

CHICAGO, Feb. 5 /PRNewswire/ -- Sarawak MediChem Pharmaceuticals, Inc., announced today at the fifth Conference on Retroviruses and Opportunistic Infections the results of its Phase 1A clinical trial of (+)-Calanolide A, a natural compound showing anti-AIDS activity. The results of the Phase 1A trial with healthy volunteers will help the company proceed with a Phase 1B clinical trial involving HIV-positive volunteers in summer 1998, pending regulatory approval. (+)-Calanolide A is the only anti-HIV natural product known to be in clinical testing.

The single-center Phase 1A trial, performed in the U.S., was designed to assess the safety, tolerability and pharmacokinetics of (+)-Calanolide A in healthy adults. It involved 47 volunteers who received single doses in escalating levels.

Researchers found that (+)-Calanolide A is absorbed and circulated in the bloodstream, resulting in higher blood concentrations than anticipated from animal data. The compound can be administered orally. It is minimally affected by food. Side effects include dizziness, oily aftertaste, headache, belching and nausea.

(+)-Calanolide A was discovered by National Cancer Institute researchers in the rain forest of Sarawak, Malaysia. In vitro studies have shown the compound, a non-nucleoside reverse transcriptase inhibitor, to be active against HIV-1, including strains resistant to AZT, Nevirapine and other nucleoside reverse transcriptase inhibitors. It has also exhibited synergistic anti-HIV activity when used in combination with AZT, Nevirapine, ddI, ddC and Carbovir in vitro. In animal studies, the compound has been shown to penetrate into viral reservoir sites by crossing the blood-brain barrier into the brain and accumulating in the lymph nodes.

Sarawak MediChem Pharmaceuticals, Inc., is a joint venture between MediChem Research, Inc., of Lemont, Ill., and the State of Sarawak, Malaysia, to advance the clinical development of (+)-Calanolide A. Formed in 1987, MediChem Research is a biotechnology firm specializing in custom organic synthesis. It holds a patent for the total synthesis of (+)-Calanolide A and has a worldwide exclusive license to the National Cancer Institute patent on the structure of the compound, as well as to the rights held by the government of Sarawak.

SOURCE: Sarawak MediChem Pharmaceuticals, Inc.

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