The Health Protection Branch in Canada recently approved BioChemPharma Inc.'s 3TC for compassionate use in the treatment of HIV.

Only patients who are refractory to or intolerant of approved AIDStherapies (AZT, ddI and ddC), have CD4 counts below 300 and do notqualify for participating in ongoing trials are eligible to receive the drugunder the compassionate-use protocol. BioChem Pharma of Laval,Quebec, is providing the drug free of charge.

An application for compassionate use is pending at FDA, and BioChemPharma's senior vice president of investor relations, Jim McDonald, saidthe company expects to receive approval soon. Applications also havebeen submitted in the six European countries participating in Phase II/IIItrials.

Four Phase II/III trials, two each in North America and Europe, werelaunched in May and June. One of the North American trials involvespatients with advanced disease and one involves asymptomatic patients;the European trials parallel these with slight differences.

Results of 3TC Phase I/II dose escalating studies were reported at theInternational AIDS Conference in June. Patients who received a dose of 8mg/kg/day 3TC had an initial rise in CD4 counts that was sustained over52 weeks.

The nucleoside analog is thought to act by inhibiting the reversetranscriptase enzyme and the DNA chain terminator.

Glaxo Group Ltd. is conducting the 3TC clinical program under acollaborative agreement with BioChem Pharma (NASDAQ:BCHXF),discoverer of the drug. Glaxo is also conducting Phase II trials of 3TC fortreatment of chronic hepatitis B infection (see BioWorld, Sept. 16).

-- Brenda Sandburg News Editor

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