BioChem Pharma presented the latest clinical trial results on itsnucleoside analog drug 3TC for treating AIDS and hepatitis Binfection at Hambrecht & Quist's 11th Annual Life SciencesConference late Tuesday.

Francesco Bellini, president and chief executive officer of theLaval, Quebec, company (NASDAQ:BCHXF), said 3TC is enteringcombined Phase II/III trials in AIDS. The data from Phase I/IItrials showed that the drug was well-tolerated, unlikecurrently marketed inhibitors of HIV reverse transcriptase.

"It's shown a very benign side effect profile in humans," saidTimothy Wilson, an H&Q analyst who follows BioChem Pharma.Wilson contrasted 3TC with current AIDS treatments AZT, ddIand ddC, which all cause substantial side effects.

3TC has shown "positive effects on CD4 cell counts" in thesepreliminary trials, as well, Wilson added. And CD4 cell countsare still thought to be the "most predictive surrogate marker"for putative AIDS therapies.

3TC is a "non-natural" nucleoside, originally part of a racemicmixture. "We expected the activity would be in the naturalenantiomer," explained John Gillard, BioChem Pharma's directorof therapeutic research. The researchers found that to be true,but the natural form also had toxic effects. The non-naturalenantiomer was also active against viral polymerases, butinactive against the human enzymes, thus explaining its lack oftoxicity.

"This is the first time it's been shown that a product with non-natural conformation has anti-viral activity," Gillard toldBioWorld. Moreover, BioChem Pharma "now has a syntheticchiral synthesis that makes only the single non-naturalenantiomer that we want," Gillard added.

BioChem Pharma has patents pending worldwide on theprocess and a U.S. patent issued on the compound 3TC itself,Gillard said.

The company reported that 3TC is active against hepatitis B invitro and in primates infected with the human virus last springat the Fifth International Conference on Anti-Viral Research inVancouver, British Columbia. Results were also reported lastOctober at the Interscience Conference on Antimicrobial Agentsand Chemotherapy in Anaheim, Calif. In progressive dose-ramping studies in two chimpanzees, 3TC showed "very potentintrinsic activity" at inhibiting hepatitis B replication in thealready-infected animals, Gillard said.

BioChem Pharma's partner, Glaxo Group Ltd., is about to beginPhase II trials for hepatitis B on this compound, which willhenceforth be called lamivudin (for treating AIDS, thecompound will retain its moniker 3TC). Glaxo is also conductingthe AIDS trials. Under the terms of the original agreementbetween the two companies, Glaxo also makes payments toBioChem Pharma, including royalties and annual researchpayments, to fund research, development andcommercializations of a variety of compounds. In return, Glaxowill receive exclusive worldwide product manufacturing rights.

BioChem Pharma's stock was off 13 cents a share onWednesday to $16.13.

-- Jennifer Van Brunt Senior Editor

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