Early Phase II clinical trial data on BioChem Pharma Inc.'snucleoside analog for treating chronic hepatitis B infection werepresented Wednesday at a meeting of the British Society ofGastroenterology held in Coventry, U.K. They indicated that thedrug, lamivudine, was well-tolerated in patients and exhibitedantiviral activity at all doses tested, but especially above 20milligrams per day.
Forty-eight individuals chronically infected with the hepatitis Bvirus (HBV) have been enrolled in the Phase II randomized,placebo-controlled dose ranging study; the researcherspresented data on 38 of those patients. They found thatlamivudine has an inhibitory effect on viral replication at alldoses tested -- from 5 to 600 milligrams per day -- asevidenced by a reduction in serum HBV DNA. For 66 percent(18 of 27) of the patients who received a dose of 20 milligramsor greater, HBV DNA was reduced to less than five picogramsper milliliter of serum during treatment. (Patients' pre-treatment serum levels of HBV were greater than 10 picogramsper milliliter.)
BioChem Pharma's drug lamivudine is not the first nucleosideanalog to be tried in clinical trials for treating chronic hepatitisB infection. But so far it's proven safe -- unlike Eli Lilly'sfialuridine (FIAU), which tragically proved fatal to half of thepatients enrolled in a Phase II clinical trial conducted at NIH(see BioWorld, Sept. 1).
BIoChem Pharma and its development partner, Glaxo GroupLtd., have been developing the same nucleoside analog (underthe name 3TC) to treat AIDS, as well. To date, 204 adults havebeen enrolled in the AIDS trials; they have received dosesranging from 0.5 milligrams to 20 milligrams per day for up to24 months, explained Jean-Yves Duthel, vice president of publicrelations at the Laval, Quebec, company. "And now we havecompleted 48 patients in the hepatitis B trials who have beentreated with five to 600 milligrams daily for one month. Thepatients have been extensively monitored with a follow-up oftwo months," Duthel said. "Overall, "there is no evidence of anyof the effects seen with FIAU," he told BioWorld.
BioChem Pharma (NASDAQ:BCHXF) is progressing to later-stagePhase II trials in HBV. Two late Phase II trials -- designed todetermine the most effective dose of lamivudine -- recentlybegan enrolling patients in the U.S., Canada and Europe.
-- Jennifer Van Brunt Senior Editor
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