ImmuLogic Pharmaceutical Corp. started a 480-patienttrial of its Allervax Ragweed therapeutic in a trial thecompany said may be sufficient to support filing formarketing approval.
The therapeutic is being developed in collaboration withMarion Merrell Dow Inc., of Kansas City, Mo. (nowcalled Hoechst Marion Roussel), which is running asimilar ragweed trial in Canada.
The trial is the first for ImmuLogic under natural ragweedconditions. It's being started now to coincide with theragweed season, which lasts from August to October. Thetherapeutic consists of three peptides designed todesensitize the immune system to ragweed allergens.
The double-blind, placebo-controlled trial will involvetwo doses _ 75 and 750 micrograms _ as well astreatment regimens of once or twice weekly over fourweeks.
ImmuLogic was unable to get significant dosing datafrom previous Phase II trials in experimental challengemodels, but did demonstrate encouraging safety data, thecompany said.
Richard Small, ImmuLogic's chief financial officer, saidthe 480-patient study "could be a pivotal trial because it ispowered to get statistically significant results. We'll onlyknow once we get results of the trial," he told BioWorld.
Another product, Allervax Cat, already is in Phase IIItrials. It is designed to help those who are allergic to cats.
ImmuLogic has received $24 million to date in licenseand milestone payments from Marion Merrell Dow, and$19.2 million in equity investments of a pre-commercialization potential of $61.2, Small said.Vaccines for Japanese cedar pollen, house-dust mites andgrasses, which are part of the collaboration, are inpreclinical development.
ImmuLogic's stock (NASDAQ:IMUL) closed Thursdayat $8.84, up 69 cents per share. n
-- Jim Shrine
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