ImClone Systems Inc. announced Tuesday that it has startedthe first clinical trial on a vaccine for treating small cell lungcancer. The Phase I pilot trialHwhich will take place under aninvestigational new drug (IND) application assigned to theMemorial Hospital affiliate of New York's Memorial Sloan-Kettering Cancer CenterHis designed to establish a drug safetyprofile for ImClone's cancer vaccine, LuVax.

LuVax is a monoclonal anti-idiotypic antibody [anti-id]designed to mimic, and consequently elicit an immune responseagainst GD3, an antigen found on the surface of small cell lungcancer cells and other tumor cells. The vaccine, whenadministered after chemotherapy, could inhibit the rapidgrowth of remaining GD3-containing cancer cells, thus reducingor preventing relapse. The anti-id in this vaccineHBEC-2His thesame parent compound that ImClone has incorporated into itsmelanoma vaccine, MelVax. And the firm knows that itsadministration "results in an immune response against GD3,"said Harlan Waksal, the executive vice president and chiefoperating officer.

Small cell lung cancer currently affects 40,000 patientsannually in the U.S. There are no effective long-term therapiesfor this disease. Most patients get chemotherapy, but it doesn'tkill all the cancerous cells. The relapse rate is essentially 100percent, within 12-18 months, according to Waksal. For thatfirst year or so, though, the patients are clinically disease-free:"we are hoping to extend that disease-free period or possiblydelay recurrence indefinitely," he told BioWorld.

The New York firm is incorporating BCG as an adjuvant to theanti-id vaccine. BCG, which is currently licensed by the FDA foruse in bladder cell carcinoma therapy, is a "very strongadjuvant," Waksal explained, but still presents some unwantedside effects, mainly local irritation. ImClone is using BCG so far because it is readily available, and the firm already has human safety data on it in conjunction with MelVax. But Waksal said the firm is currentlyinvestigating other adjuvants "with less side effects but equalefficacy."

ImClone (NASDAQ:IMCL) closed Tuesday at $11.25, up $0.625.

-- Jennifer Van Brunt Senior Editor

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