The preliminary results of a multicenter Phase II clinical trialon the biological response modifier Virulizin indicated that theproduct "provides survival and quality-of-life benefits" topatients with advanced malignant melanoma.
Jaime de la Garza of the Mexican National Cancer Institute, whocoordinated the Mexican trials on Imutec Corp.'s compound,presented the results on Virulizin last Friday at the SecondInternational Congress on Biological Response Modifiers in SanDiego.
Virulizin is extracted from bovine reticuloendothelium, andmay affect the production by white blood cells of tumornecrosis factor,
Of the 31 patients with advanced malignant melanoma whoparticipated in the trial, 61 percent had been previouslytreated with other therapies and 84 percent had a heavy tumorburden. The one-year survival rate among those 31 treatedwith Virulizin was 23 percent, compared with an historical 8percent among all advanced malignant melanoma patients.
Patients with three or more tumor sites had a one-yearsurvival rate of 17 percent; none of those in the comparablehistorical group survived this long. Median survival for thepatients in the trial was 310 days, compared with the medianof 120 days for patients with similarly advanced melanoma.Twelve patients are still alive.
As to quality of life, most patients in the study experiencedpain reduction, weight gain and tumor reduction.
"On the strength of these encouraging results, we are currentlydeveloping a protocol for Phase III clinical trials for patientswith advanced malignant melanoma in Mexico, which we willbegin in 1993," said Richard Potts, president and chiefexecutive officer of Imutec (NASDAQ:IMUTF) of Toronto,Ontario.
-- Jennifer Van Brunt Senior Editor
(c) 1997 American Health Consultants. All rights reserved.