Biomune Systems reports new data from Vanderbilt University School of Medicine prostate cancer research

Business Wire, May 16, 1995

SALT LAKE CITY--(BUSINESS WIRE)--May 16, 1995--Biomune Systems Inc. (NASDAQ:BIME) released encouraging news Tuesday that advances the hypothesis from earlier research that a drug developed from the company's Immune Technology may act as a retardant in the growth of prostate cancer tumors.

The most recent in vivo research, conducted at Vanderbilt University School of Medicine by Dr. Mitchell Steiner, was a follow-up study to a 1994 study that showed an 11% decrease in the growth rate of prostate cancer tumors when treated therapeutically with the company's Immune Technology product.

The results of the most recent study not only confirmed the earlier data, but also demonstrated that when administered prophylactically to rats that had been injected with prostate cancer tumor cells, there was a definite retardant effect upon the growth of the prostate tumor cells. According to Dr. Steiner, "The immune system, no doubt, plays a major role in preventing tumors, both by suppressing tumor growth and by preventing metastatic implantation."

"The results of this study are important because they suggest that the drug derived from the company's patented Immune Technology, when taken prophylactically, may be effective in retarding the growth of prostate cancer cells," said Biomune's Executive Vice President of Research and New Product Development, Frank A. Eldredge, Ph.D. "From my perspective these results could prove to be invaluable as we target future disease indications for development."

According to Dr. Steiner's report, the study included two groups of rats each of which had been inoculated with 10,000 prostate tumor cells. One group received an inactive placebo while the other group received active Immune Technology product. On the eleventh day of the study the group receiving Biomune's Immune Technology product showed no detectable tumors. On the other hand, 82% of the rats who received the placebo showed large tumors. By the end of the fourteenth and final day of the study, the tumors in the rats receiving the placebo were so large that the experiments could not continue, while the rats receiving the Immune Technology drug showed barely palpable tumors. The data revealed a clear downward trend in tumor volume with increasing doses of the Immune Technology drug.

Company President David G. Derrick said: "I am cautiously optimistic regarding the implications of this new data and its significance. I'm most encouraged because it clearly supports the earlier finding. Prostate cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths in men in the United States. As long as our data continues to be so encouraging, we will pursue this disease indication."

In unrelated news, the company also reported that data from the Phase II human clinical trials for the company's first biologic drug derived from the Immune Technology, Immuno-C(tm), is still being evaluated. According to the company's Executive Vice President of Research and Clinical Trials, Dr. Allan H. Barker, "Early observations lead us to believe that Immuno-C(tm) is safe and tolerable in acutely ill patients and we are very encouraged by what we are observing." Upon their release from the initial hospital study, the patients asked to remain on oral dosages of Immuno-C(tm). The company agreed to supply the volunteers with the Immuno Technology drug and continues to monitor their progress. Based on these early observations, plans are underway for expanded Phase II human clinical trials.

Biomune Systems Inc. is a biotechnology company engaged in the research and development of patented Immune Technology products designed to enhance the body's own ability to fight disease. For more information, contact Joy M. Erickson at 801/582-2345 or Sovran Financial at 305/752-6188.

CONTACT: Biomune Systems Inc., Salt Lake City

Joy M. Erickson, 801/582-2345