UBI begins trial of novel immunotherapy for prostate cancer.

HAUPPAUGE, N.Y.--(BUSINESS WIRE)--Oct. 18, 1995--United Biomedical, Inc. (UBI(R)) has begun clinical trials of a novel synthetic peptide immunotherapeutic for treatment of prostate cancer, the second leading cause of death from cancer in men.

The Phase I immunotherapy trial is being conducted at the Dana-Fisher Cancer Institute in Boston, under the direction of Dr. Philip Kantoff.

Over 200,000 new cases of prostate cancer will be diagnosed in the United States this year, with over 35,000 deaths annually attributed to this disease. Current strategies for the treatment of metastatic prostate cancer focus on blocking the production and action of androgen hormones (e.g. testosterone), since androgen hormones are known to accelerate the growth of malignant cells within the prostate. However, the current treatments for prostate cancer are often associated with adverse reactions such as disease flare-up, gastrointestinal disorders and hot flushes. They also fail to address the ultimate cause of fatal metastatic disease, namely the inevitable progression of androgen dependant tumor cells to androgen independence.

UBI(R) has designed a combination immunotherapeutic strategy, targeted at treating both androgen-dependent and androgen-independent prostate cancer. The first component of the therapy has as its basis the immuno-neutralization of luteinizing hormone releasing hormone (LHRH), a key hormone responsible for the regulation of androgen production. UBI(R) has developed a synthetic adjuvant consisting of proprietary immunostimulatory peptides, which may be linked to any non-immunogenic regulatory peptide hormone such as LHRH and render it highly immunogenic. The Phase 1 trial of the LHRH immunotherapeutic, targeted at androgen-dependent prostate cancer, will obtain baseline safety, dosing and immunogenicity data in 19-25 patients with advanced prostate cancer.

"The LHRH immunotherapy has demonstrated significant efficacy in experimental animals by stimulating potent antibody responses to LHRH which blocked testosterone production and prevented the growth of prostate tumors, without any significant adverse effects. In addition to its potential for therapy of androgen-dependent human prostate cancer, immuno-neutralization of LHRH has broad animal health applications in the areas of pet contraception, carcass quality improvement and behavior modification. Moreover, the synthetic adjuvant technology, with its broad applications for neutralization of other regulatory hormones, provides UBI(R) with another exciting platform technology for new product development," said Dr. Wayne C. Koff, UBI(R) vice president for vaccine research and development.

The second component of the UBI(R) prostate cancer immunotherapy program is targeted specifically at treating androgen-independent prostate cancer, and aims to induce cytotoxic T lymphocytes (CTL) capable of destroying the remaining tumor burden of androgen-independent tumor cells, which fail to respond to LHRH androgen-dependent immunotherapy. The UBI(R) CTL immunotherapy for prostate cancer is still undergoing preclinical testing. However, UBI(R) has already initiated clinical trials with a similar CTL-based immunotherapeutic for AIDS, which should provide important preliminary safety and immunogenicity data to validate the technology.

UBI(R) is a biopharmaceutical company actively engaged in the development of immunotherapeutics, vaccines and diagnostic products for targeted infectious diseases including AIDS and hepatitis, and malignancies including prostate, breast and colon cancer. UBI(R) currently markets synthetic peptide based diagnostic tests, and maintains manufacturing facilities at both its corporate headquarters in Hauppauge, and its subsidiary in Beijing, People's Republic of China.

CONTACT: United Biomedical

Dr. Wayne Koff, 516/273-2828