SASKATOON, Saskatchewan ¿ Biostar Inc., a private biopharmaceutical company developing novel immunizing agents for humans, food animals, and companion animals, has established its second subsidiary company, Star Biotech Inc., to concentrate on the development and commercialization of lead product Norelin and other novel therapeutics for the treatment of hormone-dependent cancers and other serious diseases.

Norelin is a therapeutic vaccine that stimulates an immune response to gonadotropin-releasing hormone (GnRH), which regulates the production of sex hormones.

Stephen Acres, president and CEO of Star Biotech and Biostar, said that by developing an antibody to GnRH, blood levels of sex hormones such as testosterone can be reduced. Sex hormones are important factors in the development and spread of prostate, breast and other cancers.

GnRH, which is produced in the brain, initiates the sex hormone cascade that leads to the production of testosterone in men, and estrogen and progesterone in women. These specific sex hormones bind to receptors in malignant cancer cells and promote the growth and spread of the disease. Cancer cells may also produce GnRH, which may then act as a local growth factor in some cases. By controlling GnRH, Star¿s technology has the potential to produce a therapeutic effect through a dual mode of action. By blocking GnRH from reaching its receptors in the pituitary gland, Norelin can reduce the amount of sex hormones in the body and prevent them from reaching the tumor. It may also block GnRH from reaching receptors on the cancer cells themselves.

The first indication for Norelin will be in prostate cancer patients, for which a Phase I/II clinical trial has been initiated. The open-label, dose-ranging trial will include up to 72 prostate cancer patients at multiple sites in the U.S. and Canada. In addition to establishing safety, the endpoint of the trial is reduction of testosterone levels.

Hormone-withdrawal therapy is a common form of treatment for prostate cancer, and is being evaluated for treatment of breast cancer and other disorders, Acres added. Norelin provides an immunological approach to hormone reduction. The company expects this will have several benefits when compared to other treatments, including reduced side effects and improved patient compliance.

The company believes that Norelin may also be useful to treat other hormone-related disorders in women including ovarian and uterine cancers, endometriosis and uterine fibroids.

Biostar has a patented technology platform based on the use of fusion protein immunizing agents which, in addition to treating hormone-dependent diseases, can be used to increase production efficiency in food animals, and to provide an alternative to surgical neutering in companion animals. The company has an animal health subsidiary, Biowest Inc., for the commercialization of these animal related products.

To assist with the financing of the Norelin trials, Biostar has recently closed a C$3.2 million (US$2.1 million) private financing, which represents the third tranche of a C$14.2 million deal that was signed in January 1998. Investors include the Canadian Medical Discoveries Fund Inc., of London, Ontario; Crown Investments Corporation Industrial Interests Inc. and Saskatchewan Government Growth Funds III and IV Ltd., of Saskatoon; and the Toronto-based companies, Working Ventures Canadian Fund Inc.; Royal Bank Capital Corp.; Business Development Bank of Canada; MDS Health Ventures (TC) Inc.; and MDS Health Ventures (PC) Inc. n

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