New Biostar subsidiary trials first human drug

Canada's Biostar has made an entry into the human health market with theinitiation of a Phase I/II clinical trial of the therapeutic vaccine Norelin for the treatment of prostate cancer, its lead product for human health applications. To date, the company has only commercialized genetically-engineered vaccines for food animals via its Biowest subsidiary. The drug, and subsequent human therapeutics, will be developed and commercialized through a new subsidiary named Star Biotech.

Stephen Acres, president and chief executive of Star Biotech and Biostar, said he was "optimistic that Norelin will be safe and effective at controlling human hormone levels." Norelin is developed from the company's patented technology platform, based on fusion protein immunizing agents, and acts by stimulating an immune response to gonadotropin-releasing hormone, a regulator of sex hormone production. Hormone blockade is commonly used to treat prostate cancer and more recently breast-cancer, and is under evaluation for the treatment of other hormone-related cancers.

Star Biotech predicts that the immunological approach to reducing hormone levels with Norelin will result in fewer side effects, improved patient compliance and better pharmacoeconomics compared to non-immunological methods. The firm will initially focus on the development of agents to treat prostate and breast cancer, but its technology platform holds potential applications in ovarian and uterine cancers, endometriosis and uterine fibroids. Similar antiGnRH vaccines are in development from Aphton/SmithKline Beecham, Proteus and MTR (Marketletters passim).