In pre-clinical and/or clinical studies, Virulizin(R) has proven to be a safe and effective drug capable of anti-tumor activity in a range of cancer types, such as pancreatic cancer, malignant melanoma and breast cancer.

The FDA awards orphan status to drugs used in the treatment of diseases that afflict fewer than 200,000 patients annually in the U.S., to encourage research and testing.

For Lorus, receiving orphan status for Virulizin(R) in the treatment of pancreatic cancer means that the FDA will help to facilitate the drug's development process by providing financial incentives and granting seven years of market exclusivity in the U.S. (independent of patent protection) upon approval of the drug in the U.S.

Virulizin(R) is a non-toxic immunotherapy that recruits killer cells, monocytes and macrophages, to attack tumor cells. The compound is in development as second line therapy for advanced pancreatic cancer patients who are refractory or intolerant to conventional first line therapies.

Based on encouraging findings from a meta-analysis of three Phase I/II studies for Virulizin(R) in the treatment of pancreatic cancer, Lorus is planning a pivotal Phase III clinical trial for Virulizin(R) in North America this year.

"We are extremely encouraged that the FDA has chosen to grant orphan status to Virulizin(R), as this designation represents another significant step toward the use of this promising drug to treat patients suffering from the devastating effects of pancreatic cancer," said Dr. Jim A. Wright, president of Lorus.

Dr. Wright added: "In addition to the benefits of financial incentives and marketing exclusivity, the FDA appointed orphan status may also help Lorus accelerate regulatory filings in countries outside the U.S., and will serve to further our discussions with appropriate pharmaceutical partners."

Lorus is a biopharmaceutical company focused on the research and development of cancer therapies. Lorus' goal is to capitalize on its research, pre-clinical, clinical and regulatory expertise by developing new drug candidates that can be used, either alone or in combination, to successfully manage cancer.

21-Feb-2001