To: StocksDATsoar who wrote (80517 ) 2/20/2001 9:45:20 AM From: SSP Respond to of 150070 LORFF - LORUS THERAPEUTICS INC. - Receives Orphan Drug Status For Virulizin(R) Toronto, Ontario, Feb 19, 2001 (Market News Publishing via COMTEX) -- Lorus Therapeutics Inc. ("Lorus") announced that the U.S. Food and Drug Administration ("FDA") has granted orphan drug status to its anti-cancer drug Virulizin(R) in the treatment of pancreatic cancer. The FDA awards orphan status to drugs used in the treatment of diseases that afflict less 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, 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." 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. About Lorus 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. Through its own discovery efforts and an active acquisition and in-licensing program, Lorus is building a portfolio of promising anti-cancer drugs. Late-stage clinical developments and marketing will be done in cooperation with strategic pharmaceutical partners. Founded in 1986, Lorus Therapeutics Inc. is a public company listed on the Toronto Stock Exchange under the symbol LOR, and on the OTC BB exchange under the symbol LORFF. Except for historical information, this press release contains forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties, which may cause actual results to differ materially from those statements. Those risks and uncertainties include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time-to-time in the Company's ongoing quarterly filings, annual information form, annual reports and 20-F filings. Lorus Therapeutics Inc.'s press releases are available through the Company's Internet site: lorusthera.com . CONTACT: TEL: (905) 305-1100 Lorus Therapeutics Inc. FAX: (905) 305-1735 Investor Relations: E-mail: ir@lorusthera.com