LORUS RECEIVES FAST TRACK DESIGNATION FROM FDA FOR VIRULIZIN^Ò

FOR THE TREATMENT OF PANCREATIC CANCER

-Designation represents another significant regulatory achievement for Virulizin^Ò-

TORONTO, ON – June 4, 2002 -- Lorus Therapeutics Inc. (“Lorus”) announced today that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track Designation for Virulizin^Ò in the treatment of pancreatic cancer.  Virulizin^Ò is the company’s most advanced drug in clinical development, currently being studied in a North American Phase III clinical trial.

The Fast Track designation means that the FDA will take actions to facilitate the development and  expedite the review of Virulizin^Ò.  Drugs designated for Fast Track are intended for the treatment of a life-threatening condition and have demonstrated the potential to address unmet medical needs.  Fast Track products usually meet the FDA’s criteria for priority review.

“Clearly the FDA recognizes the devastating effects of pancreatic cancer and the urgent need for new therapies to treat patients with this disease,” said Dr. Jim Wright, chief executive officer, Lorus.  “This regulatory achievement is further confirmation of the potential of Virulizin^Ò as an effective anticancer drug, and we are working hard to progress our Phase III clinical trial program to the New Drug Application stage.”

 Virulizin^Ò is a potent and unique immunotherapy that directly stimulates macrophages and enhances their ability to kill tumor cells. Virulizin^Ò is being studied as a first line therapy in combination with gemcitabine for the treatment of pancreatic cancer.  The Phase III clinical trial of Virulizin^Ò is a double-blind, randomized clinical trial being conducted at medical centers around North America enrolling 350 patients with advanced (unresectable, recurrent or metastatic) pancreatic cancer.  Patients are randomized to receive either treatment with gemcitabine or treatment with gemcitabine in combination with Virulizin^Ò.  Those patients who fail or become refractory to gemcitabine are treated with 5-Fluorouracil (5-FU) or with 5-FU in combination with Virulizin^Ò in a second line therapy.  All study subjects will be monitored throughout the remainder of their lifespan.

 Virulizin^Ò has already been awarded Orphan Drug Status from the FDA in 2001.   It also is approved in Mexico for the treatment of malignant melanoma.

 

About Lorus

Lorus Therapeutics Inc. is a biopharmaceutical company specializing in the research, development and commercialization of pharmaceutical products and technologies for the management of cancer.  With products in all stages of evaluation, from pre-clinical through Phase III trials, and a product approved in Mexico for malignant melanoma, Lorus is a leader in the development of therapeutics that seek to manage cancer with efficacious non-toxic compounds that improve patients’ quality of life. 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.  Lorus Therapeutics Inc.’s press releases are available through the Company’s Internet site: http://www.lorusthera.com.

 

For further information: 

Ashli MacInnis, Manager, Corporate Communications, Lorus Therapeutics Inc.,
tel: 416-798-1200;  email:  amacinnis@lorusthera.com. 

Media Contact:  Hugh Mansfield, Mansfield Communications Inc.,
tel: 416-599-0024;  email:  hugh@mcipr.com.

 

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