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 in the treatment of pancreatic cancer. VirulizinÒ 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. 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 VirulizinÒ as an effective anticancer drug, and we are working hard to progress our Phase III clinical trial program to the New Drug Application stage.”
VirulizinÒ is a potent and unique immunotherapy that directly stimulates macrophages and enhances their ability to kill tumor cells. VirulizinÒ 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 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. Those patients who fail or become refractory to gemcitabine are treated with 5-Fluorouracil (5-FU) or with 5-FU in combination with VirulizinÒ in a second line therapy. All study subjects will be monitored throughout the remainder of their lifespan.
VirulizinÒ 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.
For further information:
Ashli MacInnis, Manager, Corporate Communications, Lorus Therapeutics Inc., tel: 416-798-1200
Media Contact: Hugh Mansfield, Mansfield Communications Inc., tel: 416-599-0024
About Dalton Chemical Laboratories Inc.
Dalton Chemical Laboratories Inc is a contract pharmaceutical manufacturer that supplies chemistry and analytical services to the biotechnology and pharmaceutical industries in the areas of medicinal chemistry, fine chemical manufacture, custom peptides and antisense oligo production. Dalton has a site Establishment License and is registered with Health Canada as a drug testing lab. Dalton provides cGMP manufacturing and sterile filling capabilities to its customers at any stage of the regulatory process (Phase I, II, III or commercial). In its state-of-the-art cGMP facilities, Dalton can produce active pharmaceutical ingredients (API), at the gram or kilogram scale. Dalton can carry out sterile fills to produce batches of finished drug product in vials or syringes, either aseptically filled or terminally sterilized, under fully validated conditions.
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