VirulizinTreatment for Pancreatic Cancer
U.S. FDA Agrees to Rolling New Drug Application for Virulizin
Rolling NDA to Allow Submission to Begin This Year
TORONTO, June 13, 2005 - Lorus Therapeutics Inc. ('Lorus'), a biopharmaceutical company specializing in the development and commercialization of pharmaceutical products and technologies for the management of cancer, today announced that the United States Food and Drug Administration (FDA) has accepted Lorus' proposal for a rolling submission for its New Drug Application (NDA) for Virulizin, the company's lead anticancer drug for the treatment of pancreatic cancer.
Lorus met with the FDA on May 25th, 2005 to discuss the chemistry, manufacturing, controls (quality) and non-clinical data packages that it plans to submit as part of the rolling NDA submission.
Products in fast track drug development programs, such as Lorus' Virulizin, may be considered for priority review and filing of portions of an application (rolling NDA) as they become available for submission. The criteria for a rolling NDA are designed for drug candidates, such as Virulizin, which have received fast track designation, and allows for completed sections of an NDA to be submitted on an ongoing basis.
A drug that receives fast track designation must demonstrate that it is intended for the treatment of a serious or life-threatening condition and that it has the potential to address unmet medical needs for the condition.
Fast track status for Virulizin was granted by the FDA on May 28th, 2002. Virulizin has also been awarded orphan drug status in the United Sates and Europe for the treatment of pancreatic cancer. Results of the pivotal Phase III clinical study in pancreatic cancer are anticipated in the second half of 2005. This Phase III registration clinical trial is being conducted under a Special Protocol Assessment from the FDA.
"Pursuing a rolling NDA is an important part of Lorus' strategy to bring Virulizin to market for the treatment of pancreatic cancer, as quickly as possible after the conclusion of our global clinical Phase III trial," said Dr. Jim Wright, CEO, Lorus.
Lorus is a biopharmaceutical company focused on the development and commercialization of cancer therapies. Lorus' goal is to capitalize on its research, preclinical, 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 acquisition and in-licensing program, Lorus is building a portfolio of promising anticancer drugs. Late-stage clinical development and marketing may be done in cooperation with strategic pharmaceutical partners. Lorus currently has three products in human clinical trials with a pipeline of eight clinical trials in phase II clinical trial programs and one phase III registration clinical trial. Lorus Therapeutics Inc. is a public company listed on the Toronto Stock Exchange under the symbol LOR, and on the American Stock Exchange under the symbol LRP. Virulizin is a registered trademark of Lorus Therapeutics Inc.
Posted: June 2005