Virulizin(R) granted orphan drug status in the European Union Tuesday June 7, 7:00 am ET
- Virulizin(R) Phase III Registration Clinical Study Nearing Completion - TSX: LOR AMEX: LRP TORONTO, June 7 /CNW/ - 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 EMEA (European Medicines Agency) has given a positive opinion on Lorus' application for orphan drug status to Virulizin(R), the company's lead anticancer drug for the treatment of pancreatic cancer. This most recent orphan drug status designation for Virulizin(R) indicates that the product has potential to provide efficacy and a significant benefit to patients with this devastating condition. This positive opinion also strengthens the product's position in the European Union (EU), as the Phase III global registration clinical trial in pancreatic cancer nears completion during the second half of this calendar year. Virulizin(R) received orphan drug status for pancreatic cancer in the United States from the Food and Drug Administration (FDA) in 2001.
In order for a medicinal product to be designated as an orphan medicinal product in the EU, the sponsor must establish that a satisfactory method of treatment, which has been authorized in the European Community, does not exist for the condition, or, if such a method exists, that the medicinal product will be of significant benefit to those affected by that condition.
Significant benefit is defined in Commission Regulation (EC) 847/2000 as a 'clinically relevant advantage or a major contribution to patient care'. The applicant is required to justify the assumption that the medicinal product will be of significant benefit compared to the existing authorized medicinal products or methods at the time of designation.
"Virulizin(R) has now achieved orphan drug status for pancreatic cancer in two of the largest markets in the world providing Lorus with an important advantage in these markets," said Dr. Jim Wright, CEO, Lorus. "Further, we believe that this additional status enhances the value of our lead anticancer drug asset."
Orphan drug designation in the EU provides market exclusivity for 10 years (from products of the same mechanism of action or structural similarity) in pancreatic cancer as well as eligibility for fee reductions and the potential for accelerated review.
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(R) is a registered trademark of Lorus Therapeutics Inc.
Virulizin(R) is a novel immunotherapy that stimulates a patient's innate immune system through the activation of macrophages and the infiltration of NK cells into tumors. Virulizin(R) is currently in a fully enrolled pivotal Phase III registration clinical trial in North America, South America and Europe. It has been awarded orphan drug, fast track status and a Special Protocol Assessment (SPA) from the F.D.A. in the U.S. Lorus anticipates having the full data set from the Phase III clinical trial in the fourth quarter of calendar 2005.
About Pancreatic Cancer
Pancreatic cancer is one of the most lethal human cancers and continues to be a major unsolved health problem at the start of the 21st century. This is due to the lack of effective treatment options available at present for the pancreatic cancer patient. Despite efforts in the past 50 years, conventional treatment approaches such as surgery, radiation, chemotherapy, or combinations of these, have had little impact on the course of their aggressive neoplasm. Therefore, development of novel therapeutics of treatment of this type of cancer is important to improve patient prognosis.
The incidence of pancreatic cancer in the EU is 1.2 per 10,000 per annum. In the US, a total of approximately 30,000 new cases of pancreatic cancer are diagnosed each year, compared to approximately 53,000 cases per annum in the EU.
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Forum Alert: Lorus Therapeutics Will Present at the Informed Investors Biotechnology / Healthcare / Pharmaceutical Investor Forum at The Princeton Club of New York on Wednesday, June 15, 2005, 12:50 pm ET Friday June 10, 8:30 am ET
TORONTO--(BUSINESS WIRE)--June 10, 2005--Lorus Therapeutics (AMEX: LRP - News; TSX: LOR - News) will present at the following forum: What: Informed Investors Biotechnology / Healthcare / Pharmaceutical Investor Forum
When: June 15, 2005 @ 12:50 PM Eastern Time
Sponsors: Barron's, The Wall Street Journal, The American Stock Exchange and Business Wire
Contact: Bruce Rowlands, email@example.com , (416)798-1200, ext. 338
Lorus Therapeutics is a public Canadian biopharmaceutical company founded in 1986 and focused on the development and commercialization of novel, well-tolerated therapies that successfully manage cancer and promote improved quality of life. By developing cancer therapeutics using different mechanisms of action Lorus is targeting a wide variety of cancer indications. Lorus' diversified product pipeline provides multiple opportunities for clinical success and commercial alliances while at the same time mitigating the risk inherent in drug development. Through its own discovery efforts and an acquisition and in-licensing program, Lorus is building a portfolio of promising anticancer drugs. Lorus has developed a broad anticancer drug pipeline including immunotherapy, antisense, small molecules and tumor suppressor genes. Lorus' lead anticancer drug Virulizin® is an immunotherapy that enhances cell mediated immune response. This novel biological response modifier exerts its antitumor effect by direct activation of macrophages stimulating the production of cytokines. Lorus' antisense program has generated two lead clinical drug candidates, GTI 2040 and GTI 2501. Antisense therapy is designed to eliminate the synthesis of proteins that play a role in cancer at their source. Proteins are encoded by messenger RNA (mRNA) which in turn is transcribed from the corresponding gene. Antisense molecules are synthetic analogs of DNA that interfere with the production of specific mRNAs, leading to the reduction or elimination of the corresponding proteins. Lorus' most advanced small molecule program is focused around analogs of an existing drug, Clotrimazole. This program was out licensed to Cyclacel of Scotland in September 2003. Lorus' second small molecule program is based on an in house discovery of novel low molecular weight compounds with anticancer and antibacterial activity.
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