Lorus adopts benefits from Virulizin orphan status
Lorus Therapeutics Inc LOR
Shares issued 120,945,940 Feb 16 close $2.01
Mon 19 Feb 2001 News Release
Dr. Jim Wright reports
The U.S. Food and Drug Administration has granted orphan drug status to
Lorus Therapeutics' anti-cancer drug Virulizin 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 United States to
encourage research and testing. For Lorus, receiving orphan status for
Virulizin 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 United
States (independent of patent protection) upon approval of the drug in the
United States.
Virulizin 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 in the treatment of pancreatic cancer, Lorus is
planning a pivotal phase III clinical trial for Virulizin in North America
this year.
"We are extremely encouraged that the FDA has chosen to grant orphan status
to Virulizin, 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 preclinical and/or clinical studies, Virulizin 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.
WARNING: The company relies upon litigation protection for
"forward-looking" statements.
(c) Copyright 2001 Canjex Publishing Ltd. stockwatch.com |
