FDA Approval To Begin Clinical Trials Of Anti-Cancer Drug
GTI 2040
Lorus Therapeutics Inc. ("Lorus") announced that the U.S. Food and Drug Administration ("FDA") has approved the
Company's Investigational New Drug ("IND") application to begin clinical trials of the anti-cancer drug, GTI 2040. The clinical
trial will take place under the direction of Dr. Richard Schilsky of the Chicago Cancer Research Center.
"The primary goal of this Phase I/II clinical trial is to look at the safety of GTI 2040 in patients with a variety of tumors," said
Mr. Philippe G. Lacaille, chairman and chief executive officer at Lorus. "The clinical trial of GTI 2040 is the first involving our
antisense compounds and we are very pleased to be starting it so quickly after our recent acquisition of GeneSense
Technologies. The trial will be a dose escalating study to determine optimum dosing levels and will involve approximately 20 to
25 patients who are non-responsive to other therapies."
Although the primary goal of the clinical trial is to evaluate safety, tests aimed at monitoring potential efficacy of GTI 2040 will
also be performed.
In an earlier announcement, Lorus reported that GTI 2040 had demonstrated excellent anti-tumor activity in in vivo models
when tested against a wide variety of human tumors.
"Depending on the tumor model, we saw significant inhibition of tumor growth, disease stabilization and in some cases, dramatic
tumor regression," said Dr. Jim Wright, president and chief scientific officer at Lorus. "GTI 2040 was tested extensively for
safety in several animal models, and we expect to find similar safety characteristics in our clinical trials."
Lorus is a biopharmaceutical company focused on the development of cancer therapies. Lorus' goal is to capitalize on its
pre-clinical, clinical and regulatory expertise by developing new drug candidates that can be used, either alone, or in
combination, to successfully manage cancer. Through an active acquisition and in-licensing program, Lorus is building a
portfolio of promising anti-cancer drugs. Late stage clinical development and marketing will be done in cooperation with
strategic pharmaceutical partners. Founded in 1986, Lorus Therapeutics Inc. is a public company listed on the Toronto Stock
Exchange and the Montreal Stock Exchange under the symbol LOR and on the OTC BB exchange under the symbol LORFF.
Except for historical information, this press release contains forward-looking statements, which reflect the Company's current
expectation regarding future events. These forward-looking statements involve risks and uncertainties, which may cause actual
results to differ materially from those statements. Those risks and uncertainties include, but are not limited to, changing market
conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of
competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other
risks detailed from time-to-time in the Company's ongoing quarterly filings, annual reports and 20-F filings. TEL: (905)
305-1100 x234
Philippe G. Lacaille, Chairman and FAX: (905) 305-1584
CEO, Lorus Therapeutics Inc. EMAIL: info@lorusthera.com INET: www.lorusthera.com
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