Source: Lorus Therapeutics Inc
Monday, March 24, 2003
Lorus Therapeutics Inc.
('Lorus') today announced that the U.S. Food and Drug Administration (FDA) has
awarded orphan drug status to GTI-2040, the company's lead anticancer agent
for the treatment of advanced kidney (renal cell) cancer. GTI-2040 is
currently in a Phase II clinical trial program in major North American cancer
centers for the treatment of renal cell cancer.
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For Lorus, receiving orphan drug status for GTI-2040 in the treatment of
renal cell 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 U.S. (independent of patent protection) upon
approval of the drug in the U.S.
Specifically, orphan drug status results in costs savings from a number
of tax benefits, the opportunity to obtain additional financial support from
the U.S government for clinical study costs, and exemption from certain fees
at the time of submission of GTI-2040 to the FDA for marketing approval.
Orphan drug designation typically means that FDA marketing review times are
expedited in comparison to other drugs since orphan drug status denotes
serious or life-threatening diseases that afflict less than 200,000 patients
annually in the U.S.
"The commitment of the U.S FDA is important to companies like Lorus,
whose business strategy includes advancing new treatments in clinical
development for debilitating diseases like kidney cancer," said Dr. Jim
Wright, CEO, Lorus. "This support helps Lorus optimize the commercial
potential of GTI-2040 in this cancer indication, and enhances our continuing
track-record of success as an innovative cancer research and drug development
company."
In partnership with the United States National Cancer Institute's Cancer
Therapy Evaluation Program (CTEP) under a clinical trials agreement, Lorus and
CTEP are expanding the Phase II clinical development of GTI-2040 to include
additional clinical trials for the treatment of other cancer types.
Renal cell carcinoma is the most common type of kidney cancer with more
than 34,000 cases diagnosed annually in North America. The majority of
patients are over the age of 40. More than 10,000 patients die annually from
this disease in the U.S., and 100,000 worldwide. The age-adjusted world
incidence in renal cell carcinoma has been increasing steadily at an annual
rate of approximately two per cent. In advanced metastatic renal cell
carcinoma patients, the five-year survival rate is approximately 10 per cent.
Current treatments include interferon, interluekin-2 (IL-2), and Proleukin,
the only approved drug for the treatment of renal cell carcinoma. The use of
these agents is limited due to serious toxicities in many patients. There is a
clear need for drugs with lower toxicities to treat patients with this
difficult disease. In this regard, GTI-2040 has shown a high safety profile in
preclinical and clinical studies.
About Lorus
Lorus is a biopharmaceutical company focused on the research and
development of cancer therapies. Lorus' goal is to capitalize on its research,
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 its own discovery efforts and an active acquisition and
in-licensing program, Lorus is building a portfolio of promising anti-cancer
drugs. Late-stage clinical developments 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
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 information form, annual reports
and 20-F filings.
Lorus Therapeutics Inc.'s press releases are available through the
Company's Internet site: http://www.lorusthera.com.