30 September 2003 11:11
Lorus Therapuetics announces global expansion of the Virulizin registration Phase III clinical trial
TORONTO, Sept. 30 /PRNewswire-FirstCall/ -- Lorus Therapeutics Inc. ("Lorus") announced today a major
global expansion to clinical sites in Europe and South America of its current Phase III clinical trial of Virulizin in
advanced pancreatic cancer. The clinical study is now operating at major oncology centres in Russia, Ukraine, and
Romania, with additional sites in Poland, the Czech Republic, Hungary, Spain and Brazil in progress. The study is also
ongoing at centres in the US, Canada and Mexico. To date, over 100 clinical study sites are involved in this
international Phase III clinical trial.
The Virulizin Phase III trial in advanced pancreatic cancer is a multi-centre, double-blind clinical study comparing
Virulizin in combination with gemcitabine to gemcitabine and placebo in the first-line treatment setting. The study also
includes a second-line treatment component involving Virulizin in combination with 5-FU, versus 5-FU and placebo.
The primary efficacy endpoint of the study is survival. Secondary endpoints in the study include time to treatment
progression, which analyzes the effect of Virulizin on key clinical benefit parameters such as pain, analgesic
consumption, changes in weight, and performance status.
In addition, the study will also correlate immune parameters with clinical outcome. Virulizin has been associated
with increases in natural killer cell activity in an earlier Phase II clinical study, while animal studies have shown
similar effects, in addition to stimulation of macrophage activity and associated mediators of the immune response.
"This is a significant event in the overall clinical development program for Virulizin. Expansion of this study
to international oncology centres throughout Europe and Brazil has been a long-standing strategy for Lorus to ensure we
remain successfully on track with key milestones in our trial program," said Dr. Jim Wright, CEO of Lorus.
"This strategy also benefits Lorus' future commercial interests, as global trials optimize awareness of
Virulizin among oncologists worldwide, well before a commercial launch. Such early awareness is essential to any
successful pharmaceutical marketing strategy."
Virulizin has been shown to be a well-tolerated oncology drug with low toxicity in both pre-clinical and clinical
studies. The company received FDA fast-track designation for Virulizin in the treatment of advanced pancreatic cancer in
2002, and orphan drug status in the US for the same indication in 2001.
Virulizin is currently marketed in Mexico for malignant melanoma as part of an exclusive distribution agreement with
Mayne Pharma for Mexico. Under the terms of the agreement, Lorus receives royalties from the sales of Virulizin(R) and
is responsible for manufacturing the drug. Mayne Pharma recently exercised its option for similar agreements in Brazil
and Argentina. Lorus also supplies Virulizin through emergency drug and compassionate-use programs around the world to
patients with advanced pancreatic cancer and other cancers.
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/. Lorus Therapeutics Inc.
CONTACT: Lorus Therapeutics Inc: Corporate Communications, Grace Tse, Tel: (416) 798-1200 ext. 380, Email:
ir@lorusthera.com; Canadian Media Contact: Hugh Mansfield, Mansfield Communications Inc., Tel: (416) 599-0024; Email:
hugh@mcipr.com; US Media Contact: Jennifer Taylor, Mansfield Communications Inc., Tel: (416) 370-5045, Email:
jennifer@mcipr.com
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