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Phase III Clinical Trial of Virulizin Expanded to Europe, South America

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.

Source: Lorus Therapeutics Inc.

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