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Clinical Study Initiated To Investigate GTI-2040, Gemcitabine Combination in Solide Tumors

TORONTO, CANADA, February 10, 2004 – Lorus Therapeutics Inc. announced today the initiation of a clinical trial aimed at examining the clinical application of its antisense drug, GTI-2040, in combination with gemcitabine in patients with solid tumors. This study is part of a larger clinical development program sponsored and coordinated by the US National Cancer Institute (NCI) in collaboration with Lorus. Dr. Chris Takamoto, the principal investigator, is an oncology researcher and director of pharmacokinetics at the Institute for Drug Development, Cancer Therapy and Research Center in San Antonio, where the study will be conducted.

GTI-2040 and gemcitabine have complementary intracellular mechanisms of action for blocking DNA synthesis and subsequently inhibiting the growth of tumor cells. This convergence of drug mechanisms of action provides the potential for enhanced or synergistic effects when used in combination.

The study will determine the recommended dose of GTI-2040 when administered with gemcitabine, an established chemotherapeutic agent. In addition, the study will evaluate the plasma pharmacokinetics and pharmacodynamics of each drug and examine cellular biomarkers that may correlate with clinical outcomes. One such biomarker is R2, the gene target of GTI-2040, and an essential component of ribonucleotide reductase, an enzyme required for cell division. The R2 component is elevated in many tumor types, and as such, suppression of R2 by GTI-2040 may serve as a biomarker for clinical response. Finally a number of clinical correlates will be investigated, in particular markers for apoptosis, or programmed cell death, which may represent an additional mechanism by which GTI-2040 selectively kills tumor cells.

Preclinical research has shown that GTI-2040 has a broad spectrum of anticancer activity across a range of human tumors in mouse xenograft models, and when combined with other chemotherapies has improved antitumor activity with little additional toxicity. Gemcitabine (GEMZAR) is currently approved for the treatment of advanced pancreatic cancer and lung cancer.

“We are excited about the expanded range of clinical applications offered by this drug combination,” said Dr. Jim Wright, chief executive officer of Lorus. “Of particular interest is the potential for GTI-2040 to reduce the development and/or the extent of resistance of cancer cells to gemcitabine, an important cause of treatment failure. If demonstrated this would provide new hope for patients with drug-resistant tumors.”

Source: Lorus Therapeutics Inc.

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