EXPANDED CLINICAL PROGRAM SUPPORTED BY PROMISING RESULTS FROM COMPLETED
TORONTO, Aug. 29 /PRNewswire-FirstCall/ - Lorus Therapeutics Inc. ("Lorus") (TSX: LOR; AMEX: LRP), a biopharmaceutical company specializing in the research and development of pharmaceutical products and technologies for the management of cancer, today announced completion of a proof of concept clinical trial in Acute Myeloid Leukemia (AML), and expansion of its GTI-2040 development program in this indication, with initiation of a more advanced Phase II clinical trial with GTI-2040 and high dose Ara-C (HiDAC) in refractory and relapsed AML.
The advanced Phase II clinical trial, which is now underway, includes both an efficacy study and a novel additional study to measure intracellular target activities and pharmacological synergies between the two agents. In the first stage of the 60 patient trial, the pharmacologic and target related activity of GTI-2040 and HiDAC will be evaluated in two groups, to determine the contribution of each agent alone and in combination. The second stage of the trial will provide efficacy evaluation in a larger patient population. Lorus expects the clinical trial to be completed by the end of 2008.
The decision by Lorus to advance clinical development of GTI-2040 is based on the encouraging results from our recently completed proof of concept study of GTI-2040 in combination with HiDAC in patients with refractory and relapsed AML. This clinical trial demonstrated safety and appropriate dosing of the combination regimen and showed promising clinical responses in patients under 60 years of age. Moreover, the clinical responses correlated with downregulation of R2, the cellular target of GTI-2040, and were further supported by demonstration of intracellular GTI-2040 in circulating and bone marrow leukemic cells. Complete results from the clinical trial are expected to be presented by the investigators in a scientific publication.
"The initiation of an advanced Phase II clinical trial with GTI-2040 is a very significant step forward for Lorus, and for the development of its clinical stage pipeline. This underscores the dedication of Lorus' clinical and regulatory teams to the development of novel anticancer agents," commented Dr. Aiping Young, President & CEO of Lorus. "The clinical data for GTI-2040 in AML are consistent with an antisense mode of action, and the frequency of responses and statistical correlation of this with target activity are very encouraging. We believe that this drug will provide an important new treatment opportunity for AML patients."
This new advanced Phase II clinical trial is sponsored by Lorus and is being led by Dr. Rebecca Klisovic as Principal Investigator and Dr. Guido Marcucci as co-investigator, at The Comprehensive Cancer Center of Ohio State University. Dr. Marcucci was also the Principal Investigator on the previous clinical trial of GTI-2040 in AML, which was carried out with the sponsorship of the Cancer Therapy Evaluation Program of the US National Cancer Institute. Dr. Marcucci and his team at OSU have extensive experience with antisense and other targeted therapies in leukemic indications and in genetic studies of leukemia.
Ara-C, including HiDAC, is a key component of nearly all AML regimens, for induction, consolidation or salvage treatment. However even with intensification of the Ara-C, response to treatment in refractory and relapsed disease is limited by development of increasing resistance to Ara-C with repeated exposures. Combining GTI-2040 with Ara-C is a rational approach that in addition to potential cooperative activities may overcome resistance to Ara-C.
GTI-2040 is an antisense drug that specifically targets the R2 component of ribonucleotide reductase, which is required for DNA synthesis and cell proliferation. Through downregulation of R2, GTI-2040 has demonstrated strong antitumor and antimetastatic activity in a variety of tumor types in both in vivo and in vitro models and is under study in a multiple Phase I/II clinical program. R2 has been described as a malignant determinant that is elevated in a wide range of tumors, which can cooperate with a variety of cellular cancer causing genes known as oncogenes to enhance tumor growth and metastatic potential.
Lorus is a biopharmaceutical company focused on the research and development of novel therapeutics in cancer. Lorus' goal is to capitalize on its research, preclinical, clinical and regulatory expertise by developing new drug candidates that can be used, either alone, or in combination with other drugs, to successfully manage cancer. Through its own discovery efforts and an acquisition and in-licensing program, Lorus is building a portfolio of promising anticancer drugs. Lorus Therapeutics Inc. is listed on the Toronto Stock Exchange under the symbol LOR, and on the American Stock Exchange under the symbol LRP.
This press release may contain forward-looking statements within the meaning of Canadian and U.S. securities laws. Such statements include, but are not limited to, statements relating to: our research program plans, our plans to conduct clinical trials, the successful and timely completion of clinical studies and the regulatory approval process, our ability to fund future research, our plans to obtain partners to assist in the further development of our product candidates, the establishment of corporate alliances, the Company's plans, objectives, expectations and intentions and other statements including words such as "continue", "believe", "plan", "expect", "intend", "will", "should", "may", and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements that may be expressed or implied by such forward-looking statements, including, among others: our ability to obtain the capital required for research and operations, the inherent risks in early stage drug development including demonstrating efficacy, development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market conditions; and other risks detailed from time-to-time in our ongoing quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators and the United States Securities and Exchange Commission.
Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled "Risk Factors" in our Annual Information Form underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein.
Lorus Therapeutics Inc.'s recent press releases are available through the Company's website at http://www.lorusthera.com.
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