Healthcare Industry News: myelodysplastic syndrome
News Release - June 19, 2007
Lorus Therapeutics announces the initiation of a clinical trial of GTI-2040 in acute leukemia and myelodysplastic syndromeClinical Study builds on corporate decision to focus on leukemia indications for GTI-2040
TORONTO, June 19 (HSMN NewsFeed) - 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 that enrolment is underway in a new clinical trial in patients with acute leukemia and myelodysplastic syndrome (MDS).
The clinical study is designed to evaluate the safety and activity of GTI-2040 as a single agent for acute leukemia and MDS using a novel treatment schedule. The effect on leukemic blasts and blood count recovery will be assessed as part of a detailed investigation of the pharmacodynamic and pharmacokinetic effects, dose-response relationships and tolerability of GTI-2040 during multiple courses of treatment.
Dr. Mark Kirschbaum, Director of New Drug Development at the City of Hope National Cancer Center in Duarte California is conducting the study, which is sponsored by the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) under a Clinical Trials Agreement with Lorus. Additional investigators participating in the study are Dr. Yun Yen also at City of Hope National Cancer Center, Dr. Joseph Tuscano at the University of California Davis Cancer Center, and Dr. Kenneth Foon at the University of Pittsburgh Cancer Institute (UPCI).
The majority of MDS patients progress rapidly with mean survival rates of approximately six months to a year for the severe form of the disease. High grade MDS may also progress to an acute leukemia with even worse prognosis, and this continuum is reflected in the present study design. These patients are typically elderly and unable to sustain intensification of their prior first line therapy. More tolerable efficacious therapies are therefore needed.
"Since overall response rates (complete or partial responses) in MDS are typically only 16-20%, there is a continuing large unmet need for better treatments." commented Dr. Aiping Young, Lorus' President & CEO. "GTI-2040 has shown very encouraging clinical results so far, and we anticipate that it will also be an effective treatment for MDS."
This study complements the ongoing development program with GTI-2040 combined with high dose cytarabine in younger patients with acute myeloid leukemia (AML) in which complete responses to the combination were found to correlate with downregulation of R2, the cellular target of GTI-2040.
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 has completed one Phase II and one Phase III clinical trial. Lorus Therapeutics Inc. is listed on the Toronto Stock Exchange under the symbol LOR, and on the American Stock Exchange under the symbol LRP.
Forward Looking Statements
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 www.lorusthera.com.
Source: Lorus Therapeutics
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