Lorus Therapeutics announces the initiation of a clinical trial of GTI-2040 in acute leukemia and myelodysplastic syndrome
2007年6月19日 - 10:30PM
PRニュース・ワイアー (英語)
- Clinical Study builds on corporate decision to focus on leukemia
indications for GTI-2040 - TORONTO, June 19 /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 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. About
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. About Lorus 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 http://www.lorusthera.com/. DATASOURCE: Lorus
Therapeutics Inc. CONTACT: Lorus Therapeutics Inc., Dr. Saeid
Babaei, (416) 798-1200 ext. 490,
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