Lorus Advances Clinical Development of GTI-2040 Combined with Ara-C in Acute Myeloid Leukemia
29 August 2007 - 2:30PM
PR Newswire (US)
EXPANDED CLINICAL PROGRAM SUPPORTED BY PROMISING RESULTS FROM
COMPLETED TRIAL 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. 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 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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