Lorus Advances Clinical Development of GTI-2040 Combined with Ara-C in Acute Myeloid Leukemia


    TORONTO, Aug. 29 /CNW/ - 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
    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

    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

    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

    Lorus Therapeutics Inc.'s recent press releases are available through the
Company's website at www.lorusthera.com.

For further information:

For further information: Lorus Therapeutics Inc., Dr. Saeid Babaei,
(416) 798-1200 ext. 490, ir@lorusthera.com

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