Lorus Therapeutics Announces Publication of a Clinical Study Demonstrating Encouraging Results with LOR-2040 in Combination with
July 02 2008 - 9:00AM
PR Newswire (US)
- Study also points to potential of pre-treatment R2 levels as a
possible predictor of clinical activity - TORONTO, July 2
/PRNewswire-FirstCall/ -- Lorus Therapeutics Inc. (TSX: LOR, AMEX:
LRP) ("Lorus" or the "Corporation"), a biopharmaceutical company
specializing in the research and development of pharmaceutical
products and technologies for the management of cancer, today
announced publication by an Ohio State University (OSU) clinical
team of a paper entitled "Phase I Study of GTI-2040, an Antisense
to Ribonucleotide Reductase, in Combination with High-Dose
Cytarabine in Patients with Acute Myeloid Leukemia" (Clinical
Cancer Research 2008; 14 (12): 3889-3895). This was the first
clinical study in AML with GTI-2040, now known as LOR-2040. The
primary author, Dr Rebecca Klisovic and the Principal Investigator,
Dr Guido Marcucci, in the Division of Hematology and Oncology at
OSU carried out the study under the sponsorship of the National
Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP).
Lorus is collaborating with the Division of Cancer Treatment and
Diagnosis, NCI on the development of LOR-2040 under a Clinical
Trials Agreement. All patients in the study received LOR-2040 and
high dose cytarabine in therapeutic doses within a dose escalating
design, which determined a well-tolerated recommended Phase II
dose. In this study, the authors examined the relationship of the
targeted activity of LOR-2040 to clinical responses in AML patients
less than 60 years of age. Downregulation of R2, the target of
LOR-2040, after 24 hours of LOR-2040 was statistically significant
and was associated with complete remission. The authors have also
now reported for the first time that outcomes of complete response
were associated with high pre-treatment levels of R2, which were
statistically significant compared to nonresponders. This finding
suggests that pre-treatment R2 levels may be a predictor of
response, and provide a possible basis for treatment stratification
to LOR-2040 and high dose cytarabine combination. Favorable disease
responses included complete responses in 35% of the 23 patients and
significant cytoreduction of leukemic blasts in two others. As a
further favourable outcome, these two patients and five of the
patients who had complete responses were able to progress to a
successful transplant, a desired outcome of successful salvage
therapy. Notably, the study population included unfavourable
patients with at least one adverse prognostic characteristic. The
clinical study also measured intracellular uptake of LOR-2040 in
the bone marrow leukemic cells, and identified significant
accumulation of the drug in the bone marrow blast cells and
suggested preferential uptake of the drug by CD34+ cells, an
important malignant bone marrow cell population. The authors
concluded that LOR-2040 in combination with high dose cytarabine is
feasible, is active against its target R2, and "holds promise in
younger patients with refractory or relapsed AML". The tolerability
profile of this combination regimen was assessed as similar to that
expected from high dose cytarabine alone. "This successful clinical
study has provided a detailed supporting rationale for our ongoing
development program with LOR-2040 in AML", said Dr Aiping Young,
Lorus' President and CEO. "This study supports Lorus' view that a
highly specific targeted therapy approach can achieve efficacy with
minimal impact on toxicity". A Phase II program with LOR-2040 in
this combination is presently ongoing to extend and confirm these
findings in patients with refractory or relapsed AML. About
LOR-2040 LOR-2040 (formerly 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, LOR-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/. For Lorus'
regulatory filings on SEDAR, please go to http://www.sedar.com/.
For SEDAR filings prior to July 10, 2007 you will find these under
the company profile for Global Summit Real Estate Inc. (Old Lorus).
DATASOURCE: Lorus Therapeutics Inc. CONTACT: Lorus Therapeutics
Inc., Dr. Saeid Babaei, (416) 798-1200 ext. 490,
Copyright