Lorus
announces report of evidence of clinical activity in clinical trial of LOR-2040
combined with capecitabine and oxaliplatin in the treatment of advanced
metastatic solid tumors
TORONTO, CANADA, April 15,
2009 – Lorus
Therapeutics Inc. (TSX: LOR)
(“Lorus”),
a biopharmaceutical company specializing in the research and development of
pharmaceutical products and technologies for the management of cancer, today
announced the publication by study investigators of the results of a clinical
trial with its lead drug LOR-2040, formerly known as GTI-2040, in combination
with capecitabine and oxaliplatin in patients with advanced metastatic solid
tumors.
The
article entitled “Phase I trial of GTI-2040, oxaliplatin, and capecitabine in
the treatment of advanced metastatic solid tumors: a California Cancer
Consortium Study” was published in the Cancer Chemotherapy Pharmacology 2009
March 26 Epub ahead of print and is available online through PubMed
(http://www.ncbi.nlm.nih.gov/PubMed/).
The
Phase I trial, described in the article, was conducted as a California Cancer
Consortium study under the direction of the Principal Investigator, Dr. Stephen
I. Shibata. The study was sponsored by the National Cancer Institute (NCI),
Division of Cancer Treatment and Diagnosis (DCTD) under a Clinical Trials
Agreement (CTA) with Lorus.
The
article reported that combination therapy with LOR-2040, capecitabine and
oxaliplatin was safe with evidence of clinical activity in patients with
advanced incurable tumors, including lung, colorectal, and breast cancers,
despite the relatively low doses used in the study. Partial response
(tumor regression) with the LOR-2040 drug combination was seen in a non-small
cell lung cancer patient who had previously been treated with multiple
chemotherapy regimens. Two patients, one with breast cancer and one
with lung cancer, achieved stable disease at the maximum tolerated dose of the
three-drug combination, while a patient with colorectal cancer had stable
disease at a higher dose level. The study investigators concluded
that combination therapy with LOR-2040, capecitabine and oxaliplatin was
feasible in patients with advanced solid tumors.
"This
study again identifies a potential therapeutic benefit of LOR-2040 in
difficult-to-treat cancer patients with different solid tumors, including
heavily pre-treated non-small cell lung cancer patients for which there remains
a significant unmet medical need" said Dr. Aiping Young, Lorus’ President and
CEO. "LOR-2040 when combined with chemotherapy appears to achieve this clinical
activity without unacceptable toxicity in patients with failed prior therapies.
This study supports our ongoing programs in a range of cancer
types”.
About
LOR-2040
LOR-2040
is an RNA-targeted 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 vitro and in vivo models and is under
study in a multiple Phase I/II clinical program, including an advanced Phase II
clinical trial with LOR-2040 and high dose Ara-C (HiDAC) in refractory and
relapsed Acute Myeloid Leukemia (AML) under the CTA with DCTD, NCI. The R2
target has been described as a malignant determinant that is elevated in a wide
range of tumor types, 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.
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 continue as a going concern, our ability to repay or
refinance the convertible debentures by October 2009; 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. For Lorus' regulatory filings on SEDAR, please go
to 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).
Enquiries:
For
further information, please contact:
Lorus
Therapeutics Inc.
Dr.
Saeid Babaei, 416-798-1200 ext. 490; ir@lorusthera.com