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NEWS RELEASE
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Lorus
Successfully Completes IND-Enabling Toxicology Studies for Lead Small Molecule
Anticancer Drug LOR-253
TORONTO, CANADA, November 10, 2008 -
Lorus Therapeutics Inc. (TSX: LOR) (“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 the successful completion of toxicology studies for its lead small
molecule LOR-253 anticancer drug, formerly known as LT-253. LOR-253 represents a
new targeted approach in cancer drug development, by inducing KLF4, a tumor
suppressor factor that is reduced in a variety of important
cancers.
The
GLP, IND-enabling toxicology studies conducted for LOR-253 included maximum
tolerated dose studies and repeat-dose toxicity studies in rodents and
nonrodents. The data have established the toxicity profile for
LOR-253, which will be supportive of a Phase I clinical trial in cancer
patients. Importantly, the study results indicate that LOR-253
is well tolerated at higher dose levels than efficacious dose levels determined
from preclinical pharmacology studies.
The
toxicology studies were designed to support the dosing regimen and intravenous
route of administration for LOR-253 that is planned for a Phase I clinical trial
upon filing an investigational new drug (IND) submission with the U.S.
FDA.
“The
successful completion of the toxicology program for LOR-253 is an important
milestone in the development of this novel drug candidate which represents a
“first in class” development program”, said Dr Aiping Young, Lorus’ President
and CEO. “We are now one step closer to initiating clinical trials with this
exciting compound, which was identified at Lorus using our drug discovery
platform”.
About
LOR-253
LOR-253
is a novel small molecule that has shown selective and potent antitumor activity
in a variety of human cancers, including colon cancer and non-small cell lung
cancer, and has demonstrated an excellent therapeutic window in experimental
models. The mode of action of LOR-253 involves induction of the tumor suppressor
Kruppel like factor 4 (KLF-4), leading to the downregulation of cyclin D1, an
important regulator of cell cycle progression and cell proliferation.
Alterations in KLF-4 expression and the cyclin D1 regulatory pathway have been
linked to the development of cancer.
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 contains forward-looking statements within the meaning of Canadian
and U.S. securities laws. Such statements include, but are not limited to,
statements relating to: financings and corporate reorganizations, the
establishment of corporate alliances, the Company’s plans, objectives,
expectations and intentions and other statements including words such as
“continue”, “expect”, “intend”, “will”, “should”, “would”, “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. Such expressed or implied forward looking statements
could include, 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 filings with
Canadian securities regulators and the United States Securities and Exchange
Commission 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 its 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