TORONTO,
July 28, 2014 /CNW/ - Lorus
Therapeutics Inc. (TSX: LOR) today announced that the Food and Drug
Administration (FDA) completed its review and cleared the company's
Investigational New Drug (IND) application of LOR-253 for the
treatment of hematologic malignancies including acute myeloid
leukemia (AML), high-risk myelodysplastic syndromes (MDS),
lymphomas and multiple myeloma.
Clearance of the IND allows Lorus to initiate a
Phase 1b, multi-center, open-label, clinical study of LOR-253 in
patients with relapsed or refractory hematologic
malignancies. The Phase 1b trial will evaluate safety,
tolerability, pharmacokinetics, pharmacodynamic responses and
efficacy of LOR-253 as a single agent. The trial is expected
to enroll 45-60 patients as part of a dose-escalation program and
two separate disease-specific single-agent expansion cohorts.
LOR-253 is the only clinical-stage compound
known to induce the KLF4 gene. The suppression of KLF4 has
been reported as a key transforming event in AML and high-risk MDS,
and Lorus believes that LOR-253 may represent a targeted
therapeutic solution for a very difficult-to-treat cancer.
About Lorus
Lorus is a clinical-stage biotechnology company
with a commitment to discovering and developing targeted therapies
addressing unmet medical needs in oncology. We aim to develop
therapeutics focused on novel cellular targets on the leading edge
of cancer research coupled to companion diagnostics to identify the
optimal patient population for our products. Our pipeline of
cancer drug candidates includes small molecule products and
immunotherapies providing additive or synergistic efficacy without
leading to overlapping toxicities with existing anti-cancer
regimens, facilitating the adoption of combination therapies. 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 our 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. Many factors could cause our
actual results, performance or achievements to be materially
different from any future results, performance or achievements
described in this press release. Such expressed or implied forward
looking statements could include, 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 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.
SOURCE Lorus Therapeutics Inc.