News release via Canada NewsWire, Toronto 416-863-9350
Attention Business Editors:
Lorus Therapeutics announces that the European Medicines Agency (EMEA)
has granted the orphan drug designation to LOR-2040 for the treatment of
Acute Myeloid Leukemia (AML)
- Orphan Drug designation by the EMEA demonstrates the potential of
LOR-2040 to provide significant therapeutic benefit to AML patients -
TORONTO, June 23 /CNW/ - 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 that its lead Clinical drug,
LOR-2040, has been granted Orphan Drug status for the treatment of Acute
Myeloid Leukemia (AML) by the Committee for Orphan Medicinal Products (COMP)
of the European Medicines Agency (EMEA).
For a medicinal product to be designated as an orphan medicinal product
in the European Union (EU), the sponsor must establish that a satisfactory
method of treatment, which has been authorized in the European Community, does
not exist for the condition, or, if such a method exists, that the medicinal
product will be of significant benefit to those affected by that condition.
LOR-2040 is currently in an advanced Phase II clinical study in patients
with relapsed or refractory AML. To provide an adequate supply of LOR-2040 for
ongoing and projected clinical trials, Lorus has already secured additional
supply of LOR-2040 from Avecia Biotechnology Inc., a leading private
biotechnology company focused on the development and manufacture of innovative
medicines.
"Obtaining orphan drug designation in Europe for LOR-2040 is another
important step in the path toward commercialization of this therapeutic
approach," said Dr. Aiping Young, President and CEO of Lorus. "Orphan drug
status, together with our broad patent coverage achieved for this drug in the
EU, has served to strengthen and align our proprietary European market
position with the level we have achieved in the United States."
Orphan drug designation when granted by the EMEA provides market
exclusivity for treatment of a qualifying disease for up to 10 years following
drug approval, in addition to Scientific Advice to optimize development,
guidance on the proposed clinical design, and in preparation for the marketing
application. In addition, orphan drug designation may qualify for fee
reductions for access to the centralized community procedures before and after
marketing authorization.
The EMEA represents 25 EU countries, including the United Kingdom,
France, Italy, Germany and Spain.
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 II clinical program. The present Phase II study was based on a
completed Phase I and pharmacodynamic study in a similar AML population which
demonstrated a correlation of favourable complete response frequency with R2
downregulation. 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 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).
%SEDAR: 00025614EF %CIK: 0000882361
/For further information: Lorus Therapeutics Inc., Dr. Saeid Babaei,
(416) 798-1200 ext. 490, ir(at)lorusthera.com/
(LOR. LRP)
CO: Lorus Therapeutics Inc.
CNW 07:30e 23-JUN-08