Lorus Therapeutics announces that the European Medicines Agency (EMEA) has granted the orphan drug designation to LOR-2040 for t
June 23 2008 - 7:30AM
PR Newswire (US)
- Orphan Drug designation by the EMEA demonstrates the potential of
LOR-2040 to provide significant therapeutic benefit to AML patients
- TORONTO, June 23 /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 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 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,
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