WESTMINSTER, Colo., April 19 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (Nasdaq: ALTH) today announced that the Commission of
the European Communities, with a favorable opinion of the Committee for
Orphan Medicinal Products of the European Medicines Agency (EMEA), has
granted orphan drug designation to the Company's novel antifolate PDX
(pralatrexate) for the treatment of patients with peripheral T-cell
lymphoma (PTCL). In July 2006, the U.S. Food and Drug Administration (FDA)
awarded orphan drug designation to PDX for the treatment of patients with
T-cell lymphoma. In October 2006, the FDA granted fast track designation to
PDX for the treatment of patients with T-cell lymphoma.
"This designation underscores the critical need for new therapies to
treat peripheral T-cell lymphoma and reinforces our belief that PDX has the
potential to become an important therapeutic option for patients with this
devastating disease," said Paul L. Berns, President and Chief Executive
Officer.
The EMEA Orphan Medicinal Product Designation is intended to promote
the development of drugs that may provide significant benefit to patients
suffering from rare diseases identified as life-threatening or very
serious. Under EMEA guidelines, Orphan Medicinal Product Designation
provides ten years of potential market exclusivity once the product
candidate is approved for marketing for the designated indication in the
European Union. Orphan Medicinal Product Designation also provides
potential protocol assistance, advice on the conduct of clinical trials, a
reduced Marketing Authorization Application (MAA) filing fee for the drug's
sponsor and the potential for grant funding.
PDX is currently the subject of PROPEL, a pivotal Phase 2,
international, multi-center, open-label, single-arm study that will seek to
enroll 100 evaluable patients with relapsed or refractory PTCL who have
progressed after at least one prior treatment. The primary endpoint of the
study is objective response rate (complete and partial response). Secondary
endpoints include duration of response, progression-free survival and
overall survival. In August 2006, the Company announced that it reached
agreement with the FDA under the Special Protocol Assessment process on the
design of this pivotal Phase 2 trial. The Company currently anticipates
that patient enrollment at approximately 35 centers in the U.S., Canada and
Europe will be completed by the third quarter of 2008.
About PDX (pralatrexate)
PDX is a novel, small molecule chemotherapeutic agent that inhibits
dihydrofolate reductase, or DHFR, a folic acid (folate)-dependent enzyme
involved in the building of nucleic acid, or DNA, and other processes. PDX
was rationally designed for efficient transport into tumor cells via the
reduced folate carrier, or RFC-1, and effective intracellular drug
retention. We believe these biochemical features, together with preclinical
and clinical data in a variety of tumors, suggest that PDX may have a
favorable potency and toxicity profile relative to methotrexate and certain
other DHFR inhibitors.
About Peripheral T-cell Lymphoma
Peripheral T-cell lymphomas, or PTCLs, are a biologically diverse group
of blood cancers that account for approximately 10% to 15% of all cases of
non-Hodgkin's lymphoma (NHL), or about 6,700 patients. The average five
year survival rate for PTCL patients is approximately 25%. There are
currently no pharmaceutical agents approved for the treatment of either
first-line or relapsed or refractory PTCLs.
About Allos Therapeutics, Inc.
Allos Therapeutics, Inc. (ALTH) is a biopharmaceutical company focused
on the development and commercialization of small molecule therapeutics for
the treatment of cancer. The Company has two product candidates in
late-stage clinical development: EFAPROXYN (efaproxiral), a radiation
sensitizer currently under evaluation in a pivotal Phase 3 trial in women
with brain metastases originating from breast cancer, and PDX
(pralatrexate), a novel antifolate currently under evaluation in a pivotal
Phase 2 trial in patients with relapsed or refractory peripheral T-cell
lymphoma. The Company is also evaluating RH1, a targeted chemotherapeutic
agent, in a Phase 1 trial in patients with advanced solid tumors. For
additional information, please visit the Company's website at
http://www.allos.com.
Safe Harbor Statement
This press release contains forward-looking statements that are made
pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements include statements
relating to the potential safety and efficacy profile of PDX, the timeline
for completion of patient enrollment in the PROPEL trial; and other
statements that are other than statements of historical facts. In some
cases, you can identify forward-looking statements by terminology such as
"may," "will," "should," "expects," "intends," "plans," anticipates,"
"believes," "estimates," "predicts," "projects," "potential," "continue,"
and other similar terminology or the negative of these terms, but their
absence does not mean that a particular statement is not forward-looking.
Such forward-looking statements are not guarantees of future performance
and are subject to risks and uncertainties that may cause actual results to
differ materially from those anticipated by the forward-looking statements.
These risks and uncertainties include, among others: that the Company may
experience delays in the initiation and/or completion of its clinical
trials, whether caused by competition, adverse events, patient enrollment
rates, regulatory issues or other factors; that clinical trials may not
demonstrate that PDX is both safe and more effective than current standards
of care; that the safety and/or efficacy results of clinical trials for PDX
will not support an application for marketing approval in the European
Union; and the risk that the Company may lack the financial resources and
access to capital to fund future clinical trials for PDX or any of its
other product candidates. Additional information concerning these and other
factors that may cause actual results to differ materially from those
anticipated in the forward-looking statements is contained in the "Risk
Factors" section of the Company's Annual Report on Form 10-K for the year
ended December 31, 2005 and in the Company's other periodic reports and
filings with the Securities and Exchange Commission. The Company cautions
investors not to place undue reliance on the forward-looking statements
contained in this press release. All forward-looking statements are based
on information currently available to the Company on the date hereof, and
the Company undertakes no obligation to revise or update these
forward-looking statements to reflect events or circumstances after the
date of this presentation, except as required by law.
Note: EFAPROXYNTM and the Allos logo are trademarks of Allos
Therapeutics, Inc.
SOURCE Allos Therapeutics, Inc.
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Related links:
http://www.allos.com
CONTACT:
Jennifer Neiman, Senior Manager, Corporate
Communications, +1-720-540-5227, jneiman@allos.com, or Derek
Cole, Vice President, Investor Relations, +1-720-540-5367,
dcole@allos.com, both of Allos Therapeutics, Inc.
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