WESTMINSTER, Colo., Oct. 3 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (Nasdaq: ALTH) today announced that the U.S. Food and
Drug Administration (FDA) has granted fast track designation to the
Company's unique next-generation antifolate PDX (pralatrexate) for the
treatment of patients with T-cell lymphoma.
The fast track program is designed to facilitate the development and
expedite the review of new drugs that are intended to treat serious or
life-threatening conditions and that demonstrate the potential to address
unmet medical needs. Fast track designation allows a company to submit
portions of a new drug application (NDA) on a rolling basis, allowing the
FDA to review sections of the NDA prior to receiving the complete
application. In addition, a NDA for a fast track product ordinarily
qualifies for priority review, thereby further expediting the FDA review
process.
"We are extremely pleased that the FDA has recognized the urgent and
unmet medical need for effective new therapies for the treatment of
patients with T- cell lymphoma," said Paul L. Berns, President and Chief
Executive Officer. "Fast track designation represents a significant
regulatory milestone in the development of PDX, and further validates the
potential of PDX in this patient population."
PDX is currently the subject of 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. In July 2006, the
FDA awarded orphan drug designation to PDX for the treatment of patients
with T-cell lymphoma.
About PDX (pralatrexate)
PDX is a novel, small molecule chemotherapeutic agent that inhibits
dihdrofolate reductase (DHFR), a folic acid (folate) dependent enzyme
involved in the building of DNA and other processes. PDX was rationally
designed for improved transport into tumor cells via the reduced folate
carrier (RFC-1), and greater intracellular drug retention. These
biochemical features, together with preclinical data in a variety of
tumors, suggest that PDX has an enhanced potency and improved toxicity
profile relative to methotrexate and other related DHFR inhibitors.
About Peripheral T-cell Lymphoma
Peripheral T-cell lymphomas, or PTCLs, are a biologically diverse and
uncommon group of blood cancers that account for approximately 10% to 15%
of all cases of non-Hodgkin's lymphoma, or about 6,700 patients annually.
The average five year survival rate for PTCL patients is approximately 25%.
There are currently no pharmaceutical agents approved for use in the
treatment of relapsed or refractory PTCL.
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, next generation 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 of PDX for the treatment of
T-cell lymphoma; the Company's projected timelines for completing
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 completion of the PROPEL trial, 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
effective for the treatment of patients with T-cell lymphoma or any other
type of cancer; that data from preclinical studies and clinical trials may
not be indicative of future clinical trial results; that the safety and/or
efficacy results of clinical trials for PDX may not support an application
for marketing approval in the United States or any other country; that an
application for marketing approval may not be accepted for priority review
or at all by the FDA or any other regulatory authority; and 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: EFAPROXYN(TM) 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, Manager, Corporate
Communications of Allos Therapeutics, Inc., +1-720-540-5227,
jneiman@allos.com
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