Allos Therapeutics Receives FDA Fast Track Designation for PDX for the Treatment of T-cell Lymphoma
October 03 2006 - 9:00AM
PR Newswire (US)
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. DATASOURCE: Allos Therapeutics, Inc. CONTACT:
Jennifer Neiman, Manager, Corporate Communications of Allos
Therapeutics, Inc., +1-720-540-5227, Web site:
http://www.allos.com/
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