FDA Grants Orphan Drug Designation to Allos Therapeutics' Novel Antifolate PDX for the Treatment of T-cell Lymphoma
26 July 2006 - 11:00PM
PR Newswire (US)
WESTMINSTER, Colo., July 26 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (NASDAQ:ALTH) today announced that the U.S. Food
and Drug Administration (FDA) has awarded orphan drug designation
to the Company's novel, next-generation antifolate PDX
(pralatrexate) for the treatment of patients with T-cell lymphoma.
The Company currently plans to initiate a Phase 2 study of PDX in
patients with relapsed or refractory peripheral T-cell lymphoma
(PTCL) in the third quarter of 2006. "This designation underscores
the acute need for new therapies to treat T-cell lymphoma and
provides Allos with potential market exclusivity and other benefits
to support the development of PDX in this important clinical
setting," said Paul L. Berns, President and Chief Executive
Officer. Interim results from a Phase 1/2 study of PDX in patients
with relapsed or refractory non-Hodgkin's lymphoma (NHL) and
Hodgkin's disease currently on-going at Memorial Sloan-Kettering
Cancer Center demonstrated preliminary evidence of activity in
patients with various subtypes of aggressive and chemotherapy
resistant T-cell lymphoma. As reported at the 2005 American Society
of Hematology Annual Meeting, four of seven evaluable patients with
T-cell lymphoma achieved a complete response following treatment
with PDX, despite having failed multiple prior chemotherapies. The
addition of vitamins to the treatment regimen appeared to
successfully mitigate the previously established dose-limiting
toxicity of stomatitis. The U.S. Orphan Drug Act is intended to
assist and encourage companies to develop safe and effective
therapies for the treatment of rare diseases and disorders. Under
the Orphan Drug Act, the FDA will not accept or approve other
applications from other sponsors to market the identical medicinal
products for the same therapeutic indication for a seven-year
period once a designated orphan drug is approved for marketing. In
addition to potential market exclusivity, orphan drug designation
provides potential protocol assistance, advice on the conduct of
clinical trials, tax credits for clinical research expenses, grant
funding for research of rare disease treatments and waiver of the
Prescription Drug User Fee Act (PDUFA) filing fee for the drug's
sponsor. About PDX (pralatrexate) PDX is a novel, next-generation
small molecule chemotherapeutic agent that inhibits dihdrofolate
reductase, or 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
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 group of blood
cancers that account for approximately 10% to 15% of all cases of
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 relapsed or
refractory PTCLs. About Allos Therapeutics, Inc. Allos
Therapeutics, Inc. (NASDAQ:ALTH) is a biopharmaceutical company
focused on developing and commercializing innovative small molecule
therapeutics for the treatment of cancer. The Company's lead
product candidate, EFAPROXYN(TM) (efaproxiral), is a synthetic
small molecule designed to sensitize hypoxic, or oxygen-deprived,
tumor tissue during radiation therapy. EFAPROXYN is currently being
evaluated as an adjunct to whole brain radiation therapy in a
pivotal Phase 3 trial in women with brain metastases originating
from breast cancer. The Company's other product candidates are: PDX
(pralatrexate), a small molecule chemotherapeutic agent (DHFR
inhibitor) currently under investigation in patients with non-small
cell lung cancer and Non-Hodgkin's lymphoma; and RH1, a small
molecule chemotherapeutic agent bioactivated by the enzyme
DT-diaphorase currently under evaluation in patients with advanced
solid tumors. For more information, please visit the Company's web
site 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 Company's plans to initiate a Phase 2 study of PDX for the
treatment of patients with T- cell lymphoma; 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 United
States or any other country; 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: 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,
+1-720-540-5227, Web site: http://www.allos.com/
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