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.
SOURCE Allos Therapeutics, Inc.
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Related links:
http://www.allos.com
CONTACT:
Jennifer Neiman, Manager, Corporate
Communications of Allos Therapeutics, +1-720-540-5227,
jneiman@allos.com
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