U.S FDA Grants Pralatrexate Orphan Drug Designation for the Treatment of Patients with Follicular Lymphoma
01 Décembre 2008 - 10:00PM
Business Wire
Allos Therapeutics, Inc. (Nasdaq:ALTH), a biopharmaceutical company
focused on the development and commercialization of small molecule
therapeutics for the treatment of cancer, today announced that the
U.S. Food and Drug Administration (FDA) granted orphan drug
designation to the Company's novel antifolate, pralatrexate (PDX),
for the treatment of patients with follicular lymphoma. "We are
pleased that the FDA has recognized the unmet medical need for
effective new therapies for the treatment of patients with
follicular lymphoma," said Paul L. Berns, President and Chief
Executive Officer. �This designation further complements the orphan
drug designation that the FDA previously awarded to pralatrexate in
patients with T-cell lymphoma and diffuse large B-cell lymphoma.�
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 marketing applications from other
sponsors to market the identical active moiety 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
Pralatrexate (PDX) Pralatrexate 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. Pralatrexate
was rationally designed for efficient transport into tumor cells
via the reduced folate carrier, or RFC-1, and effective
intracellular drug retention. The Company believes these
biochemical features, together with preclinical and clinical data
in a variety of tumors, suggest that pralatrexate may have a
favorable safety and efficacy profile relative to methotrexate and
other related DHFR inhibitors. The Company believes pralatrexate
has the potential to be delivered as a single agent or in
combination therapy regimens. About Allos Therapeutics, Inc. Allos
Therapeutics is a biopharmaceutical company focused on developing
and commercializing small molecule therapeutics for the treatment
of cancer.�The Company's lead product candidate, pralatrexate
(PDX), is a novel antifolate currently under evaluation in a
pivotal Phase 2 (PROPEL) trial in patients with relapsed or
refractory peripheral T-cell lymphoma. The PROPEL trial is being
conducted under an agreement reached with the U.S. Food and Drug
Administration under its special protocol assessment, or SPA
process. The Company is also investigating pralatrexate in patients
with non-small cell lung cancer, bladder cancer and a range of
lymphoma subtypes. The Company's other product candidate�is RH1, a
targeted chemotherapeutic agent currently being evaluated in a
Phase 1 trial in patients with advanced solid tumors or
non-Hodgkin�s Lymphoma (NHL). The Company currently retains
exclusive worldwide rights to pralatrexate and RH1 for all
indications. For additional information, please visit the Company�s
website at 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
regarding the potential safety and efficacy profile of pralatrexate
for the treatment of lymphoma or any other type of cancer 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 clinical trials, whether caused by adverse events,
regulatory issues or other factors; that clinical trials may not
demonstrate that pralatrexate is both safe and effective for the
treatment of patients with lymphoma, relapsed or refractory PTCL,
or any other type of cancer; that data from preclinical studies and
clinical trials may not necessarily be indicative of future
clinical trial results; that the safety and/or efficacy results of
clinical trials for pralatrexate will not support an application
for marketing approval in the United States or any other country;
and that the Company may lack the financial resources and access to
capital to fund future clinical trials for pralatrexate 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, 2007 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.
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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