U.S. FDA Grants Pralatrexate Orphan Drug Designation for the Treatment of Patients with Diffuse Large B-Cell Lymphoma
25 11월 2008 - 6:00AM
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 diffuse large B-cell
lymphoma. "We are pleased with this designation, which highlights
the need for novel therapies to treat lymphoma,� said Paul L.
Berns, President and Chief Executive Officer. �Pralatrexate
previously received orphan drug designation from the FDA for the
treatment of patients with T-cell lymphoma. This additional
designation reinforces our intention to further evaluate
pralatrexate as a potential treatment for patients with 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) PDX 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. PDX 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 PDX may have a favorable safety and efficacy profile
relative to methotrexate and other related DHFR inhibitors. The
Company believes PDX 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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