Allos Therapeutics' PDX Granted Orphan Medicinal Product Designation by the European Commission
19 Avril 2007 - 2:30PM
PR Newswire (US)
WESTMINSTER, Colo., April 19 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (NASDAQ:ALTH) today announced that the
Commission of the European Communities, with a favorable opinion of
the Committee for Orphan Medicinal Products of the European
Medicines Agency (EMEA), has granted orphan drug designation to the
Company's novel antifolate PDX (pralatrexate) for the treatment of
patients with peripheral T-cell lymphoma (PTCL). In July 2006, the
U.S. Food and Drug Administration (FDA) awarded orphan drug
designation to PDX for the treatment of patients with T-cell
lymphoma. In October 2006, the FDA granted fast track designation
to PDX for the treatment of patients with T-cell lymphoma. "This
designation underscores the critical need for new therapies to
treat peripheral T-cell lymphoma and reinforces our belief that PDX
has the potential to become an important therapeutic option for
patients with this devastating disease," said Paul L. Berns,
President and Chief Executive Officer. The EMEA Orphan Medicinal
Product Designation is intended to promote the development of drugs
that may provide significant benefit to patients suffering from
rare diseases identified as life-threatening or very serious. Under
EMEA guidelines, Orphan Medicinal Product Designation provides ten
years of potential market exclusivity once the product candidate is
approved for marketing for the designated indication in the
European Union. Orphan Medicinal Product Designation also provides
potential protocol assistance, advice on the conduct of clinical
trials, a reduced Marketing Authorization Application (MAA) filing
fee for the drug's sponsor and the potential for grant funding. PDX
is currently the subject of PROPEL, 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. About
PDX (pralatrexate) 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. We
believe these biochemical features, together with preclinical and
clinical data in a variety of tumors, suggest that PDX may have a
favorable potency and toxicity profile relative to methotrexate and
certain other 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 non-Hodgkin's lymphoma (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 either first-line or relapsed or
refractory PTCLs. 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 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 profile of PDX, the
timeline for completion of patient 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
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 European Union; 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:
EFAPROXYNTM and the Allos logo are trademarks of Allos
Therapeutics, Inc. DATASOURCE: Allos Therapeutics, Inc. CONTACT:
Jennifer Neiman, Senior Manager, Corporate Communications,
+1-720-540-5227, , or Derek Cole, Vice President, Investor
Relations, +1-720-540-5367, , both of Allos Therapeutics, Inc. Web
site: http://www.allos.com/
Copyright
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024