Allos Therapeutics’ Pralatrexate Granted Orphan Medicinal Product Designation for the Treatment of Bladder Cancer by the Eu...
17 3월 2009 - 9:00PM
Business Wire
Allos Therapeutics, Inc. (Nasdaq: ALTH) announced today that the
European Medicines Agency (EMEA), with a positive opinion of the
Committee for Orphan Medicinal Products, has granted orphan
medicinal product designation to the Company�s novel antifolate,
pralatrexate, for the treatment of non-papillary transitional cell
carcinoma (TCC) of the urinary bladder, a form of bladder cancer.
The Company is currently investigating pralatrexate in a Phase 2
study in patients with advanced or metastatic relapsed TCC of the
urinary bladder. In April 2007, the EMEA granted orphan drug
designation to pralatrexate for the treatment of patients with
peripheral T-cell lymphoma.
�This additional orphan drug designation supports our global
development strategy for pralatrexate,� said Paul L. Berns,
president and chief executive officer of Allos Therapeutics, Inc.
�We value the positive recognition from the EMEA of the unmet
medical need for effective new therapies for the treatment of
patients with bladder cancer. In addition, the orphan medicinal
product designation further strengthens our program for
pralatrexate by offering important clinical development and
commercialization benefits.�
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.
About Bladder Cancer
Bladder cancer is the ninth most common cancer with an estimated
356,600 new cases of bladder cancer worldwide each year.
Non-papillary TCC of the urinary bladder is a life-threatening
condition. According to the American Cancer Society, an estimated
68,810 new cases of bladder cancer were expected to be diagnosed in
the United States in 2008. Transitional cell carcinoma, or TCC, is
the most common form of bladder cancer, accounting for more than
90% of all bladder cancers. There are currently no approved agents
for the treatment of advanced or metastatic relapsed non-papillary
TCC of the urinary bladder.
About Pralatrexate
Pralatrexate is a novel targeted antifolate designed to
accumulate preferentially in cancer cells. Based on preclinical
studies, the Company believes that pralatrexate selectively enters
cells expressing RFC-1, a protein that is over expressed on cancer
cells compared to normal cells. Once inside cancer cells,
pralatrexate is efficiently polyglutamylated, which leads to high
intracellular drug retention. Polyglutamylated pralatrexate
essentially becomes �trapped� inside cancer cells, making it less
susceptible to efflux-based drug resistance. Acting on the folate
pathway, pralatrexate interferes with DNA synthesis and triggers
cancer cell death. 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 innovative small molecule drugs for
the treatment of cancer. In February 2009, the Company announced
the final results from PROPEL, the Company�s pivotal Phase 2 trial
of pralatrexate in patients with relapsed or refractory peripheral
T-cell lymphoma (PTCL). The PROPEL trial was conducted under an
agreement reached with the U.S. Food and Drug Administration under
its special protocol assessment (SPA) process. Based on the results
of the PROPEL trial, the Company intends to submit a New Drug
Application to the U.S. Food and Drug Administration for
pralatrexate for the treatment of relapsed or refractory PTCL in
the first half of 2009. The Company is also investigating
pralatrexate in patients with non-small cell lung cancer and a
range of lymphoma sub-types. The Company currently retains
exclusive worldwide rights to pralatrexate 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 Company�s intent and
projected timeline to submit a New Drug Application for
pralatrexate as a treatment for patients with relapsed or
refractory PTCL, 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 design of or data
collected from the PROPEL trial may not be adequate to demonstrate
the safety and efficacy of pralatrexate for the treatment of
patients with relapsed or refractory PTCL, or otherwise be
sufficient to support FDA approval; that the Company�s New Drug
Application may not be accepted for priority review or at all by
the FDA; that the FDA may disagree with the Company�s
interpretations of data from preclinical studies and clinical
trials involving pralatrexate, including the PROPEL trial, or
otherwise determine such data are not sufficient to support
approval; that the Company may experience difficulties or delays in
the initiation, progress or completion of its clinical trials,
whether caused by competition, adverse events, investigative site
initiation rates, patient enrollment rates, regulatory issues or
other factors; and that the Company may lack the financial
resources and access to capital to support its future operations,
including the potential commercialization of pralatrexate if
approved for marketing. 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, 2008 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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