Allos Therapeutics Announces FDA Accepts Pralatrexate NDA for Filing and Grants the Application Priority Review Status
May 26 2009 - 8:00AM
Business Wire
Allos Therapeutics, Inc. (NASDAQ:ALTH) today announced that the
U.S. Food and Drug Administration (FDA) has accepted for filing the
Company�s New Drug Application (NDA) for pralatrexate for the
treatment of patients with relapsed or refractory peripheral T-cell
lymphoma (PTCL). The Company also announced that the FDA has
granted the NDA priority review status and established a
Prescription Drug User Fee Act (PDUFA) date of September 24, 2009
for a decision regarding approval of the NDA. Priority review
designation is assigned to drugs that have the potential to provide
a significant improvement compared to marketed products or provide
a safe and effective therapy where no satisfactory therapy
exists.
�We are pleased the FDA has accepted our application for filing
and granted it priority review status, a designation that
emphasizes the significant need for new agents that advance the
treatment of patients with relapsed or refractory peripheral T-cell
lymphoma,� said Paul L. Berns, president and chief executive
officer of Allos Therapeutics, Inc.��Over the next several months,
we will continue to work closely with the FDA to support their
review of the NDA. If approved, pralatrexate would be the first
agent approved by the FDA for the treatment of patients with
relapsed or refractory PTCL and represents a potential
first-to-market opportunity for Allos.�
The NDA is based on the results from the Company�s pivotal Phase
2 trial known as PROPEL (Pralatrexate in patients with
Relapsed Or refractory PEripheral T-cell
Lymphoma). The PROPEL trial was conducted under an agreement
reached with the FDA under its Special Protocol Assessment, or SPA,
process. Pralatrexate has orphan drug designation and fast track
designation in the U.S. for the treatment of patients with T-cell
lymphoma and orphan medicinal product designation in Europe for the
treatment of PTCL. The Company believes the PROPEL trial is the
largest prospectively designed single-agent trial conducted to date
in patients with relapsed or refractory PTCL. The Company retains
exclusive worldwide rights to pralatrexate for all indications.
About Pralatrexate
Pralatrexate is a 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 certain
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.
About Peripheral T-cell Lymphoma
PTCL comprises a heterogeneous group of aggressive mature T- and
NK-cell lymphomas that accounts for approximately 10% to 15% of new
non-Hodgkin�s lymphoma (NHL) cases per year in the U.S. The
American Cancer Society estimates that 66,000 new cases of NHL will
be diagnosed in the U.S. in 2009. The Company estimates the current
annual prevalence of PTCL in the U.S. to be approximately 9,500
patients. No pharmaceutical agents are currently approved for use
in the treatment of either first-line or relapsed or refractory
PTCL. In addition to those PTCL patients who do not respond to
first-line treatment, a significant number of first-line
multi-agent chemotherapy responders relapse or become refractory
after treatment. According to the clinical literature, patients
with aggressive PTCL have an overall five-year survival rate of
only approximately 25% after first-line therapy.
About Allos Therapeutics, Inc.
Allos Therapeutics (Nasdaq: ALTH) is a biopharmaceutical company
focused on developing and commercializing innovative small molecule
drugs for the treatment of cancer. The Company�s product candidate,
pralatrexate, is a targeted antifolate designed to accumulate
preferentially in cancer cells. In March 2009, the Company
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for approval to market pralatrexate for the
treatment of patients with relapsed or refractory peripheral T-cell
lymphoma. In May 2009, the FDA accepted the Company�s NDA for
priority review and established a Prescription Drug User Fee Act
date of September 24, 2009 for a decision regarding approval of the
NDA. In addition, pralatrexate is being evaluated in patients with
non-small cell lung cancer, bladder cancer and a range of lymphoma
sub-types. Allos currently retains exclusive worldwide rights to
pralatrexate for all indications. For more information about the
Company, visit 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 for
pralatrexate to be the first agent approved by the FDA for the
treatment of 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 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 Quarterly
Report on Form 10-Q for the quarter ended March 31, 2009 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.
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