Allos Therapeutics Announces FDA Advisory Committee Recommends Accelerated Approval of FOLOTYN™ (pralatrexate) for the Trea...
03 Septembre 2009 - 12:09AM
Business Wire
Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced that the
U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory
Committee (ODAC) voted 10-4 that the response rate and duration of
response observed with FOLOTYNTM (pralatrexate) are reasonably
likely to predict clinical benefit in patients with relapsed or
refractory peripheral T-cell lymphoma (PTCL). PTCL comprises a
biologically diverse group of aggressive blood cancers that has a
worse prognosis than most other types of lymphoma, including B-cell
lymphoma. If approved, FOLOTYN would be the first drug approved by
the FDA for the treatment of relapsed or refractory PTCL.
The ODAC recommendation was based on results from PROPEL, a
pivotal Phase 2 international trial that evaluated FOLTYN for the
treatment of patients with relapsed or refractory PTCL. The PROPEL
trial was conducted under an agreement reached with the FDA under
its special protocol assessment, or SPA, process. The SPA process
allows for FDA evaluation of a clinical trial protocol intended to
form the primary basis of an efficacy claim in support of an NDA,
and provides an agreement that the trial design, including trial
size, clinical endpoints and data analyses are acceptable to the
FDA.
The FDA is expected to make a decision whether to approve the
Company’s New Drug Application (NDA) for FOLOTYN by September 24,
2009. While the FDA generally follows the recommendations of its
advisory committees, it is not required to do so.
“We are very pleased that the advisory committee today voted to
recommend accelerated approval of the FOLOTYN NDA,” said Paul L.
Berns, chief executive officer at Allos Therapeutics, Inc. “We
believe FOLOTYN has the potential to offer an important new
treatment option for patients with relapsed or refractory PTCL, an
indication for which there are currently no FDA-approved therapies
and no accepted standard of care. We will continue to work with FDA
to bring FOLOTYN to the U.S. market as soon as possible so that
patients can benefit from this potential new treatment option.”
Conference Call Information
Allos will host a webcast conference call to review the outcome
from the ODAC meeting on Wednesday, September 2, 2009 at 6:00 p.m.
ET. Participants can access the call at 877-941-6009 (U.S. and
Canada) or +480-629-9771 (international). To access the live
audio webcast or the subsequent archived recording, visit the
“Investors - Presentations and Events” section of the Company’s
website at www.allos.com. Webcast and telephone replays of the
conference call will be available approximately two hours after the
completion of the call. Callers can access the replay by
dialing 800-406-7325 (domestic) or 303-590-3030 (international).
The passcode is 4151544#. The webcast will be recorded and
available for replay on the Company's website until September 11,
2009.
About PTCL
Peripheral T-cell lymphoma (PTCL) comprises a biologically
diverse group of aggressive blood cancers that has a worse
prognosis than most other types of lymphoma, including B-cell
lymphoma. PTCL accounts for approximately 10% to 15% of all newly
diagnosed cases of non-Hodgkin's lymphoma (NHL) in the U.S. The
American Cancer Society estimates that approximately 66,000 new
cases of NHL were diagnosed in the U.S. in 2008. The Company
estimates the current annual incidence of PTCL in the U.S. to be
approximately 5,600 patients. There are currently no pharmaceutical
agents approved for use in the treatment of PTCL. In addition to
those PTCL patients who do not respond to first-line treatment, a
significant number of first-line responders relapse or become
refractory after treatment. According to published clinical data,
patients with aggressive PTCL have an overall five-year survival
rate of approximately 25% to 40%, depending on sub-type.
About Pralatrexate
Pralatrexate is a selective 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 Allos Therapeutics, Inc.
Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical
company committed to the development and commercialization of
innovative anti-cancer therapeutics. The Company’s product
candidate, pralatrexate, is a selective antifolate designed to
accumulate preferentially in cancer cells. In May 2009, the FDA
accepted the Company’s NDA for pralatrexate for the treatment of
patients with relapsed or refractory PTCL for priority review and
established a Prescription Drug User Fee Act date of September 24,
2009 for a decision regarding approval of the NDA. The FDA recently
approved the trade name, FOLOTYN, for pralatrexate. In addition,
pralatrexate is being evaluated in other tumor types, including
solid tumors and a range of lymphoma sub-types. Allos retains
exclusive worldwide rights to pralatrexate for all indications. The
Company is headquartered in Westminster, Colo. For additional
information, please 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 the Company’s statements regarding the potential
for pralatrexate to offer an important new treatment option 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 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; 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 June
30, 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.
Note: The Allos logo is a trademark of Allos Therapeutics,
Inc.
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