Allos Therapeutics Announces FDA Advisory Committee Recommends Accelerated Approval of FOLOTYN (pralatrexate) for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

Wed Sep 2, 2009 6:09pm EDT

* Reuters is not responsible for the content in this press release.

-- Company to Host Webcast Conference Call on Wednesday, September 2 at 6:00
p.m. ET --
SILVER SPRING, Md.--(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.
Monique Greer, 720-540-5268 or 720-236-5959
mgreer@allos.com

Copyright Business Wire 2009

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