Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced that it
has submitted a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) for the use of pralatrexate for the
treatment of patients with relapsed or refractory peripheral T-cell
lymphoma (PTCL). The Company has requested a priority review of the
application, which, if granted, would give the FDA six months from
receipt of the submission to take action on the application. PTCL
comprises a biologically diverse group of hematologic malignancies
that typically has a worse prognosis than other types of lymphoma
and is less responsive to traditional chemotherapy regimens. There
are currently no agents approved by the FDA for the treatment of
patients with PTCL.
�The NDA submission is based on the encouraging efficacy and
safety data we reported earlier this year with pralatrexate in
patients with relapsed or refractory PTCL,� said Paul L. Berns,
president and chief executive officer of Allos Therapeutics, Inc.
�We plan to work closely with the FDA to facilitate the completion
of their review as expeditiously as possible. There are currently
no agents approved by the FDA for the treatment of patients with
PTCL, which demonstrates the clear, high-unmet need for new
therapies to treat patients with this devastating disease. If
approved, pralatrexate represents a potential first-to-market
opportunity for Allos and could be the first agent approved by the
FDA for the treatment of patients with relapsed or refractory
PTCL.�
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.
About PROPEL
This pivotal Phase 2 international, multi-center, open-label,
single-arm trial enrolled a total of 115 patients with relapsed or
refractory PTCL, 109 of whom are considered evaluable for response,
according to the trial protocol. To be eligible for the trial,
patients� disease must have progressed after at least one prior
treatment. Patients were considered evaluable if they received at
least one dose of pralatrexate and their diagnosis of PTCL was
confirmed by independent pathology review. Patients received 30
mg/m2 of pralatrexate intravenously once every week for six weeks
followed by one week of rest per cycle of treatment. Patients also
received vitamin B12 and folic acid supplementation. The primary
endpoint of the trial is objective response rate, as assessed by
central independent oncology review using International Workshop
Criteria (IWC). Duration of response is the key secondary
endpoint.
In February 2009, the Company announced final results from the
PROPEL trial. Twenty-nine of 109 evaluable patients, or 27 percent,
achieved a response as assessed by central independent oncology
review, which is the primary endpoint of the trial. The
Kaplan-Meier estimate for the median duration of response was 287
days, or 9.4 months. Duration of response is the key secondary
endpoint of the trial. The most common grade 3/4 adverse events
were thrombocytopenia, which was observed in 32 percent of
patients; mucosal inflammation in 21 percent of patients;
neutropenia in 20 percent of patients; and anemia in 17 percent of
patients. The results of the trial will be submitted for
presentation at an upcoming scientific meeting and for publication
in a peer-reviewed journal.
Of the 29 patients who achieved a response according to central
independent oncology review, 7 patients had a complete response
(CR), 2 patients had a complete response unconfirmed (CRu) and 20
patients had a partial response (PR). Responses were also assessed
by the PROPEL investigators, who determined that 42 of 109
evaluable patients, or 39 percent, achieved a response. Of these,
15 patients had a CR, 4 patients had a CRu and 23 patients had a
PR. PROPEL patients received a median of three prior systemic
treatment regimens (range of 1-12), including 18 patients, or 16
percent, who had previously undergone an autologous stem cell
transplant. In the trial, 66 percent of the patients who responded
did so after cycle one of therapy. Patients will continue to be
followed for long-term survival.
The PROPEL trial is being conducted under an agreement reached
with the FDA under its 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/or data analyses are acceptable to the FDA.
The response rate, duration of response and safety profile required
to support FDA approval are not specified in the PROPEL trial
protocol and will be subject to FDA review. In addition, the median
duration of response reported above is a Kaplan-Meier estimate
based on the length of follow up for all responders at the time the
PROPEL trial database was locked. As a result, the median duration
of response may change based on continued patient follow-up.
About Peripheral T-cell Lymphoma
PTCL comprises a biologically diverse group of hematologic
malignancies that accounts for approximately 10 to 15 percent of
non-Hodgkin�s lymphoma, or NHL, cases in the U.S. The American
Cancer Society estimated that 66,000 new cases of NHL were
diagnosed in the U.S. in 2008. 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
approximately 25 percent after first-line therapy.
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. The Company�s lead product candidate,
pralatrexate, is a novel targeted antifolate designed to accumulate
preferentially in cancer cells. 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 (FDA) under its Special Protocol Assessment process.
Based on the results of the PROPEL trial, in March 2009 the Company
submitted a New Drug Application to the FDA for the use of
pralatrexate for the treatment of patients with relapsed or
refractory PTCL. The Company is investigating pralatrexate in
patients with peripheral T-cell lymphoma, non-small cell lung
cancer, bladder cancer and a range of lymphoma sub-types; and it
currently retains exclusive worldwide rights to pralatrexate for
all indications. 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 statements regarding the potential for
pralatrexate to be 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 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 Dec. 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.
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