Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced preliminary top
line results from PROPEL, the Company's pivotal Phase 2 trial of
pralatrexate (PDX) in patients with relapsed or refractory peripheral
T-cell lymphoma (PTCL), at the 50th Annual Meeting of the American
Society of Hematology (abstract 261).
The results according to central independent oncology review at the time
of this analysis are as follows:
29 of 109 evaluable patients (27%) achieved either a complete or
partial response
11 evaluable patients had a complete response or complete response
unconfirmed
18 evaluable patients had a partial response
23 evaluable patients had stable disease as best response
3 patients had insufficient data to assess response and 14
patients could not be assessed for response because they
discontinued treatment prior to completion of cycle one. These
patients are included in the evaluable patient population for all
efficacy analyses.
The results according to the PROPEL investigators at the time of this
analysis are as follows:
42 of 109 evaluable patients (39%) achieved either a complete or
partial response
18 evaluable patients had a complete response or complete response
unconfirmed
24 evaluable patients had a partial response
21 evaluable patients had stable disease as best response
Importantly, PROPEL patients received a median of three prior systemic
treatment regimens (range of 1-12), including 18 patients (16%) who had
previously undergone an autologous stem cell transplant. Patient
response evaluations will continue and all patients will be followed for
long-term survival.
“The results of the PROPEL trial demonstrate that pralatrexate produced
durable, complete responses in heavily pre-treated patients,” said Owen
O’Connor, M.D., Ph.D., the Principal Investigator of the PROPEL trial
and the Director of the Lymphoid Development and Malignancy Program and
Chief of the Lymphoma Service at the Herbert Irving Comprehensive Cancer
Center at New York-Presbyterian Hospital/Columbia University Medical
Center, and Associate Professor of Medicine at Columbia University
College of Physicians and Surgeons. “Presently, there are no
FDA-approved treatments for patients with PTCL, either in the first-line
or relapsed or refractory setting. This underscores the need for new
therapies to treat this challenging disease. Pralatrexate has the
potential to play a clinically meaningful role in the treatment of these
patients.”
“We are very excited by these results. Following our review of the final
results of the trial, we intend to submit an NDA for pralatrexate for
the treatment of patients with relapsed or refractory PTCL in the first
half of 2009. If approved, the launch of pralatrexate will represent a
first to market opportunity for Allos,” said Paul L. Berns, President
and Chief Executive Officer of Allos. “We would like to extend our
appreciation to the patients who participated in the PROPEL trial, as
well as to their families, for helping us to identify a potential new
treatment option for this disease. I would also like to acknowledge our
investigators and employees for their commitment to this important
study.”
In the trial, 69% of the patients who responded did so after cycle one
of therapy. The median duration of treatment in responding patients was
179 days at the time of this analysis. The duration of response exceeded
three months in 17 of 29 responders (59%), including 6 of the 17
patients who continued on treatment. An accurate estimate of the median
duration of response cannot be reported at this time due to the current
length of follow up. Patients will continue to be followed until the
median duration of response can be accurately estimated. Following
review of the final results of the trial, the Company intends to submit
a New Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) in the first half of 2009 to seek marketing approval for
pralatrexate for the treatment of patients with relapsed or refractory
PTCL.
The most common grade 3/4 adverse events were thrombocytopenia, which
was observed in 32% of patients; mucosal inflammation in 21% of
patients; neutropenia in 20% of patients; and anemia in 18% of patients.
“We are pleased to share these data with the medical community. The
results show that pralatrexate, a novel targeted antifolate designed to
accumulate preferentially in cancer cells, achieved durable responses,
including complete responses, in patients with relapsed or refractory
peripheral T-cell lymphoma,” said Pablo J. Cagnoni, M.D., Chief Medical
Officer of Allos. “We believe pralatrexate has the potential to offer a
new treatment option for patients with this devastating disease for
which there are currently no approved agents.”
About PROPEL
PROPEL (Pralatrexate in patients with Relapsed Or refractory PEripheral
T-cell Lymphoma) is a pivotal Phase 2, international, multi-center,
open-label, single-arm trial that 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 the Company’s knowledge,
the PROPEL trial represents the largest prospectively designed
single-agent trial conducted to date in PTCL.
To be eligible for the trial, patients had to have progressed after at
least one prior treatment. Patients are considered evaluable if they
received at least one dose of pralatrexate and their diagnosis of PTCL
was confirmed by independent review. Patients receive 30 mg/m2
of pralatrexate intravenously once every week for six weeks followed by
one week of rest per cycle of treatment. Patients also receive vitamin B12
and folic acid supplementation. The primary endpoint of the trial is
objective response rate (complete and partial response), as assessed by
central independent oncology review using International Workshop
Criteria (IWC). Duration of response is the key secondary endpoint. All
patients enrolled in the trial will continue to be followed for
long-term survival.
The PROPEL trial was initiated in August 2006. In accordance with the
PROPEL trial protocol, three pre-planned interim analyses of safety data
were previously conducted. In January, September and December 2007, the
Company announced that an independent data monitoring committee (DMC)
completed interim analyses of safety data from the first 10, 35 and 65
evaluable patients who completed at least one cycle of treatment with
pralatrexate, respectively, and recommended that the trial continue per
the protocol at each analysis.
The PROPEL trial is being conducted under an agreement reached with the
FDA under its Special Protocol Assessment (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 a 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.
The FDA granted orphan drug designation and fast track designation to
pralatrexate for the treatment of patients with T-cell lymphoma in July
2006 and September 2006, respectively. In April 2007, the Commission of
the European Communities, with a favorable opinion of the Committee for
Orphan Medicinal Products of the European Medicines Agency, or EMEA,
granted orphan medicinal product designation to pralatrexate for the
treatment of patients with PTCL.
About Pralatrexate (PDX)
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 Peripheral T-cell Lymphoma
Peripheral T-cell lymphomas, or PTCLs, are a biologically diverse group
of blood cancers that account for approximately 10% to 15% of all cases
of non-Hodgkin's lymphoma (NHL) in the United States. According to the
American Cancer Society, approximately 66,000 patients are expected to
be diagnosed with NHL in the United States in 2008. The Company
estimates the current annual prevalence of PTCL at approximately 9,500
patients. There are currently no pharmaceutical agents approved for use
in the treatment of either first-line or relapsed or refractory PTCL. In
addition to the 30-50% of 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. A study that
included patients with aggressive PTCL found that the average five-year
survival for those patients was approximately 25%.
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 (PDX), is a
novel antifolate currently under evaluation in a pivotal Phase 2
(PROPEL) trial in patients with relapsed or refractory peripheral T-cell
lymphoma. The Company reported top line results from PROPEL in December
2008. Following review of the final results of the trial, the Company
intends to submit a New Drug Application (NDA), for pralatrexate for the
treatment of patients with relapsed or refractory PTCL in the first half
of 2009. The PROPEL trial is being conducted under an agreement reached
with the U.S. Food and Drug Administration under its special protocol
assessment (SPA) process. The Company is also investigating pralatrexate
in patients with non-small cell lung cancer, bladder cancer and a range
of lymphoma sub-types. The Company's other product candidate is RH1, a
targeted chemotherapeutic agent currently being evaluated in a Phase 1
trial in patients with advanced solid tumors or non-Hodgkin’s lymphoma
(NHL). The Company currently retains exclusive worldwide rights to
pralatrexate and RH1 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 potential for pralatrexate to offer a new
treatment option for patients with relapsed or refractory PTCL, 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 PROPEL trial may not
demonstrate that pralatrexate is both safe and effective for the
treatment of patients with relapsed or refractory PTCL; that the results
of the PROPEL trial may not support an application for marketing
approval in the United States or any other country; that an application
for marketing approval may not be accepted for priority review or at all
by the FDA or any other regulatory authority; and that the Company may
lack the financial resources and access to capital to fund future
clinical trials for pralatrexate or any of its other product candidates.
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,
2007 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.