Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced that it has
completed patient enrollment in PROPEL, the Company’s
pivotal Phase 2 trial of PDX (pralatrexate) in patients with relapsed or
refractory peripheral T-cell lymphoma (PTCL).
“The completion of enrollment in our pivotal
PROPEL trial, a quarter ahead of schedule, is an important milestone for
PDX and Allos,” said Pablo J. Cagnoni, M.D.,
Chief Medical Officer of Allos. “We gratefully
acknowledge the investigators and patients for participating in the
study and for their important role in helping to evaluate the safety and
efficacy of PDX for the treatment of relapsed or refractory peripheral
T-cell lymphoma, a disease for which there are currently no approved
treatments. We believe that PDX has the potential to offer a new
treatment option for patients with this challenging disease and look
forward to reporting top line results of the trial later this year.”
PROPEL (Pralatrexate in Patients with Relapsed Or Refractory PEripheral
T-cell Lymphoma) is a pivotal Phase 2, international, multi-center,
open-label, single-arm study that enrolled patients with relapsed or
refractory PTCL who progressed after at least one prior treatment.
Patients receive 30 mg/m2 of PDX once every
week for six weeks followed by one week of rest per cycle of treatment.
The treatment regimen also includes vitamin B12
and folic acid supplementation. The primary endpoint of the study is
objective response rate (complete and partial response). Secondary
endpoints include duration of response, progression-free survival and
overall survival.
The PROPEL trial was initiated in August 2006. In accordance with the
PROPEL trial protocol, the Company conducted three pre-planned interim
analyses of safety data and one pre-planned interim analysis of response
data. 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 PDX, respectively,
and recommended that the trial continue per the protocol at each
analysis. No major safety concerns were identified by the DMC. In
September 2007, the Company announced that the results of the interim
analysis of patient response data exceeded the pre-specified threshold
for continuation of the trial, which required a minimum of four
responses (complete or partial) out of the first 35 evaluable patients,
as determined by independent oncology review.
The PROPEL trial is being conducted under an agreement reached with the
United States Food and Drug Administration (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 new drug application (NDA),
and provides an agreement that the study design, including trial size,
clinical endpoints and/or data analyses are acceptable to the FDA.
The FDA granted orphan drug designation and fast track designation to
PDX 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 PDX for the treatment of
patients with PTCL.
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 in the United States. There are currently no
pharmaceutical agents approved for use in the treatment of either
first-line or relapsed or refractory PTCL. PTCL patients are often
treated with multi-agent chemotherapy regimens. However, a significant
number of these patients relapse or become refractory after treatment
with first-line therapy. A study that included patients with aggressive
PTCL found that the average five-year survival for those patients was
approximately 25%.
About PDX (pralatrexate)
PDX is a novel, small molecule chemotherapeutic agent that inhibits
dihydrofolate reductase, or DHFR, a folic acid (folate)-dependent enzyme
involved in the building of nucleic acid, or DNA, and other processes.
PDX was rationally designed for efficient transport into tumor cells via
the reduced folate carrier, or RFC-1, and effective intracellular drug
retention. The Company believes these biochemical features, together
with preclinical and clinical data in a variety of tumors, suggest that
PDX may have a favorable safety and efficacy profile relative to
methotrexate and other related DHFR inhibitors. The Company believes PDX
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, PDX (pralatrexate), 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 PROPEL trial is being conducted under an agreement reached
with the U.S. Food and Drug Administration under its special protocol
assessment, or SPA, process. The Company is also investigating PDX in
patients with non-small cell lung cancer and a range of lymphoma
sub-types. The Company's other product candidate is RH1, a targeted
chemotherapeutic agent currently under evaluation in a Phase 1 trial in
patients with advanced solid tumors or non-Hodgkin’s
Lymphoma (NHL). 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 PDX to offer a new treatment
option for patients with relapsed or refractory PTCL; the Company’s
projected timeline for reporting top line results of the PROPEL trial;
the potential safety and efficacy profile of PDX relative to
methotrexate and other related DHFR inhibitors; 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 Company may experience delays in the completion of the
PROPEL trial, whether caused by adverse events, regulatory issues or
other factors; that the PROPEL trial may not demonstrate that PDX 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 PDX 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.
Note: The Allos logo is a trademark of Allos Therapeutics, Inc.