Allos Therapeutics Reports Interim Response and Safety Data from Pivotal Phase 2 PROPEL Trial
15 Mai 2008 - 12:00PM
Business Wire
Allos Therapeutics, Inc. (Nasdaq:ALTH) today reported interim
response and safety data from the Company's pivotal Phase 2 PROPEL
trial of PDX (pralatrexate) in patients with relapsed or refractory
peripheral T-cell lymphoma (PTCL). The Company will host a
conference call at 9:00 a.m. Eastern, today, May 15, 2008, to
review the data. Twenty-nine percent (n=19) of the first 65
evaluable patients enrolled in the trial experienced either a
complete or partial response, as assessed by central independent
oncology review. Forty-five percent (n=29) of the first 65
evaluable patients experienced either a complete or partial
response, as assessed by the PROPEL investigators. Patients are
considered evaluable if they received at least one dose of PDX and
their diagnosis of PTCL has been confirmed by independent review.
The median duration of response for these patients cannot be
estimated at this time due to the current length of follow up. The
most common drug related grade 3/4 adverse events were mucositis
and thrombocytopenia, which were observed in 14% and 23% of
patients, respectively. Patients received a median of three prior
treatment regimens. �We are pleased to share these interim data as
we continue to evaluate the clinical utility of PDX in patients
with relapsed or refractory peripheral T-cell lymphoma,� said Pablo
J. Cagnoni, M.D., Chief Medical Officer of Allos. �We believe PDX,
a unique antifolate rationally designed for improved cancer cell
uptake and retention, has the potential to offer a new treatment
option for patients with this challenging disease. We look forward
to reporting top line results of the trial by the end of this
year.� �The PROPEL trial is the largest prospectively designed
single-agent trial conducted to date focused on patients with
relapsed or refractory peripheral T-cell lymphoma,� said Owen
O�Connor, M.D. Ph.D., Director Lymphoid Development and Malignancy
Program and Chief of the Lymphoma Service at the Irving
Comprehensive Cancer Center at Columbia University Medical Center,
and Principal Investigator of the PROPEL trial. �PDX�s pre-clinical
and clinical profile to date suggest that it has the potential to
provide therapeutic benefit to patients with this challenging
disease for which there are currently no approved treatments.� The
Company completed patient enrollment in the PROPEL trial in April
2008 and expects to report top line results of the trial by the end
of 2008. Following its review of the trial results, the Company
intends to submit a New Drug Application for PDX as a treatment for
patients with relapsed or refractory PTCL as expeditiously as
possible. 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 more than 100 evaluable 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 trial is objective response rate
(complete and partial response), which will be assessed by central
independent oncology review. 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 and one
pre-planned interim analysis of response 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 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 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 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. Conference Call The Company will
host a conference call to review the PROPEL 65-patient interim data
on Thursday, May 15, 2008, at 9:00 a.m. ET. The dial in number for
U.S. residents to participate is 800-762-8973. International
callers should dial 480-629-9041. Participants should reference the
Allos Therapeutics conference call. Webcast The Company will hold a
live webcast of the conference call. The webcast will be available
from the homepage and the investors/media section of the Company's
web site at www.allos.com and will be archived for 30 days.
Conference Call Replay An audio replay of the conference call will
be available from approximately two hours after completion of the
call through Friday, May 30, 2008. To access the replay, please
dial 800-406-7325 (domestic) or 303-590-3030 (international). The
replay pass code is 3878869#. 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 63,000
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. PTCL patients are often
treated with multi-agent chemotherapy regimens, for which
first-line treatment response rates range from 50%-70%. In addition
to the 30-50% of PTCL patients that 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 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. 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 from
the PROPEL trial, the Company�s intent to submit a New Drug
Application for PDX as a treatment for patients with relapsed or
refractor PTCL following its review of the trial results, 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.
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