Interim Safety Analysis Supports Continuation of Allos Therapeutics' Pivotal Phase 2 PROPEL Trial of PDX in Patients with Periph
27 12월 2007 - 10:00PM
PR Newswire (US)
WESTMINSTER, Colo., Dec. 27 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (NASDAQ:ALTH) today announced that an
independent Data Monitoring Committee (DMC) has completed the
pre-specified 65-patient safety review of data from the Company's
pivotal Phase 2 PROPEL trial of PDX (pralatrexate) in patients with
relapsed or refractory peripheral T-cell lymphoma (PTCL), and has
recommended that the trial continue per the protocol. This interim
assessment was based upon an evaluation of patients enrolled in the
study who completed at least one cycle of treatment with PDX. The
Company currently expects to complete patient enrollment in the
PROPEL study in the second quarter of 2008. "The DMC recommendation
represents another important milestone in the development of a
potential new treatment option for patients with relapsed or
refractory peripheral T-cell lymphoma, a patient population for
which there are currently no approved agents," said Pablo J.
Cagnoni, M.D., Senior Vice President and Chief Medical Officer of
Allos. "We remain pleased with the progress of the PROPEL trial and
look forward to continuing to drive our PDX product development and
commercialization plans in 2008." 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 will seek to enroll a minimum of 100
evaluable patients with relapsed or refractory PTCL who have
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 primary efficacy endpoint of the
study is objective response rate (complete and partial response).
Secondary efficacy endpoints include duration of response,
progression-free survival and overall survival. Owen A. O'Connor,
MD, PhD, Director, Lymphoid Development & Malignancy Program
and Chief, Lymphoma Service, Columbia University, Herbert Irving
Comprehensive Cancer Center, New York, is the international study
chair. In accordance with the PROPEL study design, in January 2007,
the DMC completed an interim analysis of safety data based on the
first 10 patients enrolled to the study who completed at least one
cycle of treatment with PDX, and recommended that the trial
continue per the protocol. Also in accordance with the study
design, in September 2007, an interim analysis of patient response
and safety data was conducted based on the first 35 patients
enrolled to the study who completed at least one cycle of treatment
with PDX. 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. In addition, the DMC identified no
major safety concerns and recommended that the trial continue per
the protocol. The PROPEL trial is being conducted under an
agreement 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 an 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 to
PDX for the treatment of T-cell lymphoma in July 2006 and granted
fast track designation to PDX for the treatment of patients with
T-cell lymphoma in September 2006. 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 the Data Monitoring Committee
(DMC) The DMC is comprised of independent medical experts and was
established by Allos as part of the Company's compliance with good
clinical practice guidelines. The DMC is responsible for monitoring
the on-going safety of patients participating in the PROPEL trial
and for conducting formal interim safety assessments of trial
results. About Peripheral T-cell Lymphoma Peripheral T-cell
lymphomas, or PTCLs, are a biologically diverse and uncommon group
of blood cancers that account for approximately 10% to 15% of all
cases of non-Hodgkin's lymphoma, or about 7,100 patients annually.
The average five-year survival rate for PTCL patients is
approximately 25%. There are currently no pharmaceutical agents
approved for use in the treatment of either first-line or relapsed
or refractory PTCL. 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 certain
other DHFR inhibitors. About Allos Therapeutics, Inc. Allos
Therapeutics is a biopharmaceutical company focused on the
development and commercialization of small molecule therapeutics
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 being evaluated in a Phase 1 trial
in patients with advanced solid tumors or non-Hodgkins Lymphoma
(NHL). For additional information, please visit the Company's
website at http://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 relating to the potential safety and efficacy profile of
PDX relative to methotrexate and certain other DHFR inhibitors, the
potential safety and efficacy of PDX for the treatment of PTCL or
any other type of cancer; the Company's projected timeline for
completing enrollment in the PROPEL trial; 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 conduct or completion
of the PROPEL trial, whether caused by competition, adverse events,
patient enrollment rates, regulatory issues or other factors; that
clinical trials may not demonstrate that PDX is both safe and
effective for the treatment of patients with PTCL or any other type
of cancer; that data from preclinical studies and clinical trials
may not be indicative of future clinical trial results; that the
safety and/or efficacy 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, 2006 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. DATASOURCE: Allos
Therapeutics, Inc. CONTACT: Derek Cole, Vice President, Investor
Relations of Allos Therapeutics, Inc., +1-720-540-5367, Web site:
http://www.allos.com/
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