Interim Safety Analysis Supports Continuation of Allos Therapeutics' Pivotal Phase 2 Trial of Its Novel Antifolate PDX in Patien
08 Janeiro 2007 - 10:00AM
PR Newswire (US)
WESTMINSTER, Colo., Jan. 8 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (NASDAQ:ALTH) today announced that an
independent Data Monitoring Committee (DMC) has completed a planned
interim analysis of 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), and has recommended
that the trial continue per the protocol. This interim assessment
was based upon an evaluation of the first 10 patients enrolled to
the study who completed at least one cycle of treatment with PDX.
No major patient safety concerns were identified by the DMC. "This
recommendation represents important progress toward the completion
of this pivotal study and provides further insight into PDX's
safety profile," said Paul L. Berns, President and Chief Executive
Officer of Allos. "We are pleased with the DMC's recommendation and
are grateful for the support received from our employees,
investigators and patients who enabled us to reach this milestone."
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
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 endpoint of the study is
objective response rate (complete and partial response). Secondary
endpoints include duration of response, progression-free survival
and overall survival. Owen O'Connor, M.D., Ph.D., Head of the
Laboratory of Experimental Therapeutics for Lymphoproliferative
Malignancies, Lymphoma and Development Chemotherapy Services,
Memorial Sloan-Kettering Cancer Center, is the international study
chair. In August 2006, the Company announced that it reached
agreement with the FDA under the Special Protocol Assessment
process on the design of this pivotal Phase 2 trial. In October
2006, the FDA granted fast track designation to PDX for the
treatment of patients with T-cell lymphoma. "Adverse events
observed as part of this analysis were primarily hematologic and
are consistent with those seen by investigators in the single
center experience," said Michael E. Saunders, Vice President,
Clinical Development of Allos. Future Milestones In accordance with
the study's design, an interim analysis of efficacy data will be
conducted after 35 patients have completed one cycle of treatment
with PDX, which is currently expected to occur in the second half
of 2007. The DMC will assess patient safety as part of the
35-patient response assessment and again after 65 patients have
completed one cycle of treatment. The Company currently anticipates
that patient enrollment at up to 35 centers in the U.S., Canada and
Europe will be completed by the third quarter of 2008. About the
Data Monitoring Committee 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 PDX (pralatrexate) PDX
is a novel, small molecule chemotherapeutic agent that inhibits
dihdrofolate reductase (DHFR), a folic acid (folate) dependent
enzyme involved in the building of DNA and other processes. PDX was
rationally designed for improved transport into tumor cells via the
reduced folate carrier (RFC-1), and greater intracellular drug
retention. These biochemical features, together with preclinical
data in a variety of tumors, suggest that PDX has an enhanced
potency and improved toxicity profile relative to methotrexate and
other related DHFR inhibitors. 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 6,700
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 Allos
Therapeutics, Inc. Allos Therapeutics, Inc. (ALTH) is a
biopharmaceutical company focused on the development and
commercialization of small molecule therapeutics for the treatment
of cancer. The Company has two product candidates in late-stage
clinical development: EFAPROXYN(TM) (efaproxiral), a radiation
sensitizer currently under evaluation in a pivotal Phase 3 trial in
women with brain metastases originating from breast cancer, and PDX
(pralatrexate), a novel, next generation antifolate currently under
evaluation in a pivotal Phase 2 trial in patients with relapsed or
refractory peripheral T-cell lymphoma. The Company is also
evaluating RH1, a targeted chemotherapeutic agent, in a Phase 1
trial in patients with advanced solid tumors. 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 of PDX for the
treatment of peripheral T-cell lymphoma; the Company's projected
timelines for conducting interim analyses and 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 and 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 peripheral T-cell lymphoma 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 clinical trials
for PDX 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, 2005 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:
EFAPROXYN(TM) and the Allos logo are trademarks of Allos
Therapeutics, Inc. DATASOURCE: Allos Therapeutics, Inc. CONTACT:
Jennifer Neiman, Manager, Corporate Communications of Allos
Therapeutics, +1-720-540-5227, Web site: http://www.allos.com/
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