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.
SOURCE Allos Therapeutics, Inc.
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Related links:
http://www.allos.com
CONTACT:
Jennifer Neiman, Manager, Corporate
Communications of Allos Therapeutics, +1-720-540-5227,
jneiman@allos.com
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