WESTMINSTER, Colo., Aug. 29 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (Nasdaq: ALTH) today announced enrollment of the first
patient in PROPEL, a pivotal multi-center Phase 2 study of the Company's
unique next generation antifolate PDX (pralatrexate) with vitamin B12 and
folic acid supplementation in patients with relapsed or refractory
peripheral T-cell lymphoma (PTCL).
"The initiation of this pivotal trial is an important milestone in the
development of PDX and has the potential to be a significant driver of the
company's future growth," said Paul L. Berns, President and Chief Executive
Officer. "Clinical experience to date suggests that PDX has the potential
to provide meaningful therapeutic benefit to a difficult to treat, drug
resistant patient population with high unmet medical need."
PROPEL (Pralatrexate in Patients with Relapsed Or Refractory PEripheral
T-cell Lymphoma) is a 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 will 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. In August 2006, the Company
announced that it reached agreement with the U.S. Food and Drug
Administration (FDA) under the Special Protocol Assessment process (SPA) on
the design of this pivotal Phase 2 trial. 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, and provides a
binding agreement that the study design, including trial size, clinical
endpoints and/or data analyses are acceptable to the FDA. The Company
currently anticipates that patient enrollment at approximately 35 centers
in the U.S., Canada and Europe will take approximately 18 to 24 months to
complete. Owen A. 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, will serve as the international study chair.
Interim results from a Phase 1/2 study of PDX in patients with relapsed
or refractory non-Hodgkin's lymphoma (NHL) and Hodgkin's disease, which is
currently on-going at Memorial Sloan-Kettering Cancer Center, demonstrated
preliminary evidence of activity in patients with various subtypes of
aggressive and chemotherapy resistant T-cell lymphoma. As reported at the
2005 American Society of Hematology Annual Meeting, four of seven evaluable
patients with T-cell lymphoma achieved a complete response following
treatment with PDX, despite having failed multiple prior therapies. The
addition of vitamins to the treatment regimen appeared to successfully
mitigate the previously established dose limiting toxicity of stomatitis.
Information regarding the PROPEL study is available at http://www.allos.com or
the U.S. government's clinical trials database at
http://www.clinicaltrials.gov.
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 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 (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 profile of PDX; the potential
for PDX to provide a meaningful therapeutic benefit to patients with PTCL,
the Company's projected timelines for completing enrollment in the PROPEL
trial; the potential for PDX and the PROPEL to be a significant driver of
the Company's future growth; 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 competition,
adverse events, patient enrollment rates, regulatory issues or other
factors; that clinical trials may not demonstrate that PDX is both safe and
more effective than current standards of care; that data from preclinical
studies and clinical trials may not necessarily be indicative of future
clinical trial results; that the safety and/or efficacy results of clinical
trials for PDX will not support an application for marketing approval in
the United States or any other country; and the risk 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.clinicaltrials.gov
http://www.allos.com
CONTACT:
Jennifer Neiman, Manager, Corporate
Communications of Allos Therapeutics, +1-720-540-5227,
jneiman@allos.com
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