WESTMINSTER, Colo., Aug. 2 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (Nasdaq: ALTH) today announced that it has reached
agreement with the U.S. Food and Drug Administration (FDA) under the
Special Protocol Assessment process (SPA) on the design of a pivotal Phase
2 trial of the company's novel, next generation antifolate PDX
(pralatrexate) in patients with relapsed or refractory peripheral T-cell
lymphoma (PTCL). 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.
"We're pleased to have reached agreement with the FDA on the design of
this important clinical trial as it provides a well defined pathway for
pursuit of marketing approval of PDX," said Paul L. Berns, President and
Chief Executive Officer. "We expect to move forward as planned with the
initiation of enrollment in this trial by the end of the third quarter."
The Phase 2, non-randomized, open-label trial will look to establish
the safety and efficacy of PDX with concurrent vitamin B12 and folic acid
supplementation in patients with relapsed or refractory PTCL. Patients will
receive PDX at 30 mg/m2 once every week for six weeks followed by one week
of rest per cycle of treatment. The Company currently plans to enroll 100
evaluable patients at approximately 35 leading cancer centers in the U.S.,
Canada and Europe. The study protocol includes interim assessments of
safety and response. 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.
"To date pralatrexate has achieved a high complete response rate that
has proven very durable among PTCL patients with a historically very poor
prognosis," said Dr. O'Connor. "These results suggest that pralatrexate may
offer a new therapeutic option for patients with PTCL -- a disease
desperately in need of new effective treatments."
About PDX (pralatrexate)
PDX is a small molecule chemotherapeutic agent that inhibits
dihdrofolate reductase, or 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 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 group
of blood cancers that account for approximately 10% to 15% of all cases of
NHL, or about 6,700 patients. The average five year survival rate for PTCL
patients is approximately 25%. There are currently no pharmaceutical agents
approved for the treatment of relapsed or refractory PTCLs.
About Allos Therapeutics, Inc.
Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical company
focused on developing and commercializing innovative small molecule
therapeutics for the treatment of cancer. The Company's lead product
candidate, EFAPROXYN(TM) (efaproxiral), is a synthetic small molecule
designed to sensitize hypoxic, or oxygen-deprived, tumor tissue during
radiation therapy. EFAPROXYN is currently being evaluated as an adjunct to
whole brain radiation therapy in a pivotal Phase 3 trial in women with
brain metastases originating from breast cancer. The Company's other
product candidates are: PDX (pralatrexate), a small molecule
chemotherapeutic agent (DHFR inhibitor) currently under investigation in
patients with non-small cell lung cancer and Non-Hodgkin's lymphoma; and
RH1, a small molecule chemotherapeutic agent bioactivated by the enzyme
DT-diaphorase currently under evaluation in patients with advanced solid
tumors. For more information, please visit the Company's web site at:
http://www.allos.com.
Conference Call
The Company will host a conference call on Thursday, August 3, 2006 at
10 AM ET with Owen A. O'Connor, M.D., Ph.D. to discuss the role of PDX in
the treatment of peripheral T-cell lymphoma. The dial in number for U.S.
residents to participate is 866-362-4831. International callers should dial
617-597-5347. The pass code to participate is 23292612.
Conference Call Replay
An audio replay of the conference call will be available from 12 PM ET
on Thursday, August 3, 2006, until 11:59 PM ET on Thursday, August 31,
2006. To access the replay, please dial 888-286-8010 (domestic) or
617-801-6888 (international). The replay pass code is 65355312.
Webcast
Allos Therapeutics will hold a live web cast of the conference call.
The webcast will be available from the investors/media section of the
Company's web site at http://www.allos.com and will be archived for 90 days.
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 interim results of the Phase 1/2 study of PDX in patients
with NHL; the potential safety and efficacy profile of PDX; the Company's
plans to initiate Phase 2 clinical development of PDX for the treatment of
patients with T-cell lymphoma; 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 interim results from the
Phase 1/2 study of PDX in patients with NHL may not be confirmed upon full
analysis of the detailed results of the trial; that the Company may
experience delays in the initiation and/or completion of its clinical
trials, including the planned Phase 2 trial of PDX in patients with PTCL,
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 there may not be a sufficient number of responses among
initially enrolled patients to support continuation; 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.allos.com
CONTACT:
Jennifer Neiman Manager, Corporate
Communications of Allos Therapeutics, +1-720-540-5227,
jneiman@allos.com
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