Allos Therapeutics Receives Special Protocol Assessment for Pivotal Phase 2 Study of the Company's Novel Antifolate PDX in Pati
August 02 2006 - 7:30AM
PR Newswire (US)
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. 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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