Allos Therapeutics Initiates Pivotal Phase 2 Study of PDX in Patients With Peripheral T-cell Lymphoma
29 August 2006 - 10:00PM
PR Newswire (US)
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. DATASOURCE: Allos Therapeutics, Inc. CONTACT:
Jennifer Neiman, Manager, Corporate Communications of Allos
Therapeutics, +1-720-540-5227, Web site:
http://www.clinicaltrials.gov/ Web site: http://www.allos.com/
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