Scheduled Combination of Allos Therapeutics' Pralatrexate Plus Gemcitabine Proves Superior to Methotrexate Plus Cytarabine in Mo
14 2월 2006 - 10:00PM
PR Newswire (US)
WESTMINSTER, Colo., Feb. 14 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (NASDAQ:ALTH) today announced the publication of
results from an Allos-sponsored pre-clinical study, designed to
compare the activity of a pralatrexate (PDX)/gemcitabine
combination relative to a commonly used combination of
methotrexate/cytarabine (ara-C) in treating lymphoma. Results of
the study, which were reported in the February 1st edition of
Clinical Cancer Research, indicate that the combination of
pralatrexate followed by gemcitabine was superior to the
combination of methotrexate/ara-C in vitro and in vivo models of
lymphoma, and was more potent in inducing apoptosis in certain
lymphoma cell lines. The study, which was performed in the
laboratory of Owen A. O'Connor, M.D., Ph.D. at Memorial Sloan
Kettering Cancer Center, assessed the effects of single agent
treatments and the pralatrexate and methotrexate combinations in
parallel in a large B-cell lymphoma cell line. Results of the
analysis indicated that in vitro, the scheduled combination of
pralatrexate/gemcitabine possessed greater cytotoxicity compared to
the methotrexate/ara-C combination, as well as significantly
increased apoptosis in a cell line specifically selected for its
resistance to pralatrexate. In vivo studies demonstrated a
significant reduction of tumor burden in mice treated with
pralatrexate/gemcitabine compared to those treated with
methotrexate/ara-C. Importantly, both in vivo and in vitro
experiments indicate a schedule-dependent interaction between
pralatrexate and gemcitabine. The sequence of pralatrexate followed
by gemcitabine was five times more effective in reducing tumor
burden and inducing apoptosis than the simultaneous exposure of the
two drugs. "This is an exciting observation," said Owen O'Connor,
M.D., Ph.D., Assistant Attending Physician, Lymphoma Service
Memorial Sloan-Kettering Cancer Center. "Given the activity of
pralatrexate in T-cell lymphomas, and the wide use of gemcitabine
in this particular setting, the combination of pralatrexate and
gemcitabine may also represent a novel treatment platform for
patients with these challenging diseases." These data established
the superior therapeutic activity of pralatrexate in models of
human non-Hodgkin's lymphoma and provide further support for the
Phase 1/2 study of pralatrexate in patients with non-Hodgkin's
lymphoma which is currently on-going at Memorial Sloan Kettering
Cancer Center. About Pralatrexate (PDX) Pralatrexate 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. Preclinical data
suggests that PDX has an enhanced potency and toxicity profile
relative to methotrexate and other related DHFR inhibitors because
of a greater affinity for the reduced folate carrier (RFC-1) and
foly-polyglutamyl synthase leading to enhanced intracellular
accumulation and polyglutamylation in tumor cells. Drugs that
inhibit DHFR, such as methotrexate, were among the first
chemotherapeutic agents discovered. Methotrexate remains one of the
most widely applied antifolate chemotherapeutics and has been used
to treat leukemia, breast, bladder, gastric, esophageal, head and
neck cancers. 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, 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 as both a single agent and
in combination therapy regimens 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, visit the Company's web site 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
pralatrexate; the potential utility of pralatrexate and gemcitabine
in the treatment of 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 future clinical
trials may not demonstrate that pralatrexate plus gemcitabine 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; 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, 2004 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. First Call Analyst: FCMN Contact:
jneiman@allos.com DATASOURCE: Allos Therapeutics, Inc. CONTACT:
Jennifer Neiman, Manager, Corporate Communications of Allos
Therapeutics, Inc., +1-720-540-5227, Web site:
http://www.allos.com/
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