Allos Therapeutics’ Pralatrexate Demonstrates Anticancer Activity in Multiple Cancer Cell Lines
19 Abril 2009 - 4:00PM
Business Wire
Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced new data
demonstrating the anticancer activity of its investigational drug,
pralatrexate, in colon, ovarian, lung, prostate, and head and neck
cancer cell lines. The preclinical research further showed that the
antiproliferative effects against these cancer lines were achieved
at drug concentrations that are attainable in humans. These data
were presented today at the American Association for Cancer
Research (AACR) Annual Meeting in Denver, CO.
The results, outlined in a poster titled �Cytotoxicity of
Pralatrexate, a Novel Synthetic Antifolate, in Human Cancer Cell
Lines (abstract #1686),� demonstrate anticancer activity of
pralatrexate in nine of 15 human cell lines tested. Importantly, it
appears from analyses of exposure time that the effect of
pralatrexate is reached rapidly, within 24-72 hours. During this
window, cancer cells susceptible to pralatrexate undergo apoptosis,
or cell death.
�The broad anticancer activity demonstrated by pralatrexate in
this in vitro study, combined with the results from prior
exploratory non-small cell lung cancer clinical trials, support our
view that the therapeutic potential of pralatrexate extends beyond
hematological malignancies and merits further study in various
types of solid tumors,� said Pablo J. Cagnoni, M.D., chief medical
officer of Allos Therapeutics. �We are currently evaluating
pralatrexate in solid tumor indications, including non-small cell
lung cancer and bladder cancer.�
Further analysis of the data demonstrated a potential
correlation between the sensitivity to pralatrexate and the
expression level of folyl-polyglutamate synthetase (FPGS), an
enzyme that catalyzes the addition of polyglutamate tails to folate
derivatives such as pralatrexate. It is believed that the
polyglutamation of pralatrexate by FPGS prevents cancer cells from
excreting pralatrexate from the cell. The ability of cancer cells
to excrete drugs through efflux pumps is a common drug resistance
mechanism and has been a challenge in the development of
antifolates. By remaining in the cancer cell for a longer period of
time pralatraxate has an opportunity to increase tumor cell
kill.
Further study is required, but FPGS may prove to be an important
biomarker to predict cancer patients� sensitivities to
pralatrexate.
About Pralatrexate
Pralatrexate is a novel targeted antifolate designed to
accumulate preferentially in cancer cells. Based on preclinical
studies, the Company believes that pralatrexate selectively enters
cells expressing RFC-1, a protein that is over expressed on cancer
cells compared to normal cells. Once inside cancer cells,
pralatrexate is efficiently polyglutamylated, which leads to high
intracellular drug retention. Polyglutamylated pralatrexate
essentially becomes �trapped� inside cancer cells, making it less
susceptible to efflux-based drug resistance. Acting on the folate
pathway, pralatrexate interferes with DNA synthesis and triggers
cancer cell death. The Company believes pralatrexate has the
potential to be delivered as a single agent or in combination
therapy regimens.
About Allos Therapeutics, Inc.
Allos Therapeutics is a biopharmaceutical company focused on
developing and commercializing innovative small molecule drugs for
the treatment of cancer. The Company�s lead product candidate,
pralatrexate, is a novel targeted antifolate designed to accumulate
preferentially in cancer cells. In February 2009, the Company
announced the final results from PROPEL, the Company�s pivotal
Phase 2 (PROPEL) trial of pralatrexate in patients with relapsed or
refractory peripheral T-cell lymphoma (PTCL). The PROPEL trial was
conducted under an agreement reached with the U.S. Food and Drug
Administration under its special protocol assessment (SPA) process.
Based on the results of the PROPEL trial, the Company submitted a
New Drug Application to the U.S. Food and Drug Administration for
pralatrexate for the treatment of relapsed or refractory PTCL in
March 2009. The Company is also investigating pralatrexate in
patients with non-small cell lung cancer, bladder cancer and a
range of lymphoma sub-types. The Company currently retains
exclusive worldwide rights to pralatrexate for all indications. For
additional information, please visit 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 concerning the potential for
pralatrexate to demonstrate anticancer activity in solid tumors,
the potential correlation between the sensitivity to pralatrexate
and the expression level of folyl-polyglutamate synthetase, and
other statements which 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 pre-clinical trial designs and results may not
be predictive of future clinical trial designs or results; that
pralatrexate may not prove to be safe or effective for the
treatment of patients with NSCLC, bladder cancer or any other type
of cancer; that the Company may lack the financial resources and
access to capital to fund ongoing or planned clinical trials for
pralatrexate or to continue evaluating its therapeutic utility in
other potential indications. 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, 2008, 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.
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