Three PDX (Pralatrexate) Studies Presented at the 2007 AACR-NCI-EORTC Conference
25 Octobre 2007 - 10:01PM
PR Newswire (US)
MTD in NSCLC Identified; Phase 2 Study Planned WESTMINSTER, Colo.,
Oct. 25 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc.
(NASDAQ:ALTH), a biopharmaceutical company focused on the
development and commercialization of small molecule therapeutics
for the treatment of cancer, today announced that results from
three PDX studies were presented as posters during the 2007
AACR-NCI-EORTC conference held October 22-26, 2007 in San
Francisco, California. The posters described the effects of PDX
(pralatrexate) in patients with non-small cell lung cancer (NSCLC),
in patients with relapsed or refractory non-Hodgkin's lymphoma
(NHL) and Hodgkin's disease, and in human cancer models in vivo and
in vitro. PDX in NSCLC (Phase 1) The poster entitled "Phase 1 study
of the antifolate pralatrexate when given with vitamin B12 and
folic acid supplementation in patients with advanced non-small cell
lung cancer (NSCLC)" presented results of this Phase 1 dose ranging
study. In the study, a total of 22 patients with relapsed or
refractory NSCLC were treated at doses of 150 to 325 mg/m2 of PDX.
The maximum tolerated dose (MTD) was determined to be 270 mg/m2,
which is twice that observed in a previous Phase 1 study in which
PDX was administered without vitamin supplementation. Clinically
significant radiologic responses were observed. Greater than 50% of
patients (13/22) received two or more prior treatment regimens.
Based on PDX clinical experience to date, the Company plans to
initiate a randomized Phase 2 study of PDX in patients with NSCLC.
PDX in NHL (Phase 1/2) The poster entitled "A Phase '2-1-2' Study
of Two Different Doses and Schedules of Pralatrexate, A High
Affinity Substrate for the Reduced Folate Carrier (RFC-1), in
Patients with Relapsed or Refractory Lymphoma Reveals Marked
Activity in T-Cell Malignancies" presented additional interim data
from the on-going study of PDX in patients with relapsed or
refractory non- Hodgkin's lymphoma (NHL) and Hodgkin's disease.
Responses were observed in 14 of 26 (54%) evaluable patients with
T-cell lymphoma, with the duration of response typically exceeding
the previously administered line of chemotherapy. No major safety
concerns were identified in this heavily pre-treated population.
These results are consistent with the interim data presented at the
2006 American Society of Hematology (ASH) meeting. PDX In Vivo and
In Vitro The poster entitled "Differential Activity and Potential
Mechanism of Action of Pralatrexate (PDX), Methotrexate (MTX), and
Pemetrexed (Alimta(R)) in Human Cancer Models In Vivo and In Vitro"
presented results from a pre- clinical study that investigated the
mechanism of action of PDX and its differences from other
antifolates. The results suggest that PDX is mechanistically
different from MTX and Alimta and that these differences may be due
to enhanced uptake of PDX into the tumor cell and/or greater
intracellular accumulation and polyglutamylation, resulting in
greater inhibition of dihydrofolate reductase (DHFR). In addition,
PDX induced greater tumor regression compared to MTX or Alimta in
two human NSCLC xenograft models, including the highly aggressive
H460 model. Copies of each of the posters referenced above are
available for review on the Allos website (http://www.allos.com/)
under the "Presentations" tab of the "Investor Relations" section
of the website. 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's lead product candidate,
PDX (pralatrexate), is a novel antifolate currently under
evaluation in a pivotal Phase 2 (PROPEL) trial in patients with
relapsed or refractory peripheral T-cell lymphoma. The PROPEL trial
is being conducted under an agreement reached with the U.S. Food
and Drug Administration under its special protocol assessment, or
SPA process. The Company is also investigating PDX in patients with
non-small cell lung cancer and a range of other lymphoma sub-types.
The Company's other product candidate is RH1, a targeted
chemotherapeutic agent for which the Company expects to initiate a
Phase 1 study in patients with advanced solid tumors in the second
half of 2007. 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 concerning the Company's plans to
initiate a Phase 2 study of PDX in patients with NSCLC, 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 the Company may experience difficulties or
delays in the initiation, progress or completion of its clinical
trials, whether caused by competition, adverse events,
investigative site initiation rates, patient enrollment rates,
regulatory issues or other factors; and that the Company may lack
the financial resources and access to capital to fund planned or
future clinical trials of its product candidates, or to continue
evaluating their 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, 2006, 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.
DATASOURCE: Allos Therapeutics, Inc. CONTACT: Derek Cole, Vice
President, Investor Relations of Allos Therapeutics, Inc.,
+1-720-540-5367, or Web site: http://www.allos.com/
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