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.
SOURCE Allos Therapeutics, Inc.
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Related links:
http://www.allos.com
CONTACT:
Derek Cole, Vice President, Investor
Relations of Allos Therapeutics, Inc., +1-720-540-5367, or
dcole@allos.com
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