Allos Therapeutics Initiates Phase 2b Study of PDX in Patients With Non-small Cell Lung Cancer
January 07 2008 - 8:00AM
PR Newswire (US)
WESTMINSTER, Colo., Jan. 7 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (NASDAQ:ALTH) today announced the initiation of
patient enrollment in a Phase 2b, randomized, multi-center study
comparing PDX (pralatrexate) and Tarceva (R) (erlotinib) in
patients with Stage IIIB/IV non-small cell lung cancer (NSCLC) who
are, or have been, cigarette smokers who have failed treatment with
at least one prior platinum-based chemotherapy regimen. "We are
pleased to advance the development of PDX in solid tumors," said
Pablo J. Cagnoni, M.D., Chief Medical Officer of Allos. "Advanced
non-small cell lung cancer represents an area of high unmet medical
need. Based on PDX's preclinical and clinical profile in non-small
cell lung cancer, we believe that PDX has the potential to offer a
new treatment option for patients with this challenging disease."
The objective of the Phase 2b study is to compare the efficacy of
PDX to that of Tarceva. The primary endpoint of the study is
overall survival (OS). Secondary endpoints include response rate
and progression-free survival (PFS), both compared to Tarceva, and
the safety and tolerability of PDX. The study will seek to enroll
approximately 160 patients in up to 50 investigative sites
worldwide. Karen Kelly, Deputy Director, The University of Kansas
Cancer Center, will serve as the study chair. In this study,
patients will be randomized 1:1 to either the PDX arm or the
Tarceva arm. Patients randomized to the PDX arm will receive PDX as
an intravenous (IV) push administered on days 1 and 15 of a
4-week/28 day cycle. The initial dose of PDX will be 230 mg/m2,
which, based on defined criteria, may be increased to 270 mg/m2 or
reduced in 40 mg/m2 decrements. Patients randomized to the Tarceva
arm will receive Tarceva 150 mg/day orally daily for the 4-week/28
day cycle. Patients in both arms will receive concurrent vitamin
therapy of B12 and folic acid. Information regarding this study is
available at http://www.allos.com/ or the U.S. government's
clinical trials database at http://www.clinicaltrials.gov/. About
Non-small Cell Lung Cancer Lung cancer is the most common cause of
cancer death in the United States. According to the American Cancer
Society, an estimated 213,380 new cases of lung cancer will be
diagnosed this year. Non-small cell lung cancer is the most common
type of lung cancer, accounting for almost 80% of lung cancer
cases. More people die of lung cancer than of breast, prostate and
colorectal cancers combined. About PDX (pralatrexate) PDX is a
novel, small molecule chemotherapeutic agent that inhibits
dihydrofolate reductase, or DHFR, a folic acid (folate)-dependent
enzyme involved in the building of nucleic acid, or DNA, and other
processes. PDX was rationally designed for efficient transport into
tumor cells via the reduced folate carrier, or RFC-1, and effective
intracellular drug retention. The Company believes these
biochemical features, together with preclinical and clinical data
in a variety of tumors, suggest that PDX may have a favorable
safety and efficacy profile relative to methotrexate and certain
other DHFR inhibitors. About Allos Therapeutics, Inc. Allos
Therapeutics 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 lymphoma sub-types. The
Company's other product candidate is RH1, a targeted
chemotherapeutic agent currently being evaluated in a Phase 1 trial
in patients with advanced solid tumors or non-Hodgkins Lymphoma
(NHL). 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 regarding the potential safety and efficacy profile of
PDX for the treatment of NSCLC or any other type of cancer; 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 this Phase 2 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, 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. Note: The Allos logo
is a trademark of Allos Therapeutics, Inc. Contact: Derek Cole Vice
President, Investor Relations 720.540.5367 DATASOURCE: Allos
Therapeutics, Inc. CONTACT: Derek Cole, Vice President, Investor
Relations of Allos Therapeutics, Inc., +1-720-540-5367, Web site:
http://www.allos.com/ http://www.clinicaltrials.gov/
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