Allos Therapeutics Initiates Phase 2b Study of PDX in Patients With Non-small
Cell Lung Cancer
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
dcole@allos.com
SOURCE Allos Therapeutics, Inc.
Derek Cole, Vice President, Investor Relations of Allos Therapeutics, Inc.,
+1-720-540-5367, dcole@allos.com
