WESTMINSTER, Colo.--(BUSINESS WIRE)--Jul. 7, 2009--
Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced the completion
of patient enrollment in the Company's randomized Phase 2b clinical
trial comparing pralatrexate to erlotinib (Tarceva®) 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.
“Advanced non-small cell lung cancer represents an area of high unmet
medical need where we believe pralatrexate has the potential to offer a
new treatment option,” said Pablo J. Cagnoni, M.D., chief medical
officer of Allos Therapeutics. “We are pleased with the strong interest
in this trial, having enrolled 201 patients in 18 months. The objective
of this Phase 2b trial is to assess the treatment effect of pralatrexate
in certain pre-specified subsets of patients with advanced non-small
cell lung cancer where we believe the agent has the potential to provide
clinical benefit.”
This randomized, open-label, international, multi-center Phase 2b trial
was initiated in January 2008 and enrolled 201 patients. The objective
of the trial is to compare the efficacy of pralatrexate to that of
erlotinib in patients with Stage IIIB/IV NSCLC who are, or have been,
cigarette smokers who have failed treatment with at least one prior
platinum-based chemotherapy regimen, including subsets of light and
heavy smokers, as well as current and former smokers. Per the protocol,
the primary endpoint is overall survival. Response rate,
progression-free survival and the safety and tolerability of
pralatrexate will also be assessed. Patients were randomized 1:1 to
receive either pralatrexate or erlotinib. Patients randomized to the
pralatrexate arm received pralatrexate as an intravenous (IV) push
administered on days 1 and 15 of a 28-day cycle. The initial dose of
pralatrexate was 190 mg/m2. Patients randomized to the
erlotinib arm received erlotinib 150 mg/day orally in a 28-day cycle.
Patients in both arms received concurrent vitamin therapy of B12
and folic acid. The primary survival analysis will be performed when a
pre-specified number of events have occurred in all randomized patients.
About Pralatrexate
Pralatrexate is a 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 certain 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.
About Pralatrexate in the Treatment of Non-Small Cell Lung Cancer
Two prior clinical studies of pralatrexate in NSCLC formed the basis of
the ongoing randomized Phase 2b study. An open-label, single-agent Phase
2 study of pralatrexate in patients with relapsed or refractory Stage
IIIB or IV NSCLC at a dose of 135-150 mg/m2 demonstrated a
response rate of 11%, a median time to progression of three months and a
median survival time of 13.5 months. The most common grade 3 or 4
adverse event was stomatitis, which occurred in 21% of the patients. As
a result of subsequent research that suggested supplementation of
pralatrexate with folic acid and vitamin B12 may reduce the
incidence of clinically significant stomatitis, the Company initiated a
Phase 1 dose escalation study of pralatrexate with vitamin B12
and folic acid supplementation in patients with previously treated Stage
IIIB/IV advanced NSCLC. In addition to establishing the dosing regimen
for the current randomized Phase 2b study, clinically significant
radiologic responses were observed.
About Lung Cancer
According to the American Cancer Society, lung cancer is the most common
cause of cancer death among men and women in the United States.
Approximately 159,390 Americans are expected to die from the disease in
2009 and an estimated 219,440 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 percent of lung cancer cases. More
people die of lung cancer than of breast, prostate and colorectal
cancers combined.
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 product candidate, pralatrexate, is a targeted
antifolate designed to accumulate preferentially in cancer cells. In
March 2009, the Company submitted a New Drug Application (NDA) to the
U.S. Food and Drug Administration (FDA) for approval to market
pralatrexate for the treatment of patients with relapsed or refractory
peripheral T-cell lymphoma. In May 2009, the FDA accepted the Company’s
NDA for priority review and established a Prescription Drug User Fee Act
date of September 24, 2009, for a decision regarding approval of the
NDA. In addition, pralatrexate is being evaluated in patients with
non-small cell lung cancer, bladder cancer and a range of lymphoma
sub-types. Allos currently retains exclusive worldwide rights to
pralatrexate for all indications. For more information about Allos,
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 regarding the potential for pralatrexate to provide a new
treatment option for patients with non-small cell lung cancer 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 2b
trial, whether caused by competition, adverse events, regulatory issues
or other factors; that clinical trials may not demonstrate that
pralatrexate 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 pralatrexate 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 pralatrexate 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 Quarterly Report on Form 10-Q for the quarter ended March
31, 2009, 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.
Tarceva is a registered trademark of OSI Pharmaceuticals, Inc.
Source: Allos Therapeutics, Inc.
Allos Therapeutics, Inc.
Monique Greer, 720-540-5268
mgreer@allos.com
