Allos Therapeutics Completes Enrollment in Randomized Phase 2b Trial of Pralatrexate in Patients with Advanced Non-Small Cell...
07 July 2009 - 10:00PM
Business Wire
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.
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Historical Stock Chart
From Jun 2024 to Jul 2024
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Historical Stock Chart
From Jul 2023 to Jul 2024