Allos Therapeutics Initiates Phase 1 PDX Study in Patients With Non-Small Cell Lung Cancer
20 Janeiro 2005 - 11:00AM
PR Newswire (US)
Allos Therapeutics Initiates Phase 1 PDX Study in Patients With
Non-Small Cell Lung Cancer WESTMINSTER, Colo., Jan. 20
/PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. (NASDAQ:ALTH)
today announced the initiation of a Phase 1 dose escalation study
of its investigational drug PDX (pralatrexate) with vitamin B12 and
folic acid supplementation in patients with previously-treated
(Stage IIIB-IV) advanced non-small cell lung cancer (NSCLC). This
open-label, non-randomized study will seek to enroll one to six
patients per treatment level cohort who have received one prior
chemotherapy regimen and may or may not have received an EGFR
Kinase inhibitor to test the safety, tolerability and
pharmacokinetics (PK) of escalating doses of PDX. To determine the
maximum tolerated dose of PDX when administered with concurrent
vitamin B12 and folic acid supplementation, patients will receive a
starting dose of 150 mg/m2. Subsequent cohorts will receive doses
of PDX increasing in 40 mg/m2 increments until protocol-defined
dose limiting toxicities (DLTs) occur. Patients will receive their
specific PDX dose intravenously twice during a 4 to 6 week period.
Vitamin supplementation will be consistent for all patients
regardless of PDX dose. Safety endpoints for the study include
DLTs, treatment-related adverse events (AEs), PK/AE correlation and
laboratory values. "The results of clinical trials to date for PDX
as both a single and combination agent have been encouraging and we
look forward to further exploring the potential of this therapy in
patients with NSCLC," said Dr. Michael Saunders, Vice President,
Clinical Development of Allos. "We expect to begin a multi-center
Phase 2 trial of PDX in patients with NSCLC once appropriate dosing
has been determined." Results of an earlier Phase 2 trial published
in the June 2003 issue of Clinical Cancer Research demonstrated
improved response rate and symptomatic benefits in patients with
Stage IIIB or IV NSCLC who received PDX therapy. Median survival
time of patients enrolled in the study was 13.5 months, with 1 and
2-year survival rates of 56% and 36%, respectively. Ten percent
(10%) of PDX-treated patients had confirmed durable responses and
31% had stable disease. About PDX PDX (pralatrexate) is an
injectable small molecule chemotherapeutic agent that has an
enhanced potency and toxicity profile relative to methotrexate and
other related dihydrofolate reductase, or DHFR, inhibitors. Drugs
that inhibit DHFR, such as methotrexate, were among the first
chemotherapeutic agents discovered. Methotrexate remains one of the
most widely applied chemotherapy drugs and has been used to treat
breast, bladder and head and neck cancers, leukemias and other
cancers. 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 171,900 new cases of lung
cancer will be diagnosed this year, which account for about 14% of
all cancer diagnoses. 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 Allos Therapeutics, Inc. Allos
Therapeutics, Inc. is a biopharmaceutical company focused on
developing and commercializing innovative drugs for improving
cancer treatments. The company's lead clinical candidate,
EFAPROXYN(TM) (efaproxiral), is a synthetic small molecule that has
the potential to sensitize hypoxic (oxygen deprived) tumor tissues
and enhance the efficacy of standard radiation therapy. In
addition, Allos is developing PDX (pralatrexate), a novel small
molecule cytotoxic injectable antifolate (DHFR inhibitor) that has
the potential to treat non-small cell lung cancer, mesothelioma and
non-Hodgkin's lymphoma, as well as RH1, a targeted cytotoxic
prodrug under investigation in patients with advanced solid tumors.
For more information, please visit the company's web site 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 potential safety and efficacy profile of PDX; the
Company's development plans for PDX; 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 clinical trials
may not demonstrate that PDX is both safe and more effective than
current standards of care; that the Company may be unable obtain
the regulatory approvals necessary to conduct additional clinical
trials; that the Company and/or its collaborators may not be able
to enroll sufficient numbers of patients in their clinical trials;
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, 2003, as amended, and in the Company's other
periodic reports and filings with the Securities and Exchange
Commission, including its Quarterly Report on Form 10-Q for the
quarter ended September 30, 2004. 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: EFAPROXYN(TM) and the Allos logo are
trademarks of Allos Therapeutics, Inc. DATASOURCE: Allos
Therapeutics, Inc. CONTACT: Jennifer Neiman, Manager, Corporate
Communications of Allos Therapeutics, +1-720-540-5227, Web site:
http://www.allos.com/
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