Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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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/