Allos Therapeutics Initiates Phase I/II Study of PDX and Gemcitabine in Patients With Non-Hodgkin's Lymphoma or Hodgkin's Diseas
31 Mai 2007 - 11:01PM
PR Newswire (US)
WESTMINSTER, Colo., May 31 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (NASDAQ:ALTH) today announced the initiation of
patient enrollment in a Phase I/IIa open-label, multi-center study
of sequential PDX (pralatrexate) and gemcitabine with vitamin B12
and folic acid supplementation in patients with relapsed or
refractory non-Hodgkin's lymphoma (NHL) or Hodgkin's disease. "We
are excited to advance the development of this promising treatment
regimen," said Pablo J. Cagnoni, M.D., Chief Medical Officer of
Allos. "Based on the clinical activity observed with both of these
agents individually in patients with relapsed non-Hodgkin's
lymphoma, coupled with the encouraging anti-tumor effects of PDX
and gemcitabine observed in pre-clinical lymphoma models, we
believe that this combination has the potential to be a new
treatment for patients with these challenging diseases. This
expansion of the PDX development program allows us to evaluate the
potential utility of PDX in a broader setting beyond that being
evaluated in the on-going pivotal Phase 2 PROPEL trial." In the
Phase I portion of this study, patients with either relapsed or
refractory non-Hodgkin's lymphoma (diffuse large B- or T-cell
lymphoma, mantle cell lymphoma, transformed large cell lymphomas)
or Hodgkin's disease will receive PDX followed the next day by
gemcitabine as part of a weekly schedule for three or four weeks
with concurrent vitamin B12 and folic acid supplementation.
Patients will receive starting doses of PDX and gemcitabine at 15
mg/m2 and 400 mg/m2, respectively, with dose escalation in
subsequent cohorts based on toxicity. Up to 54 evaluable patients
will be enrolled in the Phase I portion of the study with the
objective of determining the maximum tolerated dose (MTD), safety,
tolerability, and pharmacokinetic (PK) profile of escalating doses
of sequential PDX and gemcitabine. In the expanded Phase IIa
portion of the trial, up to 30 additional patients with relapsed or
refractory peripheral T-cell lymphoma will be enrolled at the
established MTD to assess preliminary efficacy of PDX and
gemcitabine. Steven Horwitz, M.D., Assistant Attending Physician,
Lymphoma Service, Memorial Sloan-Kettering Cancer Center, will
serve as the study chair. "This study will broaden our
understanding of PDX's clinical utility and, building off of the
encouraging pre-clinical findings, will enable us to explore the
activity of a pralatrexate/gemcitabine combination in a setting
where gemcitabine is routinely used." said Dr. Horwitz. 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-Hodgkin's lymphoma
Non-Hodgkin's lymphoma (NHL) is the most common hematological
cancer and the fifth leading cause of cancer death in the U.S. An
estimated 63,000 new cases of NHL will be diagnosed each year, of
which peripheral T-cell lymphoma represents approximately 10
percent. 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. We believe 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, Inc. (ALTH) is a
biopharmaceutical company focused on the development and
commercialization of small molecule therapeutics for the treatment
of cancer. The Company has two product candidates in late-stage
clinical development: EFAPROXYN (efaproxiral), a radiation
sensitizer currently under evaluation in a pivotal Phase 3 trial in
women with brain metastases originating from breast cancer, and PDX
(pralatrexate), a novel antifolate currently under evaluation in a
pivotal Phase 2 trial in patients with relapsed or refractory
peripheral T-cell lymphoma. The Company is also evaluating RH1, a
targeted chemotherapeutic agent, in a Phase 1 trial in patients
with advanced solid tumors. 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 relating to the potential safety and
efficacy profile of PDX and gemcitabine; the potential for PDX and
gemcitabine to provide a meaningful therapeutic benefit to patients
with NHL; 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 I/II trial,
whether caused by competition, adverse events, patient enrollment
rates, regulatory issues or other factors; that clinical trials may
not demonstrate that sequential PDX and gemcitabine 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 and gemcitabine 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: EFAPROXYN(TM)
and the Allos logo are trademarks of Allos Therapeutics, Inc.
DATASOURCE: Allos Therapeutics, Inc. CONTACT: Derek Cole, Vice
President, Investor Relations, +1-720-540-5367, , Jennifer Neiman,
Senior Manager, Corporate Communications, +1-720-540-5227, , both
of Allos Therapeutics, Inc. Web site: http://www.allos.com/
http://www.clinicaltrials.gov/
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