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.
SOURCE Allos Therapeutics, Inc.
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Related links:
http://www.allos.com
http://www.clinicaltrials.gov
CONTACT:
Derek Cole, Vice President, Investor
Relations, +1-720-540-5367, dcole@allos.com, Jennifer Neiman,
Senior Manager, Corporate Communications, +1-720-540-5227,
jneiman@allos.com, both of Allos Therapeutics, Inc.
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