WESTMINSTER, Colo., Nov. 12 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (Nasdaq: ALTH) today announced the initiation of patient
enrollment in a Phase 1, non-randomized, open-label, multi-center dose
escalation study of the Company's targeted chemotherapeutic agent RH1 in
patients with advanced solid tumors or non-Hodgkin's lymphoma (NHL).
"We are pleased to advance the development of this agent," said Pablo
J. Cagnoni, M.D., Chief Medical Officer of Allos. "RH1 is a small molecule
chemotherapeutic agent that is bioactivated by the enzyme DT-diaphorase
(DTD), which is over-expressed in many tumors, including lung, colon,
breast and liver tumors. We believe that because RH1 is bioactivated in the
presence of DTD, it has the potential to preferentially target certain
tumors while limiting the amount of toxicity to normal tissue."
In this study, patients with either advanced solid tumors or NHL will
receive a 3-hour intravenous (IV) infusion of RH1 administered once every
21 days. Patients will receive starting doses of RH1 at 1.5 mg/m2, with
dose escalation in subsequent cohorts based on toxicity. Up to 60 evaluable
patients will be enrolled in the study with the objective of determining
the maximum tolerated dose (MTD), recommended Phase 2 dose and safety
profile of RH1 in this population. Three to six patients will be enrolled
per cohort. An expanded cohort of up to 24 evaluable patients who have
tumor types with a high likelihood of DTD over-expression will be recruited
to explore possible markers of anticancer activity. D. Ross Camidge, M.D.,
Ph.D., Assistant Professor of Medical Oncology at the University of
Colorado Cancer Center, will serve as the study chair.
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 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's lead product candidate, PDX
(pralatrexate), is a novel antifolate currently under evaluation in a
pivotal Phase 2 (PROPEL) trial in patients with relapsed or refractory
peripheral T-cell lymphoma. The PROPEL trial is being conducted under an
agreement reached with the U.S. Food and Drug Administration under its
special protocol assessment, or SPA process. The Company is also
investigating PDX in patients with non-small cell lung cancer and a range
of lymphoma sub-types. The Company's other product candidate is RH1, a
targeted chemotherapeutic agent that is currently being evaluated in a
Phase 1 study in patients with advanced solid tumors or non-Hodgkin's
lymphoma. 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 RH1 for the
treatment of advanced solid tumors, non-Hodgkin's lymphoma or any other
type of cancer; the potential of RH1 to preferentially target certain
tumors while limiting the amount of toxicity to normal tissue; 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 trial, whether caused
by competition, adverse events, patient enrollment rates, regulatory issues
or other factors; that clinical trials may not demonstrate that RH1 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 RH1 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 RH1 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: The Allos logo is a trademark of Allos Therapeutics, Inc.
SOURCE Allos Therapeutics, Inc.
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Related links:
http://www.allos.com
CONTACT:
Derek Cole, Vice President, Investor
Relations of Allos Therapeutics, Inc. +1-720-540-5367,
dcole@allos.com
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