Allos Therapeutics Initiates Phase 2 Study of PDX in Patients with Advanced or Metastatic Relapsed Transitional Cell Carcinoma o
21 Julho 2008 - 9:00AM
Business Wire
Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced the
initiation of patient enrollment in a Phase 2, open-label,
single-arm, multi-center study of PDX (pralatrexate) in patients
with advanced or metastatic relapsed transitional cell carcinoma
(TCC) of the urinary bladder. �We are pleased to broaden our PDX
solid tumor development program into an additional indication,�
said Pablo J. Cagnoni, M.D., Chief Medical Officer of Allos. �TCC
of the bladder is an area of high unmet medical need with no agents
currently approved for the second-line treatment of advanced or
metastatic disease. Given the established role of antifolates in
the treatment of bladder cancer, we believe this trial represents
an important opportunity to evaluate the potential of PDX in this
setting.� The primary endpoint of the study is objective response
rate (complete and partial response). Secondary endpoints include
duration of response, clinical benefit rate, progression-free
survival (PFS), overall survival and the safety and tolerability of
PDX. The study will seek to enroll approximately 41 patients in up
to 20 investigative sites worldwide. In this study, patients will
receive PDX as an intravenous (IV) push administered on days 1 and
15 of a 4-week/28 day cycle. The initial dose of PDX will be 190
mg/m2, which may be adjusted based on criteria defined in the
protocol. Patients will receive concurrent vitamin therapy of B12
and folic acid. Information regarding this study is available at
the U.S. government�s clinical trials database at
http://www.clinicaltrials.gov. About Bladder Cancer Bladder cancer
is the ninth most common cancer. In the United States, an estimated
67,160 new cases of bladder cancer are expected to have been
diagnosed in 2007. Transitional cell carcinoma (TCC) is the most
common form of bladder cancer, accounting for more than 90% of all
bladder cancers. There are no approved agents for the treatment of
advanced or metastatic relapsed TCC of the urinary bladder. 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. The
Company believes 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 other related DHFR inhibitors. The Company
believes PDX has the potential to be delivered as a single agent or
in combination therapy regimens. About Allos Therapeutics, Inc.
Allos Therapeutics is a biopharmaceutical company focused on
developing and commercializing innovative small molecule drugs 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 subtypes. The
Company's other product candidate�is RH1, a targeted
chemotherapeutic agent currently under evaluation in a Phase 1
trial in patients with advanced solid tumors or non-Hodgkin�s
Lymphoma (NHL). For additional information, please visit the
Company�s website at 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 regarding the potential safety and efficacy
profile of PDX for the treatment of TCC of the urinary bladder or
any other type of cancer, 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 2 trial, whether
caused by competition, adverse events, patient enrollment rates,
regulatory issues or other factors; that clinical trials may not
demonstrate that PDX 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 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, 2007 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. NOTE TO
EDITORS: The "2"�in "190 mg/m2" should be superscript (meaning
"squared") but may not appear properly in some systems.
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