PDX Shows Promising Activity in Patients With Resistant T-Cell Lymphomas
12 12월 2005 - 10:00PM
PR Newswire (US)
WESTMINSTER, Colo., Dec. 12 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (NASDAQ:ALTH) today announced the presentation
of interim results from an ongoing Phase 1/2 trial of PDX
(pralatrexate) in patients with non-Hodgkin's Lymphoma. Owen
O'Connor, M.D., Ph.D., Attending Physician, Lymphoma Department,
Memorial Sloan-Kettering Cancer Center (MSKCC) and the study's
principal investigator, presented the findings in a poster
presentation yesterday at the 47th Annual Meeting of the American
Society of Hematology. "PDX has achieved a remarkably high complete
response rate in a difficult to treat, drug resistant patient
population," said Dr. O'Connor. "Results seen to date suggest that
PDX may offer distinct advantages over current approaches used in
the treatment of T-cell lymphoma." In abstract #2678, titled
"Pralatrexate (10-Propargyl-10-Deazaaminopterin (PRX(1)), a Novel
Antifolate, Effects Durable Complete Remissions (CR) in Patients
with a Diversity of Drug Resistant T-Cell Lymphomas with Minimal
Toxicity," Dr. O'Connor presented interim data from the ongoing
Phase 1/2 trial, designed to determine the maximum tolerated dose
(MTD), dose limiting toxicities and preliminary views of efficacy
of PDX in patients with relapsed or refractory aggressive
lymphomas. As part of the initial Phase 2 study, 16 patients were
treated with PDX according to a dosing schedule of 135 mg/m2 of PDX
every other week, with dose escalation (15 mg/m2) for patients
without significant toxicities. The protocol was amended in July
2004 to explore a weekly dosing schedule beginning at 30 mg/m2 for
three weeks in a four week schedule. To date, 11 patients have been
accrued to the amended Phase 1 study at dose levels up to 45 mg/m2,
including seven patients with T-cell lymphoma. In total, eight
patients with T-cell lymphoma have been treated with PDX, of whom
five were evaluable for response. Notably, four of five evaluable
patients with T-cell lymphoma achieved a complete remission within
the first cycle, despite being chemotherapy refractory. Three of
four T-cell lymphoma patients remain on treatment and in complete
remission four to nine months later. Moreover, among those patients
pre-treated with vitamins, the previously established dose limiting
toxicity of stomatitis was eliminated. Little hematological
toxicity has been observed. MSKCC investigators are currently
enrolling patients in the third dose cohort, 45 mg/m2 of PDX
administered weekly for six weeks in a seven week cycle. "We are
encouraged by the activity observed in the on-going Phase 1/2 study
and believe it provides strong rationale for continued clinical
development of PDX in T-cell lymphoma," said Michael E. Saunders,
M.D., Vice President, Clinical Development of Allos. "Our intent is
to initiate a multi-center Phase 2 study in this setting in the
first half of 2006." About the Study In this Phase 1/2 Memorial
Sloan Kettering sponsored study, patients with aggressive
non-Hodgkin's lymphoma (diffuse large B- or T-cell lymphoma, mantle
cell lymphoma, transformed large cell lymphomas) or Hodgkin's
Disease are administered increasing doses of PDX with vitamin B12
and folic acid supplementation. The initial dose level was 30 mg/m2
administered weekly for three weeks, with one week rest. The dose
was increased to 30 mg/m2 weekly for six weeks in a seven week
cycle and currently is being administered at 45 mg/m2 weekly for
six weeks in a seven week cycle. There is no limit on the number of
prior therapies. Conference Call The Company will host a conference
call on Friday, December 16, 2005, at 12 PM ET to review the data
presented at the American Society of Hematology Annual Meeting. The
dial in number for U.S. residents to participate is 800-638-5495.
International callers should dial 617-614-3946. The pass code to
participate is 57425540. Webcast Allos Therapeutics will hold a
live webcast of the conference call. The webcast will be available
from the homepage and the investors/media section of the Company's
web site at http://www.allos.com/ and will be archived for 30 days.
Slides will be available to call participants via the webcast.
About PDX (pralatrexate) PDX is a small molecule chemotherapeutic
agent that inhibits dihdrofolate reductase, or DHFR, a folic acid
(folate) dependent enzyme involved in the building of DNA and other
processes. Preclinical data suggests that PDX has an enhanced
potency and toxicity profile relative to methotrexate and other
related DHFR inhibitors. Drugs that inhibit DHFR, such as
methotrexate, were among the first chemotherapeutic agents
discovered. Methotrexate remains one of the most widely applied
antifolate chemotherapeutics and has been used to treat leukemia,
breast, bladder, gastric, esophageal, head and neck cancers. 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 56,000 new cases of NHL will be
diagnosed each year, of which T-cell lymphoma represents
approximately 12 percent, or 6,700 patients. About Allos
Therapeutics, Inc. Allos Therapeutics, Inc. (NASDAQ:ALTH) is a
biopharmaceutical company focused on developing and commercializing
innovative small molecule therapeutics for the treatment of cancer.
The Company's lead product candidate, EFAPROXYN(TM) (efaproxiral),
is a synthetic small molecule designed to sensitize hypoxic, or
oxygen-deprived, tumor tissue during radiation therapy. EFAPROXYN
is currently being evaluated as an adjunct to whole brain radiation
therapy in a pivotal Phase 3 trial in women with brain metastases
originating from breast cancer. The Company's other product
candidates are: PDX (pralatrexate), a small molecule
chemotherapeutic agent (DHFR inhibitor) currently under
investigation as both a single agent and in combination therapy
regimens in patients with non-small cell lung cancer and
Non-Hodgkin's lymphoma; and RH1, a small molecule chemotherapeutic
agent bioactivated by the enzyme DT-diaphorase currently under
evaluation 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
relating to the interim results of the Phase 1/2 study of PDX in
patients with NHL; the potential safety and efficacy profile of
PDX; the Company's plans to initiate Phase 2 clinical development
of PDX for the treatment of patients with T-cell lymphoma; 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 interim results from the Phase 1/2 study of
PDX in patients with NHL may not be confirmed upon full analysis of
the detailed results of the trial; that the Company may experience
delays in the initiation and/or completion of its clinical trials,
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, 2004 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:
EFAPROXYNTM and the Allos logo are trademarks of Allos
Therapeutics, Inc. (1) All references to "PRX" in the abstract were
the result of a typographical error, and should have properly
referenced "PDX." DATASOURCE: Allos Therapeutics, Inc. CONTACT:
Jennifer Neiman Manager, Corporate Communications of Allos
Therapeutics, +1-720-540-5227, or cell, +1-303-518-4114, Web site:
http://www.allos.com/
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