Allos Therapeutics Reports Results for Phase 3 Enrich Study of Efaproxyn in Women With Brain Metastases Originating From Breast
June 19 2007 - 5:30AM
PR Newswire (US)
Study Fails to Meet Primary Endpoint of Improvement in Overall
Survival WESTMINSTER, Colo., June 19 /PRNewswire-FirstCall/ --
Allos Therapeutics, Inc. (NASDAQ:ALTH) today announced top line
results from ENRICH, the Company's pivotal Phase 3 study of
EFAPROXYN (TM) (efaproxiral) plus whole brain radiation therapy
(WBRT) in women with brain metastases originating from breast
cancer. The study failed to achieve its primary endpoint of
demonstrating a statistically significant improvement in overall
survival in patients receiving EFAPROXYN plus WBRT, compared to
patients receiving WBRT alone. Based on these results, the Company
intends to discontinue the development of EFAPROXYN and focus on
advancing the development of PDX (pralatrexate), its novel
antifolate currently under evaluation in a pivotal Phase 2 study in
patients with relapsed or refractory peripheral T-cell lymphoma
(PTCL). "I would like to acknowledge the patients and investigators
for their participation in the ENRICH study," said Paul L. Berns,
President and Chief Executive Officer of Allos. "We continue to
move forward with focus and determination in advancing the clinical
development of PDX and RH1, and look forward to providing future
updates on our clinical progress." Results of the ENRICH study
indicated that patients who received EFAPROXYN plus WBRT did not
experience a statistically significant improvement in survival
compared to patients who received WBRT alone, according to a
stratified log rank analysis of overall survival (8.5 months vs.
7.5 months; hazard ratio 0.87, p-value = 0.23). All secondary
efficacy endpoints also failed to achieve statistical significance.
The study safety results demonstrated that EFAPROXYN was generally
well tolerated. The most common Grade 3-4 adverse events that
occurred more often in the EFAPROXYN arm included headache, hypoxia
and vomiting. Adverse events in the study appeared to be similar to
those observed in previous clinical studies with EFAPROXYN.
"Although we are disappointed with the results of the ENRICH study,
we are excited about the potential of our product pipeline," said
Dr. Pablo J. Cagnoni, Allos' Chief Medical Officer. "We expect to
provide the next update on our PDX PROPEL study later this year
following completion of a pre- specified interim analysis of
response data after 35 patients have completed at least one cycle
of treatment with PDX." About PDX PDX (pralatrexate) 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
potency and toxicity profile relative to methotrexate and certain
other DHFR inhibitors. The Company believes PDX has the potential
to be delivered as a single agent or in combination therapy
regimens. About PROPEL PROPEL is an international, multi-center,
open-label, single-arm pivotal Phase 2 clinical trial of PDX in
patients with relapsed or refractory PTCL. The trial will seek to
enroll 100 evaluable patients at approximately 35 centers across
the United States, Canada and Europe. The primary endpoint of the
study is objective response rate (complete and partial response).
Secondary endpoints include duration of response, progression-free
survival and overall survival. In August 2006, the Company reached
agreement with the FDA under the Special Protocol Assessment, or
SPA, process on the design of this pivotal Phase 2 trial. According
to the PROPEL trial protocol, the Company will conduct an interim
analysis of efficacy data from the PROPEL trial after 35 patients
have completed at least one cycle of treatment with PDX, and must
observe at least four responses (complete or partial) out of the
first 35 patients in order to continue the trial. The Company
currently expects to conduct the 35 patient efficacy analysis in
the second half of 2007 and complete patient enrollment in the
trial by the third quarter of 2008, although the actual timing of
the interim analysis or completion of enrollment may vary based on
a number of factors, including site initiation and patient
enrollment rates. About Peripheral T-cell Lymphoma Peripheral
T-cell lymphomas, or PTCLs, are a biologically diverse group of
blood cancers that account for approximately 10% to 15% of all
cases of non- Hodgkin's lymphoma (NHL), or about 6,700 patients.
The average five year survival rate for PTCL patients is
approximately 25%. There are currently no pharmaceutical agents
approved for the treatment of either first-line or relapsed or
refractory PTCLs. About EFAPROXYN EFAPROXYN (efaproxiral) is a
synthetic small molecule designed to sensitize hypoxic, or
oxygen-deprived, areas of tumors during radiation therapy by
facilitating the release of oxygen from hemoglobin, the
oxygen-carrying protein contained within red blood cells, and
increasing the level of oxygen in tumors. The presence of oxygen in
tumors is an essential element for the effectiveness of radiation
therapy. About ENRICH ENRICH was a randomized, open-label,
multi-center Phase 3 study designed to evaluate the safety and
efficacy of WBRT with supplemental oxygen with or without EFAPROXYN
in women with brain metastases originating from breast cancer. The
trial enrolled 368 patients at 78 centers in the United States,
Canada, Europe and South America. The primary endpoint of the study
was overall survival. Secondary endpoints included response rate in
the brain at three months, Karnofsky Performance Status, and
neurologic signs and symptoms assessment. Conference Call The
Company will host a conference call today at 8:30 AM ET. The dial
in number for U.S. residents to participate is 877-407-0782.
International callers should dial 201-689-8567. Call participants
should reference the Allos Therapeutics conference call. Conference
Call Replay An audio replay of the conference call will be
available from 12:00 PM ET on Tuesday, June 19, 2007, until 11:59
PM ET on Friday, July 19, 2007. To access the replay, please dial
877-660-6853 (domestic) or 201-612-7415 (international); Replay
pass codes (both required for playback): account # 286; conference
ID # 246029. Webcast The Company will also hold a live web cast of
the conference call. The web cast 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. About
Allos 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 trial in patients
with relapsed or refractory peripheral T-cell lymphoma. The Company
is also investigating PDX in patients with non small cell lung
cancer and a range of other lymphoma sub-types. The Company's other
product candidate is RH1, a targeted chemotherapeutic agent for
which the Company expects to initiate a Phase 1 study in patients
with advanced solid tumors in the second half of 2007. 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
concerning the potential safety and efficacy profile of PDX; the
potential potency and toxicity profile of PDX relative to
methotrexate and other DHFR inhibitors; the Company's projected
timelines for conducting interim analyses and completing patient
enrollment in the PROPEL trial; the Company's future product
development and regulatory strategies; and other statements which
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 difficulties or delays in the
initiation, conduct or completion of its clinical studies,
including PROPEL, whether caused by competition, adverse events,
investigative site initiation rates, patient enrollment rates,
regulatory issues or other factors; that clinical studies may not
demonstrate that PDX is both safe and effective for the treatment
of patients with peripheral T-cell lymphoma or any other type of
cancer; that data from preclinical studies and clinical trials may
not be indicative of future clinical trial results; that the safety
and/or efficacy result of clinical trials for PDX may not support
an application for marketing approval in the United States or any
other country; that an application for marketing approval may not
be accepted for priority review or at all by the FDA or any other
regulatory authority; and that the Company may lack financial
resources and access to capital to fund future clinical trials for
PDX or RH1. 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 of Allos
Therapeutics, Inc., +1-720-540-5367, or Jennifer Neiman, Senior
Manager, Corporate Communications of Allos Therapeutics, Inc.,
+1-720-540-5227, Web site: http://www.allos.com/
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