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.
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 or Jennifer Neiman, Senior Manager, Corporate
Communications of Allos Therapeutics, Inc., +1-720-540-5227,
jneiman@allos.com
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