WESTMINSTER, Colo., Sept. 1 /PRNewswire-FirstCall/ -- Allos Therapeutics,
Inc. (Nasdaq: ALTH) today announced the publication of results from its Phase
2 multi-center study of EFAPROXYN (efaproxiral) in patients with unresectable
non-small cell lung cancer (NSCLC) receiving sequential chemoradiotherapy
(S-CRT). Results from the study, which were reported in today's edition of
the Journal of Clinical Oncology (volume 23, issue 25), suggest that the
addition of EFAPROXYN to S-CRT may improve survival over S-CRT alone without
increasing radiation toxicity rates.
Authors of the manuscript compared the safety and efficacy of EFAPROXYN
when administered with S-CRT in patients with unresectable NSCLC relative to
data from a Phase 3, Radiation Therapy Oncology Group (RTOG) 94-10 study.
Results of the analysis indicate that patients in the EFAPROXYN study tended
to have better survival than patients with similar characteristics in the RTOG
94-10 study. Median survival of patients treated in the EFAPROXYN study was
20.6 months as compared to a median survival of 15.1 months for patients in
the S-CRT arm of the RTOG 94-10 study and 17.9 months in the concurrent
chemoradiotherapy (C-CRT) arm of the RTOG 94-10 study. The survival benefit
observed in the EFAPROXYN study was also accompanied by a 75% overall response
rate. Overall, EFAPROXYN was very well tolerated, with the majority of
EFAPROXYN-related adverse events being Grade 1. Notably, there were no Grade
3 or 4 EFAPROXYN-related events of radiation esophagitis. A portion of these
data previously were presented at the 2003 World Conference on Lung Cancer and
the 2003 Federation of European Cancer Societies.
"Our findings affirm the potential of EFAPROXYN to improve the survival
rate of NSCLC patients receiving sequential chemoradiotherapy," said Hak Choy,
Professor and Chairman, Department of Radiation Oncology, University of Texas
Southwestern Medical Center at Dallas and principle investigator of the study.
"Moreover, the results demonstrate that EFAPROXYN does not significantly
increase radiation toxicity, a factor of particular significance in older
patients and in those with lower performance status."
Allos is currently conducting a Phase 1 study of EFAPROXYN in patients
with locally advanced, unresectable (Stage III) NSCLC receiving C-CRT.
Enrollment in this trial is expected to be completed in 2006, at which time
the Company will determine its future development plans for EFAPROXYN in
patients with Stage III NSCLC receiving a combined chemoradiotherapy regimen.
"The optimal sequencing of chemotherapy and radiation therapy in this
patient setting remains to be determined," said Michael E. Hart, President and
Chief Executive Officer of Allos. "Upon completion of the on-going Phase 1
study of patients with Stage III NSCLC receiving C-CRT, we will be positioned
to study EFAPROXYN plus chemoradiotherapy under both accepted treatment
modalities in this patient population."
Study Design
This Phase 2, non-randomized, open-label, multi-center study was designed
to assess the efficacy and safety of EFAPROXYN as a radiation sensitizer when
administered with thoracic radiation therapy, following induction
chemotherapy, for the treatment of patients with unresectable non-small cell
lung cancer. Fifty-one previously untreated patients with NSCLC were enrolled
at 13 sites. Treatment consisted of paclitaxel (225 mg/m2 on day 1) and
carboplatin (AUC = 6 on day 1), 3 weeks apart, followed by thoracic radiation
therapy (64 Gy/32 fractions/6-7 weeks) with concurrent EFAPROXYN (50 - 100
mg/kg). Results were compared to data from the Radiation Therapy Oncology
Group study 94-10 in a case-matched comparison.
About Non-Small Cell Lung Cancer
Non-small cell lung cancer (NSCLC) accounts for 85% of all lung cancer
cases reported in the United States, occurring in approximately 160,000
patients per year. Approximately 40% of these patients are diagnosed with
Stage III disease, of which half will receive chemoradiotherapy in the first
line setting.
About EFAPROXYN
EFAPROXYN is the first 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. By increasing tumor oxygenation, Allos
believes that EFAPROXYN has the potential to enhance the efficacy of standard
radiation therapy.
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. Allos' lead product candidate,
EFAPROXYN, 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. Allos' 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, 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
concerning the potential safety and efficacy of EFAPROXYN for the treatment of
NSCLC patients receiving S-CRT or C-CRT; the Company's projected timelines for
completion of enrollment in its on-going Phase 1 study of EFAPROXYN in
patients with unresectable NSCLC receiving C-CRT; 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 clinical trials may not demonstrate
the safety and efficacy of EFAPROXYN for the treatment of NSCLC patients
receiving S-CRT or C-CRT; that the Company may experience difficulties or
delays in its clinical trials, whether caused by adverse events, investigative
site initiation rates, patient enrollment rates, regulatory issues or other
factors; that the Company may be unable to obtain the regulatory approvals
necessary to conduct additional clinical trials; that data from preclinical
studies and clinical trials may not necessarily be indicative of future
clinical trial results; and the risk that the Company may lack the financial
resources and access to capital to fund future clinical trials for EFAPROXYN
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.
Contact:
Jennifer Neiman
Manager, Corporate Communications
720-540-5227
jneiman@allos.com
SOURCE Allos Therapeutics, Inc.
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Related links:
http://www.allos.com
CONTACT:
Jennifer Neiman, Manager, Corporate
Communications of Allos Therapeutics, Inc., +1-720-540-5227,
jneiman@allos.com
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