Results Published in Journal of Clinical Oncology Demonstrate Survival Benefit of EFAPROXYN(TM) in Treating NSCLC Patients Recei
01 September 2005 - 11:00PM
PR Newswire (US)
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 DATASOURCE: Allos Therapeutics, Inc.
CONTACT: Jennifer Neiman, Manager, Corporate Communications of
Allos Therapeutics, Inc., +1-720-540-5227, Web site:
http://www.allos.com/
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