WESTMINSTER, Colo., Nov. 6 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (Nasdaq: ALTH) today announced the presentation of
updated 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). Hak Choy, M.D,
Professor and Chairman, Department of Radiation Oncology, University of
Texas Southwestern Medical Center, and the study's lead investigator,
presented the findings in an oral presentation today at the 48th Annual
Meeting of the American Society for Therapeutic Radiology and Oncology.
Dr. Choy and colleagues compared the safety and efficacy of EFAPROXYN
when administered with S-CRT in patients with unresectable NSCLC compared
to data from a Phase 3, Radiation Therapy Oncology Group (RTOG) 94-10
study. Results of a 5-year survival analysis indicated that patients in the
EFAPROXYN study exhibited superior survival to 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 13.3 months for matched cases in the S-CRT arm of the RTOG
94-10 study and 16.9 months in the concurrent chemoradiotherapy (C-CRT) arm
of the RTOG 94-10 study. The Kaplan- Meier estimates of 5-year survival
rates for matched cases were 19% in the EFAPROXYN study and 10% in both the
S-CRT and C-CRT arms of the RTOG 94-10 study. A portion of these data
previously were reported at the 2003 World Conference on Lung Cancer and
the 2003 Federation of European Cancer Societies.
Allos is currently conducting a Phase 1 study of EFAPROXYN in patients
with locally advanced, unresectable (Stage III) NSCLC receiving C-CRT. Upon
completion of this trial, the Company will determine its future development
plans for EFAPROXYN in patients with Stage III NSCLC receiving a combined
chemoradiotherapy regimen.
"These findings demonstrate the potential of EFAPROXYN to improve long-
term survival rates of locally advanced NSCLC patients receiving sequential
chemoradiotherapy," said Michael E. Saunders, M.D., Allos' Vice President,
Clinical Development. "Upon completion of the on-going Phase 1 study of
patients with Stage III NSCLC receiving concurrent chemoradiotherapy, we
believe we will be positioned to further develop EFAPROXYN plus
chemoradiotherapy under either accepted treatment regimen 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-two 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 25% - 40% of these patients are diagnosed
with Stage III disease, of which half will receive chemoradiotherapy in the
first line setting.
About EFAPROXYN
EFAPROXYN(TM) 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. (ALTH) is a biopharmaceutical company focused
on the development and commercialization of small molecule therapeutics for
the treatment of cancer. The Company has two product candidates in
late-stage clinical development: EFAPROXYN (efaproxiral), a radiation
sensitizer currently under evaluation in a pivotal Phase 3 trial in women
with brain metastases originating from breast cancer, and PDX
(pralatrexate), a novel, next generation antifolate currently under
evaluation in a pivotal Phase 2 trial in patients with relapsed or
refractory peripheral T-cell lymphoma. The Company is also evaluating RH1,
a targeted chemotherapeutic agent, in a Phase 1 trial in patients with
advanced solid tumors. 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 of EFAPROXYN for the treatment
of NSCLC patients receiving S-CRT or C-CRT; the Company's future
development plans for EFAPROXYN for the treatment of NSCLC patients
receiving S-CRT or 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,
2005, 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.
SOURCE Allos Therapeutics, Inc.
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Related links:
http://www.allos.com
CONTACT:
Jennifer Neiman, Manager, Corporate
Communications, +1-720-540-5227, Cell: +1-303-478-3340,
jneiman@allos.com
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