Updated Analysis Demonstrates Long-Term Survival Benefit of EFAPROXYN(TM) in Treating NSCLC Patients Receiving Sequential Chemor
07 11월 2006 - 2:00AM
PR Newswire (US)
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. DATASOURCE: Allos Therapeutics, Inc. CONTACT:
Jennifer Neiman, Manager, Corporate Communications,
+1-720-540-5227, Cell: +1-303-478-3340, Web site:
http://www.allos.com/
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Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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