Retrospective Analysis of Allos Therapeutics' Phase 3 REACH Study Finds Positive Correlation between Patient Outcomes and EFAPR
June 14 2006 - 8:00AM
PR Newswire (US)
WESTMINSTER, Colo., June 14 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (NASDAQ:ALTH) today announced the publication of
new findings from its Phase 3 REACH study of EFAPROXYN
(efaproxiral) plus whole brain radiation therapy in patients with
brain metastases from various primary cancers. Results of the
analysis, which were reported in the June 13th edition of the
British Journal of Cancer (volume 94, issue 12), found that
patients who achieved sufficient efaproxiral exposure to realize
the desired pharmacodynamic effect saw clinically meaningful
survival and response rate benefits. Authors of the manuscript
evaluated survival and response rate data from the REACH study in
relation to efaproxiral exposure, as defined by red blood cell
efaproxiral concentration and total number of doses. Patient
outcomes were assessed based on primary tumor type and patient body
weight. Patients who received at least 7 of 10 doses were
categorized into high or low exposure groups based on their
efaproxiral red blood cell concentration. Patients with efaproxiral
concentrations of at least 483 mcg/mL were categorized to the high
exposure group; patients with efaproxiral concentrations of less
than 483 mcg/mL were categorized to the low exposure group. Results
of the analysis indicated that patients in the high exposure group
demonstrated increased survival and response rates relative to
patients in the low exposure group and control arm. For patients
with brain metastases from breast cancer, the median survival time
was 25.7 months for patients in the high-exposure group relative to
7.3 months for low-exposure patients and 4.47 months for control
patients (p=0.0002 high exposure vs. control). Response rates in
the breast cancer subset were 79.2%, 77.3% and 50.0% in the
high-exposure, low-exposure and control groups, respectively
(p=0.017 high exposure vs. control). Importantly, a majority of
patients in the breast cancer subset achieved the target
efaproxiral concentration of 483 mcg/mL, and thus demonstrated
superior efficacy results. Likewise, patients with brain metastases
from non-small cell lung cancer (NSCLC) who were categorized to the
high exposure group also demonstrated longer survival and better
response rates relative to those with low exposure. Specifically,
median survival time was 6.97 months for NSCLC patients in the
high-exposure group relative to 4.73 months for low exposure
patients and 4.37 months for control patients, (p=0.09 high
exposure vs. control). Response rates for NSCLC patients were 55.8%
43.1% and 39.7% for the high-exposure, low-exposure and control
groups, respectively, (p=0.046 high exposure vs. control). However,
a majority of patients in the NSCLC subset did not achieve the
target efaproxiral concentration of 483 mcg/mL, which may have
contributed to the inferior efficacy results relative to the breast
cancer subset. "These findings suggest that patients with brain
metastases from non-small cell lung cancer who receive adequate
exposure to efaproxiral have the potential to achieve clinically
meaningful survival and response rate benefits," said Michael E.
Saunders, M.D., Vice President, Clinical Development of Allos. "The
information obtained from this analysis may, in part, account for
the efficacy variance observed between primary breast and NSCLC
patients in the REACH study and provides important insight into the
therapeutic dosing requirements for future clinical development of
efaproxiral in this patient setting." A copy of the paper can be
accessed at the British Journal of Cancer Web site,
http://www.nature.com/bjc . 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, the Company 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. The Company's lead
product candidate, EFAPROXYN(TM) (efaproxiral), 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. The Company's other product candidates are: PDX
(pralatrexate), a small molecule chemotherapeutic agent (DHFR
inhibitor) currently under investigation 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, please 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 patients with brain metastases from
lung cancer or any other type of cancer, the Company's projected
timelines for completion of enrollment and announcement of results
of the ENRICH trial, 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 its clinical trials, whether
caused by adverse events, investigative site initiation rates,
patient enrollment rates, regulatory issues or other factors: and
that clinical trials may not demonstrate the safety and efficacy of
the Company's product candidates in their target indications.
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. Note: EFAPROXYN(TM)
and the Allos logo are trademarks of Allos Therapeutics, Inc.
Contact: Jennifer Neiman Manager, Corporate Communications Allos
Therapeutics 720-540-5227 DATASOURCE: Allos Therapeutics, Inc.
CONTACT: Jennifer Neiman, Manager, Corporate Communications, Allos
Therapeutics, +1-720-540-5227, Web site: http://www.allos.com/
Copyright
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Historical Stock Chart
From Jun 2024 to Jul 2024
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Historical Stock Chart
From Jul 2023 to Jul 2024