Data Presented at ASCO Demonstrate That Red Blood Cell Levels of Allos Therapeutics' RSR13 Correlate With Treatment Effect in Pa
07 Junho 2004 - 10:01AM
PR Newswire (US)
Data Presented at ASCO Demonstrate That Red Blood Cell Levels of
Allos Therapeutics' RSR13 Correlate With Treatment Effect in
Patients With Brain Metastases NEW ORLEANS, June 7
/PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. (NASDAQ:ALTH)
announced the presentation of new pharmacokinetic (PK) data from
its Phase 3 clinical trial of the investigational radiation
sensitizer RSR13 (efaproxiral) in patients with brain metastases.
Preliminary data from the Phase 3 study, called REACH, were first
announced in April 2003. A retrospective analysis of the results
from the study indicate that the concentration of RSR13
(efaproxiral) in the red blood cells of patients with brain
metastases treated with whole brain radiation therapy (WBRT)
clearly correlated with the improvement in survival observed in
these patients. Patients who achieved optimal RSR13 (efaproxiral)
levels had better clinical outcomes than patients who did not.
Edward G. Shaw, MD, Professor and Chairman, Department of Radiation
Oncology, Wake Forest University School of Medicine, presented the
findings in a poster session yesterday at the 40th Annual Meeting
of the American Society of Clinical Oncology (ASCO). In abstract
#1561, titled "Pharmacokinetics (PK) of RSR13 (efaproxiral) predict
survival in patients with brain metastases randomized to receive
whole brain radiation therapy (WBRT) with or without RSR13 (REACH
RT-009)," Dr. Shaw and colleagues evaluated the impact of RSR13
(efaproxiral) dosing and the concentration of RSR13 (efaproxiral)
in red blood cells on median survival time. Blood samples were
taken for PK analysis on Day 1 of RSR13 (efaproxiral)
administration and at least once during the second week of therapy.
Successful dosing was defined as a PK greater than 483 ug/ml based
on the ability of these levels to induce the desired
pharmacodynamic effect. Results of the analysis indicated that
patients who received at least 7 successful doses of RSR13
(efaproxiral) experienced a statistically significant improvement
in median survival time compared with patients who received 7 doses
of WBRT alone. The largest improvement was observed in patients
whose brain metastases originated from breast cancer. The abstract
may be accessed online at http://www.asco.org/ at the conclusion of
the meeting. "These analyses reveal that patients in this study who
received optimal RSR13 (efaproxiral) dosing experienced a
statistically significant increase in median survival time," said
Dr. Shaw, a co-Principal Investigator on the study. "These data
support the potential utility of RSR13 (efaproxiral) as adjunct
therapy to whole brain radiation and supplemental oxygen for the
treatment of brain metastases. Additionally, the incorporation of
PK analysis into treatment regimens that include RSR13
(efaproxiral) may help to optimize RSR13 (efaproxiral) dosing and
maximize its radiosensitizing effects and benefits to patients. We
believe that this may translate into improved outcomes for patients
with brain metastases, who have few treatment options that improve
survival." "These PK analyses enhance our understanding of the
clinical outcomes observed in this Phase 3 trial," said Michael E.
Hart, President and CEO of Allos Therapeutics, Inc. The REACH study
was a randomized, open label Phase 3 clinical trial designed to
demonstrate that RSR13 is safe and effective for treating patients
with brain metastases resulting from a variety of solid tumors. The
study enrolled 538 patients and compared the safety and efficacy of
RSR13 plus WBRT and supplemental oxygen (271 patients) versus WBRT
and supplemental oxygen (267 patients) in patients with brain
metastases. Of the 271 patients in the treatment arm, 188 patients
had at least 2 PK determinations, 64 had 1 PK determination and 19
had no PK evaluation. Patients were assigned to 1 of 5 groups based
on the number of WBRT doses and the number of RSR13 (efaproxiral)
doses received. The WBRT control arm comprised two of these groups:
patients receiving fewer than 7 doses of WBRT and patients
receiving 7 or more doses of WBRT. The treatment arm comprised
three groups: Patients receiving fewer than 7 doses of RSR13
(efaproxiral); patients receiving at least 7 doses but who had
fewer than 7 successful doses; and patients receiving at least
seven successful doses. The primary endpoint of the trial was
survival. About RSR13 (efaproxiral) RSR13 (efaproxiral) is the
first synthetic small molecule designed to "sensitize" hypoxic
(oxygen-deprived) areas of tumors prior to 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 in the treatment of cancer. By increasing tumor oxygenation
at the time of treatment, RSR13 (efaproxiral) has the potential to
enhance the efficacy of standard radiation therapy. Unlike
chemotherapeutics or other radiation sensitizers, RSR13
(efaproxiral) does not have to cross the blood brain barrier or
enter the tumor to be effective. About Allos Therapeutics, Inc.
Allos Therapeutics, Inc. is a biopharmaceutical company focused on
developing and commercializing innovative drugs for improving
cancer treatments. The company's lead clinical candidate, RSR13
(efaproxiral), is a synthetic small molecule that has the potential
to sensitize hypoxic (oxygen deprived) tumor tissues and enhance
the efficacy of standard radiation therapy. In addition, Allos is
developing PDX, an injectable small molecule chemotherapeutic agent
that has an enhanced potency and toxicity profile relative to
methotrexate and other dihydrofolate reductase, or DHFR,
inhibitors. For more information, please visit the company's web
site at: http://www.allos.com/. This announcement contains
forward-looking statements that involve risks and uncertainties.
Future events may differ materially from those discussed herein due
to a number of factors, including, but not limited to, risks and
uncertainties related to the usefulness of PK analyses in
optimizing RSR13 dosing levels, and company's ability to adequately
demonstrate the safety and efficacy of RSR13 for the treatment of
brain metastases or any other type of cancer, as well as other
risks and uncertainties detailed from time to time in the company's
SEC filings, including its Annual Report on Form 10-K for the year
ended December 31, 2003, as amended. 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 assumes no responsibility to update such
statements. DATASOURCE: Allos Therapeutics, Inc. CONTACT: Fern
Lazar of Lazar Partners Limited, +1-212-867-1762, , for Allos
Therapeutics, Inc. Web site: http://www.asco.org/ Web site:
http://www.allos.com/
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