Arizona Cancer Center Investigator Presents Positive Survival and Quality of Life Data From RSR13 Phase 3 Study
03 Dezembro 2003 - 8:30PM
PR Newswire (US)
Arizona Cancer Center Investigator Presents Positive Survival and
Quality of Life Data From RSR13 Phase 3 Study SAN ANTONIO, Texas,
Dec. 3 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. announced
the presentation of positive findings from its Phase 3 clinical
trial of the investigational radiation sensitizer RSR13
(efaproxiral). The results demonstrate a significant survival
benefit for women with breast cancer and brain metastases who
received RSR13 plus whole brain radiation therapy (WBRT) versus
WBRT alone. Baldassarre Stea, M.D., Ph.D., Head of the Department
of Radiation Oncology at the Arizona Health Sciences Center in
Tucson, presented the findings today at the 26th Annual San Antonio
Breast Cancer Symposium. In poster number 175, entitled "Results
from a subgroup analysis of patients with metastatic breast cancer
(MBC) in a phase 3, randomized, open-label, comparative study of
standard whole brain radiation therapy (WBRT) with
supplemental-oxygen, with or without RSR13, in patients with brain
metastases," Dr. Stea and colleagues showed that adding RSR13 to
WBRT with supplemental oxygen nearly doubled the median survival
rate of patients with breast cancer and brain metastases to 8.67
months versus 4.57 months for patients who received WBRT alone
(p=0.006). Patients with breast cancer and brain metastases who
were treated with RSR13 plus WBRT also achieved a higher response
rate in the brain than the control group (71.7% vs. 49.1%; p=0.02).
A statistically significant stable or improvement in quality of
life at 3 months was observed in patients receiving RSR13, as
assessed by the Karnofsky Performance Score(1) (35% vs. 18%;
p=0.001) and the Spitzer Index(2)(37% vs. 24%; p=0.01). In general,
patients experienced minimal serious adverse events with the most
common being hypoxemia (3.4% n=266), which is dose-dependent and
effectively managed with supplemental oxygen. "The presentation of
survival and quality of life data at this meeting validates the
potential of RSR13 to increase the effectiveness of radiation
therapy in breast cancer patients with brain metastases," said
Michael E. Hart, President and CEO of Allos Therapeutics, Inc.
"Brain metastases are devastating to patients and new therapies are
desperately needed." "You would expect patients with higher
response rates in the brain to live longer and that's exactly what
we saw in breast cancer patients," said Dr. Stea. "Additional
analyses of the data set continue to deliver encouraging news
regarding the potential benefits of using RSR13 with whole brain
radiation therapy in patients with metastatic breast cancer. These
data suggest that RSR13 has a positive treatment effect on survival
and quality of life in patients struggling with breast cancer and
brain metastases, providing added hope in their fight against
cancer." The preliminary results from the 538-patient randomized
Phase 3 trial of RSR13 were announced in April 2003. The results
did not meet the primary survival endpoint of the study using
standard log rank analysis. In the overall study population,
patients receiving RSR13/WBRT experienced a 17.6% improvement in
median survival compared to patients receiving WBRT alone (5.26
months vs. 4.47 months; p=0.17; n=538). However, the survival
benefit for RSR13 was statistically significant in a pre-specified
Cox multiple regression model (Hazard Ratio 0.775 [95% CI 0.639,
0.941], p=0.010). The company is currently submitting a rolling New
Drug Application (NDA) for RSR13 as an adjunct to WBRT for the
treatment of brain metastases originating from breast cancer to the
U.S. Food and Drug Administration (FDA). The FDA granted Fast Track
Product designation for RSR13 in November 2000. The company expects
to complete its rolling NDA submission this month. About Brain
Metastases in Breast Cancer Patients Approximately 200,000 women
and 1,300 men will be diagnosed with breast cancer in the United
States in 2003. Approximately 20-to-30 percent of these breast
cancer patients will develop brain metastases. The most common type
of intracranial malignancy, brain metastases are tumors that have
spread to the brain from a malignant tumor in another part of the
body. This condition occurs in approximately one out of five cancer
patients, most often in patients with breast cancer or non-small
cell lung cancer. There are approximately 175,000 annual cases of
brain metastases. 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
(RSR13), 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, a novel small molecule cytotoxic injectable
antifolate (DHFR inhibitor) being developed for non-small cell lung
cancer, mesothelioma and non-Hodgkin's lymphoma. 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 company's ability to complete the submission of its
NDA to the FDA on schedule and in accordance with regulatory
requirements, to adequately demonstrate the safety and efficacy of
RSR13 for use as a radiation sensitizer in the treatment of
metastatic breast cancer and any other type of cancer, and its
ability to obtain regulatory approval for RSR13, 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, 2002. 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. (1) The Karnofsky Performance Status Scale (KPS) was
designed to measure the level of patient activity and medical care
requirements. It is a general measure of patient independence and
has been widely used as a general assessment of a patient with
cancer. (2) The Spitzer Index is a global measure that captures the
three components of health (social, physical and psychological). It
is a self-report measure that allows comparison across a variety of
cancer trials. DATASOURCE: Allos Therapeutics, Inc. CONTACT:
Monique M. Greer, VP, Corporate Communications and IR of Allos
Therapeutics, Inc., +1-720-540-5241, or cell, +1-970-215-3260, ; or
media, Fern Lazar of Lazar Partners Limited, cell, +1-917-362-2264,
, for Allos Therapeutics, Inc. Web site: http://www.allos.com/
Copyright
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Gráfico Histórico do Ativo
De Set 2024 até Out 2024
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Gráfico Histórico do Ativo
De Out 2023 até Out 2024