Allos Completes New Drug Application for Novel Treatment for Patients With Breast Cancer and Brain Metastases
04 Dezembro 2003 - 9:00AM
PR Newswire (US)
Allos Completes New Drug Application for Novel Treatment for
Patients With Breast Cancer and Brain Metastases WESTMINSTER,
Colo., Dec. 4 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc.
today announced it has submitted to the U.S. Food and Drug
Administration (FDA) the last component of its New Drug Application
(NDA) for approval to market RSR13 (efaproxiral) as an adjunct to
whole brain radiation therapy for the treatment of brain metastases
from breast cancer. The company submitted the first component of
its NDA for RSR13 in August 2003 under the FDA's rolling submission
process and has now completed this process with the submission of
clinical efficacy and safety data. With the entire NDA submission
now completed, the FDA has 60 days to notify the company of whether
or not it will accept the NDA for filing and respond to the
company's request for priority review of the application. The
electronic submission was produced in an internationally agreed
upon format (eCTD) that facilitates regulatory review in the United
States, Europe and Japan. The company plans to submit a Marketing
Authorization Application (MAA) in Europe for this indication in
the first quarter of 2004. RSR13 is the first of a new class of
pharmaceutical agents being developed as a radiation sensitizer to
be used as an adjunct to radiation therapy. A synthetic small
molecule, RSR13 decreases the hemoglobin-oxygen binding affinity,
which facilitates the release of oxygen from hemoglobin. The
presence of oxygen in tumors is an essential element for the
effectiveness of radiation therapy in the treatment of cancer. By
increasing the oxygenation of tumor tissues at the time of
treatment, RSR13 has the potential to sensitize hypoxic (oxygen
deprived) tissues and enhance the efficacy of standard radiation
therapy. Unlike chemotherapeutics or other radiosensitizers, RSR13
does not have to cross the blood brain barrier or enter the tumor
to be effective. The final component of the NDA contains safety and
efficacy data from over 700 patients treated with RSR13 under 17
study protocols and is based largely on the company's recently
completed pivotal Phase 3 clinical trial, one of the largest
randomized studies ever conducted in patients with brain
metastases. Detailed results of this Phase 3 trial were presented
at The Society for Neuro-Oncology Annual Meeting in November 2003.
The submission also includes supporting data from three Phase 2
studies of RSR13 in patients with brain metastases, primary
non-small cell lung cancer and glioblastoma multiforme. "This
submission represents a significant milestone for patients,
employees and shareholders," said Michael E. Hart, President and
CEO of Allos Therapeutics, Inc. "If approved, RSR13 will provide
women battling brain metastases from breast cancer with the first
therapeutic specifically designed to improve the efficacy of
standard whole brain radiation therapy." 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 brain cancer,
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 in the
U.S. Standard whole-brain radiation is the primary palliative
therapy for treating patients with brain metastases and has been
shown to prevent or reduce complications and to increase survival.
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, 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 whether or not the FDA will accept the
company's NDA for submission for filing, the company's ability to
complete the submission of its MAA to European authorities on
schedule and in accordance with regulatory requirements, and the
company's ability to obtain regulatory approval for RSR13 in the
U.S., Europe or any other jurisdiction, 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. DATASOURCE: Allos Therapeutics, Inc. CONTACT: Monique
M. Greer, VP, Corporate Communications and Investor Relations 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/
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