Meldung hab ich gewartet. Da wird wieder kräftig was gen Norden gehen. Jetzt die Kurse um 2,40 nutzen, mit den erwünschten 2 Dollar wirds wohl nichts, so tief gehts nicht mehr runter.
Gruss E.
Allos Therapeutics Submits First Component of Rolling New Drug Application for RSR13 for the Treatment of Brain Metastases From Breast Cancer
WESTMINSTER, Colo., Aug 5, 2003 /PRNewswire-FirstCall via COMTEX/ -- Allos
Therapeutics, Inc. (Nasdaq: ALTH) today announced that it has begun submission
of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)
for the company's investigational radiation sensitizer, RSR13 (efaproxiral), for
the treatment of patients with breast cancer that has metastasized to the brain.
The electronic submission was produced in the Common Technical Document format,
which is an internationally agreed upon format that facilitates regulatory
review in the USA, Europe and Japan. The submission will occur on a "rolling"
basis and is expected be completed by the end of the year. The first component
submitted contained the nonclinical section, consisting of one CD-ROM containing
40 volumes and over 6,900 pages of data and analysis. The chemistry,
manufacturing and controls (CMC) and the clinical modules will be submitted
later this year.
When complete, the NDA submission will contain safety and efficacy data from
over 700 patients treated under 17 RSR13 study protocols and will be 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. The submission will also include supporting data from three Phase 2
studies of RSR13 in patients with brain metastases, primary non-small cell lung
cancer and glioblastoma multiforme.
"The submission of the first section of our NDA to the FDA is an extremely
gratifying milestone for an emerging company like Allos," said Michael E. Hart,
President and CEO of Allos Therapeutics, Inc. "There is clearly an unmet medical
need for new treatments that can provide better local control of brain
metastases while extending survival. This hypothesis was confirmed by the
results of the Phase 3 trial, demonstrating a significant survival benefit in
patients with metastatic breast cancer. Our goal is to get RSR13 into the hands
of oncologists that treat patients as quickly as possible. To help facilitate
this process, we are in ongoing discussions with the FDA regarding future
development of RSR13 as a radiation sensitizer."
An estimated 211,300 women and 1,300 men will be diagnosed with breast cancer in
the USA in 2003. Approximately 20-to-30 percent of breast cancer patients will
develop brain metastases. Brain metastases, the most common type of brain
cancer, 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 USA. Standard whole brain radiation is the primary palliative therapy for
treating patients with brain metastases and it has been shown to prevent or
reduce complications and to increase survival.
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, 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: 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.
SOURCE Allos Therapeutics, Inc.
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