Allos Therapeutics Receives FDA Approvable Letter for RSR13 (efaproxiral)
June 02 2004 - 9:00AM
PR Newswire (US)
Allos Therapeutics Receives FDA Approvable Letter for RSR13
(efaproxiral) - Additional Clinical Data Requested to Support
Approval - WESTMINSTER, Colo., June 2 /PRNewswire-FirstCall/ --
Allos Therapeutics, Inc. (NASDAQ:ALTH) announced today that it has
received an "approvable" letter from the U.S. Food and Drug
Administration (FDA) for its New Drug Application (NDA) for RSR13
(efaproxiral) for the treatment of patients with brain metastases
originating from breast cancer. In the letter, the FDA indicated
that before the NDA may be approved, it will be necessary for Allos
to complete its ongoing Phase III clinical trial of RSR13 in
patients with brain metastases originating from breast cancer and
submit the results as an NDA amendment for the FDA's review. The
ongoing Phase III trial, called ENRICH (ENhancing Whole Brain
Radiation Therapy In Patients with Breast Cancer and Hypoxic Brain
Metastases), will seek to enroll approximately 360 patients at up
to 50 cancer centers across North America. In the letter, the FDA
stated, "if the study shows effectiveness in this population
(increased survival) using the pre-specified analysis, and the
study is otherwise satisfactory, we believe it would, together with
the subset result in RT-009, support approval". No other specific
deficiencies were noted in the approvable letter. However, the FDA
indicated that additional general comments from Clinical
Pharmacology, Pharmacology/Toxicology and Chemistry would be
forwarded separately. The FDA also noted that it has not completed
its inspection of the manufacturing and controls facilities listed
in the NDA, which remains a prerequisite to approval of the NDA.
"We are pleased that the FDA has determined that RSR13 is
approvable, assuming a favorable outcome of our ENRICH study," said
Michael Hart, President and Chief Executive Officer of Allos. "We
remain focused on completing the enrollment of the ENRICH study as
soon as possible, and will continue to work with the FDA with the
goal of advancing RSR13 toward approval." About RSR13 (efaproxiral)
RSR13 (efaproxiral) is the first synthetic small molecule designed
to sensitize hypoxic, or 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, we believe RSR13
(efaproxiral) has the potential to enhance the efficacy of standard
radiation therapy. 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 company's ability to successfully
complete the ENRICH trial on schedule and in accordance with
regulatory requirements, the company's ability to adequately
demonstrate the safety and efficacy of RSR13 for the treatment of
brain metastases from breast cancer or any other type of cancer,
and the company's ability to raise additional capital to support
its operations, 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, and its Quarterly Report on Form 10-Q for the quarter
ended March 31, 2004. Results from earlier clinical trials are not
necessarily predictive of future clinical results. 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
Ltd., +1-212-867-1762, for Allos Therapeutics, Inc. Web site:
http://www.allos.com/
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