FDA Advisory Committee Does Not Recommend Approval of RSR13 as Adjunctive Therapy for the Treatment of Brain Metastases Originat
03 Maio 2004 - 7:04PM
PR Newswire (US)
FDA Advisory Committee Does Not Recommend Approval of RSR13 as
Adjunctive Therapy for the Treatment of Brain Metastases
Originating From Breast Cancer WESTMINSTER, Colo., May 3
/PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. announced today
that the U.S. Food and Drug Administration (FDA) Oncologic Drugs
Advisory Committee (ODAC) did not recommend approval of the
company's investigational radiation sensitizer RSR13 (efaproxiral)
as an adjunct to whole brain radiation therapy (WBRT) for the
treatment of patients with brain metastases originating from breast
cancer. Although the FDA is not bound by ODAC's recommendation, it
generally takes such recommendations into consideration when
determining whether or not to approve a new drug product for
marketing in the United States. The FDA's Division of Oncology Drug
Products is expected to take final action on the company's New Drug
Application (NDA) by June 4, 2004. "We will await the FDA's final
decision on our NDA and continue to believe RSR13 in combination
with whole brain radiation therapy is an effective treatment for
patients with brain metastases originating from breast cancer. We
hope the agency's final decision will acknowledge the clear unmet
medical need in this patient population," said Michael E. Hart,
President and CEO of Allos Therapeutics, Inc. "Meanwhile, we
continue to enroll patients in our confirmatory Phase 3 trial,
called ENRICH, initiated to evaluate the potential of RSR13 as an
adjunct to whole brain radiation therapy for the treatment of women
with brain metastases originating from breast cancer." "Clinical
trial results with RSR13 plus whole brain radiation therapy
demonstrate that patients with brain metastases from breast cancer
can benefit from this treatment by enhancing the effect of
radiation," noted John H. Suh, M.D., Clinical Director, Radiation
Oncology, Brain Tumor Institute at the Cleveland Clinic Foundation,
Principle Investigator of the REACH Study (RT-009) and Chairman of
the ENRICH Study (RT-016). "A new therapy that has a positive
effect on a patient's survival and quality of life would
significantly improve our ability to treat this patient
population." ODAC reviewed data submitted by the company to the FDA
in a New Drug Application (NDA 21-661), which the company believes
demonstrates the safety and efficacy of RSR13 as an adjunct to WBRT
for the treatment of patients with brain metastases originating
from breast cancer. The company's NDA included data from a
randomized, open-label 538-patient pivotal Phase 3 trial which
evaluated RSR13 as a radiation sensitizer for brain metastases.
While the difference in overall survival between patients who
received RSR13 plus WBRT and patients who received only WBRT was
not statistically significant, the trial showed a positive survival
benefit among patients with brain metastases from breast cancer and
confirmed RSR13's strong safety profile. Patients with brain
metastases originating from breast cancer represent a subset of
patients that was not prospectively defined as an intent-to-treat
subgroup in the Phase 3 trial. In February 2004, the company
launched a multi-center Phase 3 randomized open label trial of
RSR13 (efaproxiral) as an adjunct to WBRT for the treatment of
brain metastases originating from breast cancer. The Phase 3 study,
called ENRICH (ENhancing Whole Brain Radiation Therapy In Patients
with Breast Cancer and Hypoxic Brain Metastases), is designed to
compare the effect of WBRT with supplemental oxygen with or without
RSR13 in women with brain metastases originating from breast
cancer. The study will also evaluate the safety profile of RSR13 in
this patient population. The study will seek to enroll
approximately 360 patients at up to 50 cancer centers across North
America. The design of the study calls for two interim analyses for
safety and efficacy. The company has successfully completed the
FDA's Special Protocol Assessment (SPA) for the ENRICH trial. Under
the SPA, the FDA evaluates whether the protocol for a clinical
trial is adequate to meet scientific and regulatory requirements
for marketing approval of the drug by the FDA. "The National Breast
Cancer Coalition (NBCC) looks forward to continuing to work with
Allos Therapeutics in support of the ongoing ENRICH trial," said
Fran Visco, President of NBCC. "Our goal is to help find safe and
effective therapies that make a significant impact in the burden of
breast cancer." NBCC partnered with Allos to support the ENRICH
trial design, oversight and enrollment and to gain additional
insight about how to improve radiation treatment for women with
brain metastases from breast cancer. Through its Clinical Trials
Initiative, the NBCC is mobilizing its nation-wide network of
advocates to inform women about this trial. Conference Call Allos
Therapeutics will hold a conference call at 5:15 p.m. EDT today to
discuss the outcome of the ODAC meeting on the company's
investigational radiation sensitizer, RSR13 (efaproxiral).
Investors and media are invited to participate. Time: 5:15 p.m. EDT
Date: Monday, May 3, 2004 Location: The Hilton Hotel, Gaithersburg,
MD Dial-in: (800) 915-4836 / (973) 317-5319 international Webcast:
http://www.allos.com/ (homepage and investor relations section)
Interested parties unable to participate in the live conference
call may access a recorded rebroadcast by dialing 1-800- 428-6051,
or +1-973-709-2089 for international callers; the conference ID
number is 353015. The replay will be available from 7:00 p.m. EDT
on Monday, May 3, 2004 until 11:59 p.m. EDT on May 10, 2004. In
addition, the webcast will be archived for on-demand listening for
30 days at http://www.allos.com/. 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 a superior 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 timing and outcome of the FDA's
decision whether or not to approve RSR13 for marketing in the
United States, the company's ability to successfully complete the
ENRICH trial on schedule and in accordance with regulatory
requirements, and 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, 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. 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, , or Amy Raskopf,
Cell, +1-917-673-5775, both for Allos Therapeutics, Inc. Web site:
http://www.allos.com/
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