Allos Therapeutics Receives Orphan Drug Designation From U.S. FDA for EFAPROXYN(TM)
04 August 2004 - 6:23AM
PR Newswire (US)
Allos Therapeutics Receives Orphan Drug Designation From U.S. FDA
for EFAPROXYN(TM) WESTMINSTER, Colo., Aug. 3 /PRNewswire-FirstCall/
-- Allos Therapeutics (NASDAQ:ALTH) today announced that the U.S.
Food and Drug Administration (FDA) awarded orphan drug status to
the Company's lead clinical candidate, EFAPROXYN(TM) (efaproxiral)
for use as an adjunct to whole brain radiation therapy (WBRT) for
the treatment of brain metastases in patients with breast cancer.
EFAPROXYN(TM) is currently being investigated in a Phase 3 clinical
trial in this indication at leading cancer centers across North
America. The FDA may award orphan drug designation to drugs that
target conditions affecting 200,000 or fewer U.S. patients per year
and provide a significant therapeutic advantage over existing
treatments. The orphan drug designation provides for U.S. marketing
exclusivity for seven years following marketing approval by the
FDA. Additionally, the designation qualifies a product for possible
funding to support clinical trials, study design assistance from
the FDA during development and other financial incentives. "We are
pleased to have been awarded the FDA's orphan drug designation for
EFAPROXYN(TM)," said Michael E. Hart, Chief Executive Officer and
President of Allos. "This designation is a significant milestone in
the development of EFAPROXYN(TM), and, if approved for marketing in
this indication, will become an important component of our
commercialization strategy." In February, Allos initiated a Phase
3, randomized, open-label, multi-center trial called ENRICH
(Enhancing Whole Brain Radiation Therapy (WBRT) In Patients with
Breast Cancer and Hypoxic Brain Metastases) designed to compare the
effect of WBRT with supplemental oxygen with or without
EFAPROXYN(TM) in women with brain metastases from breast cancer.
Results from earlier trials showed a positive survival benefit and
demonstrated a desirable safety profile in this patient population.
EFAPROXYN(TM) is also currently being evaluated as a radiation
sensitizer in patients with cervical cancer, (Stage IIIA/Stage
IIIB) non-small cell lung cancer (NSCLC) and recurrent glioblastoma
multiforme and as a possible chemo-enhancer enhancer for BCNU
(carmustine) chemotherapy for the treatment of recurrent malignant
glioma. About EFAPROXYN EFAPROXYN(TM) (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, EFAPROXYN(TM) has the potential to
enhance the efficacy of standard radiation therapy. Unlike
chemotherapeutics or other radiation sensitizers, EFAPROXYN(TM)
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, EFAPROXYN(TM), 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
(pralatrexate), a novel small molecule cytoxic injectable
antifolate (DHFR inhibitor) intended to treat 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/. Safe Harbor Statement 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 adequately demonstrate the safety and efficacy of
EFAPROXYN(TM) for use as an adjunct to WBRT for the treatment of
brain metastases in patients with breast cancer, and to obtain
regulatory approval to market EFAPROXYN(TM) for this indication, 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, as amended, for the year ended December 31, 2003. 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. Receiving orphan drug designation does not
increase the likelihood of eventual regulatory approval for a
product candidate. 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: Jennifer
Neiman, Corporate Communications Manager of Allos Therapeutics,
Inc., +1-720-540-5227, ; or Fern Lazar of Lazar Partners Limited,
+1-212-867-1762, , for Allos Therapeutics, Inc. Web site:
http://www.allos.com/
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