Gendux AB and Introgen Therapeutics, Inc. was notified by the European Medicines Agency (EMEA) Committee for Orphan Medicinal Products that ADVEXIN® p53 therapy has received Orphan Medicinal Product Designation in Europe for the treatment of Li-Fraumeni Syndrome (LFS).
Gendux AB is a wholly owned subsidiary of Introgen Therapeutics, Inc. (Nasdaq: INGN) while LFS is a genetic disorder characterized by inherited mutations in the p53 tumor suppressor gene.
According to Dr. Max W. Talbott, senior vice president of worldwide commercial development and regulatory affairs at both Introgen and Gendux:
"We are very encouraged by the recognition of the unique ability of ADVEXIN to treat the tumors of Li-Fraumeni Syndrome cancer patients without the toxicity that characterizes many other anti-cancer treatments.
We plan to seek expedited registration of ADVEXIN in Europe utilizing the Exceptional Circumstances provisions of the EMEA's registration rules.
The European registration efforts compliment our advancing registration program in the United States and will provide for ADVEXIN's availability in both major biopharmaceutical markets."
ADVEXIN, a targeted molecular therapy with broad applicability in a wide range of tumor types and clinical settings because it targets one of the most fundamental and common molecular defects --abnormal p53 tumor suppressor function, associated with cancer initiation, progression and treatment resistance, has been selected by the USFDA as a fast track program for an unmet medical need and has designated ADVEXIN for orphan drug use for recurrent head and neck cancer.
Source: Introgen Therapeutics, Inc.
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