Introgen Therapeutics, Inc. and its subsidiary, Gendux Molecular Limited, announced the advancement of a Marketing Authorization Application (MAA) for Advexin has been accepted for technical review by the European Medicines Regulatory Authority (EMEA) for the treatment of inherited Li-Fraumeni Syndrome (LFS) cancers.
This acceptance indicates that all administrative issues have been addressed and that the formal technical evaluation of the Application will be conducted under the EMEA's Exceptional Circumstances Approval rules. If approved, Advexin would be the world's first treatment specific for an inherited cancer syndrome. Advexin is targeted to reverse one of the most common cancer genetic defects that is inherited in Li-Fraumeni patients and found in the majority of non-inherited cancers.
The acceptance of the MAA for Advexin will initiate the regulatory review of the Application's preclinical, manufacturing and clinical data by EMEA. Exceptional Circumstances Approval rules available in Europe are being utilized by Gendux to expedite review of potential breakthrough therapies. The review will be based on clinical efficacy and safety results from the use of Advexin in LFS and in a wide variety of non-inherited cancers with abnormal p53 tumour suppression that is the target of Advexin treatment. Abnormal p53 is inherited in LFS and is also the most commonly identified defective gene in all solid cancers whether inherited or acquired. Patients' tumours can be checked to determine if they have the p53 abnormality targeted by Advexin using widely available tests.
Dr. Max Talbott, senior vice president, Worldwide Regulatory Affairs, said, "The Advexin application is a historic submission, and could represent a truly personalized cancer therapy approach. We are encouraged by the EMEA's acceptance of our Application under the Exceptional Circumstances Approval provisions and now look forward to working with the European regulatory authorities during the technical review process."
Advexin p53 therapy is a targeted molecular therapy with broad applicability in a wide range of tumour types and clinical settings because it targets one of the most fundamental and common molecular defects, abnormal p53 tumour suppressor function, associated with cancer initiation, progression and treatment resistance. Advexin has demonstrated tumour growth control in recurrent head and neck cancer, lung cancer, breast cancer, esophageal, prostate and other cancer indications. Advexin has demonstrated clinical activity in a number of solid tumour types in multiple phase 1, 2 and 3 clinical trials conducted worldwide.
LFS is a cancer syndrome characterized by the inheritance of an abnormal p53 tumour suppressor. Normal p53, known as the Guardian of the Genome, suppresses cancer and tumour formation. Without p53 tumour suppression, cancer patients can lose the ability to naturally combat cancer. Without a normally functioning p53 defence, LFS cancer patients often develop spontaneous and widespread tumours at an early age. Frequently, multiple members of the same family suffer from this genetic disorder and currently there are no approved therapies to specifically treat LFS.
Introgen is a biopharmaceutical company focused on the development, manufacturing and commercialisation of targeted tumour suppressors, a new class of therapies for the treatment of cancer. Introgen's technology delivers targeted molecular therapies that increase production of normal cancer-fighting proteins and cytokines
Gendux Molecular Limited is a non-resident Irish company based in Dublin, Ireland. The Company is focused on the commercialisation of targeted molecular therapies to be applied with molecular diagnostic tools to introduce personalized medical products in European and other markets.