Simultaneously, Gendux Molecular, an Introgen subsidiary, submitted a marketing authorization application to the European Medicines Evaluation Agency for the same indication. Advexin reportedly represents the first of a new class of tumor suppressor cancer therapy and is claimed to be the first of its kind to be submitted for regulatory approval in the US and Europe.
Introgen has requested priority review from the FDA for Advexin. Priority review is typically granted to compounds that provide significant medical benefit compared to existing treatments for a disease. If priority review is granted, the FDA will have up to six months from submission date to take action on the dossier.
The FDA submission is based on positive pivotal Phase II and III clinical trials evaluating survival, tumor response and safety in patients with recurrent, refractory end-stage, squamous cell carcinoma of the head and neck. These trials incorporated common diagnostic tests to identify patients most likely to benefit from Advexin treatment based upon pre-treatment tissue analyses to determine p53 profile status.
David Nance, Introgen’s chairman and CEO, said: “Our findings realize the promise of personalized medicine and indicate that Advexin can be an effective treatment for patients who are easily identified by simple diagnostics tests.”