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Two pharmaceutical firms have applied for a new cancer therapy to be licensed in Europe and the United States.
The submission to the US Food and Drug Administration (FDA) by Introgen Therapeutics is based on positive phase II and III clinical trials of the tumour suppresser Advexin p53.
Meanwhile, Gendux Molecular has submitted an application to the European Medicines Agency for the same drug.
Advexin harnesses the body’s natural tumour suppression mechanisms to fight cancer, specifically in patients with recurrent, refractory end-stage, squamous cell carcinoma of the head and neck.
Designed to restore patients’ ability to fight cancer using the guardian gene p53, it delivers large doses of the normal tumour suppresser p53 gene to target abnormal p53 function present in tumour cells. This triggers natural tumour suppression mechanisms in cancer without harming normal cells.
Introgen has asked the FDA for Priority Review, which is typically granted to compounds that provide significant medical benefits compared with existing treatments for a disease.
If Priority Review is granted, the FDA will have up to six months from the submission date to take action.
“This is an important milestone in the clinical application of gene therapy for cancer patients,” said Professor Jack A Roth of the M D Anderson Cancer Centre and inventor of Advexin.
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