Introgen Therapeutics, Inc. submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) requesting marketing approval for Advexin p53 therapy to treat recurrent, refractory head and neck cancer. Simultaneously, Gendux Molecular Limited, an Introgen subsidiary, submitted a Marketing Authorization Application (MAA) to the European Medicines Evaluation Agency (EMEA) for the same indication. Advexin represents the first of a new class of tumour suppressor cancer therapy and is the first of its kind to be submitted for regulatory approval in the United States 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. Advexin is considered an 'Orphan Drug' in the US for the treatment of recurrent, refractory head and neck cancer, which, if approved, entitles the drug to extended market exclusivity for the approved indication.
This is an important milestone in the clinical application of gene therapy for cancer patients, said Jack A. Roth, MD, inventor of Advexin and Professor and Bud Johnson Clinical Distinguished Chair, Department of Thoracic and Cardiovascular Surgery, at M.D. Anderson Cancer Center . With the use of p53 biomarkers, Advexin will provide more effective and less toxic treatment for head and neck cancer patients who have limited treatment options.
Advexin p53 therapy harnesses the body's natural tumour suppression mechanisms to fight cancer, without the toxicities associated with conventional cancer treatments. Abnormalities in protective tumour suppressor p53 pathways are associated with the majority of all solid cancers. Designed to restore patients' ability to fight cancer using the guardian gene p53, Advexin delivers large doses of the normal tumour suppressor p53 gene to target abnormal p53 function present in tumour cells which triggers natural tumor suppression mechanisms in cancer without harming normal cells.
These filings represent a significant step toward making this important cancer treatment available to patients in the US and Europe, said Max W. Talbott, PhD, Introgen's senior vice president of Worldwide Commercial Development and Regulatory Affairs. We are committed to improving the lives of cancer patients and look forward to working with regulators to make this therapy available as soon as possible.
The FDA submission is based on positive pivotal phase II and III clinical trials evaluating survival, tumour 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.
The company plans to host a conference call to be scheduled in July, 2008 to review the Advexin clinical trial results. The call will include principal investigators familiar with the clinical use of Advexin.
The positive results of the Advexin pivotal trials have significant implications for the management of patients with refractory head and neck cancers who need new effective therapies. 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, said David G. Nance, Introgen's chairman and CEO.
Introgen Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted molecular therapies for the treatment of cancer and other diseases.
Gendux Molecular Limited is a non-resident Irish company based in Dublin, Ireland. The company is focused on the commercialization of targeted molecular therapies to be applied with molecular diagnostic tools to introduce personalized medical products in European and other markets. Gendux is a subsidiary of Introgen Therapeutics, Inc