First Head and Neck Cancer Gene Therapy Faces FDA Review
Introgen Therapeutics, Inc (NASDAQ: INGN) has become the first biotechnology company to seek government approval for a gene therapy to treat recurring head and neck cancers.
The Austin, Texas-based corporation submitted Advexin® for priority review by the US Food and Drug Administration (FDA) on Monday, June 30, 2008. Advexin® is a gene therapy that’s been under development for 14 years and the first gene-based drug to get this far in the US drug approval process.
Introgen Therapeutics, which is partly owned by MD Anderson Cancer Center researcher Dr Jack Roth and the University of Texas, is also seeking approval to market the drug in Europe.
Advexin® uses deactivated cold viruses to insert p53 tumor suppressor genes into cancer cells. It is designed to restore p53 function in patients who have a low levels of the p53 gene so healthy cells can be replenished while malignant cells die. The company’s clinical trials on Advexin® indicated two-thirds of patients with difficult to treat head and neck cancers may be potential candidates for the treatment.
If the FDA accepts the gene therapy for priority review – and if the treatment meets drug safety standards – approval could come in as little as six months. Without priority consideration, the FDA’s decision would likely take closer to a year. Either way, this application is going to be closely tracked by cancer patients, healthcare providers and pharmaceutical industry insiders who are curious about the potential of gene-based treatments. As one securities analyst said,
“It’s a major milestone for gene therapy, because it’s a first-in-class drug.”
Introgen is also evaluating Advexin® for the treatment of certain breast and lung cancers, but this week’s FDA application is only for the treatment of recurrent head and neck cancer. Approximately 40,000 people are diagnosed with head, neck and throat cancers in the US each year.
If you’re a patient in the US who’d like to learn more about head and neck cancer treatments, you can visit the National Cancer Institute’s Head and Neck Cancer page.
Source: Austin American-Statesman
Related Links: WebMD.com; seekingalpha.com
Technorati Tags: laryngeal cancer; oncology; oral cancer; oropharyngeal carcinoma; personalized medicine and pharmacogenomics; targeted therapies; orphan drugs
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