Introgen Therapeutics Inc., citing "significant progress" on its Advexin cancer therapy, says it will soon begin crunching statistical numbers from its Phase 3 clinical trials of the gene treatment.
Introgen CEO David Nance said in a conference call with investors Thursday that the company reached an agreement with the U.S. Food and Drug Administration over the statistical methodology for the analysis and will begin in early 2007. The analysis will go toward Introgen's eventual licensing of the therapy for head and neck cancers.
Advexin uses a cancer tumor-fighting gene to kill cancer cells unreceptive to other treatments.
Nance also said Introgen will pursue European regulatory approval for therapy in early 2007.
NASDAQ:INGN
To help with the expensive late-stage regulatory approval process here and abroad, the company recently sold 5 million shares of its common stock to raise about $30 million. Nance said the company will add the new cash to its existing stash to create $50 million in reserves to support the regulatory process.
Advexin works by delivering the tumor suppressor protein p53 that targets a fundamental molecular cancer defect and selectively kills cancer cells. Expanded p53 biomarker studies confirmed with high statistical significance the survival benefit of ADVEXIN therapy in patients with abnormal p53 function. The new results demonstrated that patients with the abnormal p53 biomarker in recurrent squamous cell carcinoma of the head and neck were most likely to have a survival benefit from their use of ADVEXIN therapy.
Despite the seemingly good news, the Austin biotech firm's stock was down more than 6 percent Friday to $4.40.
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment