West Coast Editor

With findings in hand from a Phase II trial with Advexin as monotherapy against a subpopulation of patients with recurrent, unresectable head and neck cancer, and two Phase III studies under way in the same indication, Introgen Therapeutics Inc. has filed to start a rolling biologics license application for the gene therapy.

The company's stock (NASDAQ:INGN) closed Thursday at $8.77, up 52 cents.

Channing Burke, director of communications for Austin, Texas-based Introgen, told BioWorld Today the company plans to publish data and file patents, and, for now, will limit information to disclosures in a press release.

Data from the Phase II trial showed that tumor growth control - defined by confirmed complete responses, partial responses with greater than 50 percent tumor reduction, or stable disease - was observed in 41 percent of patients.

The confirmed objective response rate (complete responses and partial responses) was 15 percent in the study, and patients achieving disease control also showed clinical benefit reflected by either lack of progression and/or improvement in disease-related morbidity (performance score, weight loss and pain).

Median survival in the subpopulation was 13.5 months for the patients who achieved tumor growth control, and 31.4 months for those with an objective response.

Introgen is pursuing accelerated approval for Advexin, and has asked the FDA that the process for the rolling BLA start immediately, with the completion of filing expected before the end of next year.

Advexin works by inducing expression of the tumor suppressor p53 protein (a normal cell constituent that recognizes damaged cells and stops their growth) in high concentrations in cancer tissue to selectively kill cancer cells. The drug combines the p53 gene with a non-replicating, non-integrating adenoviral gene-delivery system developed by Introgen.

Tested clinically as a monotherapy and in combination with chemotherapy, radiation therapy and surgery, Advexin also is being tried as a rinse or mouthwash for patients with oral pre-malignancies.

Earlier this month, Introgen said Phase II findings reported at the San Antonio Breast Cancer Symposium showed Advexin combined with neoadjuvant chemotherapy yielded a reduction of more than 50 percent in tumor size in all patients, and complete tumor removal by subsequent surgery was achieved in all of them. Results of the therapy with Advexin proved better than would be expected from neoadjuvant chemotherapy treatment alone, the company said.

Introgen's second tumor suppressor product candidate, INGN 241, is in Phase I/II development, as is the tumor vaccine INGN 225.

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