Phase II study shows strong clinical responses.

2003 JUL 3 - (NewsRx.com & NewsRx.net) -- Introgen Therapeutics, Inc., (NASDAQ:INGN) and its collaborators at The University of Texas M.D. Anderson Cancer Center reported preliminary data from a phase II study in patients with locally advanced breast cancer indicating that Advexin can be safely combined with a two-drug standard chemotherapy regimen and that 90% of the patients had major responses to the therapy.

The data was published in conjunction with the annual meeting of the American Society of Clinical Oncology.

Dr. Massimo Cristofanilli, assistant professor of breast medical oncology at M.D. Anderson, and principal investigator said, "These patients are typically difficult to treat because of the advanced nature of their disease. We use neoadjuvant therapy to shrink the large tumors before surgery and radiotherapy to improve patient outcomes. Our hypothesis is that Advexin can improve our current neoadjuvant regimen."

The phase II study is evaluating Advexin therapy combined with systemic Taxotere, marketed by Aventis, and Adriamycin, marketed by Pharmacia, in locally advanced breast cancer and is being administered prior to surgery. After 4 months of neoadjuvant therapy, patients in the study underwent standard surgery to remove any residual cancer and then had post operative therapy. The tumor status was evaluated at the time of surgery. The primary endpoint of the study was the complete pathological remission rate at the time of surgery. Ninety percent of the patients treated had clinical complete responses or partial responses. Pathological examination revealed only scattered residual tumor cells. No patients had progressive disease.

"We have seen very few side ...