03.06.2008 at 08:00
- Category:
Cancer and Oncology
Introgen Therapeutics, Inc. and Moffitt Cancer Center announced plans to begin a phase 2 randomized, controlled study of INGN 225, Introgen's investigational immunotherapy product in patients with metastatic small-cell lung cancer (termed extensive stage SCLC).
INGN 225 is an immunotherapy using a patient's own cells to stimulate an anti-tumor immune response to fight cancer. The immunotherapeutic targets a molecular abnormality found in over half of all solid cancers.
The National Institutes of Health National Cancer Institute awarded a grant of approximately $1.3 million to fund this trial, which is expected to enroll as many as 80 patients starting early next year upon completion of the protocol with the NCI and U.S. Food and Drug Administration.
Results from a previous Phase 2 trial were presented today at the 12th World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer, in Seoul, Korea showing a 45 percent response rate in patients with platinum-resistant small-cell lung cancer who received chemotherapy following INGN 225. Interim results from this study also were presented earlier this year at the annual meeting of the American Society of Clinical Oncology. The historical response rate is generally less than 15 percent in these patients. Among the 43 patients evaluable for survival following INGN 225 treatment, survival was also improved compared to historical controls.
"The data to date indicate that INGN 225 could be a promising treatment in terms of survival, response rate and tolerability in a disease with virtually no treatments after chemotherapy has failed," said Dr. Dmitry Gabrilovich, professor of Oncology at Moffitt Cancer Center. "We are looking forward to confirming these earlier findings in a randomized, controlled phase 2 study that, if successful, could be expanded to become a registration study since there is such an acute medical need for new treatments in patients with extensive stage small-cell lung cancer resistant to chemotherapy."
The controlled, randomized trial, which will be co-led by Dr. Scott Antonia, program leader, Immunology and medical director, Cellular Therapies Core, and Dr. Gabrilovich, is being designed to evaluate the efficacy and safety of INGN 225 in patients with extensive stage SCLC at multiple centers and will include a control arm.
Copyright 2007, Cancer Weekly via NewsRx.com
