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news.Introgen Therapeutics and Moffitt Cancer Center are to begin a Phase II randomized, controlled study of Introgen's investigational immunotherapy product in patients with metastatic small-cell lung cancer.
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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 FDA.
Results from a previous Phase II trial showed a 45% response rate in patients with platinum-resistant small-cell lung cancer who received chemotherapy following INGN 225. The historical response rate is generally less than 15% 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 II 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.”