California-based biotechnology company Anixa Biosciences Inc (NASDAQ: ANIX) announced on Tuesday that the US Food and Drug Administration (FDA) has granted approval to the company's collaborator, Moffitt Cancer Center, for an individual patient Investigational New Drug Application (IND) to allow a second dose of its CAR-T therapy for a patient who may be demonstrating clinical activity to the initial treatment.

Dr Robert Wenham, chair of the Department of Gynecologic Oncology at Moffitt, and the principal investigator for the trial, said: "In the first cohort and at the lowest dose administered, despite an initial increase in tumour size that met criteria for progression, one patient has remained off new therapy for many months with no new disease. Even her tumour marker that was initially elevating later began to fall. A biopsy demonstrated tumour with necrosis, inflammation and T cell infiltration by Immunohistochemistry (IHC). Based on these findings, we sought approval from the FDA to administer a second treatment to her, aiming to increase the likelihood of a partial or complete response. Recently, we received that approval from the FDA."

The Phase I clinical trial at Moffitt is treating recurrent ovarian cancer patients who have failed standard-of-care therapies. To date, six patients have been treated in the dose escalation trial: three in the first cohort and three in the second cohort. Dose escalation will continue after confirming that the previous dosages are safe.