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Anixa Amends Phase I Trial Protocol to Allow Second Dose of CAR T-Cell Therapy in Ovarian Cancer

NEW YORK – Anixa Biosciences on Tuesday said it has submitted an amendment to the Phase I trial protocol of its CAR T-cell therapy for ovarian cancer to allow patients who benefit from an initial dose to receive a second dose of the therapy. 

The amendment to the Phase I study was submitted after Anixa and the researchers received an approval for an investigational new drug (IND) application that allowed them to administer a second dose of the CAR T-cell therapy for one ovarian cancer patient in the study. The initial treatment with the therapy led to signs of biological activity in this patient, and the researchers and Anixa hope to further enhance these positive results with a second dose. 

"While this is a single patient, the positive clinical activity observed, including necrosis and T- cell infiltration, is an encouraging sign of the therapy's potential effectiveness," Robert Wenham, chair of the department of gynecologic oncology at Moffitt Cancer Center and the principal investigator of the trial, said in a statement. "Based on these results, we recently submitted an amendment to the current trial protocol to allow patients who may benefit to receive a second dose. We are excited to continue evaluating this treatment in our ongoing trial, and we are optimistic about the potential long-term benefits it may offer to patients with ovarian cancer." 

Anixa's autologous CAR T-cell therapy uses engineered T cells to target follicle-stimulating hormone receptors (FSHR) expressed on ovarian cells. The trial is enrolling patients with recurrent ovarian cancer who have failed standard-of-care therapies. To date, six patients have been treated in the study, Anixa said.