OncologyMemgen Reports Positive Results For ISF35 In High-Risk Chronic Lymphocytic Leukemia
Memgen announced that the ongoing Phase Ib study of its cancer immune therapy, ISF35, has produced positive results, including a complete remission in the trial"s first patient who had 17p deleted chronic lymphocytic leukemia (CLL).
The study, which is co-sponsored by the Leukemia & Lymphoma Society, assesses the ability of ISF35 to re-sensitize refractory and/or 17p deleted CLL to chemotherapy. The trial, which is actively recruiting patients, is being conducted by Januario Castro, M.D., of the University of California, San Diego (UCSD). The course of treatment evaluated in this trial - three infusions of ISF35-transduced cells followed by three courses of FCR - has been well-tolerated.
Results from the study show that pretreatment with autologous ISF35-transduced cells re-sensitized refractory and/or 17p deleted CLL to fludarabine, cyclophosphamide, and Rituxan® (FCR). The first patient in the ongoing trial achieved a complete remission that tested negative for minimal residual disease, indicating that the patient"s bone marrow was cancer-free. The second patient in the trial has already experienced a complete resolution of lymphocytosis and lymphadenopathy after ISF35 and only one cycle of FCR and is scheduled to receive the remaining two cycles of FCR.
Correlative analysis and preclinical studies have suggested that ISF35, combined with chemotherapy, may result in greater anti-leukemic activity and potentially extend survival in refractory CLL, where, according to numerous studies, patients are documented to live only 9-24 months on average.
To position ISF35 for the possibility of rapid FDA approval for this urgent unmet medical need, Memgen is now working with academic institutions and pharmaceutical firms to initiate a multi-center Phase II trial of ISF35 in combination with chemotherapeutic agents for refractory CLL patients.
Memgen