Abiogen Pharma's New Cell Therapy Starts a Clinical Phase I-II in Peritoneal Carcinosis.

PISA, Italy -- Abiogen Pharma today announced the start of a Phase I-II clinical trial in Italy using ABIO 05/01 cells for the treatment of peritoneal carcinosis.

The Phase I-II trial on peritoneal cancer patients will be conducted at the Oncology-Haematology Department of the University of Modena. The study will enrol approximately 18 patients with advanced tumors who have not responded to existing therapies. The purpose of the Phase I-II study is to evaluate ABIO 05/01's safety in humans and to establish safe dose ranges for further studies.

ABIO 05/01 is a cytotoxic cell line derived from the cells of a child with a rare form of T-cell leukaemia by Daniela Santoli, Ph.D., a professor at The Wistar Institute in Philadelphia. In vitro and in vivo, ABIO 05/01 cells have successfully caused the regression and disappearance of certain tumors without affecting normal tissue or producing side effects.

Preclinical data to date show that ABIO 05/01 cells are effective against a number of cancers, including leukaemia, lymphomas, ovarian, prostate, breast and brain tumors. Toxicity has been evaluated in several species, including normal and tumor bearing mice, healthy primates and pet dogs with spontaneous tumors. Safety has been demonstrated in these preclinical studies using both non-irradiated and lethally irradiated ABIO 05/01 cells.

Furthermore, two phase I trials conducted in the USA to determine toxicity of ABIO 05/01 therapy in women with metastatic refractory breast cancer and in paediatric patients with a variety of solid tumors or leukaemia showed that ABIO 05/01 cells were well tolerated by both patients population.

The ABIO 05/01 cells are delivered as final products in infusion bags by ARETA INTERNATIONAL.

ARETA INTERNATIONAL provided ABIO 05/01 production and scale-up in full GMP compliance and ISO 9001 certification.

Abiogen Pharma is a private Italian Pharmaceutical Company, born in Pisa in 1997, involved in R&D, Manufacturing and Marketing. Abiogen owns a prestigious R&D Pipeline and showed along the years significant skills in innovative compound development, also broadening out to the biotechnological field.