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Isotechnika and Roche completes patient recruitment for ISA247 Phase II A clinical trial in kidney transplantation
Edmonton | Friday, October 4, 2002, 08:00 Hrs  [IST]

Isotechnika Inc has achieved its objective of enrolling 130 patients in the Phase II A clinical trial evaluating its lead drug as a potential treatment therapy in kidney transplantation. ISA247 is being developed under a global collaboration agreement with Roche.

The Phase II trial is a randomized, open label study of ISA247 and Cyclosporine A in stable kidney transplant patients who are at least six months post-operative. The twelve week study is being conducted at twenty two centers in Canada and the United States. Patients on ISA247 were initially dosed at half of their previous Neoral (Cyclosporine A) dose and then titrated to achieve trough blood level concentrations of ISA247 one third that of Neoral. The primary objectives of the study are to maintain a low incidence of acute rejection and to maintain stable kidney function. It is expected the last patient will complete the 90 day study in January, 2003.

Isotechnika Inc and Roche have signed an agreement for the global co-development and commercialization of Isotechnika''s innovative transplant drug, ISA247. This agreement represents the largest Canadian drug development deal between a large pharma and a biotech company.

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