23 Jan 2008 - Oxford BioMedica announced that its partner MolMed has received regulatory approval to start a Phase III trial of TK therapy for high risk acute leukaemia. Under a license agreement with Oxford BioMedica, MolMed's TK therapy product employs Oxford BioMedica's retroviral ex vivo gene delivery technology. The start of a Phase III trial of TK therapy triggers an undisclosed milestone payment to Oxford BioMedica.
MolMed S.p.A. announced that the AIFA, the Italian Health authority, authorised the start in Italy of a Phase III trial (TK008) of MolMed's TK cell therapy in patients affected by high risk acute leukaemias and receiving haematopoietic stem cell transplantation from a partially compatible family donor (haplo-HSCT). AIFA clearance, the very first one in Italy for a Phase III of a cell/gene therapy, requires the completion of analytical characterisation of TK components within the treatment of 20% of patients involved in the study, and follows approval of the clinical protocol, obtained in December 2007 by the Ethical Committee of the first clinical centre involved. In preparing Phase III, MolMed was supported by the EMEA, that provided protocol assistance and scientific advice as granted by the Orphan Drug designation of TK (Orphan Drug is awarded to therapeutics for life-threatening or chronically debilitating conditions affecting not more than 5/10,000 people in the EU). The multicentric, randomised Phase III trial will assess the very positive outcome of Phase I/II trial TK007 that resulted in an exceptional improvement in survival of patients by promoting rapid and sustained immune reconstitution, and proved safety and efficacy of haplo-HSCT, thus enabling feasibility of transplantation from partially incompatible family donors.
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