BioWorld International Correspondent
Modex Therapeutics Ltd. plans to move its encapsulated cell therapy for delivery of erythropoietin (EPO) into Phase II clinical trials before the end of the year. This follows a successful Phase I safety study on six patients with renal failure.
The Lausanne, Switzerland-based company also aims to commence Phase I studies on encapsulated cell delivery of interferon alpha and interferon beta, for treatment of hepatitis C and multiple sclerosis, respectively, during the first half of next year, said Chief Financial Officer David Jones.
The six participants in the EPO delivery trial are undergoing dialysis, and they usually receive several injections of recombinant erythropoietin per week, Eric Roland, head of development at Modex, told BioWorld International. They were selected because of the stability of their EPO requirements, he said. Their regular treatment was halted in advance of the trial. In its place, they each received an implant in the forearm of Modex's proprietary BioDelivery device, which measures 30 millimeters by 1 millimeter. Each contains 1 million fibroblast cells producing human EPO protein.
The trial participants did not receive any supplementary EPO injections during the eight-week study, and none showed any complications or immune responses to the expressed protein. The company is now drawing up a protocol for an expanded six-month Phase II study, Roland said. "Our aim is to initiate that in the fourth quarter."
Modex has exclusive rights to the encapsulated cell technology for applications outside those associated with the central nervous system and the eye. It originally licensed the system from StemCells Inc., of Sunnyvale, Calif. (formerly CytoTherapeutics Inc.), although that company sold the technology to Evry, France-based Neurotech SA early last year. In addition to its own interferon alpha and beta programs, Modex has also collaborations in the protein delivery area with Novartis AG, Geron Corp. and Serono SA.
Modex's overall strategic focus is on the area of tissue repair, replacement and regeneration. It aims to acquire additional technologies and products in these areas and develop them to the Phase III stage, at which point the company will seek partners. Its second principal strand of activity at present is in wound healing.
Its lead product, EpiDex, a skin replacement technology, is currently undergoing clinical trials but can already be sold on a case-by-case basis in Germany, Switzerland and Austria. The company purchased German wound specialist company BioCare Biotechnologie fuer die Therapie GmbH for CHF1.9 million (US$1.1 million) last year, and earlier this month licensed wound treatment technology from the Blood Transfusion Center of Lille, France.