Agenix starts process for commercial scale manufacture of ThromboView(R) with Diosynth Biotechnology

15-Aug-2005

Agenix Limited has signed a contract with Diosynth Biotechnology, a division of Organon, the human healthcare business unit of Akzo Nobel to begin the process of manufacturing ThromboView(R) for Phase III clinical trials and commercial sale.

Over the past twelve months, in conjunction with Florian Wurm PhD, CSO of ExcellGene SA. in Monthey Switzerland, and his team, Agenix has been able to increase the productivity of the cell line ten-fold, resulting in smaller scale commercial manufacture and significant economic benefits.

The process development and manufacturing agreement will see Agenix transfer the manufacturing process developed by the company to the Research Triangle Park facility of Diosynth Biotechnology for further process refinement and cGMP manufacturing commencing immediately. The Diosynth Biotechnology facility has been inspected by the FDA and EMEA. The goal of the collaboration is to enable Agenix to supply cGMP material for Phase III clinical trials by the third quarter of next year.

Recruitment for the Phase Ib PE (pulmonary embolism) safety trial in Australia has commenced with 4 patients now successfully enrolled out of the planned 14.

The Phase II DVT (deep vein thrombosis) trial in the United States and Canada is underway and has recruited nearly 32 patients. There is an interim analysis of this trial planned after 50 patients have been recruited. The first patient in that trial was recruited in early March 2005.

Agenix plans to conclude a Sales, Marketing and Distribution agreement by the end of this year and the manufacturing transfer and the results of the ongoing studies are key components of this agreement.

https://www.bionity.com/en/news/48296/agenix-starts-process-for-commercial-scale-manufacture-of-thromboview-r-with-diosynth-biotechnology.html