Neovacs to expand clinical testing of TNF-α Kinoid
Neovacs, a French biotechnology company developing proprietary immunotherapeutics for autoimmune and chronic diseases, plans to initiate a Phase II study of its TNF-α Kinoid, subject to regulatory consent, in rheumatoid arthritis patients who have failed treatment with at least one TNF-α inhibitor.
Neovacs, a French biotechnology company developing proprietary immunotherapeutics for autoimmune and chronic diseases, plans to initiate a Phase II study of its TNF-α Kinoid, subject to regulatory consent, in rheumatoid arthritis patients who have failed treatment with at least one TNF-α inhibitor.
The decision is based on an initial review of encouraging data from the company's Phase I/II study in Crohn's disease.
The proposed trial will initially test two dose levels of the TNF-Kinoid, with the option of expanding recruitment and extending follow-up in one dose group on the basis of serological and clinical responses.
The multi-centre, Europe-wide trial received funding from OSEO, the French state innovation agency.
GuyCharles Fanneau de La Horie, ceo of Neovacs, said: "With all the initial dose groups having received the Kinoid, we have not seen any significant adverse reactions; importantly, it is very clear that the Kinoid does not induce cell mediated immunity.
"Furthermore, all the patients in the higher dose groups treated to date have mounted an antibody response and are in clinical remission. It makes sense to take a further step forward by testing the Kinoid in a Phase II rheumatoid arthritis trial."
Neovacs is a spin-off from Pierre & Marie Curie University in Paris, founded by Professor Daniel Zagury, a leading immunologist.