Néovacs To Expand Clinical Testing Of Its TNF-alpha Kinoid Lead Product Candidate Following Positive Preliminary Findings From A Phase I/II Study

Main Category: Arthritis / Rheumatology
Also Included In: Clinical Trials / Drug Trials
Article Date: 23 Jun 2009 - 5:00 PDT

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Neovacs, a biotechnology company developing proprietary immunotherapeutics for autoimmune and chronic diseases, announced that subject to regulatory consent, it plans to initiate a Phase II study of its TNF-alpha Kinoid later this year in rheumatoid arthritis patients who have failed treatment with at least one TNF-alpha inhibitor. The decision to proceed with the trial was 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 multicentre, Europe-wide trial received significant public funding from OSEO, the French state innovation agency.

"We are highly encouraged by the safety data and preliminary indications of efficacy that are emerging from our Crohn's disease study," commented Neovacs CEO Guy-Charles Fanneau de La Horie. "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. We are grateful for the public funding that is enabling us to expand our clinical efforts without delay", added Mr de la Horie.

The ongoing Phase I/II dose-escalation study (taking place in South Africa and Switzerland) is recruiting between 12 and 18 patients with active Crohn's Disease and is intended to evaluate the Kinoid's safety and immunogenicity. In the context of active immunotherapy, safety parameters include (i) the absence of adverse reactions and (ii) serological measurements of the nature of the immune response, such as the kinetics of the antibody response and whether the cellular immune system (and specifically T cell memory) is stimulated. The trial is also tracking a clinical endpoint for disease status - the Crohn's Disease Activity Index.

Source
Neovacs