Neovacs Initiates a Phase II Clinical Trial of TNFa Kinoid in Rheumatoid Arthritis
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Neovacs has announced the initiation of a Phase IIa clinical study of its TNFa Kinoid immunotherapy in rheumatoid arthritis patients who have ceased to respond to an anti-TNFa monoclonal antibody and who test positive for anti-drug antibodies (ADAs). The announcement follows trial clearance by the French regulatory authority (AFFSAPS) and the central ethics committee.
Neovacs has also submitted the trial protocol to the relevant authorities in two other European countries and has already received regulatory clearance in one and ethics committee approval in the other.
“This is a major milestone and an excellent way to end 2009 – a year that has seen Neovacs make significant progress”, stated Guy-Charles Fanneau de la Horie, CEO of Neovacs, “Along with the ongoing Phase Ib trial in Crohn’s patients, this new Phase IIa trial adds a second indication for our TNF-Kinoid. We also plan to initiate clinical testing of our second product, IFNa Kinoid, in early 2010.”
The Phase IIa study, to be performed in collaboration with the diagnostics company BMD, is part-financed by significant funding from OSEO/ISI, the French state innovation agency. The double-blind, placebo-controlled trial will recruit up to 48 patients in three European countries. The primary objective is to select the dose levels and a dosing schedule to be tested in a subsequent Phase IIb study. The treatment’s safety and clinical efficacy will be secondary endpoints.
“Anti-TNF monoclonals are very effective, but often lose their efficacy over time. ADAs are a major factor in this therapeutic failure”, commented Professor Marie-Christophe Boissier, Head of the Rheumatology Department at Avicenne Hospital, Bobigny, France, and the study’s coordinating investigator for France “Active immunotherapy with Neovacs’ TNFa Kinoid may be of significant value in a patient population that currently has limited effective treatment options.”
Neovacs has also submitted the trial protocol to the relevant authorities in two other European countries and has already received regulatory clearance in one and ethics committee approval in the other.
“This is a major milestone and an excellent way to end 2009 – a year that has seen Neovacs make significant progress”, stated Guy-Charles Fanneau de la Horie, CEO of Neovacs, “Along with the ongoing Phase Ib trial in Crohn’s patients, this new Phase IIa trial adds a second indication for our TNF-Kinoid. We also plan to initiate clinical testing of our second product, IFNa Kinoid, in early 2010.”
The Phase IIa study, to be performed in collaboration with the diagnostics company BMD, is part-financed by significant funding from OSEO/ISI, the French state innovation agency. The double-blind, placebo-controlled trial will recruit up to 48 patients in three European countries. The primary objective is to select the dose levels and a dosing schedule to be tested in a subsequent Phase IIb study. The treatment’s safety and clinical efficacy will be secondary endpoints.
“Anti-TNF monoclonals are very effective, but often lose their efficacy over time. ADAs are a major factor in this therapeutic failure”, commented Professor Marie-Christophe Boissier, Head of the Rheumatology Department at Avicenne Hospital, Bobigny, France, and the study’s coordinating investigator for France “Active immunotherapy with Neovacs’ TNFa Kinoid may be of significant value in a patient population that currently has limited effective treatment options.”
