Neovacs’ Second Kinoid enters clinical testing

Initiation of Phase I/II study of IFNalpha Kinoid in lupus patients

09-Apr-2010 - France

Neovacs announced that it has initiated a Phase I/II study of its Interferon alpha (IFNalpha) Kinoid in lupus patients. Regulatory and ethics committee approvals for the trial have been received in France and Belgium, and further approvals are being sought in a number of other European countries. The IFNalpha-K is the second product candidate based on Neovacs’ novel Kinoid immunotherapy platform to enter clinical testing.

“There remains an urgent need for new therapies for lupus, and targeting interferon alpha is one of the most promising strategies being explored,” commented Professor Frédéric Houssiau, head of the Department of Rheumatology at St. Luc University Hospital in Brussels and the Principal Investigator of the study. “We therefore welcome the opportunity to test Neovacs’ novel immunotherapy to IFNα in lupus patients.”

The Phase I/II study will employ a double-blinded ascending dose design, with a placebo group within each dose cohort. Subject participants must have moderate levels of disease. The primary objective of the study is to collect safety information. Secondary objectives are the immune response to the Kinoid, and measures of disease, including disease activity indices and markers for IFNalpha activity. Subject to recruitment of participants, first unblinded data from the study should be available early in 2011.

“We are very excited to have our second product entering clinical evaluation,” said Pierre Vandepapelière, Chief Medical Officer of Neovacs. “We believe that our novel approach may offer lupus patients key advantages, including the potential to be effective against all 13 subtypes of interferon alpha and the compliance advantages of an infrequent dosing regime.”

https://www.bionity.com/en/news/115995/neovacs-second-kinoid-enters-clinical-testing.html