IDSMB gives positive review for Neovacs' Phase IIb clinical trial of IFNalpha Kinoid in lupus.
M2 EQUITYBITES-July 11, 2017-IDSMB gives positive review for Neovacs' Phase IIb clinical trial of IFNalpha Kinoid in lupus
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Neovacs SA (EPA: ALNEV) has received a positive data review from the Independent Data and Safety Monitoring Board (IDSMB) for the ongoing Phase IIb clinical trial of IFNalpha Kinoid in lupus, the French biotech company announced on Tuesday.
In its review -- the third IDSMB data review of the ongoing Phase IIb clinical trial -- the board looked at cumulative data, focusing on the safety data. The board told the company that no safety concerns were identified and it recommended continuing the study without any modifications.
The Phase IIb trial is a randomised, placebo-controlled, multicentre study (IFN-K-002) in systematic lupus erythematosus (LES). It is now fully enrolled, with 178 participants randomised to receive either injection of the IFNalpha Kinoid vaccine or placebo.
The trial's objective is to evaluate the biological and clinical efficacy of IFNalpha Kinoid, the company's most advanced product, in patients with moderate to severe lupus.
The ongoing trial is taking place in 21 countries across Europe, the US, Latin America, Asia and North Africa.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Jul 11, 2017|
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