Neovacs achieves key clinical milestones
Neovacs announced the achievement of important milestones in its clinical development programs.
Consent to proceed to higher dose in the Phase I/II study of IFNalpha Kinoid in lupus patients
Recruitment and dosing of the first dose cohort in the Phase 1/2 study of IFNalpha Kinoid in lupus patients are complete, and the data related to these patients has been reviewed by the Data and Safety Monitoring Board (DSMB), an independent committee which is responsible for overseeing the conduct of the study and in particular for patient safety. As a first in man study of a novel immunotherapy, the trial design calls for DSMB review and consent prior to the initiation of each escalating dose group. As a result of the DSMB’s review, this consent has now been received and screening of patients for the second cohort is underway. Preliminary results from this study are expected in Q1 2011.
“We are very pleased with the progress of this trial to date,” commented Pierre Vandepapeliere, Neovacs’ Chief Medical Officer “In particular, the DSMB’s consent to recruit patients into a higher dose group is indicative of the absence of any serious safety concerns so far.”
The Phase IIa study of TNFalpha Kinoid in rheumatoid arthritis patients also advances to higher dose group
Concerning the ongoing Phase 2 study of TNFalpha Kinoid in patients with rheumatoid arthritis who have failed a TNFalpha inhibitor and have antibody to the drug they failed, recruitment and dosing of the first dose cohort have been completed. Following a review of the safety data that raised no concerns, recruitment at the second dose level is being initiated. Preliminary data from this study is expected to be available in Q2 2011. This study is part of a collaborative program with bmd, a French diagnostics company, and is financed in part by Oséo/ISI, the French state innovation agency.
Regarding the ongoing Phase 1/2 study of TNFalpha Kinoid in Crohn’s disease, this trial is fully enrolled as previously announced and patient follow-up continues, with final data expected to be available by the end of 2010 as planned.
“We continue to make good progress in our clinical programs” noted Guy-Charles Fanneau de La Horie, CEO of Neovacs “Importantly, we are on track to deliver the multiple clinical trial datasets in H1 of 2011, as promised during our IPO process earlier this year.”
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