Neovacs achieves significant milestones in two clinical trials
Successful completion of patient recruitment in the company's Phase I/II trial of TNFalpha-KinoidTM in Crohn's disease
Neovacs announced that it has recruited the last two patients into its Phase I/II clinical trial of anti-TNFalpha-KinoidTM (TNF-K) in Crohn's disease and has administered interferon-alpha KinoidTM (IFN-K) to the first patient in its Phase I/II trial in lupus.
"These two milestones are consistent with our expectations at the time of our IPO in April; our clinical development programs are hitting their milestones on schedule. The final results of the Phase I/II trial of TNF-K in Crohn's disease should be available by the end of this year. We now have three clinical studies underway, with TNF-K in Crohn's disease (Phase I/II), TNF-K in rheumatoid arthritis (Phase II) and IFN-K in lupus (Phase I/II)", commented Neovacs CEO Guy-Charles Fanneau de La Horie.
Trial in Crohn's disease
The trial is an open-label, non-controlled, dose-escalation Phase I/II study with 3 dose levels of TNF-K (60, 180 and 360 mcg) administered at 0, 7 and 28 days or 0, 7, 28 and 168 days in patients with moderate-to-severe Crohn’s disease. Two patients have received three 60 mcg doses, one has received four 60 mcg doses, seven have received three 180 mcg doses, two have received four 180 mcg doses, two have received four 360 mcg doses and seven have received three 360 mcg doses. The last 2 patients recruited will both receive three 360 mcg doses. No product-related serious adverse events have been reported and none of the patients has withdrawn from the study for tolerability or safety reasons. The study's primary objective is to assess the KinoidTM's safety and its ability to induce an immune response to tumor necrosis factor alpha (TNFalpha). A secondary objective is to look at the therapeutic effect, as measured by the clinical disease score and markers of disease activity.
"This study is the first to have produced positive immunologic and clinical results with an active, anti-cytokine immunotherapy in the treatment of a chronic inflammatory disease. The preliminary results are very encouraging and additional studies are now underway or being planned, in order to confirm and complete these observations", added Pierre Vandepapelière, Chief Medical Officer at Neovacs.
Trial in lupus
This double-blind, dose-escalation Phase I/II study will recruit up to 28 patients, with randomization by dose level. Study subjects must present moderate disease symptoms. The study's primary objective is to gather information on the treatment's safety and tolerability. Secondary objectives include measurement of the immune response to the KinoidTM, the disease activity index and disease markers related to interferon-alpha (IFNalpha). Depending on patient recruitment, the study's preliminary results (after the blinding codes have been broken) may be available in early 2011. Neovacs has already obtained approval for the trial from the regulatory authorities in France, Belgium and Bulgaria and clinical trial applications have been filed in other European countries.
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