Neovacs SA Announces Positive IDSMB Review Of The Phase 2b Study Of TNF-Kinoid In Rheumatoid Arthritis
3/12/2014 11:35:14 AM
Paris, March 12, 2014 - NEOVACS (Alternext Paris : ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, announces that an independent Data and Safety Monitoring Board (iDSMB) reviewing the safety data of the phase IIb clinical trial of TNF-Kinoid in Rheumatoid Arthritis (RA) issued a positive assessement of the study.
The iDSMB is an independent committee of 4 international auto-immune disease experts. Following its evaluation of the safety data on nearly half of the patients forseen in the study, the committee issued a final report on March 11, 2014 with unrestricted approval based on :
- the good safety profile of the Kinoid at the actual stage of the study,
- A unanimous recommendation to pursue the study without modification.
"There are two positive impacts about this recommendation by the iDSMB" comments Miguel Sieler, CEO of Neovacs. "It confirms the excellent safety profile of TNF-Kinoid, as shown in previous studies of the product accross indications. It also sends a positive signal regarding our ongoing clinical trial in RA" .
The phase IIb clinical trial of TNF-Kinoid in RA is an international, randomized, versus placebo efficacy study, conducted in 140 patients over 10 countries of Central and Eastern Europe and Lebanon.
All study centers (about 40) are operational. Recruitment is on track with study results expected Q4 2014.
Neovacs is a biotechnology company focused on an active immunotherapy technology platform (Kinoids) with applications in autoimmune and/or inflammatory diseases. On the basis of the company's proprietary technology for inducing a polyclonal immune response (covered by six patent families that run until at least 2023) Neovacs is focusing its development efforts on two active immunotherapies: TNF-Kinoid is being developed for the treatment of TNF-mediated autoimmune diseases such as rheumatoid arthritis and Crohn's disease, whereas IFN-Kinoid is being developed for the indication of lupus. Neovacs is also conducting preclinical works on IFN-Kinoid in certain chronic viral infections, VEGF-Kinoid in Age-related Macular Degeneration (AMD) and solid tumors, and IL-4-Kinoid for the treatment of allergies. The goal of the Kinoid approach is to enable patients to have access to safe treatments with efficacy that is sustained in these life-long diseases.
For more information on Neovacs, visit www.neovacs.fr
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