Phase IIa study results in Rheumatoid Arthritis Patients selected for oral presentation at the 25th Annual Meeting of the French Society of Rheumatology

NEOVACS : Phase IIa study results in Rheumatoid Arthritis Patients selected for oral presentation at the 25th Annual Meeting of the French Society of Rheumatology

10/12/2012| 02:50am US/Eastern

October 12 is World Arthritis Day


Regulatory News:

Neovacs (Alternext Paris: ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, is proud to announce its participation to the 25th Annual Meeting of the French Society of Rheumatology (FSR) that will take place in Paris December 9-12, 2012.

« We are honored that the TNF-Kinoid study in RA has been selected by the scientific committee of the French Society of Rheumatology for an oral presentation during the annual meeting" said Professor Marie-Christophe Boissier, head of Rhumatology at the Avicenne University Hospital in Bobigny (Paris area) and study coordinator for France. "Neovacs' therapeutic approach is not only innovative but it also represents a potential medical breakthrough for thousands of patients"

In a special session dedicated to Rheumatoid Arthritis at the FSR Annual Meeting, Neovacs will present the results and excellent safety profile of its active immunotherapy in RA patients resistant to anti-TNF biologics, including anti-TNF monoclonal antibodies. Follow-up data of patients at week 12 will notably be presented for the first time.

« Today is World Arthritis Day, a great occasion to raise awareness about Rheumatoid Arthritis, a serious and invalidating disease with major unmet medical needs. We are especially proud to announce today that the results of our TNF-Kinoid Phase II study in Rheumatoid Arthritis (RA) have been selected for an oral presentation at the largest gathering of French Rheumatology experts, evidencing the quality of the published results as well as their scientific interest for physicians and patients" said Guy-Charles Fanneau de La Horie, Neovacs Chief Executive.

In January 2012, Neovacs announced the full results for its TNF-K-003 clinical trial with TNF-Kinoid in rheumatoid arthritis (RA), a double-blind, placebo-controlled, randomized clinical trial in patients having received at least one anti-TNF treatment prior to inclusion. The trial met its objectives to establish the best dose and the best administration schedule, based on immune response to the Kinoid.

The study also demonstrated an improvement in the RA symptoms in patients who had developed anti-TNF antibodies. Study results further confirmed the very good safety profile of the TNF-Kinoid: no patient withdrew from the study because of an adverse event and no Kinoid-related serious adverse events were reported.

A second phase II study involving TNF-Kinoid is currently ongoing in patients with moderate to severe Crohn's Disease. Top-line results were released in June and full results are expected during Q4, 2012.

Rheumatoid arthritis

Rheumatoid arthritis (RA) is a major public health issue; it is the most frequent, serious chronic inflammatory rheumatic disease and affects between 0.3% and 1% of the worldwide population: over 3 million people in the world's 7 largest pharmaceutical markets (source: Datamonitor, 2011). In recent years, population ageing has increased the number of RA sufferers. The disease attacks all the joints in the body (e.g. the feet, hands, knees, ankles, wrists, shoulders, hips and elbows) and is characterized by a combination of joint pain, morning stiffness and a type of joint swelling known as synovitis. Today's monoclonal antibody treatments are based on passive immunotherapy and frequently lose their efficacy over time. Consequently there remains a major need for therapies with sustained efficacy.

About Neovacs

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 five 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. 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




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