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Neovacs SA Phase I/II Results in Lupus Patients Selected for an Oral Presentation at the ACR/ARHP Annual Scientific Meeting, November 8th, 2011 in Chicago  
8/25/2011 12:13:14 PM

Paris, August 25, 2011 - Neovacs? (Alternext Paris: ALNEV), a biotech company focused on an active immunotherapy technology platform (Kinoids) with applications in the treatment of autoimmune and inflammatory diseases and cancer, today announced that its phase I/II results with IFNa-Kinoid in lupus patients will be the subject of an oral presentation at the American College of Rheumatology and Association of Rheumatology Health Professionals Meeting. The ACR/ARHP Meeting is the world largest gathering of physicians and researchers in the field of rheumatologic diseases. This year it will be held in Chicago, November 4th to November 9th 2011.

The ACR/ARHP Planning Subcommittee selected for oral presentation the published abstract entitled “Active immunization against Interferon alpha with IFNa-Kinoid in SLE1 patients is safe, immunogenic and induces down regulation of IFN-mediated genes”. The presentation is scheduled for November 8th in the category: Systemic Lupus Erythematosus - Clinical Aspects: New Therapies. Only abstracts which provide clinical, evidence-based and quality focused content are selected by the Scientific Committee for oral presentation.

“The Subcommittee decision to grant us an oral presentation is a very good news, evidencing the quality of the published results with IFNa-Kinoid as well as their scientific interest for physicians and for lupus patients”, said Guy- Charles Fanneau de La Horie, Neovacs Chief Executive. He added: “The oral presentation of the phase I/II results will focus on the good safety profile of IFNa-Kinoid as well as its activity in inducing an immune response. There will also be a more specific emphasis on the role of IFNa-Kinoid in the down-regulation of a number of overexpressed genes associated with excess interferon a and with lupus disease.”

By way of reminder, the IFN-K-001 Phase I/II study conducted with IFNa-Kinoid is a double-blind, placebo-controlled, dose-escalation design testing four different IFNa-Kinoid dose levels (30,60,120 and 240 mcg). The 28 patients recruited have mild to moderate lupus, defined as a SLEDAI2 score of between 4 and 10. The product was administered at day 0, 7, 28 with a fourth injection at day 84 for half the patients. The preliminary published data have evidenced the safety and tolerance of the IFNa-Kinoid, as well as its capacity, in 100% of patients receiving IFNa-Kinoid, to induce an antibody response to IFNa. Very importantly, it has also been observed to produce a significant reduction in the activity of overexpressed genes that are associated with excess interferon a and with Lupus disease; this is an additional evidence of the IFNa-Kinoid activity.

1 Systemic Lupus Erythematosus

2 Systemic Lupus Erythematosus Disease Activity Index

About lupus

Systemic Lupus Erythematosus (SLE) is an autoimmune disease in which the immune system produces antibodies to cells within the body leading to widespread inflammation and tissue damage. Prevalence estimates vary widely, and range as high as 1.5 million in North America (the Lupus Foundation of America) and 5 million worldwide. The Center for Disease Control estimates a prevalence between 322,000 and one million with definite or probable SLE in the US. Lupus disease may first occur at any age, though peak diagnosis is between the ages of 15 and 40. It is far more common in women than men. People with SLE may experience fatigue, pain or swelling in joints, skin rashes, and fevers. It can also affect the lungs, kidneys, and blood vessels. It remains an area of significant unmet medical need. Scientists have highlighted the overproduction of the interferon alpha cytokine as a key factor in the causation and development of the disease. The market for lupus treatments is estimated by analysts to be several billion US$.

About Neovacs

Neovacs? is a biotechnology company focused on an active immunotherapy technology platform (Kinoids™) with applications in autoimmune diseases and other chronic conditions. Neovacs? proprietary technology, protected by five patent families, aims to induce a polyclonal immune response from the patient’s own immune system targeting an over-expressed cytokine. Neovacs?' current portfolio consists of 2 drug candidates which are tested in clinical studies: TNF-Kinoid and IFNa-Kinoid. The company’s lead immunotherapy program (TNF-Kinoid) targets TNF-mediated chronic inflammatory diseases. For TNF-Kinoid, a Phase I/II clinical trial in Crohn’s disease has been completed and Phase II trials in rheumatoid arthritis (RA) and Crohn’s Disease are ongoing. The RA clinical study is also the focus of collaboration with the French diagnostics company BMD, with the goal of developing theranostic tools for personalized care in RA. IFN-Kinoid is developed in the treatment of lupus.

For more information, visit the Neovacs? website at www.neovacs.com


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