Legal Proceedings Report • Jul 11, 2017
Legal Proceedings Report
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Third positive data review by IDSMB follows completion of patient recruitment
Paris and Boston, July 11th , 2017 - Neovacs (Euronext Growth: ALNEV), a leader in active immunotherapy for the treatment of autoimmune diseases, today announces that it received a positive data review by the Independent Data and Safety Monitoring Board (IDSMB) for the ongoing Phase IIb Clinical Trial of IFNα Kinoid in lupus.
This is the third IDSMB data review of the ongoing Phase IIb clinical trial. The board reviewed the cumulative data, notably safety data from the study and informed the company that it has identified no safety concerns, and recommended the continuation of the study without any modifications. The trial is now fully enrolled with 178 patients randomized to receive either injection IFNα Kinoid vaccine or placebo.
Dr. Thérèse Croughs, Chief Medical Officer of Neovacs, commented: "We are pleased with this favorable IDSMB decision which comes following completion of patient enrollment. All patients are now followed during 9 months, and our goal is to report data in Q2 2018."
As a reminder, this phase IIb trial is a randomized, placebo-controlled, multicenter study in systemic lupus erythematosus (LES) (study IFN-K-002). The objective of this study is to evaluate the biological and clinical efficacy of IFNα Kinoid, the most advanced product in the Neovacs product portfolio, in patients with moderate to severe Lupus. The trial is currently taking place in 21 countries across Latin America, Asia, Europe, North Africa and the United States.
Systemic lupus erythematosus (SLE) or lupus erythematosus is a debilitating, chronic autoimmune disease whose etiology remains unknown. SLE is characterized by a loss of tolerance of self-antigens, with the production of autoantibodies, especially antinuclear antibodies that attack healthy tissues and cause inflammatory reactions in different parts of the body. The disease can affect multiple organs (skin, kidneys, joints, heart, lungs, central nervous system, etc.) and is characterized by heterogeneous clinical signs (skin rashes, arthritis, photosensitivity, nephritis, neurological disorders, anemia, thrombocytopenia, etc.), which vary from one person to another and change during the progression of the disease. Systemic lupus erythematosus affects mostly women.
Neovacs targets pathologies associated with an overproduction of endogenous cytokines. This technology is based on active immunotherapy to generate an immune response through the administration of an immunogenic complex involving the target cytokine to a carrier protein. The intramuscular injection of this Kinoid induces an immune response and stimulates the production of polyclonal antibodies against the target cytokines. It is thus possible to block cytokine overproduction and its pharmacological effects. Several autoimmune and inflammatory diseases (e.g. systemic lupus erythematosus, dermatomyositis, Type 1 diabetes etc.) are characterized by a disorder of cytokines that are found to be produced in excess (ex: IFNα), promoting inflammation and dysregulation of the immune system.
Listed on Euronext Growth since 2010, Neovacs is today a leading 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 potentially run until 2032) Neovacs is focusing its clinical development efforts on IFNα-Kinoid, an immunotherapy being developed for the indication of lupus, dermatomyositis and also in preclinical trial for Type 1 diabetes. Neovacs is also conducting preclinical development works on other therapeutic vaccines in the fields of autoimmune diseases, oncology and 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. www.neovacs.fr
NEOVACS – Corporate Communication & Investor Relations Charlène Masson +33 1 53 10 93 14 [email protected]
LIFESCI ADVISORS – Investor Relations / Financial Communications Chris Maggos +41 79 367 6254 [email protected]
NEWCAP- Press relations Annie-Florence Loyer +33 1 44 71 00 12 / + 33 6 88 20 35 59 [email protected]
Léa Jacquin +33 1 44 71 20 41 / +33 6 58 14 84 66 [email protected]
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