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November 6, 2016

Neovacs begins enrolment for Phase IIb study of IFNalpha Kinoid to treat systemic lupus erythematosus

Neovacs has begun enrolment for its international Phase IIb clinical study of IFNalpha Kinoid to treat systemic lupus erythematosus (SLE).

Neovacs has begun enrolment for its international Phase IIb clinical study of IFNalpha Kinoid to treat systemic lupus erythematosus (SLE).

SLE, or lupus erythematosus, is a debilitating, chronic autoimmune disease that causes self-antigens loss of tolerance, with the production of autoantibodies such as anti-nuclear antibodies that attack healthy tissues and cause inflammatory reactions in different parts of the body such as skin, kidneys, joints, heart, lungs and central nervous system.

A first clinical centre has begun to enrol patients in the study, which initially planned to include five investigation centres.

The trial has attracted interest from a large number of American sites and auto-immune disease specialists. Due to the demand, Neovacs plans to open additional centres, increasing the total number of trial sites to 15.

"Our lead drug candidate represents a potentially very interesting option for the treatment of lupus, an area where current therapeutic standards have failed to prove long-term efficacy."

This Phase IIb trial is part of a randomised, multicentric, international clinical study that began in September 2015.

The ongoing study is analysing IFNalpha Kinoid versus placebo in the treatment of systemic lupus erythematosus (SLE).

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Its aim is to evaluate assess the biological and clinical efficacy of IFNalpha Kinoid, a product in Neovacs' pipeline, in patients who have moderate-to-severe SLE.

The trial plans to include 178 patients in 21 countries in Latin America, Asia, Europe and the US.

Neovacs CEO Miguel Sieler said: "The enthusiasm among US investigators confirms the strong therapeutic interest in our product for the treatment of autoimmune diseases. 

"Our lead drug candidate represents a potentially very interesting option for the treatment of lupus, an area where current therapeutic standards have failed to prove long-term efficacy. 

"This is an area with a significant unmet medical need, and we look forward to continuing the study with the goal or providing a new therapeutic option for patients in need."

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