Neovacs enrolls the first U.S. Patient in Phase IIb study of IFNa Kinoid for treatment of Systemic Lupus Erythematosus (SLE)
November 07 2016 - 2:15AM
Neovacs (Alternext Paris:ALNEV) (PEA-eligible
SMEs), a leader in active immunotherapy for the treatment of
autoimmune diseases, today announced the enrolment of the first
U.S. patient in its international phase IIb clinical study of IFNα
Kinoid in lupus.
A first clinical center has started to enrol patients in this
study, initially planned to include 5 investigation centers.
The study has attracted interest from a large number of American
sites and autoimmune disease specialists. Due to this high demand,
Neovacs will open additional centers, increasing the total number
of trial sites to 15.
This Phase IIb trial is part of a randomized, multicentric,
international clinical study, initiated in September 2015. The
ongoing study is evaluating IFNα Kinoid versus placebo in the
treatment of systemic lupus erythematosus (SLE). Its objective is
to assess the biological and clinical efficacy of IFNα Kinoid, the
most advanced product in Neovacs’ pipeline, in patients who have
moderate to severe SLE. The trial is planned to include 178
patients in 21 countries in Latin America, Asia, Europe and
USA.
Miguel Sieler, CEO of Neovacs declared: “The enthusiasm among
U.S. 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.”
About Lupus
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.
In 2014, there were 37,369 patients in France, of which 88% are
women. The prevalence is 47 cases per 100,000 people, while the
overall annual incidence reached 3.32 cases per 100,000 people,
peaking in the female population aged 30 to 39 years (9.11 cases
per 100 000 people).
About Neovacs Technology
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 (Type 1
diabetes, systemic lupus erythematosus, psoriasis, etc.) are
characterized by a disorder of cytokines that are found
produced in excess (ex: IFNa). This overproduction will promote
inflammation and dysregulation of the immune system.
About Neovacs
Listed on Alternext Paris 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 auto-immune
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
Contacts
NEOVACS – Corporate Communication & Investor Relations
Charlène Masson
+33 (0)1 53 10 93 14
cmasson@neovacs.com
Investor Relations / Financial Communications Germany – MC Services
Raimund Gabriel
+49-89-21-02-28-30
raimund.gabriel@mc-services.eu
Press / U.S. Inquiries – The Ruth Group
Lee Roth / Joseph Green
+1-646-536-7012 / 7013
lroth@theruthgroup.com / jgreen@theruthgroup.com
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