Neovacs Announces Positive IDSMB Review for Phase IIb Clinical Trial of IFNalpha Kinoid in Lupus
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Neovacs Announces Positive IDSMB Review for Phase IIb Clinical Trial of
IFNalpha Kinoid in Lupus
Third positive data review by IDSMB follows completion of patient recruitment
Paris and Boston, July 11(th), 2017 - 7:30 am CET - 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 IFNalpha 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
IFNalpha 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
IFNalpha 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.
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.
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 (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: IFNalpha), promoting inflammation and dysregulation
of the immune system.
About Neovacs
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 IFNalpha 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 1 53 10 93 14
cmasson(at)neovacs.com
LIFESCI ADVISORS - Investor Relations / Financial Communications
Chris Maggos
+41 79 367 6254
chris(at)lifesciadvisors.com
NEWCAP- Press relations
Annie-Florence Loyer
+33 1 44 71 00 12 / + 33 6 88 20 35 59
afloyer(at)newcap.fr
Léa Jacquin
+33 1 44 71 20 41 / +33 6 58 14 84 66
ljacquin(at)newcap.fr
Pdf:
http://hugin.info/160718/R/2119389/807147.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: NEOVACS via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 11.07.2017 - 07:30 Uhr
Sprache: Deutsch
News-ID 551721
Anzahl Zeichen: 5957
contact information:
Town:
Paris
Kategorie:
Business News
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