DGAP-News: Neovacs S.A. / Key word(s): Study
NEOVACS RECEIVES FIRST REGULATORY APPROVALS FOR A PHASE IIb TRIAL OF
IFNα-KINOID IN LUPUS
01.09.2015 / 08:00
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PRESS RELEASE
NEOVACS RECEIVES FIRST REGULATORY APPROVALS FOR A PHASE IIb TRIAL OF
IFNα-KINOID IN LUPUS
IFN-K-002 clinical trial to launch in coming weeks
Paris and Boston, September 1, 2015 - NEOVACS (Alternext Paris: ALNEV), a
leader in active immunotherapies for the treatment of autoimmune diseases,
today announced that it has been granted first approvals by regulatory
agencies and ethics commitees in several European countries for a Phase IIb
clinical trial of IFNα-Kinoid in Systemic Lupus Erythematosus (SLE) or
lupus.
The upcoming trial was notably assessed favorably using the Voluntary
Harmonization Procedure (VHP) of Europe's Heads of Medicine Agencies, which
allows for a harmonized assessement of clinical trials by relevant national
health authorities.
Acceptance by competent authorities enables Neovacs to initiate IFN-K-002,
a Phase IIb clinical study to assess the biological and clinical efficacy
of Neovacs' lead active immunotherapy product candidate IFNα-Kinoid in
patients suffering from lupus. Inclusion of first patients is expected to
begin in the coming weeks. Approvals from other European, Asian and Latin
American countries are expected in the second half of 2015.
Phase IIB trial design for IFN-K-002 in SLE
IFN-K-002 is a double-blind, randomized, placebo-controlled multicentric
Phase IIb clinical trial designed to assess the efficacy and safety of
IFNα-Kinoid in moderate to severe lupus patients. The study will recruit
166 patients across 19 countries in Europe, Asia and Latin America.
The co-primary endpoints for the trial are biogical efficacy and clinical
efficacy nine months after first immunization with IFNα-Kinoid. Biological
efficacy is defined as IFNα-signature neutralization, while clinical
efficacy will be measured by the BILAG-based* Composite Lupus Assessment
(BICLA) response.
Timelines for the study
Regulatory and ethics committee approvals pave the way for a rapid
initiation of the study IFN-K-002. These centers will begin screening and
immunizing patients in the coming weeks. Results of the clinical trial are
expected in the first quarter of 2017.
*The British Isles Lupus Assessment Group (BILAG) is a validated index to
measure lupus disease activity listed in FDA guidance on lupus. See FDA
Systemic Lupus Erythematosus working group report at:
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidan
ces/UCM072063.pdf#sthash.qR2f2REj.dpuf
About Neovacs
Created in 1993, 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 and dermatomyositis. 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.
For more information on Neovacs, please visit www.neovacs.fr
Contacts
NEOVACS - Investor Relations
Nathalie Trépo
+33 (0)1 53 10 93 00
ntrepo@neovacs.com
Investor Relations / Financial Communications - NewCap
Valentine Brouchot / Pierre Laurent
+33 (0)1 44 71 94 94
neovacs@newcap.fr
Investor Relations / Financial Communications Germany - MC Services
Raimund Gabriel
+49-89-210228-30
raimund.gabriel@mc-services.eu
Press / U.S. Inquiries - The Ruth Group
Melanie Sollid-Penton
1.646.536.7023
msollid@theruthgroup.com
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Language: English
Company: Neovacs S.A.
3-5, Impasse Reille
75014 Paris
France
Phone: +33 (0)1 53 10 93 00
Fax: +33 (0)1 53 10 93 03
E-mail: www.neovacs.fr
Internet: info@neovacs.fr
ISIN: FR0004032746
WKN: A1CVKR
Listed: Regulated Unofficial Market in Stuttgart; Open Market in
Frankfurt
End of News DGAP News-Service
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DGAP-News: NEOVACS RECEIVES FIRST REGULATORY APPROVALS FOR A PHASE IIb TRIAL OF IFNα-KINOID IN LUPUS
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