DGAP-News: Neovacs obtains FDA approval to extend its Phase IIb clinical trial in Lupus to United States


DGAP-News: Neovacs S.A. / Key word(s): Study
Neovacs obtains FDA approval to extend its Phase IIb clinical trial in Lupus
to United States

28.04.2016 / 17:40
The issuer is solely responsible for the content of this announcement.

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PRESS RELEASE

Neovacs obtains FDA approval to extend its Phase IIb clinical trial in
Lupus to United States

Paris and Boston, April 28th, 2016 - Neovacs (Alternext Paris: ALNEV) a
leader in active immunotherapy for the treatment of autoimmune diseases,
today announced that the Company has received the approval "Investigational
New Drug" (IND), from the Food and Drug Administration (FDA), to extend its
ongoing Phase IIb clinical trial of IFNα Kinoid for the treatment of Lupus
to the United States.

Miguel Sieler, CEO of Neovacs commented:  "This clearance by the FDA is a
real success for Neovacs and will allow us to extend our actual trial to
American investigators and patients. The FDA has given this approval within
the regulatory time frame which demonstrates the complete and convincing
character of our file. Important investigating centres notably in New York,
Oklahoma and Miami have been waiting for this authorisation to set up the
trial.  Therefore the recruitment of patients will start very soon."

This Phase IIb trial now FDA approved, is a worldwide multicentric study,
randomized versus placebo, initiated in October 2015 in Lupus. Its
objective is to evaluate the biological and clinical efficacy of the IFNα
Kinoid, the most advanced product of the Neovacs portfolio in patients with
a moderate to severe form of Lupus disease. This 18 months trial will now
enroll 178 patients in 19 countries throughout Europe, Asia, Latin America,
and now the United States.

This approval is an important step for Neovacs. Indeed the high prevalence
of Lupus disease in the United States as well as its ethnic diversity,
reinforce our clinical development strategy for this therapeutic vaccine.
Full Phase IIb results are expected in mid-2017. They will be presented to
the relevant health Authorities in Europe (EMA) and in the US (FDA) in
order to validate the start into Phase III trial of IFNα Kinoid in Lupus.

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. 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 - NewCap 
Valentine Brouchot / Pierre Laurent
+33 (0)1 44 71 94 94
neovacs@newcap.eu

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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28.04.2016 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements,
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Media archive at www.dgap-medientreff.de and www.dgap.de

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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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458725 28.04.2016