DGAP-News: Neovacs S.A. / Key word(s): Study
NEOVACS INITIATES CLINICAL PROGRAM IN DERMATOMYOSITIS
16.06.2015 / 08:00
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PRESS RELEASE
NEOVACS INITIATES CLINICAL PROGRAM IN DERMATOMYOSITIS
- Extension of IFNα-Kinoid program to include Dermatomyositis
- Formation of Clinical Advisory Board
- Anticipated trial launch early 2016
Paris and Boston, June 16, 2015 - NEOVACS (Alternext Paris: ALNEV), a
leader in active immunotherapies for the treatment of autoimmune diseases,
today announced the launch of its clinical development program in
Dermatomyositis (DM), an orphan skin and muscular condition with
significant unmet medical need.
Neovacs is extending its IFNα-Kinoid clinical program beyond lupus to
include adult and pediatric DM - an indication where a positive IFNα
signature plays a decisive role[1]. The decision follows a recommendation
earlier this year by the Company's Scientific Advisory Board to pursue
IFNα-Kinoid as a potential treatment for DM and extensive due diligence in
researching IFN-related diseases that could benefit from this treatment
modality. Neovacs plans to conduct a multicentric phase I/IIa trial of
IFNα-Kinoid in adult DM in 15 patients which is anticipated to launch in
early 2016 in France and other European countries.
"Dermatomyositis demonstrates a promising therapeutic candidate pipeline
expansion, given the demonstrated role of IFNα in this auto-immune disease.
As DM is an orphan condition, this is also an opportunity to bring needed
relief to thousands of patients, most of them children, for whom there is
currently no satisfactory biotherapy," commented Miguel Sieler, CEO of
Neovacs. "We believe that the IFNα-Kinoid in DM will be a development
driver for Neovacs, with a limited impact on expenditures. Neovacs will
apply for grants dedicated to rare diseases to support the funding of the
DM program."
DM is an inflammatory disease characterized by severe skin lesions and
muscle weakness with a variable impact on physical capacities. DM can also
affect the vascular, pulmonary, gastrointestinal and cardiac systems.
Approximately one third of DM patients will develop cancer within three
years[2]. DM affects primarily children, and mostly females. No biological
treatment has been registered to date in this indication.
With a prevalence between 1 in 50,000 and 1 in 10,000 cases[3], DM is
considered an orphan disease both in North America and in Europe. It is
estimated that there are currently approximately 87,000 patients[4] with DM
in the EU. Because of the recognized orphan status of DM, Neovacs estimates
that clinical development of IFNα-Kinoid in this indication could be
considerably shortened, with the potential to bring a treatment to patients
in a few years.
Formation of a Clinical Advisory Board
To sustain and support it in this endeavor, Neovacs has formed a cross
disciplinary Clinical Advisory Board (CAB) composed of leading experts in
DM:
- Prof. Olivier Benveniste, M.D., Ph.D.,
Hôpital Pitié-Salpêtrière, Paris
- Prof. Eric Hachulla, M.D., Ph.D.,
Centre Hospitalier Regional
Universitaire de Lille, France
- Dr. Jean-David Bouaziz, M.D.,Ph.D.,
Hôpital Saint-Louis, Paris
- Prof. Werner Stenzel, M.D. ,Ph.D.,
Charité Universitätmedizin, Berlin
- Prof. Ingrid Lundberg, M.D.,
Karolinska Universitetssjukhuset, Stockholm
These board members will be instrumental not only in bringing their
expertise to Neovacs in preparing for and defining the metholodology,
target population, and evaluation criteriafor the DM trial; but also in
assisting with trial development and patient recruitment.
The IFNα-Kinoid program in DM could be initiated as early as 2016.
[1] Baechler, ART 2011; Wong, Plos One 2012; Greenberg, Genes immun 2012;
Shiba, Rheumatol Int 2014
[2] http://www.orpha.net/consor/cgi-bin/OC_Exp.php?Expert=221
[3] Ibid
[4]Estimated population assessed taking into account a 1.7/10,000
prevalence in the European Union, and a total EU population of 511,100,000
(Eurostat 2014). Source: EMA/COMP/660609/2014, 12 January 2015
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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368519 16.06.2015
DGAP-News: NEOVACS INITIATES CLINICAL PROGRAM IN DERMATOMYOSITIS
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