NEOVACS ANNOUNCES THE COMPLETION OF PATIENT ENROLLMENT IN PHASE IIB CLINICAL STUDY OF IFNalpha KINOID IN LUPUS
(Thomson Reuters ONE) -
NEOVACS ANNOUNCES THE COMPLETION OF PATIENT ENROLLMENT IN PHASE IIB CLINICAL
STUDY OF IFNalpha KINOID IN LUPUS
Company Expects the Availability of Results from the Study in Q2 2018
Paris and Boston, June 20, 2017 - 7:00 AM CET - Neovacs (Alternext Paris:
ALNEV), a leader in active immunotherapies for the treatment of autoimmune
diseases, today announced
the completion of patient enrollment for its phase IIb clinical study, IFN-K-
002, evaluating IFNalpha Kinoid for the treatment of lupus.
"The completion of enrollment is an important milestone for our IFN Kinoid
program and confirms the interest of leading clinicians conducting our trial in
this novel therapeutic approach" said Therese Croughs, Chief Medical Officer of
Neovacs. "We are looking forward to the results from the study in Q2-2018".
Study IFN-K-002 includes 178 patients who have moderate to severe systemic lupus
erythematosus (SLE). This worldwide, randomized, multicentre international phase
IIb study is evaluating IFNalpha Kinoid versus placebo and is being conducted
under IND[1] in Europe, Asia, North Africa, South America, and the United
States. All the patients are being treated and followed up for 9 months for the
main study.
Neovacs designed this Phase IIb clinical trial to obtain relevant and meaningful
data on:
* Biological efficacy: by measuring the decrease of interferon gene signature,
one of the primary markers of disease activity.
* Clinical efficacy: by using the BICLA[2] response score at Month 9. This
score is one of the end-points validated by health authorities to evaluate
the clinical response in lupus clinical studies.
The company has chosen a successful strategy which promotes the recruitment of
eligible patients in this phase IIb clinical trial in lupus, a rare and complex
disease, with a number of patients worldwide estimated to 5 million[3].
In order to ensure the validity of the clinical results of this study, Neovacs
is taking advice from three expert committees: 1) the independent Data Safety
Monitoring Board "iDSMB", whose mission is related to assessing safety, 2) an
independent "Adjudication Committee" to evaluate the consistency of the clinical
response data to the vaccine-(BICLA), and 3) an internal "Steering Committee" to
oversee the conduct of the clinical trial.
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 targeted cytokine to a carrier protein. The intramuscular injection of this
Kinoid induces an immune response and stimulates the production of polyclonal
antibodies against the targeted cytokines. It is thus possible to block cytokine
overproduction and its pharmacological effects. Several autoimmune and
inflammatory diseases (lupus, dermatomyositis, Type 1 diabetes ...) are
characterized by a disorder of cytokines that are found produced in excess. As
an example, the overproduction of IFNalpha will promote inflammation and
dysregulation of the immune system.
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 as the
disease progresses. Systemic lupus erythematosus affects mostly women.
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 IFNalpha-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, allergies and Type 1 diabetes. 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(at)neovacs.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
LIFESCI ADVISORS- Investor Relations / Financial Communications
Chris Maggos
+41 79 367 6254
chris(at)lifesciadvisors.com
--------------------------------------------------------------------------------
[1] Neovacs obtains FDA approval to extend its Phase IIb clinical trial in Lupus
to United States
http://neovacs.fr/wp-content/uploads/pr-29-04-16.pdf
[2] The BILAG-Based Composite Lupus Assessment- BICLA score : Wallace D. Ann
Rheum Dis 2014;73:183-190
[3] The lupus foundation of America : http://www.lupus.org/
Pdf:
http://hugin.info/160718/R/2114221/804355.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: 20.06.2017 - 07:00 Uhr
Sprache: Deutsch
News-ID 548711
Anzahl Zeichen: 6999
contact information:
Town:
Paris
Kategorie:
Business News
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