Esperite (ESP) leads international consortium for clinical translation of extracellular vesicles use in various therapies
(Thomson Reuters ONE) -
Esperite (ESP) leads international consortium for clinical translation of
extracellular vesicles use in various therapies
Extracellular vesicles (EVs) disruptive technology targets unmet needs in
neuroinflammatory diseases at lower costs than allogenic stem cell therapies.
Esperite's business unit The Cell Factory develops EVs-based therapeutics in
treatment of drug-resistant epilepsy in children jointly with Bambino Gesù
Children's Hospital, Mario Negri Institute for Pharmacological Research and the
Women's and Children's Health Department of the University of Padua.
Zutphen, The Netherlands - 30 September 2016
Esperite N.V. (Euronext: ESP, "Esperite") sponsors an international consortium
of the leading teams in paediatric regenerative medicine to bring extracellular
vesicles (EVs) technology to the clinic with niche applications in treatment of
severe neuro-inflammatory diseases. Its first project focuses on EVs application
in untreatable-yet acute and chronic drug-resistant epilepsy in children. The
consortium will also investigate EVs and exosomes characteristics, potency, and
a mode of action and will further improve the EVs production processes.
Led by Professor Federico Vigevano at Bambino Gesù Children's Hospital with Dr
Alessandra Fierabracci providing her expertise in Immunology and Dr. Annamaria
Vezzani at Mario Negri Institute, pre-clinical tests of mesenchymal stem cells
(MSC)-derived EVs are underway to confirm the safety and efficacy already
demonstrated in multiple in vitro and in vivo models. This project will enable
the first-in-man use of MSC-derived EVs and exosomes in treatment of drug-
resistant epilepsy in children. The project follows a long-term collaboration
between the Children's Hospital and the Esperite group initiated and liaised by
Professor Stefano Grossi, Esperite's Scientific Director in Italy.
In parallel, Esperite's regenerative medicine division, The Cell Factory, in
partnership with Professor Maurizio Muraca's team at University of Padua, are
better characterising EVs to establish clinical grade standards for production,
purification, quantification, bio-distribution and molecular characterisation of
new EV-based therapeutics.
Professor Muraca has also agreed to join the Scientific Board of The Cell
Factory to support EVs products development and clinical translation. Professor
Muraca has extensive and long-term experience in immunology, EVs and MSCs
research, and the expertise in regulations of advanced therapies use in clinic.
The Cell Factory produces ultra-pure EVs and exosomes according to GLP/GMP
guidelines, using proprietary technology for expansion of MSC in fully defined
media with no use of animal-derived components at any stage. Stem cells
expansion is performed in the most efficient and scalable 3D culture systems
using microcarrier beads. The Cell Factory's proprietary closed cell culture
system produces high purity EVs and exosomes using pharmaceutical-quality
sequential filtration system for EVs extraction and purification. The system can
be easily scaled up improving significantly EVs production costs, footprint and
process scalability. EVs products can be manufactured with this technology at
least 10x more efficiently and cheaper when comparing to MSC equivalent.
The consortium will investigate the anti-inflammatory and anti-epileptic effect
of the "off-the-shelf" EVs derived from non-HLA-matched MSC lines. The
advantages of using EVs in treatment of acute and chronic epilepsy are product
stability and low production costs providing the "off-the-shelf" drug for
immediate and repeated non-invasive application. In a broader perspective, the
positive results of using immunosuppressive EVs in a central nervous system
would open up a possibility of immediate intervention in acute diseases in
neurology such as stroke, traumatic brain, spinal cord injury, newborn hypoxic
ischemia and many others.
Diseases of central nervous system are among most devastating for patients and
their relatives. Neurological disorders are generating a significant additional
cost related to hospitalisation, rehabilitation, often eliminate the patients
and their relatives from a job market. CDC estimated that annual costs related
to epilepsy exceeds 15 billion USD in the United States alone with 50 million
patients worldwide (WHO). Cost related to brain stroke in the United States is
estimated to 34 billion USD per year (CDC), with 15 million new patients
worldwide each year (WHO). Cumulative cost related to traumatic brain injury
(TBI) and spinal cost injury in the United States is over 80 billion USD per
year (CDC and AANS), with up to 0.5 million new incidents of spinal cord injury
and 10 million of TBI per year (WHO). Most of these diseases have no effective
therapy yet. It is expected that EVs products will be effective in the niche
indications of above-mentioned conditions preventing neuroinflammatory-related
damage of central nervous system. Moreover, EVs will be able to target an acute
diseases i.e. TBI, brain stroke, spinal cord injury, more effectively when
comparing to allogenic MSCs, due to the EV's stability and easier administration
at shorter time what is critical for successful therapy. The latter would
additionally expand a potential market of EVs products beyond the competitive
allogenic MSCs products.
Epilepsy is one of the most common brain diseases affecting about 1 in 100
children under 17-year old according to CDC. Epilepsy carries significant
detrimental effects on the quality of life and can lead to a secondary brain
damage. The disease can have different aetiology, including stroke, brain
trauma, and neuro-inflammation. Severity of the seizures is variable and the
antiepileptic drugs are effective only in about 2/3 of the patients.
About the consortium partners:
Ospedale Pediatrico Bambino Gesú OPBG (Rome, Italy) is the largest paediatric
Hospital and research center in Europe, providing over 1.550.000 healthcare
services each year to children and adolescents from all over the world. OPBG
pursues excellency in health care through advanced research and clinical
activities, while improving processes to exploit the progress of biomedical
science. The Hospital's clinical activities run side by side with its scientific
research, aiming at constantly improving and innovating diagnostic and
therapeutic procedures. OPBG's Research Laboratories are located in a 5,000 sqm
research facility, fully equipped with high-tech systems, supporting genomics,
metagenomics, metabolomics, proteomics, microarray technology, cytogenetic and
FISH applications, cytofluorimetry and cell sorting, cell and molecular biology.
Within the Research Laboratories the team led by the Immunologist Dr Alessandra
Fierabracci has established potency assays for evaluating the immunomodulatory
activity of MSC-derived exosomes in vitro.
The IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri" (www.marionegri.it)
in Milan, Italy is a non-profit biomedical research institute. The Institute's
constant research areas include cardiovascular, psychiatric and neurological
diseases, and tumours. Over the years, in line with technical advances, research
has spread into the fields of environment and health, kidney diseases, organ
transplantation, and rare diseases,
The Institute works regularly with various associations, hospital groups with
different specialties, general practitioners, and nurses, setting up nation-wide
cooperation networks. Underlying all this is basic research in pharmacokinetics,
pharmacology, immunology, cell biology, genomics, proteomics, and metabolomics;
it organizes controlled randomized clinical trials, studies on cohorts of
elderly people, systemic reviews and meta-analyses.
Dr Annamaria Vezzani is Head of the Laboratory Experimental Neurology, Dept of
Neuroscience, and she will be contributing to the project by sharing her long
standing expertise with animal models of epilepsy and neuroinflammation to test
the therapeutic anticonvulsive potential of extracellular vesicles and provide
proof-of-concept evidence for clinical applications.
The department of Woman's and Child's Heath of the University of Padua is a 269-
bed tertiary paediatric academic care centre, serving the entire North East
region of Italy, devoted to provide excellence in patient's care, teaching and
research, also including a ten-store research building. It is one of the eleven
fully recognised Italian Children's Hospitals.
The University of Padova was founded in 1222. It includes 32 Departments, 1
University Hospital, 1 Veterinary Hospital, 1 Experimental Farm, 1 School of
Excellence. It counts 61,000 Students and 12,000 Graduates per year.
ESPERITE Group, listed at Euronext Amsterdam and Paris, is a leading
international company in regenerative and predictive medicine established in
2000.
The Cell Factory is a biotech platform-based business unit of ESPERITE Group.
The Cell Factory led by Dr. Marcin Jurga develops highest quality therapeutic
tools for affordable regenerative medicine.
To learn more about ESPERITE Group, or to book an interview with CEO Frederic
Amar: +31 575 548 998 - ir(at)esperite.com or visit the websites at
www.esperite.com and www.genoma.com.
Press Release Consortium:
http://hugin.info/143308/R/2045670/764265.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: Esperite N.V. via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 30.09.2016 - 07:17 Uhr
Sprache: Deutsch
News-ID 498023
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