|[April 17, 2014]
Neurovive Pharmaceutical: NeuroVive Presents Medical Breakthrough in Cellular Energy Regulation
STOCKHOLM --(Business Wire)--
NeuroVive (STO:NVP), a leading mitochondrial medicine company, is
presenting a breakthrough in the company's work on energy regulation at
the cellular level. Based on the UK company Selcia Ltd's medical
chemistry technology and NeuroVive's assays and knowledge of
mitochondrial dysfunction, the parties have produced an all-new class of
experimental drug which potentially could be used to treat genetic
diseases and acute medical conditions that affect energy production in
the mitochondria. This project has been designated NVP015 "the Amber
Project" in-house. An extensive patent application on these compounds
and their potential usage was published in the WIPO (World Intellectual
Property Organization) database on April 10. The underlying scientific
data for this breakthrough will be presented for the first time at an
international research symposium in Pittsburgh on June 4 - 7.
In simplified terms, the mitochondria can be considered as the energy
factory of cells. There is currently scientific data indicating that
many medical conditions, from chronic diseases to acute conditions
affecting the heart and brain, are linked to their function. Succinic
acid is a central component in energy production. This compound is
involved in many pathogenic changes to energy production, which means
that adding succinic acid can restore energy production. However,
succinic acid is normally unable to transit the cell wall independently.
NeuroVive's and Selcia's researchers have resolved this problem by
altering succinic acid in various ways, with the result that the
compound is able to transit the cell wall and then be freed up and
utilized in mitochondrial energy production.
Therapy areas and current development work The new drug candidates may
potentially be used to prevent or treat primary or secondary
mitochondrial conditions and restore normal function. This means that if
current development work is successful, they may be suitable to treat a
large number of rare genetic conditions, as well as more general
disorders where there is an increased need for energy. This dual
application extends the potential for this new class of pharmaceutical.
These new experimental drugs are currently undergoing formulation work.
Their efficacy and potential adverse events must be examined in animal
studies before they can be trialed on humans. The first major validation
study on animals will be conducted in 2014.
New medical analysis method for mitochondrial function in human cells
NeuroVive's research team has also developed a medical analysis method
for energy regulation in human cells that enables the study of molecules
and pharmaceuticals that can directly increase or decrease energy
production. This method, called ToxPhos®, has the potential for future
use to support the diagnosis of mitochondrial disease and medical
conditions. The method, although not used to produce the 'Amber'
compounds, was central in the screening process of the energy-regulating
experimental drugs and is the foundation for the development of several
preclinical models for mitochondrial conditions. The patent application
for this method was also published in the WIPO patent database on 10
"Research into mitochondrial medicine in recet years has demonstrated
that far more diseases and medical conditions may potentially be sourced
from mitochondrial defects than previously believed. That's why it was a
natural move for us to start developing pharmaceuticals that not only
protect the mitochondria in cell damage, but also offer the potential
for cells to produce normal amounts of energy in injury and disease.
These new experimental drugs that we're developing may potentially be
used as emergency treatment in cellular energy crisis in children with
congenital limitations to energy production and, potentially, for other
conditions where raised energy production counters the course of
diseases. We're really proud to be able to present the underlying
scientific discoveries at this symposium in June," commented Eskil
Elmér, NeuroVive's CSO.
"The new experimental drugs have the potential to address a market worth
billions of kronor and a substantial medical need in the treatment of
rare diseases that affect the mitochondria. This application has great
potential to secure orphan drug designation, which means a fairly speedy
process prior to market launch and a long period of market exclusivity.
These diseases usually affect children, which makes it extra urgent to
start designing a suitable formulation and begin preparation of
preclinical safety testing required before experimental drugs can be
administered to patients in clinical trials," continued Mikael
Brönnegård, NeuroVive's CEO.
Presentation at an international symposium in June These new
experimental drugs and the underlying scientific discoveries, including
the new medical analysis method ToxPhos®, will be presented by
NeuroVive's researchers at the United Mitochondrial Disease Foundation
Symposium in Pittsburgh on June 4-7. There's more information on the
conference at www.umdf.org.
About NeuroVive NeuroVive Pharmaceutical AB (publ), a leading
mitochondrial medicine company, is developing a portfolio of products to
treat acute cardiovascular and neurological conditions through
mitochondrial protection. These medical conditions are characterized by
a pressing medical need and have no approved pharmaceutical treatment
options at present. NeuroVive's products CicloMulsion® (heart attack)
and NeuroSTAT® (traumatic brain injury) are currently being evaluated in
phase III and phase II studies, respectively. NeuroVive's research
programs also include products for the treatment of anti-viral
indications (Hepatitis B/C), brain cell injury in stroke patients, and
drug candidates for cellular protection and treating
mitochondria-related energy regulation diseases. NeuroVive's shares are
listed on NASDAQ OMX, Stockholm, Sweden.
Current status of NeuroVive's products
CicloMulsion® NeuroVive's product CicloMulsion® is the first cyclophilin
inhibitor developed for treating reperfusion injury. The product's
potential for treatment of myocardial infarction is currently being
evaluated in a clinical phase III study. The final participant of a
total of 972 patients was enrolled on 16 February 2014. The results of
this study are scheduled for presentation in 2015 after a one-year
follow-up is completed on all patients and study data has been compiled.
NeuroSTAT® NeuroVive is developing NeuroSTAT® for treating patients with
severe traumatic brain injury (TBI). NeuroSTAT® is currently being
evaluated in a clinical phase IIa study at Rigshospitalet, Copenhagen.
The study is focusing on safety and pharmacokinetics, and 5 of a planned
20 patients have been enrolled. The design and planning work for a phase
III study has commenced. The company has obtained orphan drug
designation for NeuroSTAT® for moderate to severe cranial injury in the
US and EU. Orphan drug designation confers market exclusivity for 7
years in the US and 10 years in the EU from the date when the company
secures marketing authorization.
NVP018 The recently acquired cyclophilin inhibitors are part of a family
of molecules called Sangamides, and based on a new and unique chemical
platform of what are known as polyketides. NVP018 is NeuroVive's primary
drug candidate in the company's new portfolio of potent cyclophilin
inhibitors. It has undergone extensive preclinical development and has
been developed for treating hepatitis B/C. This product demonstrates
potent efficacy against virus replication and has a positive safety and
pharmacokinetic profile. Cyclophilin inhibitors have the potential for
broad-based application, and NeuroVive is also currently evaluating
NVP018's potential against other viral indications.
More information on all products developed by NeuroVive is available at www.neurovive.se/index.php/en/research-development/our-products
NeuroVive Pharmaceutical AB (publ)
Medicon Village, SE-223 81 Lund, Sweden
Tel: +46 (0)46 275 62 20 (switchboard), Fax: + 46 (0)46 888 83 48, firstname.lastname@example.org,
NeuroVive Pharmaceutical AB (publ) is required to publish the
information in this news release under The Swedish Securities Market
Act. The information was submitted for publication on 17 April 2014, at
8:45 a.m. CET.
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