[March 28, 2014] |
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Neurovive Pharmaceutical: NeuroVive presents significant hepatitis B data for its drug candidate NVP018
STOCKHOLM --(Business Wire)--
Regulatory News:
NeuroVive Pharmaceutical (STO:NVP):
NeuroVive's anti-viral preclinical program, with compound designated
NVP018, has generated significant data indicating that NVP018 has the
potential to become an effective alternative or addition to current
drugs for treating chronic hepatitis B infections. This new data will be
presented at the EASL (European Association for the Study of the Liver)
congress in London, in April 2014 (www.ilc-congress.eu).
The results indicate that NVP018 has a dual effect against the hepatitis
B virus. Firstly, the data generated suggests that NVP018 directly
inhibits several stages in viral propagation in liver cells, and
secondly, NVP018 also operates indirectly by strengthening the immune
response. The data also indicates that the risk of developing
resistance, a significant clinical problem with current therapy
alternatives for hepatitis B, is very low with NVP018. Finally, NVP018
also demonstrates activity in an animal model of chronic hepatitis B
infection.
According to the WHO, over 2 billion people have been in contact with
the hepatitis B virus and 240 million people have developed chronic
hepatitis B. This means that the disease is one of the largest global
medical challenges. The chronic disease is estimated to cause more than
600,000 deaths yearly through advanced cirrhosis of the liver or primary
liver cancer. The disease is worldwide, but most common in Southeast
Asia, Eastern Europe and Africa, with over 8% chronic carriers. In
Western Europe and the US, the frequency is less than 1%. Currently
available pharmaceuticals display limited effectiveness and there is a
significant risk of the virus developing resistance, so accordingly,
there is a substantial need for new pharmaceuticals.
NVP018 is an oral preparation of NeuroVive's leading drug candidate in
the company's new portfolio of cyclophilin inhibitors. The preclinical
development program has demonstrated that NVP018 has unique
characteristics that make it a promising anti-viral drug candidate and
the new research results underscore NVP018's clinical potential for
treating chronic hepatitis B infection.
"The results of the preclinical tests of NVP018, conducted by bodies
including the prestigious Scripps Research Institute are very promising,
with convincing data that cyclophili inhibitors have a positive effect
to hepatitis B virus infection. NVP018 is currently in a preclinical
program, to be administered on patients at a later stage in clinical
trials," commented Jan Nilsson, COO of NeuroVive.
Current status of NeuroVive products:
http://news.cision.com/neurovive-pharmaceutical/i/project-eng,c1460379
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, the Copenhagen teaching
hospital. 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 traumatic brain
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 the 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 currently evaluating NVP018's
potential for other viral indications.
Other products
More information on all products developed by NeuroVive is available at www.neurovive.se/index.php/en/research-development/our-products
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.
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, info@neurovive.se,
www.neurovive.se
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 28 March 2014, at
8:30 a.m. CET.
This information was brought to you by Cision http://news.cision.com

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