NeuroVive Pharmaceutical AB (publ), the mitochondrial medicine company, announces that it has entered into a research partnership with University of Pennsylvania to enhance NeuroVive's traumatic brain injury (TBI) research and development program.
The research partnership will focus on an important unsolved problem in the medical field: nerve cell protection following moderate to severe brain trauma. The agreement between University of Pennsylvania and NeuroVive represents the expanding footprint beyond Europe into the US and will further advance the company's understanding of and presence in the US market.
The research collaboration is to provide more data on NeuroVive's drug for the treatment of TBI, NeuroSTAT®, and will provide the company with additional preclinical data to support the regulatory filings for the TBI indication. NeuroVive will, via this partnership, get access to highly experienced scientists at University of Pennsylvania and the Children's Hospital of Philadelphia whom have world-renown expertise in the area of TBI research.
"The collaboration with Drs. Susan Margulies and Todd Kilbaugh at the University of Pennsylvania and the Children's Hospital of Philadelphia is a very positive step for NeuroVive. The company is progressing its TBI research program through the CHIC trial and these next steps together with UPENN will provide us with supporting evidence which will complement the ongoing CHIC trial evaluating the safety of NeuroSTAT® in TBI. We hope to initiate the first studies during the first quarter of 2016" said Eskil Elmér, Chief Scientific Officer of NeuroVive.
"Our team of researchers and scientists at the University of Pennsylvania and the Children's Hospital of Philadelphia are enthusiastic about the opportunity to leverage our investigations at the forefront of TBI research to identify TBI treatments. This partnership with NeuroVive is designed as a pre-clinical translational bridge between potential therapies and clinical trials, to explore treatments for TBI where there are few options for patients" commented Dr. Susan S. Margulies, Professor in Bioengineering and Neurosurgery at the University of Pennsylvania.
Traumatic brain injury (TBI) is brain damage that occurs after an external trauma to the head, where nerve cells receive immediate damage. The injury deteriorates for several days after the accident, often leading to a significant impact on the overall injurious effect. TBI afflicts approximately 1.7 million Americans annually with more than 52,000 associated deaths and 275,000 hospitalisations.* Both direct and indirect costs associated with TBI are estimated at more than $60 billion with a high number of patients left with moderate to severe disabilities requiring intensive care and support. It is hoped that better treatments for TBI, such as NeuroSTAT®, will lead to increased survival and greatly improved outcomes in terms of the ability of patients to function normally following moderate to severe TBI.
NeuroVive Pharmaceutical AB (publ) is a mitochondrial medicine company committed to the discovery and development of highly targeted candidates that preserve mitochondrial integrity and function in areas of significant therapeutic need. NeuroVive's business approach is driven by value-adding partnerships with mitochondrial research institutions and commercial partners across the globe.
NeuroVive's portfolio consists of two clinical projects in acute kidney injury (AKI) and traumatic brain injury (TBI), one candidate in preclinical development and two drug discovery platforms. NeuroSTAT® has orphan drug status in Europe and in the US for treatment of moderate to severe traumatic brain injury and is currently being evaluated in a Phase II study. CicloMulsion® is being evaluated in an on-going Phase II study, CiPRICS, in acute kidney injury during major surgery. NeuroVive's shares are listed on NASDAQ Stockholm, Sweden.
This release may contain forward-looking statements that can be identified by words such as "recommends," "indicating," "risk," "recommended," "believe," "could," "commitment," "will," "implications," "supports," "thought," "designed," "growing," "continues," or similar terms, or by expressed or implied discussions regarding potential marketing approvals for NeuroSTAT®, or regarding potential future revenues from NeuroSTAT®. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that NeuroSTAT® will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that NeuroSTAT® will be commercially successful in the future. In particular, management's expectations regarding NeuroSTAT® could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors.
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 the 12 January 2016, at 08.30 CET.