STOCKHOLM--Regulatory News: CicloMulsion® development to continue in acute kidney injury and increased focus on development of other drug candidates. Shareholder information meeting to be held on 10th September 2015 in Lund, Sweden to present and discuss the NeuroVive portfolio. NeuroVive Pharmaceutical AB (publ), the mitochondrial medicine company, announces it will not pursue development of CicloMulsion® in the indication of acute myocardial infarction (AMI). The company will now place strategic focus on progressing the research and development activities of CicloMulsion® in acute kidney injury, the development of its other drug candidates as well as accelerating its discovery programs.
This decision follows the data presentation from the investigator-initiated Phase III CIRCUS study of CicloMulsion® in patients with a specific type of heart attack known as ST-segment elevation myocardial infarction (STEMI) at the European cardiology meeting in London, UK. The data presented showed that CicloMulsion® had no therapeutic effect on AMI patients undergoing PCI (percutaneous coronary intervention). However, the CIRCUS study confirmed the safety profile of CicloMulsion®.
"The CIRCUS study has given us a better understanding of target therapeutic areas and how our drug candidates may be best used. The lack of therapeutic effect in AMI patients may be due to the administration time, as significant injury to the cardiac muscle has already occurred at the time of PCI. We will continue to evaluate our drug candidates in different organs and conditions. We are confident in our research and development pipeline and the potential of cyclophilin D inhibitors in a broad range of indications." commented Eskil Elmér, MD, CSO of NeuroVive.
NeuroVive remains committed to the Phase II CiPRICS study of CicloMulsion® in pretreatment of acute kidney injury during major surgery, as well as the Phase II CHIC study of NeuroSTAT® in traumatic brain injury. CicloMulsion® is one of several investigational products in clinical and preclinical development.
Shareholder information meeting on Sept 10 at Medicon Village in Lund, Sweden
NeuroVive will host an information meeting on Thursday 10th September 2015 at 18:00 in the auditorium, Scheelevägen 2, to discuss the implications for CicloMulsion® of the CIRCUS trial results, and present and discuss the NeuroVive portfolio.
NeuroVive Pharmaceutical AB (publ) is a mitochondrial medicine company committed to the discovery and development of therapeutic applications for mitochondrial medicine in areas of significant unmet clinical need. NeuroVive's business strategy focuses on maximising value from its projects through strategic partnerships and out-licensing.
NeuroVive's portfolio, containing three cyclophilin D candidates in clinical and preclinical development, is fuelled by three additional drug discovery platforms in neurology, mitochondrial disorders and organ protection. NeuroVive's product CicloMulsion® is being evaluated in an ongoing Phase II study, CiPRICS, in acute kidney injury during major surgery. The NeuroSTAT® product is currently being evaluated in a Phase II study in traumatic brain injury. NeuroVive's shares are listed on NASDAQ OMX, 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 express or implied discussions regarding potential marketing approvals for CicloMulsion®, or regarding potential future revenues from CicloMulsion®. 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 CicloMulsion® will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that CicloMulsion® will be commercially successful in the future. In particular, management's expectations regarding CicloMulsion® 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.
For investor relations and media questions in Sweden, please contact:
Johannes Nebel, Laika Consulting, Tel: +46 (0)735 81 71 68 or [email protected]
For media questions outside Sweden, please contact:
Gemma White, inVentiv Health, Tel: +44 (0)77 13 88 9992 or [email protected]
It is also possible to arrange an interview with NeuroVive's CEO Mikael Brönnegård or COO Jan Nilsson at the above contacts.
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 31st August 2015, at 08.30 CET
NeuroVive Pharmaceutical AB (publ) - the mitochondrial medicine company. The company is listed on NASDAQ OMX Stockholm, Small Cap, under the ticker symbol NVP. The share is also traded on the OTC market in the US. NeuroVive Pharmaceutical (OTC: NEVPF) trades on the OTC Pink Market. Investors can find Real-Time quotes and market information for the company at www.otcmarkets.com/stock/NEVPF/quote
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