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Abliva — Regulatory Filings 2014
Aug 14, 2014
3131_rns_2014-08-14_a96e8ec9-00ea-4a1a-b7a4-9027b671821c.pdf
Regulatory Filings
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NEWS RELEASE NeuroVive Pharmaceutical AB (publ)
556595-6538
14 August 2014
Enrollment to phase II study on NeuroSTAT® continues
Enrollment to the ongoing clinical phase IIa study with NeuroVive's drug candidate NeuroSTAT® for treating patients with severe traumatic brain injury (TBI) is continuing, and another two patients have been enrolled. Accordingly, at present, seven of a total of 20 patients have been enrolled in the study.
The enrollment of new patients to the study has taken somewhat longer time than scheduled, but NeuroVive assumes that the ten patients to be treated with a lower dose will have been enrolled by year-end, or during Q1 2015 at the latest. Subsequently, the plan is to conduct interim analysis of data from these first ten patients with the aim of forming an opinion of treatment safety. If there are no safety concerns, the objective is for another ten patients to be enrolled during 2015 with treatment at a higher dose. In addition to planned interim analysis, continuous assessment treatment safety is being conducted. Based on safety assessments of the first patients, treatment with NeuroSTAT at the lower dose is considered to be safe and patient enrollment is continuing as planned.
This phase IIa study is an open, non-comparative study involving a total number of 20 patients. Its primary endpoint is to evaluate NeuroSTAT's® pharmacokinetics1 and safety in TBI. Secondly, a number of measurements will be conducted, firstly to study NeuroSTAT's® efficacy at the mitochondrial level, and to study how biochemical processes are affected by NeuroSTAT® post-TBI. TBI is a segment subject to a major medical need, where there are no registered pharmaceutical therapies at present.
About NeuroVive Pharmaceutical
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. The share is also traded on the OTC market in the US, under the NEVPF ticker symbol.
Pharmacokinetics is the study of a pharmaceutical's transformation in the body, i.e. how content of the pharmaceutical in the body changes through absorption, distribution, metabolism and excretion.
NeuroVive Pharmaceutical AB (publ) is a leading mitochondrial medicine company. The company is listed on NASDAQ OMX Stockholm, Small Cap, under the ticker symbol NVP. For IR questions, please contact [email protected] or +46 (0)46 275 62 21.
NEWS S RELEAS SE
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14 Augus st 2014
Current t status of N NeuroVive's 's products
CicloMulsi ion®
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NeuroSTA T®
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NVP018
NVP018 is cyclophilin structures pre‐clinica potency ag based app NeuroVive's pr n inhibitors, pre are based on a al development gainst virus rep plications and N rimary drug can eviously acquire new and uniqu and has been d plication and ha NeuroVive is cur ndidate in the c ed, are part of a ue chemical pla developed for th as a positive saf rrently evaluatin company's new a family of mole atform of what he treatment of fety and pharm ng NVP018's po w portfolio of po ecules known as are termed pol f Hepatitis B/C. macokinetic prof otential for oth tent cyclophilin s Sangamides, w lyketides. It has The product ha file. Cyclophilin er anti‐viral ind n inhibitors. The whose molecul s undergone ex as demonstrate inhibitors have dications. lar tensive ed high e broad‐
NVP019
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NeuroVive Stockholm, e Pharmaceutic Small Cap, und cal AB (publ) is der the ticker sym s a leading mito mbol NVP. For IR ochondrial medi R questions, pleas icine company. se contact ir@ne The company is eurovive.se or +4 is listed on NAS 46 (0)46 275 62 2 SDAQ OMX 21.
NEWS RELEASE
NeuroVive Pharmaceutical AB (publ) 556595-6538
14 August 2014
be evaluated for these purposes in collaboration with external partners such as Hospices Civils de Lyon within the auspices of the OPeRA program.
Other products
More information on all the products NeuroVive is developing is at http://www.neurovive.se/index.php/en/researchdevelopment/research-overview
For Investor Relations and media questions, please contact:
Ingmar Rentzhog, Laika Consulting, Tel: +46 (0)46 275 62 21 or [email protected] It is also possible to arrange an interview with NeuroVive's CEO Mikael Brönnegård via the above contact.
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 [email protected], 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 14 August 2014, at 10:00 a.m. CET.