Date: 2014-06-04
Type of information: Development agreement
Compound: CicloMulsion® cremophor-free IV cyclosporine formulation
Company: NeuroVive Pharmaceutical (Sweden) Hospices Civils de Lyon (France)
Therapeutic area: Cardiovascular diseases
Type agreement: development
Action mechanism: NeuroVive’s product CicloMulsion® is the first cyclophilin inhibitor developed for the treatment of reperfusion injury. The product’s potential in the treatment of myocardial infarction is currently being evaluated in a clinical phase III study. The last of a total of 972 patients was enrolled on 16 February 2014. The results of the study are due to be announced in 2015 following the completion of the one-year follow-up of all patients and the presentation of the study data.
Disease:
Details: * On June 4, 2014, NeuroVive announced it has extendied its collaboration with Hospices Civils de Lyon (HCL) and Professor Ovize, which broadens the scope of NeuroVive’s cardiovascular business area and creates the right conditions for the company to retain its leading position in mitochondrial medicine. The new collaboration agreement, designated OPeRA (Organ Protection & Replacement Institute), includes pre-clinical research and development programs as well as clinical phase II programs, providing NeuroVive with access to medical technology and patient groups for the evaluation of its drug candidates. NeuroVive began its collaboration with HCL, and the ongoing phase III study in CicloMulsion in Europe, in 2011. Research into CicloMulsion’s efficacy beyond the treatment of reperfusion injury following heart attack grew out of the concept of mitochondrial protection in connection with organ injury focusing on heart disease. The OPeRA program has received financial backing from the French government and from several industry players including NeuroVive and covers the period up until 2018. The program encompasses a number of different medical areas and is based on multidisciplinary programs in diabetes, metabolic disorders, transplantation, cardiovascular diseases, inflammatory conditions and infectious diseases. By becoming an industrial partner in the OPeRA program, NeuroVive has secured access to a unique scientific platform in mitochondrial medicine where its already developed cyclophilin inhibitors such as CicloMulsion, and new drug candidates, can be studied in various animal models for efficacy against cardiovascular diseases before being tested in humans. The clinical studies program at HCL plans to study CicloMulsion in several phase II studies with the intention of generating proof of concept, i.e. demonstrating CicloMulsion’s efficacy in a smaller patient group before a decision is made to move on to a larger phase II study. A number of phase II studies in CicloMulsion are scheduled in the period up until 2018. The partnership under the OPeRA program not only gives NeuroVive the rights to the projects directly covered by the collaboration with HCL, but also provides access to research findings for potential commercial development across all areas of the program. NeuroVive’s product CicloMulsion® is currently being evaluated in a clinical phase III study. The last of a total of 972 patients was enrolled on 16 February 2014. The results of the study are due to be announced in 2015 following the completion of the one-year follow-up of all patients and the presentation of the study data.
Financial terms:
Latest news:
