The FP7 CARDIMMUN project brings together SMEs and selected academic partners. The main goal for the CARDIMMUN project is to develop PC-mAb into a phase where we together with a partner can enter into larger clinical trials. The consortium was constructed to bring together expertise in the areas critical to reach this goal.
Athera Biotechnologies AB, Sweden
Athera was founded to exploit breakthrough innovations in cardiovascular disease made at Karolinska Institutet. PC-mAb is a fully human antibody and the lead project for the company. Athera owns the IPR covering the therapeutic candidate PC-mAb. Athera is the leading SME in CARDIMMUN and was a major partner in the FP6 project CVDImmune. Athera has formed a virtual pharmaceutical development company with experienced people covering the critical competences needed for the early development of PC-mAb.
Clincal Trial Consultants CTC AB, Sweden
CTC is a CRO conducting early clinical trials, and has the operational responsibility for the clinical trials within CARDIMMUN. The focus is on the clinical conduct of hospital-based early phase trials (0/I/IIa) through their own GCP certified center (including logistics, recruitment and study conduct with dedicated doctors and research nurses including qualified competence in intensive care which is required in safety studies). The clinic is inspected and approved by Swedish MPA for First in Human studies.
Leiden University Medical University (LUMC), The Netherlands
LUMC has developed and validated preclinical models for cardiovascular inflammation and was a strong contributing partner in the EU FP6 project CVDImmune. The main objective of LUMC in CARDIMMUN is to deliver information on the efficacy of PC-mAb in preclinical disease models of translational value. Demonstration of efficacy of PC-mAb in a vein bypass grafting model is an important task that will add strength to the use of PC-mAb to prevent graft failure in patients with severe peripheral arterial disease (PAD). LUMC will also carry out studies to investigate effects of PC-mAb on functional and biochemical markers of systemic and vascular inflammation in preclinical disease models.
Smerud Medical Research, Norway
Smerud is a CRO primarily focused on clinical project management and monitoring of phase I/II – III studies and regulatory affairs. Since 1993, Smerud has been involved in more than 800 clinical trials and over 400 regulatory projects. Smerud has over the last 5 years invested heavily in self-funded clinical research, and has vast experience from participating in and leading various EU funded clinical development programs, partly in FP7 but mainly through the EUROSTARS program. Smerud is responsible for regulatory management of the clinical studies included in CARDIMMUN.
Turku University PET Center, Finland
Turku University PET Centre has developed clinical imaging using PET technology that improves the usefulness of these technologies for cardiovascular studies. Their technology uniquely enables measurements of glucose uptake by FDG-PET in coronary arteries and coronary flow reserve (CFR) both in patients and in mice. This means that the technologies to be used in the clinical development can be validated in preclinical studies. A major objective in CARDIMMUN is to validate the intended clinical development of PC-mAb and the strategy is to perform preclinical experiments in disease models that resemble the patients that are to be treated with PC-mAb, and to use technologies in these studies that are similar to what we intend to use in future clinical studies.