Project: Development of a biopharmaceutical to reduce reperfusion injury after myocardial infarction

Project goals:_x000D_ (1) Development of a new biopharmaceutical._x000D_ (2) Deliver new possibilities for a therapeutic intervention into the CO acute events of atherosclerosis (myocardial infarction (MI) and stroke). After completion of this project this task will be delegated to a SME termed HEART-HEAL._x000D_ (3) Deliver new possibilities for a prophylactic intervention into the process of atherosclerosis. After completion of this project this task will be delegated to a SME termed HEART-PROTECT._x000D_ (3) Create new jobs in green industry (or in fact grey industry i.e. not light-dependent). A protein is produced in yeast for doing research, and for selling on the market for natural & research grade products (non-pharma) and the market for human and veterinary biodrug industries (pharma)._x000D_ (4) Increase diversity in the sector of industry and export in Iceland._x000D_ (5) Create possibilities of increased national income in foreign currency._x000D_ (6 Decrease costs in the health sector._x000D_ (7) Build capacity of skills for research and practical work in genetic engineering and biopharmaceuticals._x000D_ _x000D_ Background:_x000D_ Less than 10% of the global market for pharmaceuticals consists of protein-based drugs; this is predicted to grow to 30% in only a few years. Vaccinia virus complement control proteins (VCP) is an inhibitor of the complement system and may function as a general inhibitor of inflammation. It has recently emerged that VCP given as a bolus can reduce tissue damage after myocardial infarction (MI) by 44%, and repeated injections can prevent 50% of the process of atherosclerosis; this can possibly be brought to 100% by changing the injection regime. The CO applicant of the currrent Eurostars project, IceCP, has a patent for both these utilities of VCP (treatment and prophylaxis) in USA and a patent is pending in Canada, Europe and India. In Canada, the process has started and will be finished in 2011 based on the US patent. In Europe, the process started in 2010 and all claims relating to VCP have been ceded (similar to the USA process); a patent will likely be issued in 2012. Validation of the EU patent in UK will quickly lead to a patent in India._x000D_ _x000D_ The aim of this project is the development of VCP as a biopharmaceutical, including GMP validation and acute toxicity studies, both of which are necessary to obtain a EMEA permit for entering human clinical trials for therapeutic (bolus dose) use. Such trials will be initiated within 2 years of completion of the current project. We will also do subchronic toxicity studies and obtain a EMEA permit for entering human clinical trials for prophylactic (repeated injections) use, starting these trials when finance is in place._x000D_ _x000D_ The ultimate product is VCP in a formulation ready for intravenous (i-v) use as a bolus when a patient with MI, stroke or embolism is reperfused by angioplasty or drug therapy. This product will be ready in 2016 after 2 years of clinical studies by a drug company, -by preference a company dedicated to development of VCP as a drug for acute events of atherosclerosis, here termed HEART-HEAL. The patent for acute events will be licensed to HEART-HEAL and the patent for prophylaxis to HEART-PROTECT, and after that, IceCP will focus entirely on producing VCP by contracts with these SME's. Surplus VCP can be marketed as a natural and/or research grade product without interference from the drug developers, using general patents held by Girish Kotwal in USA, UK and India. A huge market exists for research on VCP in utilities such as xenotransplants, allografts, brain and spinal cord injury, Alzheimer's, rheumatoid arthritis (RA), sepsis, chronic obstructive pulmonary disease (COPD), acute respiratory distress (ARD), and age-related macular degeneration (ARMD) (the cause of >50% global blindness). The market for VCP as research grade product is huge, with only one other supplier, who started offering VCP in USA 4 months ago asking $1000/mg; this is currently allowed by the patent owner (GJK) due to his own need for the product, but will not be allowed after our production can satisfy the needs of VCP buyers. Besides, we have a better product (>98% pure and pyrogen-free, the other being of uncertain quality and may contain endotoxins) and we are able to sell at a lower price._x000D_ _x000D_ The production of VCP can become extremely profitable but will from the start aim for only a modest price, i.e. cost of production plus a very low profit margin (<8%) in order to hold the market even after competitors have learned the technology necessary for VCP production. Initially all the world is a market, but the option of retracting into the patented area (USA, Canada, Europe and India) will be strongly considered when the technology of VCP production has been mastered by others. The patented area is inhabited by 54% of the global population and a great majority (>90%) of the market (patients with treatable MI and buying power).

Acronym CardioVCP (Reference Number: 7148)
Duration 01/01/2012 - 31/12/2014
Project Topic VCP is a complement inhibitor which prevents 44% of the damage incurred after reperfusion after myocardial infarction. Development of VCP as a drug in myocardial infarction necessitates good manufacturing practice (GMP) validation and an EMEA compatible acute toxicity test on the product.
Network Eurostars
Call Eurostars Cut-Off 7

Project partner

Number Name Role Country
3 Laboratory of Pharmacology and Toxicology Observer Germany
3 Iceland CardioPharma Coordinator Iceland
3 Pipeline Biotech Partner Denmark