Sernova Corp. (TSX-V: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical stage regenerative medicine company, announced today it has received its initial € 566,500 ($875,000 CDN) installment of non-dilutive funds from the HemAcure Grant funded by the EU Horizon 2020 Program. Sernova will use the payment to fund activities related to the development of a GMP clinical grade Factor VIII releasing therapeutic cell product combined with Sernova’s Cell Pouch(TM) to treat severe hemophilia A, a serious genetic bleeding disorder caused by missing or defective factor VIII in the blood stream.
“We are excited that the HemAcure consortium partners, a group developing a therapeutic that is highly disruptive to the current standard of care treatments for hemophilia A, are already working diligently to advance the program. Together, we are working to address, with a sense of urgency, the critical challenges posed by severe hemophilia A,” remarked Dr. Philip Toleikis, Sernova President and CEO.
The therapeutic goal is to use the patient’s own cells after correcting for the factor VIII gene deficiency. These cells are placed in the implanted Cell Pouch(TM) and release factor VIII on a continual basis at a rate that is expected to significantly reduce disease-associated hemorrhaging and joint damage. The constant delivery of factor VIII from the corrected cells may also reduce or eliminate the need for multiple weekly infusions – the current standard of care for the prophylactic treatment of hemophilia A which uses plasma-derived or recombinant, genetically engineered factor VIII.
“Sernova continues to benefit from the judicious use of partnerships, grant applications and other forms of non-dilutive funding to advance our technology platform and products in development, thereby maximizing potential returns for our stakeholders,” added Dr. Toleikis.
Sernova has developed a highly innovative, scalable, implantable medical device (Cell Pouch(TM)) for the placement and long term survival and function of therapeutic cells. It has proven to be safe and efficacious in multiple small and large animal preclinical models and has demonstrated safety alone and with therapeutic cells in a clinical trial in humans for another therapeutic indication. We believe the Cell Pouch(TM) platform is the only such patented technology that when implanted under the skin is proven to become incorporated with blood vessel enriched tissue-forming chambers for the placement and long term survival and function of therapeutic cells.
About Hemophilia A
People with Hemophilia have prolonged abnormal bleeding as a result of trauma. Hemophilia A, also called factor VIII (FVIII) deficiency is the most common form of Hemophilia and is a genetic disorder caused by missing or defective FVIII, a blood clotting protein. Severe hemophilia occurs in about 60% of cases where the deficiency of FVIII is less than 1% of normal blood concentration. While it is passed down from parents to children, about 1/3 of cases are caused by a spontaneous change in the gene. According to the US Centers for Disease Control and Prevention hemophilia occurs in about 1 in 5,000 births. If the prolonged bleeding occurs in the brain of a person with hemophilia, it can be fatal. Prolonged bleeding in joints can cause inflammatory responses and permanent joint damage. Approximately 20,000 people in the United States and 10,000 in Europe have the moderate or severe form of hemophilia A, as well as approximately 2,500 in Canada. All races and ethnic groups are equally affected by hemophilia A. Though there is no cure for the disease, it can be controlled with regular infusions of recombinant clotting FVIII. Annual costs for the treatment of the disease for each patient may range from $60,000 to $260,000 US for a total cost of between $2-5B per year in North America and Europe.
About Horizon 2020 Programme
Horizon 2020 is the biggest EU Research and Innovation program ever with nearly €80 billion of funding available over seven years (2014 to 2020). It promises more breakthroughs, discoveries and world-firsts by taking great ideas from the lab to the market. The project is funded as part of societal challenges “personalizing health and care” in a specific call about innovative treatments and technologies. New therapies, such as gene or cell therapies, often require technological innovation in the form of development of specific component tools and techniques such as isolation and multiplication of a cell or development of a scaffold, delivery of the therapy to the patient and for following-up the effect of the therapy in the patient. In particular, achieving therapeutic scale production and GMP standards at reasonable cost is often underestimated. The European Union aims to improve the development of advanced methods and devices for targeted and controlled delivery, and to bring these innovative treatments to the patient.
HemAcure is the name of the consortium developing a product for hemophilia A. This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 667421. The consortium members include the University Hospital Wurzburg (Coordinating Institute), IMS – Integrierte Management Systeme in Heppenheim, Germany, Universita del Piemonte Orientale “Amedeo Avogadro,” Loughborough University, GABO:mi Gesellschaft für Ablauforganisation: milliarium mbH & Co. and Sernova Corp. The main objective of the HemAcure project is to develop and refine the tools and technologies for a novel ex vivo prepared cell based therapy within Sernova’s prevascularized Cell Pouch to treat this bleeding disorder that should ultimately lead to improved quality of life of the patients.