Ehud Ziv, PhD, Diabetes Research Center, Eleazar Shafrir, PhD, Department of Clinical Biochemistry, Hadassah University Hospital.
Background
Type 2 diabetes, also known as adult-onset diabetes, is a major health problem worldwide and is one of the most costly and burdensome chronic diseases that is increasing in epidemic proportions throughout the world.
Medical Need: Although the treatment of diabetes has become increasingly sophisticated, the normalization of blood glucose for any appreciable period of time is seldom achieved. Glucose-lowering drugs require monitoring, have been associated with significant adverse side effects, and are contraindicated in some individuals. Hypoglycemia (low blood sugar), usually caused by too much insulin or oral anti-diabetic medication, is also dangerous and, if untreated, can be fatal. Despite intensive therapy of type 2 diabetes, glycemic control progressively worsens and lifestyle interventions combined with one, then multiple, therapeutic agents (combination therapy) are needed. More than 60% of diabetics have poor diabetic control. Even in well-controlled so-called "intensively" treated patients, serious complications still occur, and the economic and personal burden of diabetes remains.
The ongoing need for new therapies to address the growing burden of type 2 diabetes is clear.
Market
It is estimated that nearly 200 million people worldwide have diabetes. Of that population, it is estimated that approximately 90-95% have type 2 diabetes. It is estimated that there are more than 38 million people with diabetes in seven major markets (US, Japan, France, Germany, Italy, Spain, UK) and this figure is set to rise to 50 million in 2012. The American Diabetes Association has estimated that 17 million people in the United States have type 2 diabetes, with approximately 1.5 million new cases diagnosed each year. From 1997 through 2003, new cases of diagnosed diabetes among Americans aged 18-79 increased by 52%. The total annual cost associated with treating patients with type 2 diabetes mellitus in the United States is an estimated $132 billion. Annual cost of these treatments per patient with type 2 diabetic is about USD 2,000.
The Innovation
The inventors have found that PKC-derived peptides are capable of inhibiting the interaction between the PKC enzyme and its substrate (or substrates in the insulin signaling pathway) and to abolish or ameliorate the insulin resistance. The significance of this innovation is that it provides a modality which may be used against the spread of the worldwide epidemics: hyperglycemia and insulin resistance syndrome. It is directed at the molecular pathogenic impact of Protein Kinase C (PKC) in contrast to other modalities in use today which do not have well-defined pathophysiology targets.
R&D Program
A series of synthesized PKC-derived peptides are studied using the Psammomys animal model. Pre-clinical type 2 diabetes research (in vitro and in vivo) use animal models for better understanding of diabetes complications in human populations and for the study of the mechanism of the disease onset, its phenomena and regulation. The sand rat (Psammomys obesus) used by the inventors, is characterized by primary insulin resistance and is a well-defined model for dietary induced type 2 diabetes.
Milestones:
- Major focus and effort to obtain full in vivo and in vitro pre-clinical data with a series of synthesized PKC-derived peptides in the animal model.
- Optimization of synthesized PKC-derived peptides; establishment of a series of drug candidates.
- Proof-of-Concept of therapeutic potential of the drug candidates.
- Understanding and model for mechanism of action.
- Establishment of initial safety (toxicology) and pharmacological profiles for drug candidates; establishment of a clinical candidate.
Contact
Yuval Kupitz,
Business Development, Pharmaceuticals
Tel: +972-2-6778364
Email: yuvalk@hadasit.co.il
