Insulin
About Diabetes
In 2007, the global pharmaceutical market for diabetes amassed more than $26124 million USD in revenues, with $11565m derived from human insulin and analogue sales.
In 2004, the World Health Organization predicted that by 2030, 4.4% of the world population will have diabetes, which equates to more than 366 million diabetics worldwide. Those figures indicate that diabetes is becoming an epidemic and supports the need for new and innovative products in the marketplace. There are three types of diabetes, Type 1 or Insulin Dependent Diabetes, Type 2 or Non-Insulin Diabetes and Gestational Diabetes.
Type 1 Diabetes is characterised by a pancreatic malfunction, which prevents the pancreas from producing insulin. It is considered to be a progressive auto-immune disease, as the beta cells of the pancreas are attacked and gradually destroyed by cytokine immune factors produced by the patient’s own body. Its treatment requires insulin.
Type 2 Diabetes is characterised by insulin resistance, in which the pancreas produces sufficient amounts of insulin, but insensitive insulin receptors fail to adequately respond. It is the most prevalent form of diabetes and accounts for 90-95% of all diabetic cases. The treatment goal for Type 2 is to ensure adequate insulin and to increase the insulin receptivity of the cell walls. It can be managed with oral anti-diabetics, sometimes in combination with insulin.
Gestational Diabetes is insulin-resistance in pregnant women and is caused by the pregnancy. It can cause various fetal complications and is an under-diagnosed condition worldwide. It is a version of Type 2 diabetes and usually corrects itself post-pregnancy. However, women who have had gestational diabetes, have a 20-50% likelihood of developing chronic Type 2 diabetes within 15 years of the gestational diabetes pregnancy.
About TPM/Insulin
The product will offer patients the world’s first transdermally delivered insulin product, providing patients with long-acting, sustained release insulin over an 8-12 hour period. TPM/insulin will target Type 1 and Type 2 diabetic patients requiring regular glucose regulation and who seek to more actively control and manage their diabetes.
Phase I and II Studies
Phosphagenics has established safety and pharmacodynamic activity in healthy subjects in two Phase I studies and in Type 1’s with one small-scale phase II study. These studies, which were conducted in collaboration with the Joslin Diabetes Center of Harvard Medical School, demonstrated significant reductions in blood glucose, endogenous insulin and c-peptide levels from a single application of TPM/insulin with no irritation observed.
In December 2009, Phosphagenics announced that its TPM/insulin project is on track to return to the clinic for human trials in the first half of 2010, following the adaptation of the successful TPM® patch technology. Additionally, the company revealed that its scientists have:
- completed dose optimisation of the insulin formulation, substantially reducing the amount of insulin required to achieve therapeutic dose
- completed and tested the matrix insulin patch on animals, demonstrating that blood glucose levels were lowered for the duration of the studies.
TPM/Insulin Fact Sheet