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One of the most significant therapeutic devices recently introduced for diabetes treatment is the insulin pump that Medtronic (Minneapolis) currently markets. Medtronic got the insulin pump through the acquisition of MiniMed, founded by Alfred Mann.
Manns new company, Mannkind (Valencia, CA) is in Phase III clinical trials with a device that will deliver insulin through dry powder (Technosphere) inhalation into the deep lung. Recently completed Phase IIb studies showed significant reductions in HbA1c levelthe most important diagnostic markerover a three-month period with no increased risk of hypoglycemia. The Technosphere product is designed to deliver insulin in a manner that approximates the first phase insulin spike normally seen in healthy individuals following a meal.
The FDA advisory committee voted 7-2 for approval of Exubera (r-DNA insulin), an inhalable rapid-acting dry powder for treatment of type 1 and type 2 diabetics, in September. Nektar Therapeutics (San Carlos, CA) with Pfizer (New York City) and Sanofi-Aventis as partners developed the proprietary inhalation device.
Although there were some safety concerns, such as potential lung function toxicity for patients with lung conditions such as asthma, Exubera is expected to offer convenience of use compared to injection and hence better compliance. Additional safety studies and data may be required prior to FDA approval.
Since only about 7% of all diabetics achieve their target numbers for blood glucose, cholesterol and blood pressure, earlier diagnosis, monitoring, and insulin delivery will be a growing market. Market potential for Exubera is in the $2B range, however Sanford Bernstein analysts project inhaled insulin sales of only $1.7B worldwide by 2011.
Diagnostic devices for monitoring insulin levels are a huge multibillion dollar market dominated by players such as Bayer (Leverkusen, Germany), Johnson and Johnson (New Brunswick, NJ) and Abbott (Abbott Park, IL). The holy grail of the next diagnostic product upgrade is to design a non-invasive device that eliminates finger pricks for daily blood testing.
The potential applications of stem cell therapy have been well chronicled in a variety of diseases. One important application would be tissue engineering to create cell lines for transplants. For example, the European Commission funded a $31 million project at the University of Liverpool in the U.K. to develop tissue cells from stem cells to treat diseases such as diabetes, heart failure, and chronic ulcers.
The stem cells could be used to replace pancreatic cells for treatment of type 1 diabetes. New sources of stem cells other than embryos are cells from the umbilical matrix and most recently Harvard researchers published on creating stem cells out of human skin tissue.
Scientists at the Joslin Diabetes Center, affiliated with Harvard Medical School, used DNA chip technology to discover a new gene implicated in type 2 diabetes. The researchers studied genes from type 2 diabetics that were altered in their expression of islet beta cells from the pancreas. They then showed in mouse studies that one of these genes called ARNT resulted in altered insulin secretions. This gene could possibly result in a new target for treatment of the disease. Joslin is also developing new islet cells from pancreatic duct cells harvested from human donor pancreatic tissue.
Vaccines for type 1 diabetes are at an early stage of research and development. The vaccine strategies involve treatment with DNA or antigens and are designed to prevent the bodys destruction of islet cells.
Advances in biotechnology will help create new therapies for diabetes. Drug delivery systems, such as pulmonary inhalers; peptide mimetics for identifying new drug targets; DNA chip arrays for genetic analysis and receptors; tissue engineering including stem cell creation for islet cell replacement: and transplant are among the most promising technologies advancing diabetes treatments.