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WARF: P09141US02

Vitamin D Analogs 2MD and 2AMD Prevent Type 1 Diabetes without Inducing Hypercalcemia


INVENTORS -

Hector DeLuca, Lori Plum, Jamie Nehring, Ehren Rudolph

The Wisconsin Alumni Research Foundation (WARF) is seeking commercial partners interested in developing vitamin D compounds that can prevent type 1 diabetes in a subject at risk of developing the disease without causing hypercalcemia.
OVERVIEWAccording to the Juvenile Diabetes Research Foundation, more than three million people in the United States have type 1 diabetes. Type 1 diabetes is an autoimmune disease that results when the immune system destroys insulin-producing beta cells in the pancreas. It can lead to serious complications, including blindness, cardiovascular disease, kidney damage and lower-limb amputations.

Treatment consists of daily insulin injections. There is no cure, and no clinically useful means of preventing this disease currently exists.

While the cause of type 1 diabetes is still not fully understood, available evidence suggests analogs of the hormonally active form of vitamin D, known as calcitriol or 1,25 dihydroxyvitamin D3, could play an important role in understanding the disease and possible therapeutic solutions. Vitamin D is essential for normal insulin secretion, and vitamin D receptors have been described in pancreatic beta cells. In non-obese diabetic (NOD) mouse models, calcitriol has been shown to prevent the development of diabetes.

While promising, the concentrations of calcitriol required for effective diabetes prevention can be toxic. The hormone mobilizes calcium from bones and increases intestinal absorption of dietary calcium. Effective therapeutic concentrations can lead to hypercalcemia; a condition characterized by elevated blood calcium levels, alterations in mental status, muscle weakness and calcification of soft tissues and organs such as the heart and kidneys.
THE INVENTIONUW–Madison researchers have identified vitamin D analogs that can prevent type 1 diabetes in the NOD mouse at doses that do not induce hypercalcemia. The vitamin D compounds are 2α-methyl-19-nor-20(S)-1,25-dihydroxyvitamin D3, known as 2AMD, and 2-methylene-19-nor-20(S)-1,25-dihydroxyvitamin D3, known as 2MD.
BUSINESS OPPORTUNITY
  • Diabetes affects 246 million people worldwide and nearly 8% of the U.S. population. By 2025 experts predict 380 million people will be afflicted with diabetes.
  • In 2007, the five countries with the largest numbers of people with diabetes were India (40.9 million), China (39.8 million), United States (19.2 million), Russia (9.6 million) and Germany (7.4 million).
  • Global diabetes treatment market was valued at over $21 billion in 2006.
  • The Juvenile Diabetes Research Foundation estimates there are over 3 million people in the US with T1D and nearly 15,000 new cases of T1D diagnosed yearly.
  • Multiple source funding is available for diabetes translational research.
APPLICATIONS
  • Prevention of type 1 diabetes in humans and other animals
KEY BENEFITS
  • Provides safer, less calcemic compounds than the natural hormone calcitriol
  • Offers a fresh therapeutic approach for gaining access to the diabetes market
  • Provides a drug development opportunity in a growing market space
  • Innovative licensing and/or development terms are available.
STAGE OF DEVELOPMENTThe analogs offered in this portfolio have been subjected to in vitro/in vivo models for early-stage pre-clinical evaluation. 2MD has successfully completed phase I clinical trials.

Please contact our office for updates as study data sets may be evolving with compounds under development.
Contact Information
For current licensing status, please contact John Nagel at jnagel@warf.org or 608-960-9848.
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These include the Small Molecule Screening Facility at the UW Comprehensive Cancer Center; the Zeeh Pharmaceutical Experiment Station, which provides consulting and laboratory services for developing formulations and studying solubility, stability and more; the Waisman Clinical Biomanufacturing Facility; the Wisconsin Institute for Medical Research, which provides UW–Madison with a complete translational research facility; and the innovative, interdisciplinary Wisconsin Institutes for Discovery, home to the private, nonprofit Morgridge Institute for Research and its public twin, WID, part of the university's graduate school. The highly qualified experts at these facilities are ready to work with you to create a library of candidates for drug development.