MILANO, Italy, April 26, 2002 (PRIMEZONE) -- BioXell SpA announced today the publication of a study in the May issue of the journal Diabetes describing the ability of a synthetic analogue of the active form of vitamin D3 (1,25-dihydroxyvitamin D3) to arrest the development of autoimmune diabetes (type 1 diabetes) in non-obese diabetic (NOD) mice. This study is the first to demonstrate the ability of a selected vitamin D3 analogue to block ongoing diabetes in the adult NOD mouse, a model that closely resembles the pathogenesis of human type 1 diabetes.
"The demonstration that ongoing autoimmune diabetes can be arrested by a relatively short treatment of a vitamin D3 analogue in adult NOD mice suggests that a similar treatment may also inhibit disease progression in pre-diabetic or newly diagnosed type 1 diabetes patients," said Dr Luciano Adorini, Chief Scientific Officer of BioXell and director of the study. "The mechanism of action of this analogue is particularly intriguing because inhibition of disease is associated with an increased frequency of a cell subset in pancreatic lymph nodes, that has recently been demonstrated to have a regulatory role in humans."
The paper, entitled "A 1a,25-Dihydroxyvitamin D3 Analogue Enhances Regulatory T Cells and Arrests Autoimmune Diabetes in NOD Mice," demonstrates that this particular analogue inhibits diabetes development without inducing toxic side effects. There is an unmet clinical need for a safe drug that inhibits disease progression and does not rely on exogenous insulin administration, given the very severe complications associated with this disease. Vitamin D3 analogues have been shown to inhibit autoimmune diseases in several animal models, including autoimmune diabetes, but the compounds tested so far show efficacy in NOD mice with ongoing disease only if combined with strong immunosuppressive agents, like cyclosporine A.
This particularly potent analogue, which embodies 20 years of research, was designed and synthesised by Milan Uskokovic, VP for Chemistry at BioXell Inc., a subsidiary of BioXell located in Nutley, NJ. Dr Uskokovic, a co-author of the paper, developed Rocaltrol, the first Vitamin D3 analogue to enter the market.
About BioXell
BioXell is a private research and development biopharmaceutical company with a competitive edge in immunology developing two strong technology platforms based on the TREM receptor system and Vitamin D3 analogues. From these, BioXell has identified molecules to be developed in secondary hyperparathyroidism, benign prostatic hyperplasia, as well as research programmes in type 1 diabetes, transplantation and psoriasis. In March 2002, BioXell raised Euro22m in a first-round financing from a consortium of three top-tier venture capital firms: MPM Capital, Index Ventures and Life Science Partners. BioXell has a network of academic collaborations, including Washington University, St. Louis and the Universities of Arkansas, Milan, Florence, Modena and Zurich.
Notes to editor
Diabetes is a life- long disease for which there is not yet a cure. There are several forms of diabetes: insulin dependent diabetes (type 1); non- insulin dependent diabetes (type 2); and gestational diabetes. Type 1 diabetes is an autoimmune disease, which results in the immune system attacking the insulin-producing beta cells in the pancreas and destroys them. Subsequently, the pancreas then produces little or no insulin and someone with type 1 diabetes needs to take insulin daily to live.
With inadequate insulin, glucose builds up in the blood stream instead of going into cells. The body is unable to use glucose for energy despite high levels in the blood stream. This causes symptoms such as extreme thirst, urination and hunger. Within 5 to 10 years after diagnosis, the insulin producing cells of the pancreas are completely destroyed and no more insulin is produced. The disease is accompanied by severe complications, such as blindness and chronic renal failure that are not adequately controlled by insulin administration.
Of the 16 million people in the United States who have diabetes, between 5% and 10% have type 1 diabetes and accounts for 3% of all new cases of diabetes each year. There is one new case per 7000 children every year. The number of cases decreases after the age of 20.
Vitamin D3 analogues are hormone- like molecules, which are important in modulating the immune response and controlling cell proliferation. Vitamin D3 analogues are currently being used for the topical treatment of psoriasis, an autoimmune disease of the skin, where they have shown an efficacy comparable to topical steroids.