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A one-two diabetes punch
CHARLOTTESVILLE, Va.—With plans to bring to market a unique combination therapy for type 1 diabetes, DiaKine Therapeutics Inc. and Kinexum Metabolics Inc. last month announced an agreement to jointly develop two drugs that together have shown in preclinical studies to cause type 1 diabetes to go into remission by protecting and promoting the growth of new insulin-producing cells.
Under the terms of the agreement, DiaKine and Kinexum will share expenses and commercial revenues for the new combination therapy, which consists of DiaKine's Lisofylline (LSF) and Kinexum's INGAP peptide. The companies expect to begin a Phase II clinical trial with the combination drug later this year.
The combination therapy has the potential to be a "blockbuster drug," says Keith D. Ignotz, president and CEO of DiaKine, a development-stage company commercializing novel immune modulators located in Charlottesville, Va.
"The only treatment currently available for type 1 diabetes in insulin, and that is life support, not a cure," Ignotz says. "Cure is a strong word, but this is an approach that would restore the endogenous insulin of type 1 diabetes patients and relieve them of today's current therapies, which treat them only symptomatically."
Pursuing a cure for Type 1 diabetes has been the career focus of Dr. Alexander "Zan" Fleming, who headed diabetes drug review at the FDA and now serves as chief medical officer of Harper's Ferry, W. Va.-based Kinexum, a biopharmaceutical company focused on the development of therapies for the treatment of Type 1 and Type 2 diabetes and other metabolic conditions. The addition of Fleming to the partnership has resulted in both a scientific and corporate collaboration for achieving a definitive treatment, Fleming says.
"We're targeting a highly unmet clinical need that is generally ignored by the big pharmas," Fleming says. "I think we can demonstrate a new model that comes out of relatively modest monetary resources, but with high intellectual resources."
In April, University of Virginia researchers Drs. Jerry Nadler and Sarah Tersey presented the results of a pre-clinical study on the combination therapy at the Keystone Symposia on Beta Cell and Islet Biology in Snowbird, Utah. The researchers found that 70 percent of mice with Type 1 diabetes treated with the combination of LSF and INGAP peptide went into complete remission and no longer needed insulin to maintain normal blood sugar levels. Additionally, mice treated with the combination therapy required less insulin during the treatment regimen than the controls.
Fleming admits the companies have encountered "more skepticism and resistance than we ever would have dreamed of," but says they believe that a two-pronged approach with an immune modulator such as LSF, in combination with an islet cell growth factor such as INGAP Peptide, "offers the best hope of allowing the body to generate insulinproducing cells."
"Conventional wisdom holds that you can't develop two experimental therapies at the same time, and big-pharma tends to focus on developing a single drug to achieve a desired result," Fleming says. "But in the case of addressing Type 1 diabetes, we believe this disease requires a two-pronged approach. While there is nothing totally unique about what we have done, we believe we have the elements to create a very unique situation." DDN