What PharmaCyte has accomplished with the 16-member Diabetes Consortium is to essentially speed up the time it will take to get the company’s diabetes treatment into human clinical trials. The treatment they’re all working to advance combines PharmaCyte Biotech’s signature live-cell encapsulation technology, Cell-in-a-Box^®, with a novel cell line, called Melligen cells, that produces insulin in response to a patient’s blood sugar levels.

Earlier this month the first of the Diabetes Consortium’s work in animals with the Melligen cells returned favorable data to PharmaCyte and its investors. The company announced that its latest preclinical safety study showed that Melligen cells are as safe as the cells that were encapsulated with the Cell-in-a-Box technology and then used together with the cancer drug ifosfamide to treat patients with advanced pancreatic cancer in previously conducted clinical trials.

These results mean that the cells used in the company’s diabetes treatment are just as safe to use as the cells that the company uses in its pancreatic cancer treatment that is preparing to go into a Phase 2b or “mini” Phase 3 human clinical trial. PharmaCyte announced that additional safety, as well as efficacy and dose finding studies, of the Melligen cells are planned for the near future.

The additional studies that lie ahead for PharmaCyte will be where the Diabetes Consortium will shine. Dr. Eva Maria Brandtner is the Director of Diabetes Program Development at PharmaCyte, and like a conductor, she is responsible for orchestrating this large group of experts to a successful conclusion. After all, it will be the expertise that each member brings to the group that will benefit PharmaCyte and its treatment.

The CEO of PharmaCyte, Kenneth L. Waggoner, explains why the Diabetes Consortium was put together and some of its more important benefits. “We knew we had to find a way to condense the time it would take to get into clinical trials, given the world-wide and growing epidemic of patients who need insulin to treat their disease,” said Kenneth L. Waggoner. “We have assembled five prestigious research universities working on parallel but complementary research tracks at the same time, rather than conducting experiments sequentially as would normally be the case in a single institutional setting.”

“This will dramatically shorten the time we need to conduct the bench and animals studies that are necessary before clinical trials on humans are undertaken. In addition, we have scientists in our Diabetes Consortium who have ‘one of a kind’ animal models that accelerate the time an animal develops diabetes — again compressing the overall development timeline,” said Waggoner.

The multidisciplinary, international team of experts that comprise this unique consortium should rapidly advance the development of PharmaCyte Biotech’s encapsulated cell based therapy for diabetes and should accelerate the development process as well as provide both compelling and comprehensive safety, dosing and clinical efficacy data.

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