Phase II--Islet Regeneration


Phase II Begins for a New Islet Regeneration Treatment

Exsulin Corporation announces next phase II trial of novel islet regeneration treatment in Type 1 diabetes. Leading diabetes research centers collaborate on new trial designed to further evaluate regeneration treatment for people with Type 1 diabetes.

Exsulin Corporation announces the start of a phase II human clinical trial of Exsulin™, a peptide drug product aimed at restoring insulin production in people with diabetes. The randomized, controlled 12-week trial in patients with established Type 1 diabetes (T1DM) will be co-led by Mayo Clinic in Rochester, Minn., and McGill University Health Centre in Montreal, Canada.

First results are expected to be available in Q2 2010. The design of the study is based on previous trials which showed improvement in insulin secretion and glucose control in both Type 1 and Type 2 diabetes patients treated with Exsulin.

“Exsulin is a hormone that is being studied for its potential ability to regenerate islets – and possibly restore insulin production – in the pancreas,” said G. Alexander Fleming, MD, founder and chairman, Exsulin Corporation. “We look forward to the results of this important study, which will build on previous findings and further characterize the effects of Exsulin on insulin production and glucose control.”

“This phase II trial represents a critical milestone in demonstrating the potential of Exsulin as a novel approach to diabetes treatment,” said Lisa Jansa, founder and CEO, Exsulin Corporation. “Exsulin is the only islet regeneration hormone now in clinical development for people with established T1DM. If this trial confirms previous data, we are confident we can advance Exsulin to phase III trials, with the ultimate goal of bringing an innovative new treatment to the millions of patients living with diabetes.”

Exsulin’s phase II trial will be undertaken by a cross border effort led by diabetes research centers at Mayo Clinic in Rochester, Minnesota, and the McGill University Health Centre in Montreal, Canada. Teams in both locations will begin recruitment of T1DM patients with established disease (greater than two years since diagnosis) for enrollment in the trial. Selection of patients will require an A1c of 7.5 or less. McGill University has a long history in diabetes care and research.

Age requirements? Side effects to this treatment?

If you go to their site (highlighted) in my post, there’s a link for clinical trials.

Thank you Gerri…very interesting. I am keeping my fingers crossed. :slight_smile:

Dare we get our hopes up? There’s some promising research & trials going on. My money’s on Diabecell, if those in the US ever get to reap the benefits. Hope the smart insulin folks get this out while we’re waiting.

Yes, Smart insulin!!! Maybe a millionaire would help in funding smart insulin? Know any? :slight_smile:

I do:)

It seems clear that this alone will not be sufficient to address type 1 diabetes thanks to low-grade inflammation which results in ongoing autoimmunity that destroys pancreatic beta cells, including newly generated ones. This will need to be combined with a treatment to arrest the autoimmune process that causes type 1 diabetes to happen. There are a number of treatments in various stages of clinical trials aimed at doing that, among them the Macrogenics/Lilly teplizumab (Protege study), Tolerx/GlaxoSmithKline to develop a similar anti-CD3 antibody to preserve beta cell function in newly-diagnosed patients; Bayhill Therapeutics Inc., which just entered into a collaboration agreement with Genentech, Inc., a wholly-owned subsidiary of the Swiss pharmaceutical giant the Roche Group, to further develop and potentially commercialize a novel antigen-specific immunotherapeutic which aims to reverse the immune response that causes type 1 diabetes. Each of these were facilitated by JDRF’s Industry Discovery and Development Partnership (IDDP) program, through which JDRF provides early-stage research funding to drug and/or biotech companies working on technologies and therapeutic candidates. There are also some others being pursued without JDRF’s assistance, among them are the much discussed BCG trials being undertaken at Mass. General Hospital using Denise Faustman’s protocol. Another is Teva’s Diapep 277, which is undergoing some trials at present (although I believe these are still Phase II trials if I’m not mistaken). Other drug candidates also include the one that Exsulin hopes to pursue partnership with Diakine’s lisofylline treatment. A few of these are now entering Phase III trials themselves, although so far, most have only been tried on newly-diagnosed patients, not long-standing type 1 patients, although in theory, if FDA-approved, it could be prescribed off-label until trials prove the drugs efficacy in long-standing type 1 patients. This is great progress, but don’t assume a cure is imminent, a lot more work still needs to be done!