Encouraging Data From Islet Transplantation Studies In Primates, MicroIslet, Inc.

Main Category: Transplants / Organ Donations
Also Included In: Diabetes
Article Date: 16 Apr 2006 - 0:00 PDT

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MicroIslet, Inc. (Amex: MII), a biotechnology company engaged in the research, development and commercialization of patented technologies in transplantation therapy for people with insulin-dependent diabetes, today announced encouraging data from preclinical primate studies.

The data shows that minimally-invasive transplantation of encapsulated porcine islets into diabetic primates resulted in significant and prolonged (greater than 30 days) improvement of blood sugar, with reduced insulin use, in the primate subjects.

These results were accomplished using MicroIslet's proprietary encapsulation formulation, which is designed to more effectively assure immunoisolation of the encapsulated islets while preserving their access to nutrients, oxygen, and transport of low molecular weight proteins. In other words, the insulin-producing islets were sufficiently isolated from the subjects' immune systems to prevent their destruction as foreign tissues during the recorded survival period. At the same time, the encapsulated islets were able to receive necessary nutrients and oxygen from the bloodstream and release blood-glucose-modulating insulin into the bloodstream through the outer layers of the islet capsules.

In the primate studies, the encapsulated porcine islets were transplanted by means of intraperitoneal injection rather than by more invasive surgical procedures. This procedure significantly reduces the trauma and infection risks inherent in major surgery, and minimizes post-transplant recovery time.

For the therapeutic approach being developed, MicroIslet anticipates that some patients with diabetes may require periodic transplantations of additional islet cells after an initial procedure. The second procedure would replace previously transplanted insulin-producing islets whose immunoisolation has been compromised by the patient's natural immune rejection reaction or by cell attrition over time. The Company previously conducted re-transplantation experiments in small animals and found that the subsequent transplants were at least as effective and well tolerated as the first transplant. Parallel tests in primates are planned for later stages of the primate studies currently underway.

"The crucial elements of our proprietary approach to treating diabetes through transplantation are coming together," commented Dr. James R. Gavin III, M.D., Ph.D., Interim President and Chief Executive Officer of MicroIslet. "Although the data is preliminary and there remain challenges, we are encouraged by the data received to date. As I discussed in my recent communication to shareholders, MicroIslet enjoys exclusive access to the Mayo Foundation's designated pathogen free pig facility for the treatment of diabetes, and we know of no other facility in the United States that is presently able to supply such pigs. MicroIslet's islet replacement program thus combines an existing supply of suitable cells with a promising approach for addressing immune response, both of which are essential elements for a sustainable program of successful transplantation of islet cells from foreign sources."

About MicroIslet

MicroIslet is a biotechnology company engaged in the research, development, and commercialization of patented technologies in the field of transplantation therapy for people with insulin-dependent diabetes. MicroIslet's patented islet transplantation technology, exclusively licensed from Duke University, includes methods for isolating, culturing, cryopreservation, and immuno-protection (microencapsulation) of islet cells. MicroIslet is working to develop and commercialize a first product, called MicroIslet-P(TM), a microencapsulated porcine islet cell suspension that will be used for transplantation in patients with insulin-dependent diabetes. Additional information about MicroIslet can be found at http://www.microislet.com.

Except for the historical information contained herein, the matters set forth in this press release, including the implication and interpretation of preliminary data, the expectation of development of new therapeutic products and the impact of MicroIslet's products on diabetes patients, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including MicroIslet's ability to continue as a going concern, the risks and uncertainties inherent in medical treatment discovery, development and commercialization, the risks and uncertainties associated with MicroIslet's early stage xenotransplantation technologies, the risks and uncertainties of governmental approvals and regulation, dependence on the Mayo Foundation for Medical Education and Research as a sole source supplier of animal parts for pre-clinical and clinical studies, MicroIslet's need to raise substantial additional capital to proceed through human clinical trials and bring any product to market, the risks that MicroIslet's competitors will develop or market technologies or products that are more effective or commercially attractive than MicroIslet's products, and other risks detailed from time to time in MicroIslet's most recent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. MicroIslet disclaims any intent or obligation to update these forward-looking statements.

MicroIslet, Inc.
http://www.microislet.com