MicroIslet Provides Safety and Efficacy Data Update
To date, MicroIslet has seen no adverse events attributable to MicroIslet-P(TM) in its animal models. The Company has tested hundreds of rodents and is currently completing a trial with nineteen non-human primates. Eighteen of the nineteen have been tested, and the last primate has received its final dose. Importantly, the primates have been subjected to one, two, or even three, separate transplant procedures, with no observed ill effects.
MicroIslet also has efficacy data demonstrating that MicroIslet-P(TM) can produce normoglycemia in both immune comprised and immune competent rodents. Additionally, all primates tested to date, post-implant, have demonstrated decreases in insulin requirements needed to maintain their blood glucose levels at a healthy concentration. Finally, post-implant, the primates have been primarily managed with long-acting insulin as opposed to acute insulin treatment, indicating improved glucose homeostasis (control).
MicroIslet is now in the process of patenting a new, enhanced, encapsulation formulation, which is being used in a current Good Laboratory Practices (GLP) rodent toxicity trial, and is the Company's intended formulation for use in its planned human trial. The improved capsules appear to be not only more durable, but they also retain, and may increase, the positive functionality characteristics of previous formulations. Accordingly, MicroIslet believes that the new formulation will enable: (a) a greater decrease in insulin requirements, (b) better blood glucose control, and (c) increased capsule longevity.
"We feel that these are significant and meaningful results as we move closer to our planned human clinical trials," said Michael J. Andrews, chief executive officer of MicroIslet. "Additionally, I'm pleased to announce that the Company recently held a 'developmental summit' with our corporate partners to ensure that we are staying the course for our previously stated goal of filing an Investigational New Drug application (IND) in late third quarter 2008."
About MicroIslet, Inc.
MicroIslet is a biotechnology company engaged in the research, development, and commercialization of patented technologies in the field of cell therapy for patients with insulin-dependent diabetes. MicroIslet has licensed several technologies from Duke University for isolation, culturing, storage, and microencapsulation of insulin-producing islet cells from porcine sources. The Company believes that these technologies, and other proprietary methods developed in-house, are significant advances in the field of cellular therapeutics. MicroIslet is planning human clinical trials in the U.S., and exploring possible trials abroad. MicroIslet's ultimate goal is to offer cell transplantation therapies for diabetic patients worldwide.
The Company's lead product, MicroIslet-P(TM), consists of microencapsulated porcine islets for implantation into the abdominal cavity using a minimally invasive procedure. Microencapsulation involves surrounding islet cells with formulations of a highly biocompatible, ultra-pure biopolymer, called alginate, or other similar biocompatible polymers. The alginate coating allows insulin, glucose, oxygen and other nutrients to diffuse freely, while blocking antibodies and reducing the patient's immune response to the implanted islet cells. It is hoped that MicroIslet-P(TM) will provide physiologic and self-regulating blood glucose control, thus reducing the need for insulin injections or infusions and constant blood glucose monitoring. The long term complications associated with type 1 diabetes, such as peripheral neuropathies, heart and kidney disease, and skin disorders, may be mitigated by the tighter blood glucose control that would result from such a product.
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 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 working capital deficit, which includes a substantial amount of indebtedness which is matured and due on demand; MicroIslet's need to raise substantial additional funds in order to fund its development plan and 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, including foreign government approvals for clinical trials outside the United States; dependence on a sole source supplier of animal parts and a sole source manufacturer of encapsulated islets for pre-clinical and clinical studies; 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.
Michael J. Andrews, CEO, 858-657-0287
The Investor Relations Group
Erika Moran, 212-825-3210
Lynn Granito/Steven Melfi, 212-825-3210
Posted: July 2008