MII Microislet

* Company preparing for IND filing toward trials of insulin-producing islet allotransplantation therapy to combat diabetes SAN DIEGO, Dec. 13 /PRNewswire-FirstCall/ -- 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 that it has concluded a positive Pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA). The focus of the meeting was the Company's plans for the commencement of clinical trials of its microencapsulated insulin-producing islet transplantation therapeutic approach to treat Type 1 (insulin-dependent) diabetes. As a result of the meeting, MicroIslet has clarified details of the development path for its allotransplantation (same-species) candidate therapeutic approach, which involves microencapsulation of insulin-producing human islet tissues to protect them from immune system rejection, and implanting them, using a minimally invasive procedure, in diabetic patients. Prior pre-clinical testing of the procedure in laboratory animals has demonstrated a strong safety profile. "We appreciate the thoughtful, comprehensive and responsive hearing we received in our pre-IND meeting with the FDA," commented James R. Gavin III, M.D., Ph.D., President and Chief Executive Officer of MicroIslet. "While we introduced both our allotransplantation and xenotransplantation plans in this meeting, the primary focus was our near-term plan to build upon the promising results of the Edmonton Protocol studies in 2002." Allotransplantation refers to transplantation between members of the same species; xenotransplantation involves transplanting tissues between one species and another. Dr. Gavin continued, "The Edmonton Protocol established the utility of human-to-human islet transplantation to provide the patient with a steady supply of insulin, in contrast with the sharp peaks and troughs of blood insulin levels experienced by many patients with diabetes who fail to achieve control using repeated injections of insulin, which is today's treatment standard. Our view is that employing our proprietary microencapsulation techniques to protect the transplanted islets may allow recipients of transplanted islets to forgo the chronic regimens of immunosuppressive medications employed in Edmonton Protocol patients and thus to avoid substituting one chronic problem with another." Dr. Gavin concluded, "We believe that this useful and timely meeting provided us with essential guidelines on the structure and scope of the toxicity studies that we plan to conduct in preparation for submitting an IND application. In addition, the meeting helped affirm the appropriateness of the types of patients targeted for the clinical trials, and as such, the Company expects to initiate clinical trials as previously outlined in the Company's public filings." The Company currently plans to file an Investigational New Drug (IND) application in Q3 2007. An IND application is documentation that must be submitted to the FDA before a new drug (or biologic) can be used for human testing. The documentation includes evidence that the compound is biologically active and is safe for initial administration to humans in clinical investigations (i.e., pre-clinical efficacy, safety tests, pharmacology, dose ranging, manufacturing procedures and proposed first protocol). An IND is subject to an automatic 30-day review period. If no clinical hold is issued within the 30-day period, the sponsor may begin the clinical trials with Institutional Review Board approval. Pre-IND meetings are conducted with the appropriate FDA review division that would review the drug marketing application, and these meetings are requested by the sponsor of a drug. Meetings at this stage in the process are useful opportunities for open discussion about testing phases, data requirements, and any scientific issues that may need to be resolved prior to IND submission. 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 islet transplantation technology, including patented 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-H(TM), a microencapsulated human islet cell suspension that will be used for transplantation in patients with insulin- dependent diabetes. MicroIslet is also working to develop and commercialize a second product, MicroIslet-P(TM), a microencapsulated porcine islet cell suspension for transplantation in patients with insulin-dependent diabetes, which if successful, will address the inherently limited supply of human islets. 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 timing of the filing of an IND application and the commencement of human clinical trials, 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 allotransplantation and 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 complete all of the steps prior to the IND submission, commence human clinical trials and ultimately proceed through such 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. For more information, please visit our Web site at http://www.microislet.com/. For further information, contact: Kevin A. Hainley, MicroIslet Inc. 858-657-0287, Sean Collins, Senior Partner CCG Investor Relations & Strategic Communications 310-231-8600 ext. 202 ISIN US59507Q1067 DATASOURCE: MicroIslet, Inc. CONTACT: Kevin A. Hainley of MicroIslet, Inc., +1-858-657-0287, ; or Sean Collins, Senior Partner of CCG Investor Relations & Strategic Communications, +1-310-231-8600, ext. 202, for MicroIslet, Inc. Web site: http://www.microislet.com/

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