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MicroIslet Holds Positive Pre-IND Meeting With FDA

Wednesday December 13, 8:00 am ET

* 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 www.microislet.com.
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