MicroIslet Holds Positive Pre-IND Meeting With FDA
December 13 2006 - 7:00AM
PR Newswire (US)
* 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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