Discusses Filing Requirements for the Company's Lead Product
SAN DIEGO--(BUSINESS WIRE)--Dec. 13, 2007--MicroIslet, Inc.
(MIIS.OB, http://www.microislet.com), a biotechnology company engaged
in the development and commercialization of transplantation therapies
for diabetes, announced that it has met with the U.S. Food and Drug
Administration (FDA) to discuss requirements for the filing of an
Investigational New Drug (IND) application for MicroIslet-P(TM), a
microencapsulated suspension of pancreatic islet cells.
As a result of the meeting, MicroIslet has clarified details of
the development path for its xenotransplantation approach, which
involves microencapsulation of insulin producing porcine islet cells.
The Company's last meeting with the FDA in December 2006 related to a
proposed IND for allotransplantation of microencapsulated human islet
cells. The Company's current strategy is to proceed directly to human
clinical trials of its xenotransplantation approach, which overcomes
the inherently limited supply of human islets. The proprietary
encapsulation methods used in MicroIslet-P(TM) are designed to shield
the islet cells from immune system rejection, while the planned
implantation procedures will be minimally invasive. The Company's
pre-clinical testing to date has demonstrated a strong safety profile
for xenotransplantation of porcine islets in rodents and non-human
"MicroIslet appreciates the positive instruction and interactions
we received in our pre-IND meeting with the FDA," said Michael J.
Andrews, Chief Executive Officer of MicroIslet. "Their clear advice
will greatly assist our IND application planned for the third quarter
of 2008, and the subsequent initiation of MicroIslet's "first in man,"
U.S. clinical trial. Based on the meeting, we are excited that a
regulatory path is in place for the initiation of MicroIslet's
U.S.-based human clinical trials."
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.
About MicroIslet, Inc.
MicroIslet is a biotechnology company engaged in the research,
development, and commercialization of patented technologies in the
field of transplantation 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
transplantation. MicroIslet is exploring possible human clinical
trials in both the U.S. and abroad. MicroIslet's ultimate goal is to
offer cell transplantation therapies for diabetic patients worldwide.
Additional information about MicroIslet can be found at
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 need to
raise substantial additional funds in order to fund its new strategy
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.
CONTACT: The Investor Relations Group
Daniel Berg/Conrad Mir
Hayden Lynch/Janet Vasquez
SOURCE: MicroIslet, Inc.