EXHIBIT 99.4
MICROISLET AND PROGENITOR CELL THERAPY ENTER INTO AGREEMENT FOR THE
MANUFACTURING OF MICROISLET-P, AN ENCAPSULATED ISLET CELL PRODUCT FOR THE
TREATMENT OF TYPE 1 DIABETES
Monday September 17, 10:05 am ET
SAN DIEGO and HACKENSACK, N.J., Sept. 17, 2007 (PRIME NEWSWIRE) -- MicroIslet,
Inc. (OTC BB:MIIS.OB - NEWS), a development-stage biotechnology company with
patented and proprietary technologies focused on transplantation therapy for
people with insulin-dependent diabetes, and Progenitor Cell Therapy, LLC (PCT),
a leading cell therapy services company, announced today that they have signed
an agreement for the manufacturing of MicroIslet's premier product,
MicroIslet-P(tm).
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.
MicroIslet-P(tm) will be manufactured at PCT's California facility under strict
cGMP (current Good Manufacturing Practices) and will be used in MicroIslet's
ongoing preclinical studies and planned clinical programs.
"MicroIslet has refocused its efforts to accelerate the clinical testing of the
Company's xenograft MicroIslet-P(tm) product. This plan required us to secure a
cGMP manufacturing partner to produce MicroIslet-P(tm) for human trials. This
arrangement with PCT is a major step forward toward execution of our plan. PCT
has state-of-the-art facilities and some of the most qualified cell therapy
specialists I have encountered in my 25-year career in biological manufacturing.
We are quite pleased to be working with PCT," said Xxxx Xxxxxxx, MicroIslet's
chief executive officer.
"Progenitor Cell Therapy's management team has over 100 years combined
experience in cell therapy, built 5 cGMP facilities, and participated in over 50
regulatory filings in the US and Europe. The company has, to date, served over
100 clients, manufactured over 17,000 cell therapy products, approximately 5,000
of which have already been used for patient treatment, and performed over 30,000
cell therapy procedures involving over 20 different types of cell-based
products. We are pleased to be leveraging this experience for MicroIslet," said
Xx. Xxxxxx X. Xxxxx, president and chief scientific officer of PCT.
About Progenitor Cell Therapy, LLC:
Progenitor Cell Therapy, LLC (PCT) is a client-based company providing turnkey
cell therapy services solutions for the research, development, manufacture and
commercialization of cell-based therapies. With its network of cell therapy
manufacturing facilities and team of professionals, PCT provides current Good
Manufacturing Practices (cGMP)-compliant services for pre-clinical and clinical
development, manufacture, and commercialization of cellular therapies for
clients throughout the world. For more information, please visit
xxxx://xxx.xxxxxxxxxxxxxxxxxxxxx.xxx.
About MicroIslet:
MicroIslet is a biotechnology company engaged in the research, development, and
commercialization of proprietary and patented technologies in the field of
transplantation therapy for people with conditions requiring cell-based
replacement treatments, with a focus on type 1, or insulin-dependent, diabetes.
MicroIslet's patented islet transplantation technology, exclusively licensed
from Duke University, along with its own proprietary developments, constitute
methods for isolating, culturing, cryopreservation, and immuno-protection
(microencapsulation) of islet cells. MicroIslet intends to continue its research
and development efforts, and ultimately, to introduce products to the market.
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
immediate 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.
Additional information about MicroIslet can be found at
xxxx://xxx.xxxxxxxxxx.xxx.
CONTACT:
MicroIslet, Inc.
Xxxxxxx X. Xxxxxxx, Chief Executive Officer
(000) 000-0000
Progenitor Cell Therapy, LLC
Xxxxxx X. Xxxxxxxxxx, Chief Business & Financial Officer
(000) 000-0000
