|BICO lays groundwork for human clinical trials of diabetes transplant technique |
By Gregory Thomas
Published by OTCNN.com
09/15/2000 09:12 AM EST
A new team of California biotech specialists leaves next week for North Carolina to lay the groundwork for human clinical trials of a new diabetes transplant technique developed at the Duke University Medical Center.
The recruits made travel plans as Pittsburgh based BICO, Inc. (OTCBB: BICO) announced two appointments yesterday at its 20% subsidiary, MicroIslet Inc., of La Jolla, California - Fred R. Kohn was named Vice President for pre-clinical and clinical development and Mayank Patel becomes Director of engineering.
MicroIslet holds several licenses on diabetes transplant technology developed by the research team of Dr. Emmanuel Opara, Duke's Director of islet transplant research.
BICO announced August 22 that Duke researchers had performed an islet cell transplant on a laboratory monkey afflicted with severe diabetes. The animal showed blood glucose readings in excess of 600mg/dl prior to the procedure. BICO said the transplant restored proper glucose control for a period well into the fourth month, giving the test animal consistently normal blood glucose readings between 80 and 110 mg/dl.
Kohn, who started at MicroIslet this week, says the visit to Duke would last two weeks or more.
"We have to communicate and co-ordinate activities very closely with Duke.They're the ones developing this technology. Our job is to take this technology and make it viable for human clinical trials," he told OTCNN.
Ten year process
Experimental transplant techniques generally undergo a rigorous nine to ten year series of clinical trials prior to U.S. Food and Drug Administration approval.
Kohn, formerly director of project management at Skye Pharma, Inc., holds a Ph.D. in Pharmacology from the University of Minnesota. At Skye Pharma, he lead the project team responsible for the development of sustained-release encapsulated morphine for the treatment of acute post-surgical pain.
Patel, a chemical engineer with an MBA in operations management from Rutgers, was senior process engineer at Sequenom, Inc. At Sequenom, he was responsible for implementing the production of diagnostic test kits for chip based DNA analysis.
Now Patel's role is managing and refining the clinical development process to ensure its suitability for clinical trials.
Kohn says he was recruited by Haro Hartounian, another former Skye Pharma executive and engineer, who joins MicroIslet to lead the diabetes project as company President.
The team will report to company founder and CEO John F. Steel IV, who said yesterday that additional key personnel would be joining the company in the near term. Kohn says Steel himself was diagnosed with type 1 diabetes over 20 years ago.
One priority facing MicroIslet is the establishment of a contract manufacturing facility that will meet and exceed FDA requirements for good manufacturing practices (GMP).
"We need a facility that can produce material under GMP," said Kohn. "We need that just for the initial clinical trial. That's standard for any kind of product development in the biotech area."
The company announcement says Patel has broad experience with an extensive background in aseptic pharmaceutical equipment design, commissioning, validation, and automation.
Kohn says the facility is likely to open in close proximity to the Duke University Medical Center.
Kohn continued, "I will be involved with running any pre-clinical research that is needed for getting into a clinical trial, as well as coordinating any regulatory and clinical activities. I will be responsible for putting together protocols, clinical boards, getting clinical sites set up, interaction with regulatory agencies, setting up quality assurance programs. Basically, all the pieces that are required for development of the product to get it into the clinic." In the past, researchers have attempted to transplant islet cells from a healthy pancreas to a diabetic patient, but researchers have failed to develop a successful cure for type 1 diabetes.
15 million Americans have diabetes, a chronic disease of the pancreas with no known cure. 2200 new cases are diagnosed each day. Diabetes is the seventh leading cause of death in the U.S.
Kohn speaks passionately of the potential for what he describes as the multiple intellectual properties licensed to MicroIslet.
"The cells are difficult to work with. It's difficult to keep them happy so they continue to produce insulin and the other hormones that they produce. That's been one of the main challenges that people have had, trying to get very viable cells."
"Many past processes for isolating islets damage them, so they do not produce enough insulin, or they do not survive for a long enough time."
Kohn says the researchers at Duke are developing new techniques for isolating the islet cells. There are also new techniques for preparing and culturing the cells in an ultra-pure alginate, and new techniques for cryo-preserving (freezing) them. As a result, the cells survive in a highly robust state.
"These cells are much happier when they're transplanted," he concludes.
BICO (formerly Biocontrol Technology), 20% parent of MicroIslet Inc., develops and manufactures biomedical devices and environmental products. It's 52% subsidiary Diasensor.com, Inc. owns the patents and rights to a noninvasive glucose monitor for diabetics, currently in the FDA approval process.