September 19, 2003 A Forbes Magazine article today on Dr. Patrick Soon-Shiong of American Bioscience, Inc., quotes Scott R. King of Islet Sheet Medical on the impact Dr. Soon-Shiong's former research on the cell transplantation industry.
Because we have been raising money we have posted little new information here. So here is an update on our progress toward a venture financing.
Some degree of investor hope in the future has returned after two years' absence. The Edmonton Islet Transplantation Protocol has been shown to work at several centers with over 100 people cured of diabetes (at the cost of expensive life time drug therapy). Scientists and analysts are increasingly concluding that Islet Sheet is the most promising technology to make islet transplantation possible without drugs. New technologies (such as stem cells) promise unlimited islet supplies. As a result of these developments investors are coming forward to fund Islet Sheet Medical LLC's Series A equity round.
Our goal is to begin clinical studies with the Islet Sheet within two years of the closing of the Series A financing.
Click here to see a slide presentation on the company (broadband only).
September 3, 2002 Rick Mendosa, a prominent writer on diabetes issues, has published a review of Islet Sheet Medical's "Hanuman Garden" web site in his column on the ADA web site. Click here to see.
November 1, 2001 Regulatory requirements will limit what I can add to the Islet Sheet Medical web site for the next few months, so here is a roundup of new developments.
First, we have decided to do our first equity financing to fund the remaining preclinical studies. Because the cost of large animal research is so high (over $25,000 per experiment!) we are no longer able to raise money fast enough from "angels". We are very grateful to the 21 angels that have funded our work for our first four years -- when we started, there was virtually no interest in the bio-artificial pancreas, and without the angels we would not have accomplished our proof of principle. Thanks to their $800,000, we have the most impressive results in our industry.
Things have changed in the investment world because of a changing investment environment (the dot.com collapse) and, in particular, appreciation of the Edmonton Protocol. I can now express our goal in a single phrase: "to make the benefits of the Edmonton protocol available without drugs." That makes a difference! Last week in New York I talked about the changing environment at the TechVest conference. You can take a look at my slides; click here (big graphics; recommended for broadband only). I concluded with a strategic analysis demonstrating that Islet Sheet Medical is in the best strategic position in the bio-artificial pancreas industry.
The message was received and believed. I have just agreed to undertake under the auspices of a medical venture capitalist an equity financing. Our goal is to raise enough money to get the Islet Sheet into clinical studies. Out new partner is an M.D. and has treated many people with diabetes, and is excited about our work and results. The SEC unfortunately has strict restrictions on companies that are raising money, so for the next few months I will be unable to post news here.
Finally I would like to mention a new link. Our friend Mary Connors has a new book about diabetes, Sweet Blood & Fury. It is a good read. My recommendation is unaffected by her interview of me starting on page 246. Mary is donating $1 to ISM for every book sold. Thanks Mary! Click on the book cover below to learn more.
September 20, 2001 We have nearly finished our analysis of the large animal data we generated over the past year. I am pleased to tell you that, taken as a whole, the data support a logical understanding of what happens to an Islet Sheet implanted into a large animal. Now we are addressing the practical steps needed to develop methods to attach sheets permanently.
Let me first review the problem we face. For many reasons, Islet Sheet Medical has been devoted to developing methods to encapsulate islets of Langerhans into a fairly large (business card size) thin sheet. The most difficult problem has been making a device this large that is tolerated by the body, one that is not recognized as foreign and isolated by the process of fibrosis. Early this year we demonstrated that the current Islet Sheet (made without cells) is tolerated for months without significant reaction (click here for bioneutrality studies). This was the key breakthrough, the one that showed us that the sheet is likely to work. We anticipated that adding the islets would produce the same result and we could begin studies of Islet Sheets in diabetic large animals.
To our surprise the first Islet Sheets with cells were not well tolerated. And the problem was not fibrosis, which usually appears in days or weeks, but an immediate reaction that looked like some local irritation. At first we were puzzled. We did some additional large animals studies, and then some laboratory studies. Now we believe that we have isolated the causes. Since these results are surprising, we will not publish them yet.
Our immediate task is to prove our hypotheses. Fortunately this can be done in small animal studies. We are now looking at Islet Sheets that are implanted in rats. (Recently our progress was disrupted by the freezing of international flights to Canada.)
We project that we will be returning the large animal preclinical studies in the first quarter of 2002.
July 4, 2001 Our preclinical studies at the University of Alberta continue with the goal of finding the best site for sheet implantation and the best method for securing the sheets in place. Suturing the corners of the sheets works, but is complicated to get right, so we are looking at other means. We have implanted Islet Sheets in four large animals since March without yet finding a site and an attachment method that meets all requirements. It appears that it may take several more months of such investigations before long term metabolic studies can begin.
The rate of progress has been less that we hoped. The sort of problems that occur in exploratory investigations have happened more often than we would like. For instance, one animal successfully received an autograft of Islet Sheets in several sites: the liver, the abdominal wall, and under the skin. The surgery went well but we found that the sheets were contaminated by bacteria, and naturally the animal reacted badly to the presence of bacteria. So we learned only that bacterial contamination is bad, which we already knew. Bacterial contamination of animal islets is rare but sometimes occurs.
We are trying to do something no one has ever done before: attach a thin sheet the size of the business card to the liver. We believe this problem will be overcome but we want to know the best solution before we begin long term studies. The large animal that received several autologous Islet Sheets this week is the most promising yet. June 29, 2001 In the Summer 2001 issue of Countdown, published by the Juvenile Diabetes Research Foundation, Robert S. Dinsmoor devotes his "The Scoop Behind the Scoop" column to Islet Sheet Medical. This is the first time an official publication of the JDRF has acknowledged Islet Sheet Medical's work. We hope this signals future collaboration between two organizations working toward a cure.