Saturday, December 29, 2007

The First Stem Cell Corporation Podcast

Welcome to this podcast. I am Ken Aldrich, Chairman and co-founder of International Stem Cell Corporation.

International Stem Cell Corporation recently announced that our scientific team, led by our Chief Scientist, Dr. Elena Revazova, has created a new class of human stem cell lines that do not involve the use of fertilized eggs and may enable hundreds of millions of people of different sex, ages and racial groups to benefit from cell based therapy with cells that will not be rejected by the patients own immune system after transplanting. The article was published in the on line edition of the well known peer-review publication, Cloning and Stem Cells on December 19, 2007

Since that time, we at International Stem Cell Corporation have received many questions about this discovery, most of which revolve around two basic questions: how are these cells different from what already exists and why does it matter? Since we are a public company that trades on the Bulletin Board--our symbol for those who are curious is ISCO.OB--a great deal of information about these questions has already been filed with the SEC and also been posted to our website, but I think a summary will be helpful, particular for those unfamiliar with the science of therapeutic cell implantation.

The 20th Century saw the development of whole organ transplants as a means to treat injury or diseases affecting the heart, liver, kidneys and other organs. The 21st Century has already seen the beginnings of a newer and even more promising therapy: the transplantation of human cells to enable damaged organs to begin functioning again on their own. Some of the new cell based treatments are quite advanced; others are in development, but all transplant programs to date share three basic problems:

  • First, the only source of organs or cells has been human donation, usually from cadavers, or cells derived from fertilized embryos. The need for cadavers has meant that only a tiny portion of the patients who needed cell or organ therapy could obtain a donation.
  • Second, until now, the only source of cells that had the potential produce cells in unlimited quantity for any organ of the body have been cells derived from fertilized embryos. That has raised religious and ethical questions that have hampered research and continue to do so.
  • Finally, all of treatments available so far require heavy use of immune suppressing drugs to prevent rejection of the new cells by the patient’s immune system.

That is why Dr. Revazova’s two recent discoveries are so important. They open the door to obtaining an unlimited supply of cells, without the use of cadavers or fertilized embryos, and that can be immune matched to hundreds of millions of patients so that that they will not be immune rejected after transplantation.

Our cell lines are known by the tongue twisting name of “Parthenogenetic HLA-homozygous” lines, and you can expect to be hearing a lot more in the months to come about Parthenogenesis, HLA matching and “homozygous” cell lines. However, the easiest way to think of what we are doing is to think of a blood bank in which a physician can find blood to match the need of any patient. HLA matching is more complex, but the concept is the same—provide cells that will not be rejected after transplanting.

To put that in perspective, if you are a 5 year old child whose immune system is still developing and you are diagnosed with a dreaded disease, there may cell transplant treatments already being tested or in use that might provide a cure, but they will be of no use to you because of the difficulty of finding a tissue match and the danger to a young child of taking large doses of immune suppressing drugs. The drugs could be far more dangerous to a child than the disease itself.

We have just taken the first giant step toward solving that problem.

Our cells also have great potential in the treatment of genetic disorders such as Alzheimer’s, diabetes, muscular dystrophy, Parkinson’s disease, and many others because we can provide cells from cell lines that do not carry the same genetic defects, but that is a complex subject that is better left to a later discussion.

There is still much work to be done to make cell based therapy available to all who could use it and no one company can do it all. That is why, although our scientists are the only people in the world who have perfected a technique for creating parthenogenetic HLA-homozygous cells, we have filed patents that describe how such cells can be created so that we can share with others the secrets of how to do it. Our goal is to work with researchers throughout the world to assure that, in time, no person who could be helped by a cell transplant need ever go without that help because there were not enough cells available that were compatible with his or her immune system.

To listen to a Podcast of this posting, please press the green arrow below or visit the ISCO Podcast home page at http://internationalstemcell.podbean.com




Sunday, December 23, 2007

Science Daily Article

Human Embryonic Stem Cell Lines Created That Avoid Immune Rejection

ScienceDaily (2007-12-21) -- In a groundbreaking experiment scientists have derived four unique embryonic stem cell lines that open the door for the creation of therapeutic cells that will not provoke an immune reaction in large segments of the population. The stem cell lines are "HLA-homozygous," meaning that they have a simple genetic profile in the critical areas of the DNA that code for immune rejection. The stem cells under development are derived from unfertilized donor eggs, not from fertilized embryos, so the technique does not carry the same ethical burden.

Source: http://www.sciencedaily.com/releases/2007/12/071220123837.htm#

Wednesday, December 19, 2007

International Stem Cell Corporation Creates Human Stem Cell Lines That Can Eliminate Immune Rejection by Patients;

Discovery is a Step Closer to a Universal Stem Cell Line for Human Therapeutics and Creation of a Global Stem Cell Bank

Oceanside, California, December 19, 2007— Scientists at International Stem Cell Corporation (OTCBB: ISCO) have created unique human stem cell lines that make them easily "immune matched" to human beings and could enable the creation of a bank of stem cells that could be used, without rejection, by a majority of the different people and races of the world.

The findings are outlined in a scientific peer review paper entitled "HLA Homozygous Stem Cell Lines Derived from Human Parthenogenetic Blastocysts" which was announced in the December 19, 2007 online edition of Cloning and Stem Cells Journal: http://www.liebertonline.com/doi/pdfplus/10.1089/clo.2007.0063


Contacts:

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
kaldrich@intlstemcell.com

Jeff Krstich, CEO
jkrstich@intlstemcell.com
760-940-6383

Media Relations:
The Orbach Company, Inc.
Nevena Orbach
818-904-0500
nevena@orbachco.com

ABOUT INTERNATIONAL STEM CELL CORPORATION:
International Stem Cell is a biotechnology company currently focused on developing therapeutic and research products through the use of human stem cells. In the area of therapeutic product development, ISCO's objective is to create an unlimited source of human cells for use in the treatment of several diseases, including diabetes, liver disease and retinal disease through cell transplant therapy. In furtherance of this objective, ISCO has developed pluripotent human stem cells from unfertilized human eggs, and techniques to cause those stem cells to be "differentiated" into the specific cell types required for transplant. It has developed manufacturing protocols to produce the cells minimizing contamination with animal by-products, a characteristic likely to be important in meeting U.S. Food and Drug Administration requirements. ISCO also provides the specialized cells and growth media needed for therapeutic cell transplantation research to academic and commercial researchers in related fields. For more information, visit the ISCO website at: http://www.internationalstemcell.com/.

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http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

Forward-Looking Statements

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development and potential opportunities for the company and its subsidiary, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.

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Sunday, December 9, 2007

A Message from the CEO - Jeff Krstich

Recently it was widely reported by the media that two groups of scientists have succeeded in turning human skin cells into cells that are very similar, though not identical, to embryonic stem cells. The media reports highlight that the method used to create stem cells from skin cells, called de-differentiation, does not involve the destruction of any human embryos.

As expected, the media attention generated numerous inquiries to our company, primarily on how this new research differs from ours, and what effect it might have on the field of stem cell research and our activities in that field.

Although the new discovery is scientifically exciting, it will not alter International Stem Cell’s basic strategy for providing human cells for transplant therapy. The reason is that our scientists, through our proprietary process called “Parthenogenesis”, have already created human stem cell lines that have the same characteristics as embryonic stem cells, and also do not involve the use or destruction of any fertilized human embryos.

Parthenogenesis enables us to produce Parthenogenetic Stem Cells Lines that can deliver an unlimited supply of cells for research or therapy, as needed and on demand. Our “Parthenotes” are already being produced in our laboratories and are available for use today by qualified researchers in any country that honors US and International patent laws. We have also differentiated some of those Parthenotes into specific cell types such as nerve cells and heart cells; some of which are already in production and expected to be used in human trials in 2008.

Unlike the cells derived through the recently announced de-differentiation of skin cells, our Parthenogenetic process does not involve viruses that can transmit disease, nor the use of specific genes that the scientists who published the recent work acknowledge are known to potentially be cancer producing. In addition, ISCO Parthenotes are developed with either no use or minimal use of animal serums or animal by-products, a problem that affects all of the lines currently “approved” by the Federal Government.

For all these reasons, we have chosen not to pursue de-differentiation, but to focus on creation of Parthenogenic Stem Cell Lines and the cells that can be created from them. Although we actually hold license rights to a technology for producing de-differentiated cells, we prefer to focus on Parthenotes, which offer the same freedom from the use or destruction of human embryos, are already available for production in quantity for research (or therapy once appropriate approvals are received), and are not burdened by the risks of introducing viruses or potentially cancer causing genes.

To summarize:

1. De-differentiation is an interesting discovery that may best be utilized for drug testing in a lab setting. Unfortunately, because of its inherent cancer producing potential, coupled with its use of viruses that may transmit disease, it is not currently suitable for human therapeutics.

2. If, however, the inherent flaws in de-differentiation are somehow solved and the process evolves to show greater promise, our company already holds license for a similar process and we could quickly pursue that avenue as well.

3. Our Parthenogenetic Stem Cells already can provide all the things that de-differentiation derived cells promise, and more:

a) Our stem cells do not require fertilized embryos and thus no fertilized embryos are destroyed in the process.

b) Our stem cells do not employ the use of any cancer causing genes.

c) Our stem cells use no viruses that can cause disease.

d) Our stem cells use none or minimal animal serums or animal by-product.

e) Our stem cells hold the promise for human therapeutic use with the distinct advantage of requiring little or no immunosuppressant drugs.

f) We are already producing human stem cells suitable for clinical trials, doing so in quantity and under strict quality control, and expect to be using those cells in two Phase I trials shortly.

In conclusion, although we respect and indeed applaud the scientific achievement of this newly published research, we do not believe it will have significant impact on our scientific pursuits, and certainly not a negative one. On the contrary, we find that every advance in stem cell research buoys the entire field. It generates excitement and optimism. Most importantly, it shines more light on what we believe to be the most promising area of medicine, and brings us ever closer to cure disease and reduce human suffering.

As always, we stand ready to respond to your questions and comments.

Most sincerely,

Jeff Krstich,

Chief Executive Officer.

Forward-Looking Statements

This news release and the "Message from the CEO" on the company's website to which it refers, contain statements pertaining to future research, clinical development and potential opportunities for the company and its subsidiary, along with other statements about the future expectations, beliefs, plans, goals, or prospects expressed by management. Those and any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should be considered forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.