Sunday, February 10, 2008

Summing Up Stem Cells by Kenneth Aldrich

As I have been traveling around the U.S. talking to editors and financial analysts about our company, International Stem Cell Corporation (“ISCO.OB), I am constantly struck by how much confusion there is about what stem cells are, what the difference is between “adult” and “embryonic” stem cells, and how they can be used in developing ways to treat dreadful diseases. Let me offer some thoughts that may be helpful.

First of all, let me refer you to what I think is the finest explanation of stem clls for the non-scientist I have ever read. It is contained in an article by Dr. Douglas Melton of Harvard University that was recently published in the Bulletin of the American Academy. (http://www.amacad.org/publications/bulletin/summer2007/stemcell.pdf). I urge anyone interested in understanding the world of stem cells to download it and read it.

However, there is one thing not covered by the article because it was not widely known at the time. Dr. Melton speaks of the differences between adult stem cells, which are limited in their capacity to become other types of cells, and embryonic stem cells, which can become any cell in the body. Embryonic stem cells are also at the heart of all the current debate about the ethics of stem cell research because they are obtained from fertilized human eggs.

What was not widely known at the time of Dr. Melton’s article is that there is a way of creating stem cells that have the same capacity to be changed into any cell in the body that might be needed for therapy or research, but do not use fertilized eggs. These are stem cells developed by my company, International Stem Cell Corporation, created by a process called Parthenogenesis. The cells are called Parthenotes. At the risk of sounding like a commercial, let me explain why we think these cells are so important.

The first reason is obvious. By avoiding the need to use fertilized eggs, we believe we can put to rest the fears of those who believe that destroying a fertilized embryo is destroying a human life. For reasons that can get quite technical, it is generally agreed that in humans a Parthenote cannot be implanted back into the donor’s womb and grow to be a human being. It is a cluster of cells that can still produce any cell in the body, but lacks a critical element necessary to allow it to attach to the uterus and become a baby.

The second reason is even more important. Any implanting of a cell to treat a disease is like transplanting a miniature organ. If you don’t have a match with the patient’s immune system, the body will reject the cell. It is one of the big problems not yet solved in cell transplant therapy and millions of dollars have been spent trying to find ways to trick the body into not attacking the implanted cell.

We think we have a better way by far. Because Parthenotes contain only the dna of the mother from whose egg they were derived, and not that derived from a father’s sperm, it is possible to create cells from a single stem cell line that can match the immune profile of hundreds of millions of people. That means that instead of having to search through hundreds of thousands of cell lines trying to find one that matches, a very small number of lines might suffice for most of the world’s population.

I’ll have more to say on the subject in a later posting, but this is probably enough for today.

Ken Aldrich
CEO
International Stem Cell Corporation
(ISCO.OB)

Thursday, January 24, 2008

The Loss of Jeff Krstich Spawns Several Beautiful Tributes

We were all deeply saddened by the sudden loss of ISCO's CEO Jeff Krstich. Listed below is a sampling of recently published articles eulogizing a great man and father.

North County Times - “International Stem Cell CEO Krstich Dies” By: BRADLEY J. FIKES - Staff Writer

OCEANSIDE ---- Jeff Krstich, chief executive of International Stem Cell Corp., died Jan. 20, the company announced Tuesday.

Krstich, 60, died of "an apparent heart attack", the company said in a press release. Kenneth C. Aldrich, chairman, has replaced Krstich as chief executive and will retain the chairman title.

The Oceanside-based company (ticker ISCO, which trades over the counter) is developing therapies from stem cells derived from unfertilized, or parthogenic, human egg cells.

"We are all shocked that Jeff would be taken at such a young age, but we are determined to use this tragic event as motivation to vigorously pursue stem-cell based therapeutic remedies that would help to fulfill Mr. Krstich's dream," Aldrich stated.

To read the article in full, please visit the Source Link Below
Source: http://www.nctimes.com/articles/2008/01/22/business/news/6_31_761_22_08.txt



Signs on San Diego - “CEO inspired others at his company, in personal life” By Terri Somers UNION-TRIBUNE STAFF WRITER

January 23, 2008
Whether he was meeting with his employees at International Stem Cells Inc. or coaching diminutive 5-year-olds in flag football, Jeff Krstich made people feel good about themselves and their contribution to the team effort, people who knew him say.

Or, as one International Stem Cell consultant said, “He always made me feel like I was the brightest penny in the room.”

Krstich, a former Navy test pilot who had been CEO at the Oceanside-based company since 2006, died Sunday of a heart attack. He was 60.

Friends, relatives and colleagues expressed shock yesterday that the robust and fit former captain of the U.S. Naval Academy football team, who had played lacrosse Saturday, is now gone.

“He was one of, if not the best, person I ever worked with in my entire career because he had vision and knew where we were going and made you so happy to be there,” said Jeffrey Janus, president of International Stem Cells.

To read the article in full, please visit the Source Link Below
Source: http://www.signonsandiego.com/news/business/biotech/20080123-9999-1b23iscc.htmll

Wednesday, January 16, 2008

San Diego North Coast Times Publishes ISCO Eye Surgery Trial Article


International Stem Cell Corp. Joins Eye Surgery Trial

OCEANSIDE -- Shares of International Stem Cell Corp. rose nearly 19 percent Monday after the company said it will supply corneal cells for human trials in an effort to improve vision correction surgery.

The Oceanside-based company's stock closed at 95 cents per share, up 15 cents for the day.

It is producing the corneal cells from unfertilized, or parthenogenic human egg cells, said Jeff Krstich, chief executive of the company, on Monday. These cells act like surface -- or epithelial -- cells for the cornea, the clear tissue in front of the eye.

Dr. Paul H. Chen is conducting the trial with the UCSD Shiley Eye Center, the Burnham Institute in La Jolla, the University of Michigan and other centers.

The trial will test whether adding the corneal cells after a laser surgery called photorefractive keratectomy, or PRK, can speed healing and reduce pain. Chen is also testing parthenogenically produced keratinocytes, a type of skin cell, Krstich said.

PRK is one popular kind of operation to correct vision. During the surgery the surface cells are removed. The procedure can cause pain and healing takes longer than another popular corrective surgery, LASIK, which preserves the surface cells, Krstich said.

(Click on the link below to read the article in full.)

Source: http://www.nctimes.com/articles/2008/01/15/business/news/7_10_411_14_08.prt

Tuesday, January 15, 2008

ISCO to Provide Corneal Epithelial Cells Differentiated from Its Parthenogenetic Stem Cells for Use in Photorefractive Keratectomy FDA Clinical Trial

International Stem Cell (OTCBB:ISCO) announced today that it will be providing corneal epithelial cells, derived from its Parthenogenetic stem cells and human keratinocytes (a type of skin cell), for use in Federal Drug Administration (FDA) clinical trials aimed at creating a tissue transplant technology to improve photorefractive keratectomy (PRK).

ISCO entered into a research agreement with Dr. Paul H. Chen, M.D. who has developed the cell transfer technology. He has a separate collaboration with the University of Michigan and is expanding his research team to include the University of California San Diego Shiley Eye Center, and Burnham Research Institute, both located in La Jolla, CA, and The State University New York (SUNY) Albany. Dr. Chen is on staff at Scripps Memorial, La Jolla and Scripps Encinitas Hospitals.

Today's announcement is part of ISCO's efforts to increase the clinical utility of its discoveries in culturing corneal-like tissues from its Parthenogenetic stem cells and to provide human stem cells for the study and cure of disease. Parthenogenetic cells come from unfertilized human eggs and can be immune-matched to millions of people therefore reducing ethical and immune rejection issues. "Our goal, in addition to conducting our own clinical trials in our targeted areas of ocular, liver and pancreatic diseases, is to do collaborations with other prominent researchers and provide our Parthenogenetic stem cells for their human trials," said Jeff Krstich, CEO, International Stem Cell Corporation.

"It is exciting to have our cells involved in studies that could lead to a safer and more effective treatment that hopefully will provide improved visual recovery, less pain, and an improved refractive correction outcome," noted Krstich. "If successful, such technology might also provide broader applications for the treatment of a variety of conditions, including non-healing epithelial defects, such as diabetic epithelial defects, neuropathic epithelial defects, and alkali burn epithelial defects."

PRK was the first clinical laser procedure to be developed for refractive vision correction, but lost favor to LASIK because the PRK procedure calls for laser ablation of the surface of the cornea which is relatively more painful and requires a longer healing time. PRK's advantages, however, include better vision improvement and fewer side effects associated with complications of the surgical "flap" that is created in the LASIK process. The PRK procedure does not require the creation of a flap and is associated with less risk of corneal ectasia, dry eyes, flap striae and epithelial ingrowth.

ABOUT INTERNATIONAL STEM CELL CORPORATION:

International Stem Cell Corporation (ISCO) is a California biotechnology company focused on developing therapeutic and research products. ISCO's technology, Parthenogenesis, results in the creation of pluripotent human stem cell lines from unfertilized human eggs that can be transplanted without immune-rejection. One of these lines called phSC-Hhom-4 can be a source of therapeutic cells that will not be immune rejected after transplantation into millions of individuals of differing sexes, ages and racial groups. These advancements offer the potential to create the first true "Stem Cell Bank" and addresses critical ethical issues by eliminating the need to use or destroy fertilized embryos. ISCO also produces and sells specialized cells and growth media worldwide for therapeutic research through its subsidiary Lifeline Cell Technology. For more information, visit the ISCO website at: www.internationalstemcell.com.

To subscribe to receive ongoing corporate communications please click on the following link: www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

About Dr. Paul H. Chen, M.D.

Dr. Paul H. Chen is a Board Certified ophthalmologist who provides comprehensive eye care with an interest in cataracts, glaucoma, eyelid enhancements, and laser vision correction.

Dr. Chen graduated summa cum laude in Molecular Biology from Princeton University and received his MD degree from Harvard Medical School. He completed his specialty training in Ophthalmology at the UCSF Medical Center in San Francisco.

His laboratory investigations have resulted in several scientific publications. Furthermore, he is the inventor of two U.S. patents used for the rapid diagnosis of infections. Dr. Chen has been involved in FDA clinical research on new eye drop treatments for corneal erosions, and he performed the first AlphaCor artificial corneal implants in San Diego County.

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.

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
kaldrich@intlstemcell.com
or
Jeff Krstich, CEO
jkrstich@intlstemcell.com
760-940-6383
or
Media Relations:
The Orbach Company, Inc.
Nevena Orbach, 818-904-0500
nevena@orbachco.com

Monday, January 7, 2008

San Diego Union Tribune Article Features ISCO

The Sunday Business Section of San Diego's Union Tribune included a timely article discussing the application of research companies for state funded planning grants. ISCO was mentioned several times. Check out the beginning of the article here or scroll down for the source link to read it in its entirety.

Photo by Sean DuFrene/San Diego Union Tribune/ZUMA Press

10 companies, 56 groups apply for grants to get stem cell products to trial

UNION-TRIBUNE STAFF WRITER
January 6, 2008

For the first time in its three-year existence, the state taxpayer-funded stem cell institute is offering grant money to biotechnology companies.

Ten companies, including at least two in San Diego, said they plan to apply for money for so-called disease teams, a cutting-edge concept of bringing academia and industry together to share expertise and perhaps speed the lengthy and expensive process of getting new therapies and diagnostics to market.

To read the complete article, please visit this source link:
http://www.signonsandiego.com/news/business/20080106-9999-lz1b6teamup.html

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