RegBlog: Over-Regulation of Parthenotes Stifles Valuable Scientific Research - by Sean J. Kealy

A recent article in Scientific American questioned whether research on stem cell lines derived from unfertilized eggs was too tightly regulated by the federal government.  Now that technology allows the creation of stem cells without fertilization, there is no question that federal laws and guidelines are overly restrictive, causing a detrimental effect on valuable scientific inquiry.  

Since 1996, Congress has included the Dickey-Wicker Amendment in the annual federal budget.  This amendment was a conservative reaction to what some considered to be scientific research that showed little respect toward life.  

For example, speaking to the Senate in 1996, Robert Smith (R-NH) said, “Just because a private party wants to destroy life, why should Government force taxpayers to give their blessing to that act?  Let private parties use private money for their ethically challenged experiments.”  Similarly, Representative Jay Dickey (R-AR) said, also in 1996, that embroyonic research was “an attack on the sanctity of life,” and pointed out that several pro-life organizations supported the amendment. 

Please click here to read the complete article. 

Source: http://www.law.upenn.edu/blogs/regblog/2011/12/over-regulation-of-parthenotes-stifles-valuable-scientific-research.ht

Listen to International Stem Cell Corporation's November 17th Business Update Conference Call

To listen to International Stem Cell Corporation's November 17th Business Update Conference Call, please click HERE

California Stem Cell Report Article: “Trounson, Parthenotes and International Stem Cell”

Source: http://californiastemcellreport.blogspot.com/2011/11/trounson-parthenotes-and-international.html

The president of the California Stem Cell Agency, Alan Trounson, popped up in a recent article in Scientific American dealing with a method for creating pluripotent stem cells from unfertilized human eggs. 

The piece by Julia Galef said that "many investigators remain frustrated" that the method "remains offlimits" for federal funding, a barrier that does not apply to financing from the $3 billion California stem cell agency. 

Galef wrote that one California firm, International Stem Cell Corp., of Carlsbad, is using the method to develop products. She said the firm's work involves "a process called parthenogenesis, in which researchers use chemicals to induce the egg to begin developing as if it had been fertilized. The egg—called a parthenote—behaves just like an embryo in the early stages of division. Because it contains no genetic material from a father, however, it cannot develop into a viable fetus." 

To read the complete article on "California Stem Cell Report", please click here  

International Stem Cell Comments on Recent SCIENTIFIC AMERICAN Article: “You Say Embryo, I Say Parthenote”

“We at International Stem Cell Corporation (ISCO.OB) are finding it increasingly gratifying that mainstream and highly respected publications like Scientific American are now beginning to take notice of the fact that our Parthenogenetic Stem cells have tremendous potential to accelerate disease cures, lower health care costs, and create jobs here in America -- all free from the bioethical issues that have long clouded the stem cell debate."

Like embryonic stem cells, our Parthenogenetic stem cells can be converted into almost any kind of cell that might ever be needed for therapy, but can also provide a solution to the two biggest issues that have surrounded embryonic stem cell research: 1) the ethics of destroying a fertilized embryo, which our process never does, and 2) the problem of immune rejection by the patient.  We hope you enjoy the attached article." 

Ken Aldrich, Founder and Co-Chairman, International Stem Cell Corporation

October 21^st, 2011

“You Say Embryo, I Say Parthenote”

Stem cells from unfertilized eggs may be too tightly regulated

By Julia Galef

Article: http://www.scientificamerican.com/article.cfm?id=you-say-embryo-i-say-parthenote

Source: Scientific America November 2011

International Stem Cell Corporation and Reproductive Medicine Associates of New York Announce Breakthrough in Creating an Abundant and Ethical New ...

International Stem Cell Corporation and Reproductive Medicine Associates of New York Announce Breakthrough in Creating an Abundant and Ethical New Source of Human Pluripotent Stem Cells

Oceanside, Calif., October 27, 2009 — International Stem Cell Corporation (OTCBB:ISCO, www.internationalstemcell.com) and Reproductive Medicine Associates of New York (RMA of New York) have shown that immature, unfertilized human eggs can be used to create “parthenotes” from which human parthenogenetic stem cell lines may be derived. Immature eggs are normally discarded during standard in vitro fertilization (IVF) procedures due to their inability to create an embryo. This discovery vastly increases the opportunity for ISCO to create new stem cell lines and hastens the time when “banks” of stem cells that match a patient’s immune system may be available. This vision of a “patient matched stem cell bank” could function similarly to how blood banks currently store and distribute blood products.

A “parthenote” results when an egg divides without using sperm (no fertilization) and can yield “parthenogenetic” stem cells that have similar medical potential as embryonic stem cells to create various human tissues for therapy yet have the additional medical advantage of allowing immune-matching to reduce the chance of rejection - a significant potential problem with the use of embryonic stem cells. Parthenogenesis also addresses critical ethical issues by eliminating the need to use fertilized embryos.

According to Dr. Alan Copperman, Director of the Division of Reproductive Endocrinology and Infertility and Vice-Chairman of the Department of Obstetrics, Gynecology, and Reproductive Science at Mount Sinai Medical Center in New York, “This scientific breakthrough opens many new opportunities for our clinical and scientific teams to explore. Transforming immature oocytes into stem cell lines capable of differentiating into a variety of cell types has the potential to revolutionize the field of regenerative medicine.”

Dr. Copperman is an accomplished infertility specialist who practices at Reproductive Medicine Associates of New York and is a member of ISCO’s Scientific Advisory Board.

This ground-breaking work was presented at the American Society for Reproductive Medicine’s 65th Annual Meeting held in Atlanta, GA on October 19, 2009.

Jason Barritt, PhD, Scientific Director of RMA of New York noted, “This work shows that immature oocytes that are normally unusable and discarded in standard IVF procedures may be used for scientific innovation and clinical application. Using a currently experimental technique, these oocytes can be matured, frozen and thawed and used to produce parthenotes that may be instrumental for the study and derivation of parthenogenetic stem cells. I want to add that we are very grateful to our patients who have made this work possible by donating unused immature oocytes.”

ISCO’s technology, called parthenogenesis, results in the creation of pluripotent human parthenogenetic stem cell lines from unfertilized human eggs. This new methodology offers the potential to create the first stem cell bank composed of stem cell lines that can be immune-matched to large segments of the population. ISCO also produces and sells the Lifeline brand of specialized cells and growth media worldwide for therapeutic research through its wholly-owned subsidiary Lifeline Cell Technology.

According to Jeffrey Janus, Senior VP of ISCO and CEO of Lifeline Cell Technology, “The accomplishments of Drs. Copperman and Barritt and the ISCO research team have expanded the potential that parthenogenetic stem cells will be an important part of discovering and providing cures for many devastating diseases. We are fortunate to be working with such noted and respected researchers and clinicians.”

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):

International Stem Cell Corporation 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. ISCO scientists have created the first Parthenogenetic homozygous stem cell line (phSC-Hhom-4) that can be a source of therapeutic cells that will minimize immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. These advancements offer the potential to create the first true “Stem Cell Bank” and address ethical issues by eliminating the need to use or destroy fertilized embryos. ISCO also produces and markets 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: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

For more news and information on International Stem Cell Corporation please visit www.IRGnews.com/coi/ISCO where you can find the CEO’s video, a fact sheet on the company, investor presentations, and more.

About Reproductive Medicine Associates of New York:

RMA of New York is the reproductive endocrinology and infertility division of Mount Sinai Medical Center and has been caring for patients in the midtown Manhattan location since 2001, with additional locations in Westchester and Long Island. RMA of New York is a full-service fertility center that consistently achieves high live birth rates, while maintaining low rates of triplet and higher birth outcomes. Highly individualized patient care is offered through seven reproductive endocrinologists, a urologist, a complementary care team of a clinical psychologist and a licensed clinical social worker, and highly qualified staff. For more information, please call 212.756.5777 or visit www.rmany.com.

FORWARD-LOOKING STATEMENTS:

Statements pertaining to anticipated future financial and/or operating results, future growth in research, technology, clinical development and potential joint venture and other 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, application of capital resources among competing uses, 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.

Key Words: Stem Cells, Biotechnology, Parthenogenesis

Contact:

International Stem Cell Corporation

Kenneth C. Aldrich, Chairman, CEO

kaldrich@intlstemcell.com

760-940-6383

or

The Investor Relations Group

212-825-3210

Laura Colontrelle

lcolontrelle@investorrelationsgroup.com

International Stem Cell's Presentation at the 20th Annual Roth Capital Partners OC Growth Stock Conference

Please visit Wall Street Webcasting to view the original presentation;
http://www.wsw.com/webcast/roth16/isco/index.html

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)

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.