An extremely comprehensive article about stem cell programs in opthalmology by Irving J. Arons

A Primer on the Use of Stem Cells in Ophthalmology
by Irving J. Arons

I recently came across an interesting news release from International Stem Cell Corporation (ISCO) announcing that it had formed a new business unit, Cytovis, to focus on stem cell programs in ophthalmology, including CytoCor for the cornea and CytoRet for the retina.

That got me thinking about how little I knew about what was going on in stem cell research in ophthalmology, despite having written about two developments in the field, the London Project to Cure Blindness and the University of California Irvine (UCI) program to develop an artificial retina based on stem cell research.

I decided to become better informed by taking a closer look at what was happening in this field, and presenting that story.

Introduction
Commenting on a EuroRetina Meeting held earlier in 2008, John Morrow of Newport Biotech Consultants noted, as reported by Ophthalmology Times Europe in September 2008, “Stem Cells are looked upon as either an ethical train wreck or the gateway to the alleviation of human illness, depending on which side of the political spectrum one resides. This unfortunate notoriety has resulted in unprecedented coverage in the media, but this has not done much to advance the cause of this technology. Yet recent ophthalmologic research suggests that the medical applications of stem cells hold notable promise for the treatment of ocular degenerative conditions and that realization of this potential may come about in the near future.”

I think Dr. Morrow’s thoughts eloquently sum up the subject. Stem cell research is politically charged but holds tremendous promise for the future, especially in ophthalmology.

What are Stem Cells?
Every organ and tissue in our bodies is made up of specialized cells that originally come from a pool of stem cells in the very early embryo (“embryonic stem cells”). Throughout our lives we rely to a much more limited degree on rare deposits of stem cells in certain areas of the body (“adult stem cells”) to regenerate organs and tissues that are injured or lost, such as our skin, our hair, our blood and the lining of our gut.

Stem cells are like a blank microchip that can be programmed to perform particular tasks. Under proper conditions, stem cells develop or “differentiate” into specialized cells that carry out a specific function, such as in the skin, muscle, liver, or in the eye. Additionally, stem cells can grow extensively without differentiating and give rise to more stem cells...

To read the full article, please visit - http://irvaronsjournal.blogspot.com/2010/09/primer-on-use-of-stem-cells-in.html

OCEANSIDE, CA – August 26, 2010 – International Stem Cell Corporation (OTCBB:ISCO), http://www.internationalstemcell.com, announced today that the recent action of a federal district judge blocking federal funding of embryonic stem cell research is not expected to have negative effects on ISCO’s therapeutic programs using its human parthenogenetic stem cells.

According to ISCO’s Chairman Ken Aldrich, “Because we have never depended on federal or state money to fund our research, the new ruling is simply not applicable to any of our programs in the US or any of our international efforts. Although we believe anything that restricts legitimate scientific research is detrimental to science and our Country and hope the ruling is quickly reversed, the ruling could in a strange way benefit ISCO by creating additional incentives for researchers to use our parthenogenetic stem cell lines.”

Because ISCO’s technology, parthenogenesis, does not destroy or damage a viable human embryo, its parthenogenetic stem cell lines (“hpSC”) offer an alternative way to continue research previously done with embryonic cell lines without raising ethical issues about the destruction of life. Published peer-reviewed papers have shown hpSC to be “pluripotent”, a characteristic shared with embryonic stem cells that allows them to become tissues leading to all the cells found in the human body. Therefore, ISCO’s hpSC lines offer an alternative to the ethical issues that continue to be problematic for embryonic stem cells.

When enacted, legislation prohibiting the creation of a human embryo for research purposes prohibited both successful methods, such as fertilization, as well as less understood methods such as parthenogenesis. Parthenogenetic methods since developed by ISCO do not create human embryos that could become viable human beings, yet can result in pluripotent hpSC lines with potential therapeutic value. “The recent court ruling may cause Congress to revisit its legislation. If so, then ISCO’s research showing its hpSC lines present an alternative to embryonic stem cells, without raising the ethical concerns about the creation or destruction of viable human life, may lead to Congress allowing federal funding of hpSC in future legislation. ISCO would then be free to provide hpSC lines to federally-funded researchers and move more of our work back into the US from foreign jurisdictions”, said Jeffrey Janus, Senior Vice President of ISCO and one of its founders.

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)
International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO's core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryos and, unlike all other major stem cell types, can be immune matched and be a source of therapeutic cells with minimal rejection after transplantation into hundreds of millions of individuals across racial groups. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, develops a line of cosmeceutical products via its subsidiary Lifeline Skin Care and advances novel human stem cell-based therapies where cells have been proven to be efficacious but traditional small molecule and protein therapeutics do not. More information is available at ISCO's website, http://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

FORWARD-LOOKING STATEMENTS
Statements pertaining to anticipated technological developments and therapeutic applications, the potential benefits of collaborations, affiliations, and other opportunities for the company and its subsidiaries, 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," "should," "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

CONTACTS:
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
Or
Jeffrey Janus
Sr. Vice President, Operations
760-640-6383
jjanus@intlstemcell.com

This is Ken Aldrich and I am Chairman of International Stem Cell Corporation and I thought I should comment briefly on the recent decision of the federal district court of the District of Columbia concerning stem cell research.

What the court did was to announce that it was prohibiting the use of federal funding by the NIH for embryonic stem cell research which is a major blow if the decision is upheld for the stem cell industry. It’s interesting because it actually does not affect International Stem Cell Corporation in any direct negative manner.

The truth of the matter is we have not been able to use federal funding since the very beginning of the company because of a particular provision in the Dickey Wicker amendment that specifically calls out parthenogenic stem cells as a form of embryo, in spite of the fact that they genuinely are not an embryo in fact cannot ever become any living human being and don’t involve the destruction of anything that could become human being. Nevertheless, we have always been caught up in the Dickey Wicker amendment. So we haven’t been hurt by this decision, if anything it has perhaps leveled the playing field for us a bit with the embryonic stem cell group.

But the bottom line is we don’t really think it is good for the country and we hope there will be a change. But we do hope is that perhaps this will open the political debate and as people begin to look at the broader spectrum and realize that parthenogenic stem cell, which is our stock and trade, do not involve the destruction of any embryos, it may be that the specific language of the Dickey Wicker amendment can ultimately be removed and we would then become eligible along with everyone else for federal funding through the NIH and other government programs. If so, it would be a wonderful result. In the meantime, it is a difficult time for everyone in the industry. We’ll keep you informed. Thank you

International Stem Cell Corporation (OTCBB:ISCO), http://www.internationalstemcell.com, today announced that its stem cell therapeutic programs focused on protective, transparent corneas (CytoCor™) in the front of the eye and the light-sensitive retinal tissue (CytoRet™) in the back of the eye will be formalized into a new business unit, Cytovis™. Together these programs will leverage external and internal development, regulatory and commercial expertise in cellular ophthalmology to form a focused portfolio of complementary product candidates designed to address high unmet medical needs with apparent pharmacoeconomic and quality of life benefits.

CytoCor is the brand name for ISCO's corneal tissue that can be derived from the company's proprietary parthenogenetic stem cells or commonly used embryonic stem cells. Research and development with partners Absorption Systems in the US,Sankara Nethralaya in India and Automation Partnership in the UK continues for the purpose of optimizing the tissue for transplantation in the 10 million people worldwide suffering from corneal vision impairment and as an alternative to the use of live animals and animal eyes in the $500+M market for safety testing of drugs, chemicals and consumer products. ISCO's goal in the coming months is to establish funding and infrastructure in India for accelerated development of CytoCor for the therapeutic application and to advance and implement the chemical testing application with partners in the US and Europe.

CytoRet is the brand name for ISCO's stem cell-derived retinal tissue. ISCO is using its parthenogenetic stem cells to develop individual retinal pigmented epithelial ('RPE') cells and layered retinal structures internally and in collaboration with the laboratory of Dr. Hans Keirstead, Professor of Anatomy and Neurobiology at the University of California, Irvine. ISCO recently commenced a new research collaboration with UC Irvine to launch the next phase of its retinal studies with that institution, including preclinical trials. Potential therapeutic applications include retinitis pigmentosa, an untreatable inherited disease affecting about 100,000 Americans, and the dry form of age-related macular degeneration, a major cause of blindness in the elderly of the Western world. ISCO's goal is to establish functional proof of concept for RPE cellular therapy in models of human disease in the next twelve-eighteen months.

Jointly referred to as Cytovis ('cyto' for cellular, 'vis' for vision), these two cellular ophthalmology programs share a number of features and benefits. First, with the aging of the population worldwide and the growing number of work-related eye injuriesin India, China and other major countries, the market opportunity is growing steadily. Second, there are strong pharmacoeconomic and quality-of-life rationales for full or partial vision restoration or delay of vision impairment diseases. Third, delivery of cells and tissues to the confined anatomy of the eye inherently provides for better safety and efficacy than, for example, the systemic circulation or the central nervous system. This will likely result in lower regulatory barriers and shorter and less costly development paths compared to that of anatomically deeper and more widespread diseases. Fourth, a number of eye diseases cannot be treated with surgery or traditional small molecule or protein therapeutics, yet cell and tissue therapy is proven to work but currently limited by availability of safe and sufficient cells and tissue from human donors. Finally, eye care development programs like CytoCor and CytoRet share a number of regulatory, development and commercial aspects that make it feasible for a relatively small team to produce substantial clinical outcomes and achieve competitive presence in the marketplace alone or in collaboration with dedicated partners.

Brian Lundstrom, ISCO's President, says: 'ISCO's proprietary parthenogenetic stem cell technology continues to form the foundation for the company's long term regenerative medicine therapy programs. In the nearer term, CytoCor and CytoRet's unique benefits in the field of cellular ophthalmology offer the potential for partnering and funding at a relatively early stage. Combined with the current and future revenue of Lifeline Cell Technology and the revenue potential of Lifeline Skin Care, scheduled for launch in the 4^th quarter, Cytovis adds significantly to ISCO's diversity and value creation potential for its investor base in a cost-efficient fashion.'

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)

International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO's core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryos and, unlike all other major stem cell types, can be immune matched and be a source of therapeutic cells with minimal rejection after transplantation into hundreds of millions of individuals across racial groups. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, develops a line of cosmeceutical products via its subsidiary Lifeline Skin Care and advances novel human stem cell-based therapies where cells have been proven to be efficacious but traditional small molecule and protein therapeutics do not. More information is available at ISCO's website, http://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.

FORWARD-LOOKING STATEMENTS

Statements pertaining to anticipated technological developments and therapeutic applications, the potential benefits of collaborations, affiliations, and other opportunities for the company and its subsidiaries, 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," "should," "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

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
or
Brian Lundstrom, President
760-640-6383
bl@intlstemcell.com

Northern Exposure by Emmet Pierce, San Diego Business Journal, August 16, 2010. Excerpt:

An example of San Diegans collaborating with Canadians is the work that has taken place at the UC San Diego Moores Cancer Center in cooperation with research at the University of Toronto. The partnership has enabled San Diego researchers to acquire a $20 million grant to develop drugs to be used against leukemia stem cells, Barr says.Dr. Catriona Jamieson, director of the stem cell research program at the Moores center, said scientists from Toronto and San Diego share "a deep and abiding interest in cancer stem cell biology." The Canadian consulate in San Diego was instrumental in helping to create a relationship in which both institutions would benefit, sharing information and applying for funds to support their research.

"The idea was to establish a Canada-California cancer stem cell initiative and obtain connections with Canadian funding agencies, particularly Genome Canada and the Ministry of Health," she said.

Jamieson added, "The most important thing is it allows people with disparate abilities and backgrounds to work together on the same problem."

Barr said the University of Toronto also was able to secure a $20 million research grant because of the collaboration, "so the team is greater than the sum of its parts."

THE ANTIDOTE
Bioweapons, Health, and the Individual
by Doc Holliday
from the Laissez Faire City Times

Ever read one of those Internet articles on biowarfare? Have you seen the TV tabloid terror shows about government incompetence/malfeasance with the handling of biological agents of horrifyingly destructive power? Did you read the Hot Zone by Richard Preston or see his article in the New Yorker this week called "The Bioengineers"?

I have seen all of the above, and I'm shocked. I am shocked at the insanity of blindly believing "national interests" are at stake and governments should "do something" to protect "the people." I am repulsed by the stupidity of immediately turning to government for solutions to problems that are in fact a consequence of the world-wide growth in nation-state power over the individual during the last three centuries. Read more...

Healthy blood

Single patient Clinical Trial are not new idea, FDA did not focus since such trial canot prove the efficacy and safety of medicine over a large pool of patient with sufficient data. But I was forced to re-think after reading the article http://www.technologyreview.in/biomedicine/12537/ why cant we use the the concept mentioned in to overcome the ethical and other challenges in current mode of trials.

So I decided to ask the question to the linkedin audience http://www.linkedin.com/answers/technology/biotech/TCH_BIO/667022-9262868?browseIdx=0&sik=1272969161323&goback=.amq

Oxygen in Stem Cell Biology: A Critical Component of the Stem Cell Niche by Ahmed Mohyeldin, Tomás Garzón-Muvdi and Alfredo Quiñones-Hinojosa, Cell Stem Cell 2010(Aug 6); 7(2): 150-61. Review. [PubMed citation][FriendFeed entry]. Via Twitter @CellStemCell: Access [to the full text] is free in August worldwide so readers can try out new enhanced online format.

Abstract:

The defining hallmark of stem cells is their ability to self-renew and maintain multipotency. This capacity depends on the balance of complex signals in their microenvironment. Low oxygen tensions (hypoxia) maintain undifferentiated states of embryonic, hematopoietic, mesenchymal, and neural stem cell phenotypes and also influence proliferation and cell-fate commitment. Recent evidence has identified a broader spectrum of stem cells influenced by hypoxia that includes cancer stem cells and induced pluripotent stem cells. These findings have important implications on our understanding of development, disease, and tissue-engineering practices and furthermore elucidate an added dimension of stem cell control within the niche.

The following is an excerpt from the August 3, 2010 Breakthrough Technology Alert, published by Agora Financial. Agora Financial is a fully independent publisher and has no financial connections to companies listed below. Breakthrough Technology Alert's editor is industry expert Patrick Cox. Patrick is renowned for his innovative forecasts and keeping readers "ahead of the story".

For more information about Patrick Cox and Breakthrough Technology Alert please visit http://www.agorafinancial.com

ISCO Collaborations Accelerate

Last week, I told you about International Stem Cell Corp.'s (OTCBB: ISCO) new European subsidiary, ISCO Europe. That announcement closely followed an announced alliance with a leading Indian provider of corneal transplants. Now ISCO has announced that it has entered into a distribution agreement for its Lifeline brand of human cell culture products in India.

Jeffrey Janus, senior vice president of operations of ISCO and CEO of its subsidiary Lifeline, said in a press release, Sristi Biosciences is part of one of the most experienced biotechnology companies in India and the first to advance cell therapy into human trials in that country. Their network among academic and corporate researchers and experience and capacity to import and handle primary cell cultures, media and growth factors in India will be highly valuable for Lifeline to continue the international commercial expansion of its brand.

For transformational profits,

Patrick Cox

To learn more about Patrick Cox and Breakthrough Technology Alert please click here. © 2010 by Agora Financial, LLC. 808 St. Paul Street, Baltimore, MD 21202. All rights reserved. No part of this report may be reproduced by any means or for any reason without the consent of the publisher. The information contained herein is obtained from sources believed to be reliable; however, its accuracy cannot be guaranteed.

(HealthDay News) -- Researchers have identified a molecule that can reduce symptoms and prolong the life of mice with a type of amyotrophic lateral sclerosis (ALS).

The molecule, called microRNA-206 (miR-206), is produced naturally by skeletal muscles in response to nerve damage caused by ALS, also known as Lou Gehrig's disease. The molecule acts as a chemical signal to guide new nerve endings and maintain their interactions with muscles.

However, this research in mice suggests that miR-206 only works for a limited period of time. As nerves continue to die because of ALS, eventually surviving nerves can no longer compensate and symptoms such as muscle weakness begin to develop.

"While miR-206 initially prompts nearby surviving nerves to send new branches to the muscles, it only delays the inevitable," study senior author Eric Olson, chairman of molecular biology at the University of Texas Southwestern Medical Center, said in a university news release. Read more...

Immunice Support

Scientists at UCLA find cell of origin for human prostate cancer by Kim Irwin, UCLA Newsroom, July 29, 2010. Excerpts:

"Certainly, the dominant thought is that human prostate cancer arose from the luminal cells because the cancers had more features resembling luminal cells," said Witte, senior author of the study and a Howard Hughes Medical Institute Investigator. "But we were able to start with a basal cell and induce human prostate cancer, and now, as we go forward, this gives us a place to look in understanding the sequence of genetic events that initiates prostate cancer and defining the cell-signaling pathways that may be at work fueling the malignancy, helping us to potentially uncover new targets for therapy."

.....

The new human-in-mouse model system developed in the study was created by taking healthy human prostate tissue that will induce cancer once it is placed in mice, instead of taking malignant tissue that is already cancerous and implanting it. This model can now be used to evaluate the effectiveness of new types of therapeutics. By using defined genetic events to activate specific signaling pathways, researchers can more easily compare therapeutic efficacy. The new model, by deconstructing tissue and then reconstructing it, also will aid in analyzing how the cells change during cancer progression.

This news release is based on the publication: Identification of a Cell of Origin for Human Prostate Cancer by Andrew S Goldstein and 5 co-authors, including Owen N Witte, Science 2010(Jul 30); 329(5991): 568-71. [PubMed citation][FriendFeed entry][Twitter trackbacks via Topsy].