OCEANSIDE, CA – August 26, 2010 – International Stem Cell Corporation (OTCBB:ISCO), 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, www.internationalstemcell.com.
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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
Thursday, August 26, 2010
Wednesday, August 25, 2010
International Stem cell Corporation Chairman Discusses Recent Stem Cell Research Funding Decision
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
Thursday, August 19, 2010
International Stem Cell Corporation Formalizes Stem Cell Based Eye Care Programs into Cytovis™
International Stem Cell Corporation (OTCBB:ISCO), 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 4th 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, 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
Tuesday, August 17, 2010
Video: Summary of Recent Developments in Stem Cell and Regenerative Medicine from Kenneth Aldrich, Chairman of International Stem Cell Corporation
Greetings. This is Ken Aldrich, I am Chairman of International Stem Cell Corporation and thought I would share with you briefly some of the thoughts that I’ve had recently about developments in the stem cell and regenerative medicine area. One of the things that I have noticed from a lot of emails that we get, there is a fair amount of confusion out there about the significance of some of the new events that have taken place.
Specifically, I have gotten a lot of requests to explain what the impact of the recent announcement by Geron Corporation that they had entered FDA human trials might be. Well frankly, it is a very, very important step and one that benefits, I think, everyone in our industry and I wanted to comment on it a little bit. What that means is that one of the companies in our field has finally found the mechanism and found the procedures to begin the process of bringing cells to the clinic through human trials. So Geron, which is one of the largest companies, and has spent an enormous amount of money developing this, is now leading the path for all of us. I think we will learn from their experiences and it will make the path getting through to the FDA a lot more productive for all of us that follow.
There is another aspect to this however, that is unique to our company, International Stem Cell Corporation, in that we have also realized that the United States in only one part of the global market. And as a result, we’ve spent a lot of energy over the last year or so exploring foreign collaborations in those areas where perhaps the US is not the most attractive market. For example, we are working in India with replacing human corneas with corneas developed from our parthenogenic stem cells. The U.S. is probably not a major market for this because our systems here in this country allow for cornea transplants rather well. But in countries like India, as well as China and Korea and other places, the infrastructure doesn’t exist to harvest corneas from cadavers and deliver them and as a result, we have a wide open market there with enormous interest. I think that is one example of how the international market will impact the development of regenerative medicine.
We’re looking at that and we are looking at a variety of other areas and I’m sure other companies are doing the same. Eventually, we are all in this boat together to try to cure major diseases. We’re delighted with the progress with the FDA from companies here. We’ll be following in those footsteps when we can and we also be hopefully be leading the way in some of the international collaborations that may make all of us better off in the world of regenerative medicine.
Thank you.
Specifically, I have gotten a lot of requests to explain what the impact of the recent announcement by Geron Corporation that they had entered FDA human trials might be. Well frankly, it is a very, very important step and one that benefits, I think, everyone in our industry and I wanted to comment on it a little bit. What that means is that one of the companies in our field has finally found the mechanism and found the procedures to begin the process of bringing cells to the clinic through human trials. So Geron, which is one of the largest companies, and has spent an enormous amount of money developing this, is now leading the path for all of us. I think we will learn from their experiences and it will make the path getting through to the FDA a lot more productive for all of us that follow.
There is another aspect to this however, that is unique to our company, International Stem Cell Corporation, in that we have also realized that the United States in only one part of the global market. And as a result, we’ve spent a lot of energy over the last year or so exploring foreign collaborations in those areas where perhaps the US is not the most attractive market. For example, we are working in India with replacing human corneas with corneas developed from our parthenogenic stem cells. The U.S. is probably not a major market for this because our systems here in this country allow for cornea transplants rather well. But in countries like India, as well as China and Korea and other places, the infrastructure doesn’t exist to harvest corneas from cadavers and deliver them and as a result, we have a wide open market there with enormous interest. I think that is one example of how the international market will impact the development of regenerative medicine.
We’re looking at that and we are looking at a variety of other areas and I’m sure other companies are doing the same. Eventually, we are all in this boat together to try to cure major diseases. We’re delighted with the progress with the FDA from companies here. We’ll be following in those footsteps when we can and we also be hopefully be leading the way in some of the international collaborations that may make all of us better off in the world of regenerative medicine.
Thank you.
Thursday, August 5, 2010
International Stem Cell Corporation - Breakthrough Technology Alert
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 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
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