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Friday, October 30, 2009
International Stem Cell Corporation CEO Kenneth Aldrich Speaks at Stem Cells USA & Regenerative Medicine Congress
Dr Anthony Atala 
Dr Story Landis 
Dr Ruth McKernan 
Mr Paul Grayson 
Wednesday, October 28, 2009
Letter to the Shareholders Regarding Leap in Making Regenerative Medicine Available and Affordable
Since the press release of October 27, 2009 announcing that ISCO had collaborated with Reproductive Medicine Associates of New York to demonstrate that immature human eggs (oocytes) could be used in place of mature eggs to create the parthenotes that are the starting point for our stem cell lines, I have been swamped with questions.
They all boil down to the same question: "What does this mean?" That is a very fair question, so let me try to explain. Obtaining the unfertilized eggs that are needed to create parthenogenetic stem cell lines has been a problem, particularly in the US, for a simple reason. Even though only a few of the 10-20 eggs that are harvested as part of a typical IVF procedure are ever used, common practice, particularly in the US, has been to fertilize all the eggs the woman produces and freeze the excess. That can result in 10 or 15 frozen embryos that are never used, but the physicians running IVF clinics are reluctant to recommend to their patients that they withhold eggs from fertilization because they want to maximize the chance of obtaining successful implantation. That has made it difficult for ISCO and other researchers to obtain unfertilized eggs.
But there is another by-product of the IVF procedure. Among the mature eggs that are fertilized for use in the IVF procedure are a number of immature eggs that are unsuitable for transplant and could not be fertilized successfully to become babies. Until now, those were just medical waste, of no value to anyone. What our discovery means is that we may now be able to use these waste and immature eggs to produce cell lines that could result in cures for millions of people.
As you may recall if you have been following our company, one of our most important goals is to create a "bank" of stem cell lines that will match the immune systems of almost anyone on the globe. This is not like banking of umbilical cord blood, which benefits only the donor and her immediate family; it is instead analogous to a blood bank from which anyone can withdraw blood that his or her body will not reject. To create such a bank, we need donations of unfertilized eggs from women of widely diverse genetic backgrounds. Those are hard to obtain when physicians routinely fertilize all of a woman's mature eggs. However, when all that is asked for is what is now considered waste tissue, it is very easy for both the physician and the mother-to-be to donate. Not only are they helping science and other people, they may get a stem cell line that is a perfect genetic match for themselves.
With that advantage, we at ISCO believe we have made a giant leap forward in our quest to make regenerative medicine available and affordable for everyone.
Sincerely,
Kenneth Aldrich, Chairman
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 .
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.
Dear friends of International Stem Cell Corporation (ISCO):
Since the press release of October 27, 2009 announcing that ISCO had collaborated with Reproductive Medicine Associates of New York to demonstrate that immature human eggs (oocytes) could be used in place of mature eggs to create the parthenotes that are the starting point for our stem cell lines, I have been swamped with questions.
They all boil down to the same question: “What does this mean?” That is a very fair question, so let me try to explain. Obtaining the unfertilized eggs that are needed to create parthenogenetic stem cell lines has been a problem, particularly in the US, for a simple reason. Even though only a few of the 10-20 eggs that are harvested as part of a typical IVF procedure are ever used, common practice, particularly in the US, has been to fertilize all the eggs the woman produces and freeze the excess. That can result in 10 or 15 frozen embryos that are never used, but the physicians running IVF clinics are reluctant to recommend to their patients that they withhold eggs from fertilization because they want to maximize the chance of obtaining successful implantation. That has made it difficult for ISCO and other researchers to obtain unfertilized eggs.
But there is another by-product of the IVF procedure. Among the mature eggs that are fertilized for use in the IVF procedure are a number of immature eggs that are unsuitable for transplant and could not be fertilized successfully to become babies. Until now, those were just medical waste, of no value to anyone. What our discovery means is that we may now be able to use these waste and immature eggs to produce cell lines that could result in cures for millions of people.
As you may recall if you have been following our company, one of our most important goals is to create a “bank” of stem cell lines that will match the immune systems of almost anyone on the globe. This is not like banking of umbilical cord blood, which benefits only the donor and her immediate family; it is instead analogous to a blood bank from which anyone can withdraw blood that his or her body will not reject. To create such a bank, we need donations of unfertilized eggs from women of widely diverse genetic backgrounds. Those are hard to obtain when physicians routinely fertilize all of a woman’s mature eggs. However, when all that is asked for is what is now considered waste tissue, it is very easy for both the physician and the mother-to-be to donate. Not only are they helping science and other people, they may get a stem cell line that is a perfect genetic match for themselves.
With that advantage, we at ISCO believe we have made a giant leap forward in our quest to make regenerative medicine available and affordable for everyone.
Tuesday, October 27, 2009
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/
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
760-940-6383
or
The Investor Relations Group
212-825-3210
Laura Colontrelle
Saturday, October 17, 2009
International Stem Cell Corporation, Through Its Subsidiary Lifeline Cell Technology, Announces the Launch and Sale of New Products into the Human...
OCEANSIDE, Calif.--(BUSINESS WIRE)--International Stem Cell Corporation (OTCBB:ISCO) (www.internationalstemcell.com), announces that it has launched fifteen new human cell culture products into the commercial research markets over the last twelve months through its wholly-owned subsidiary, Lifeline Cell Technology, (Walkersville, MD), leading to a 12-month average month-to-month revenue growth of 50%. ISCO, the parent company, is the first company to create human “parthenogenetic” stem cells from unfertilized eggs. Parthenogenetic stem cells not only solve ethical problems, but also promise to minimize immune-rejection by providing cells that can be immune-matched to large segments of the population.
These products represent milestone achievements in ISCO’s strategy of generating revenue from the sale of research products, while building infrastructure from that effort to expand the manufacturing and quality control capacities ISCO needs to commercialize the therapeutic applications of human parthenogenetic stem cells.
One of its newest and most promising products consist of “xeno-free” human cells and culture reagents that allow researchers to study embryonic stem cells without contamination from animal (non-human) components. These products meet the needs for stem cell research to be done using “human-only” systems. Other products include Lifeline’s living human cells and reagents for research and drug development into cardiovascular, kidney, lung, nerve, eye and skin disease. Lifeline is continuing to develop unique reagents and media for the growing field of stem cell research. The “Lifeline” brand of products consist of human cells and the culture reagents and growth factors needed to grow the cells.
According to Jeffrey Janus, CEO of Lifeline, “We are proud of the quality of our new products, as reflected in the sales growth they are exhibiting in the human cell research markets. We look forward to launching more new products into the growing markets for stem cell research and drug development. These products will contribute to the success of ISCO, not only by supporting ISCO’s therapeutic research, but also through the development of critical manufacturing and quality control systems necessary for ISCO to produce therapeutic human cells in the future.”
Lifeline’s products can be found at www.lifelinecelltech.com
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 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.
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, Cornea, Parthenogenesis
Friday, October 16, 2009
ISCO Eyes See Path to Huge Profits by Patrick Cox
Dear Breakthrough Technology Reader,
The important Nobel Prize news last week was the recognition of three American scientists for their role in the discovery of telomerase. More attention was garnered by the rather puzzling Peace Prize award, but that has become routine. The five Norwegians who pick the Peace Prize winners are specifically selected, it seems, by Norway's liberal parliament primarily to comment on and meddle in American politics.
Regardless, the prize for medicine this year is extremely significant. Telomerase, as you know, is the “immortalizing enzyme,” produced by stem cells. When administered to adult cells, telomerase adds life-extending telomeres to the ends of a cell's DNA. There has been no more important discovery in the history of medicine.
The list of scientists credited with the discovery is sorely short, having ignored the contributions of Dr. Michael West, the CEO of BioTime (BTIM: OTCBB), and other critical researchers who have made crucial contributions to the current state of the science. I'm glad, however, that the award will help bring attention to regenerative medicine.
As more people learn what regenerative medicine can do, it will attract additional capital and accelerate progress. It will also, of course, push up the value of companies that hold important patents covering telomerase and other stem cell technologies.
The most important patents associated with telomerase and stem cells are already in our portfolio. Geron (GERN: NASDAQ) is the most obvious, with specific patent rights to telomerase. It's not the only company with critical IP in this area, however. This week, I'd like to update you on recent developments with another of our extremely important stem cell companies: International Stem Cell Corporation (ISCO: OTCBB). Once again, this is a longer alert than the usual weekly update, but ISCO is one of our most important stocks and it warrants a little extra attention.
ISCO's Parthenogenic Patent Strength
International Stem Cell, as I've explained before, holds all the major patents regarding parthenogenic stem cells (hpSCs). This alone makes the company worthy of investors' attention. Virtually every other stem cell company will share some future revenues, at least, with the Wisconsin Alumni Research Foundation, holder of certain basic SC patents. Moreover, ISCO already has an established laboratory supply business, Lifeline Cell Technology, that is on track to cover the expenses for the entire company. This is NOT a struggling company.
The big deal about ISCO, however, is its parthenogenic stem cell technology. These cells are derived from unfertilized ovum. They have only half the normal DNA and are, therefore, much, much easier to HLA match to minimize or eliminate immune reactions. They also have a huge near-term marketing advantage in that these cells have nothing to do with embryos and are, therefore, more acceptable to consumers who have ethical objections to the use of cells that could theoretically become embryos.
Of course, with the rise of iPS technologies, virtually any cell in your body could be transformed into an embryo. That, however, is a story I don't have the time or space to deal with today, though it is a fascinating story.
HLA, incidentally, is the acronym for human leukocyte antigens. These antigens determine how your body will respond to transplanted tissue. A close HLA match with a donor assures that transplants are well tolerated. A poor match can result in rejection or require significant immune system suppression, which has all kinds of undesirable side effects.
I think that induced pluripotent stem (iPS) cells are destined to be the “Cadillac” of stem cell treatments. A little of your blood can be used to produce stem cells that exactly match your body, provoking no immune reaction. For some time, however, iPS cells will be high-end therapies and relatively expensive.
The advantage that hpSCs have is that they hold the promise of cheap “off-the-shelf” therapies for a wide range of critical medical conditions. ISCO is working on hpSCs for renal failure, macular degeneration and severe diabetes. The company expects to enter clinical testing for macular degeneration soon. In the long term, they it also plans to produce cells for more dramatic therapies such as heart and vascular tree rejuvenation.
The genius of hpSC technology is that scientists believe it is possible to HLA match 99% of the world's population with a limited number of cell donors. Between 50-100 donors could provide the raw materials that would allow the mass production of incredibly powerful stem cell therapies that require little or no immune suppression. Even when iPS cell technology is developed and automated, in fact, I believe the market for these mass-market SC therapies will remain huge for decades.
Clearly, we're not quite there yet. ISCO needs more time, money and FDA approval. In the short run, however, the company has developed several important strategies for continuing growth.
One, as I mentioned above, is Lifeline. Another product, which has produced huge enthusiasm, is a skin stem cell growth media that ISCO scientists accidentally discovered to be an incredibly effective “cosmeceutical.” To the disappointment of many, ISCO has slowed the development process of this product to assure its safety and efficacy, but CEO Ken Aldrich tells me he expects to see it sold to clinics, at least, by Q1 next year.
Now, ISCO has announced another potential near- to midterm revenue blockbuster. As I've told you before, ISCO can already grow perfectly formed human corneas in petri dishes. Eventually, these corneas should provide hundreds of millions in revenues from the international market, where there are desperate shortages of transplant corneas.
ISCO is on track to filling another huge eye-related market. I'm talking about live animal drug and cosmetics testing.
As you probably know, many drugs and cosmetics are safety tested on the eyes of live animals. This is not only an incredibly expensive process, requiring facilities for breeding and taking care of animals, but it is extremely unpopular with consumers. While necessary, no one likes to think about the bunnies in bondage having potentially dangerous, damaging and painful chemicals put in their eyes. Neither, in fact, do the technicians who actually perform the tests.
ISCO's alternative is to provide actual human eye cells. These artificial eyes would not only have more accurate responses to substances than rabbits and other non-human subjects, they are far less expensive and experience no pain. The company is collaborating with a major provider of biological assay system, Absorption Systems, to get its artificial hpSC corneas pre-approved by the FDA and ready for market.
According to the press release, “The collaboration between the companies is focused on using Absorption Systems’ know-how in creating assay systems to develop superior preclinical methods of testing drugs. Such methods can also reduce the use of laboratory animals currently necessary for other tests, including the very large global commercial need for a reliable and reproducible non-animal method for eye safety testing of consumer products.
“In the past, researchers have grown corneal cells in the laboratory, but ISCO is believed to be the only company to grow a self-assembling corneal construct from parthenogenetic stem cells that is suitable for toxicity testing and possibly suitable for corneal transplants. ISCO’s corneal constructs include cell layers and structures normally found in a human cornea, as confirmed by an independent third-party laboratory.”
Let me be clear. This testing market is worth hundreds of millions of dollars. ISCO is not predicting how long it will take to get its alternative to live animal testing validated by the FDA, but I can't believe the administration will resist this product. I really don't think it will take “years,” simply because of the politics involved. Even the providers of live animals want an alternative to the current technology, because of consumer disapproval of their current testing methods.
If the FDA dared drag its feet on this issue, a phone call to PETA could turn this story into a high-profile political issue that no administration would want to deal with. I consider ISCO's decision to pursue this short-term product more evidence that this brilliantly run company will thrive until it can offer the really revolutionary products, including off-the-shelf SC injections that cure pancreatic, liver and heart disease.
Best of all, ISCO's stock prices have dipped recently, and for no detectable reason. This is a perfect opportunity for people who failed to buy when I first recommended the stock.
For transformational profits,
Patrick Cox
To read the article on the Agora Financial Website, please visit here
Tuesday, October 13, 2009
International Stem Cell Corporation, Through Its Subsidiary Lifeline Cell Technology, Announces the Launch and Sale of New Products into the Human...
International Stem Cell Corporation (OTCBB:ISCO) (www.internationalstemcell.com), announces that it has launched fifteen new human cell culture products into the commercial research markets over the last twelve months through its wholly-owned subsidiary, Lifeline Cell Technology, (Walkersville, MD), leading to a 12-month average month-to-month revenue growth of 50%. ISCO, the parent company, is the first company to create human "parthenogenetic" stem cells from unfertilized eggs. Parthenogenetic stem cells not only solve ethical problems, but also promise to minimize immune-rejection by providing cells that can be immune-matched to large segments of the population.
These products represent milestone achievements in ISCO's strategy of generating revenue from the sale of research products, while building infrastructure from that effort to expand the manufacturing and quality control capacities ISCO needs to commercialize the therapeutic applications of human parthenogenetic stem cells.
One of its newest and most promising products consist of "xeno-free" human cells and culture reagents that allow researchers to study embryonic stem cells without contamination from animal (non-human) components. These products meet the needs for stem cell research to be done using "human-only" systems. Other products include Lifeline's living human cells and reagents for research and drug development into cardiovascular, kidney, lung, nerve, eye and skin disease. Lifeline is continuing to develop unique reagents and media for the growing field of stem cell research. The "Lifeline" brand of products consist of human cells and the culture reagents and growth factors needed to grow the cells.
According to Jeffrey Janus, CEO of Lifeline, "We are proud of the quality of our new products, as reflected in the sales growth they are exhibiting in the human cell research markets. We look forward to launching more new products into the growing markets for stem cell research and drug development. These products will contribute to the success of ISCO, not only by supporting ISCO's therapeutic research, but also through the development of critical manufacturing and quality control systems necessary for ISCO to produce therapeutic human cells in the future."
Lifeline's products can be found at www.lifelinecelltech.com
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 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.
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, Cornea, Parthenogenesis
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman, CEO
760-940-6383
kaldrich@intlstemcell.com
or
Lifeline Cell Technology
Jeffrey Janus, CEO
janusj@lifelinecelltech.com
or
The Investor Relations Group
Laura Colontrelle
212-825-3210
lcolontrelle@investorrelationsgroup.com
Monday, October 5, 2009
International Stem Cell Corporation and Absorption Systems Announce Potential Stem Cell Alternative to Live Animal Testing for Corneal Damage
International Stem Cell Corporation (OTCBB:ISCO)(www.internationalstemcell.com), the first company to perfect a method of creating human "parthenogenetic" stem cells from unfertilized eggs, announces positive results of its collaboration with Absorption Systems to study ISCO's stem-cell-derived human corneal tissue as an alternative to live animals for drug testing. Initial results using non-animal or "in vitro" tests indicate an excellent correlation between the rates at which drugs pass through ISCO's lab-grown corneal tissue and rabbit corneal tissue. The results offer great promise for reducing the use of living animals for eye safety testing. ISCO's human corneal tissue is created from parthenogenetic stem cells in the laboratories of Lifeline Cell Technology (Walkersville, MD), ISCO's wholly-owned subsidiary. According to Dr. Chris Bode of Absorption Systems. "The rank order correlation of the eight drugs tested so far is almost perfect." The collaboration between the companies is focused on using Absorption Systems' know-how in creating assay systems to develop superior preclinical methods of testing drugs. Such methods can also reduce the use of laboratory animals currently necessary for other tests, including the very large global commercial need for a reliable and reproducible non-animal method for eye safety testing of consumer products. In the past, researchers have grown corneal cells in the laboratory, but ISCO is believed to be the only company to grow a self-assembling corneal construct from parthenogenetic stem cells that is suitable for toxicity testing and possibly suitable for corneal transplants. ISCO's corneal constructs include cell layers and structures normally found in a human cornea, as confirmed by an independent third-party laboratory. ISCO's proprietary lines of parthenogenetic stem cells remove the need for fertilized embryos and, in a therapeutic setting, may minimize the threat of immune rejection. This breakthrough was published in the peer-reviewed journal Cloning & Stem Cells (Volume 9, Number 3; September 2007:432-449 and, Volume 10, Number 1; March 2008: 11-24). "These initial experiments are very encouraging and will be followed up with more extensive testing. Absorption Systems' proficiency in performing tissue-based assays may provide a powerful and unique drug testing model for the large commercial markets in the pharmaceutical industry and the field of ophthalmology," commented Jeffrey Janus, Senior VP of ISCO and CEO of Lifeline. "In addition, this work complements ISCO's effort to use its parthenogenetic stem cells to create cell transplant therapies for diseases of the eye. We plan to further develop our corneal tissue technology with a goal of routinely growing living human corneas for ultimate use in human corneal transplants." "ISCO's corneal construct, combined with Absorption Systems' expertise in assessing drug disposition, may provide pharmaceutical and ophthalmology researchers with new insight, without the need for animal models," said Patrick M. Dentinger, President and CEO of Absorption Systems. "Absorption Systems' services yield the type of definitive data expected by the FDA, so we believe that our combined products will be of great interest to researchers studying diseases of the eye." 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 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. ABOUT ABSORPTION SYSTEMS: Founded in 1996 by Patrick Dentinger and Ismael J. Hidalgo, Ph.D., Absorption Systems, LP focuses on performing assays that can predict the Absorption, Distribution, Metabolism, Excretion and Toxicity (ADMET) of small molecules using a variety of in vitro, in situ, and in vivo biological models. Absorption Systems supports these assays with state-of–the-art bioanalytical capabilities and preclinical formulation services. For more information, visit: www.absorption.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 Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6064890&lang=en
International Stem Cell Corporation |