International Stem Cell Corporation (OTCBB: ISCO), www.internationalstemcell.com , announced today that it has signed up the first two in vitro fertilization (IVF) clinics and engaged an experienced pharmaceutical industry executive to lead the establishment of the company's universal stem cell bank, UniStemCell™. International Stem Cell Corporation has made breakthrough stem cell discoveries that result in unique advantages over the only two other proven methods of making human pluripotent stem cells. In particular, for the first time in industry history, this will enable the establishment of a bank containing a manageable number of stem cell lines that will be immunological matches for large patient populations of different ethnic origin.
The company uses unfertilized eggs (oocytes) to create human "parthenogenic" stem cells (hpSCs). Like embryonic stem cells (ESCs), hpSCs are pluripotent (i.e. have the capacity to become almost any cell type in the body), yet avoid ethical issues associated with use or destruction of viable human embryos. Unlike induced pluripotent stem cells (iPSs), hpSCs do not involve extensive gene manipulation, which may have unknown biological impact. Unlike both ESCs and iPSs, hpSCs can be created in a homozygous form such that each line will be an immunological match for millions of patients.
International Stem Cell Corporation has partnered with two IVF clinics in Southern California, California Center for Reproductive Medicine under the leadership of Dr. Lori Arnold and Acacio Fertility Center under the leadership of Dr. Brian Acacio. Both clinics provide exceptional clinical care for egg donors and IVF patients, not only regionally but across the US and abroad. California Center for Reproductive Medicine and Acacio Fertility Center provide a US source of oocytes under full regulatory and medical oversight that allow for the creation of the first clinical grade hpSC lines anywhere in the world. Dr. Acacio says: "We look forward to participating in this important research with the ultimate goal of each egg donation not only helping a single couple but millions of people with degenerative diseases." Dr. Arnold says: "While we provide world-class care for our IVF patients, we are excited to add our clinical expertise and join International Stem Cell Corporation in this medical frontier of regenerative medicine."
International Stem Cell Corporation has also engaged Dr. Simon Craw to implement the integrated process of oocyte donation and processing in coordination with the IVF clinics and under proper regulatory and medical oversight. The creation of hpSC lines will take place in the company's central cGMP facility. In addition, Dr. Craw will oversee the expansion, tracking and storage of hpSCs for research and clinical development globally. Dr. Craw is an experienced pharmaceutical executive who has served in firms such as Novartis and AstraZeneca, and recently as head of Merck's California operations and ACADIA's information technology and regulatory operations (including FDA filings).
Brian Lundstrom, ISCO's President, says: "International Stem Cell Corporation has already differentiated its hpSCs into functional cells of the eye (retinal pigment epithelium and corneal tissues), the liver (hepatocyte precursor cells) and other organs. While we and our external collaborators continue to advance these therapeutic applications, we are now formally launching the creation of a universal stem cell bank, UniStemCell. This collection of hpSC lines will enable researchers around the world to develop novel stem cell therapies knowing that, whatever non-embryonic, pluripotent hpSC line they use, there will be sister lines available that immunologically match almost any potential patient and will require only temporary immune suppression, if any." He continues: "By combining the proven oocyte retrieval experience and clinical excellence of California Center for Reproductive Medicine and Acacio Fertility Center with the pharmaceutical and operational experience of Dr. Craw, International Stem Cell Corporation is well positioned to generate the world's first cGMP quality hpSC lines in 2010."
International Stem Cell Corporation will initially focus on oocyte-derived hpSCs from US population groups. However, the company offers its intellectual property, process and business experience to other companies for development and commercialization of universal stem cell banks targeting ethnic groups that are less represented in the US, e.g. Asians and Hispanics. Cell lines from each of these banks will be made available to government, academic and corporate researchers worldwide, thus enabling the global research community to develop therapeutic applications of their interest with the unique ethical, biological and immune-matching benefits of homozygous hpSCs.
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 eggs (oocytes). ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology. 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 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
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, January 26, 2010
International Stem Cell Corporation Progresses towards Establishment of the Industry's First Universal Stem Cell Bank, UniStemCell™
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Labels: biopharmaceutical, International Stem Cell Corporation, ISCO, IVF, oocytes, parthenogenetic, stem cell blog, Unistemcell
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
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Labels: biotechnology, International Stem Cell Corporation, ISCO, IVF, parthenogenesis, parthenotes, regenerative medicine, RMA, stem cell
Friday, May 22, 2009
Kenneth Aldrich, CEO of International Stem Cell Corporation, Addresses Some Questions Regarding Letter in Response to NIH Proposed Guidelines
In light of recent comments made by International Stem Cell in response to the NIH proposed Guidelines, I have been asked a lot of questions. Let me try to answer a few of the most common ones.
Q: Will the proposed guidelines hurt International Stem Cell unless they are revised?
A: No. They will be an inconvenience and perhaps force us to accept funding from foreign instead of US sources, but will not change the fundamental prospects of our company at all. We have been operating under the same kind of restrictions since the founding of our company and can continue to do so. NIH funding is of far more importance to academic researchers than to companies and a change specifically permitting Federal funding for Parthenogenesis research would enable more researchers in the US to use our cells. That would enable us perhaps to do more of our work here at home, but we truly are an international company and expect to be able to obtain the kind of funded research and researchers even if the proposed rules are not changed. However, we would greatly prefer to develop our technology with US based scientists in US universities if possible.
Q: Why then are you so opposed to the present proposed Guidelines?
A: The present proposals specifically exclude the use of Parthenogenesis (our technology) and SCNT (technology that we have licensed but do not currently use). Both of these are potentially very valuable sources of cells for the treatment of human diseases and can do things that can't be done with Embryonic stem cells or the iPS cells that are derived from genetically re-programmed human tissue. For example, parthenogenetic stem cells can be matched to the immune systems of millions of individuals, thus allowing the efficient creation of true stem cell banks for the population. Different stem cell technologies increase the potential for new medical breakthroughs and we believe that parthenogenesis is the strongest technology with the most medical potential. If the US government restricts the kind of technology it will support, whether because of politics or ignorance of the facts, it could deprive millions of people of the benefit of cures that might otherwise have been discovered.
Q: Why do you think the NIH has restricted its funding in these Guidelines?
A: I believe there are several issues, but none of them apply for Parthenogenesis. The NIH does not want federal money spent to derive human embryos for research use only. This does not apply for Parthenogenesis, because Parthenogenesis requires unfertilized human eggs – not fertilized human embryos. We believe this places Parthenogenesis on higher ethical ground. In addition, all of our Parthenogenetic lines have been created by women who entered IVF clinics with the intent of undergoing in-vitro fertilization (IVF), not the intent of creating stem cell lines.
I can only speculate, but strongly suspect that an additional reason may be a fear that somehow these technologies will lead to the need for thousands of human eggs and that women donors will be abused or taken advantage of to obtain such eggs for research. Nothing could be farther from the truth. The reality is that Parthenogenetic stem cells are derived from the excess eggs that fertilization clinics will eventually throw away. The only relevant difference between how stem cells are created through Parthenogenesis and how embryonic stem cells are created is whether or not the eggs are fertilized before being used as a source of stem cells. That has no impact on the donor at all. She produces the same number of eggs in the same way and only the excess are used for research, all under the same kinds of consent regulations. In addition, Parthenogenesis is an efficient process and does not require large numbers of eggs to produce a stem cell line. In fact, because Parthenogenesis can create a single line from a single donor that can be immune-matched to millions of individuals from multiple racial groups, once a bank of these lines is created, the need to obtain more human eggs will be greatly diminished or eliminated.
I hope these comments will clear up some of the mystery.
Sincerely,
Kenneth Aldrich
Chairman & CEO
International Stem Cell Corporation (ISCO.OB)
760-940-6383 (corporate office)
310-454-3055 (direct line)
310-593-1180 (mobile)
kaldrich@intlstemcell.com
www.internationalstemcell.com
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Labels: biotechnology, International Stem Cell Corporation, IVF, NIH, parthenogenesis, stem cell
Friday, May 8, 2009
International Stem Cell Corporation's Letter to the NIH
International Stem Cell Corporation respectfully requests that the NIH grant to researchers using stem cells created through parthenogenesis the same access to Federal funding as is provided for embryonic stem cells.
The fundamental basis for our request is that, although parthenogenetic stem cells are derived from unfertilized human eggs, not human embryos, the currently proposed Guidelines are likely to be interpreted to prohibit funding for such lines, even though the donation procedures otherwise meet all the requirements being imposed on embryonic stem cells.
Both types of cell lines are derived from human eggs obtained in the normal process of in-vitro fertilization. The difference is that making embryonic stem cells requires the creation (by fertilization) and subsequent destruction of viable human embryos, while parthenogenesis requires only unfertilized eggs from which no viable embryo is ever created or destroyed.
If parthenogenesis is denied funding, the source of stem cell lines that raises the fewest ethical issues (parthenogenesis) would be denied funding while the source that raises the most (embryonic stem cells) would receive Federal funding. Of possibly greater importance is the fact that while the stem cell industry is still in its infancy, with none of the hopes for embryonic, iPS or any other cell types yet verified in the clinic, the arbitrary exclusion from funding of an alternate technology that might offer new solutions could result in wasted opportunities to save human lives.
Both types of cell lines are obtained from eggs donated by women who have already made the decision to seek in-vitro fertilization. The primary motives of the donors are the same, and the consent procedures and donor protections are also the same. No public purpose is served by excluding parthenogenic stem cell lines from federal funding simply because the donated eggs were not fertilized in the process of creating stem cells.
Based on these distinctions, we propose that so long as the primary motivation of the donors is the same and the same ethical and informed consent standards are applied, whether or not excess eggs from IVF clinics are fertilized or not fertilized should not affect whether they may be used for federally sponsored research.
We suggest that the following factors also be considered in determining the final form of the Guidelines:
· The fear that viable human embryos are being created solely for research purposes or that women are being exploited for their eggs simply does not apply to parthenogenesis. First, as mentioned above, parthenogenesis does not lead to the creation of viable human embryos. No potential human life is destroyed. Second, the existing parthenogenetic stem cell lines were created from eggs donated by women with the primary intent of participating in IVF, and the same standard can and should be maintained for future lines. Whether excess eggs are fertilized or unfertilized does not pose any additional risk to the donors. In fact, every woman who has ever donated eggs to our company that led to the creation of parthenogenetic stem cell lines has had a successful pregnancy.
· Parthenogenesis may actually reduce the number of donations required because it allows for the creation of single lines of pluripotent stem cells that can be immune-matched (similar to how bone marrow is matched between donors and recipients) to large population groups. In other words, once a stem cell bank of perhaps 50 to 100 parthenogenetic stem cell lines is established, the need to continuously seek more eggs to match a population group may be greatly reduced or eliminated. The resulting immune-matched stem cell bank would become a valuable medical resource for regenerative medicine that is not available from any other source of cells. As a result, the total number of unfertilized eggs needed to create such a stem cell bank may be far fewer than the number of viable human embryos needed under the currently proposed Guidelines.
· The proposed Guidelines could create an unintended de-facto monopoly on the economic benefits of stem cell research. Today, a small number of organizations and companies control most of the current patents for embryonic cells. If cells subject to those patents are the only cells that can receive Federal funding, there will be no competition in the licensing of patents and no incentive for lower cost licensing of those rights. This could easily increase the cost of cures to the patient or repress innovation. Allowing alternative methods of creating stem cells, so long as they comply with the ethical rules of informed consent and utilize only appropriate donors, could avoid those problems.
· Blocking access to Federal funding for alternative methods of stem cell research could limit research opportunities for NIH-based scientists and also drive research and jobs overseas. Due to their unique characteristics, parthenogenetic stem cells offer a valuable research model to study immune response, cell differentiation and epigenetic processes such as imprinting, methylation, reprogramming and maternal effects. Under the proposed Guidelines, this research model would not be available to NIH-funded researchers in the U.S. U.S. companies now developing parthenogenesis technology are already receiving offers from various foreign countries such as Korea, India, and China to provide funding and move research to those countries. Without access to federal dollars, there will be no practical imperative to prevent U.S. companies from locating overseas. If disease cures are then developed outside the U.S., the potential profits and jobs will go elsewhere and the cures developed could come back to the U.S. at a much higher price.
We appreciate this opportunity to make our comments public, make ourselves available to the Institute for consultation on issues relating to stem cell research, and look forward to a rigorous review process prior to the finalization of the Institute’s guidelines.
Sincerely,
Kenneth C. Aldrich
Chairman, CEO, and Co-Founder
International Stem Cell Corporation
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Labels: International Stem Cell Corporation, IVF, NIH, parthenogenesis, pluripotent, stem cell bank, stem cell research