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CARLSBAD, CA--(Marketwired - Dec 18, 2013) - International Stem Cell Corporation (OTCQB: ISCO), a California-based biotechnology company developing novel stem cell based therapies, today announced that it was awarded the Presidential Poster of Distinction by the American Association for the Study of Liver Disease (AASLD) at the 64th Annual Liver Meeting in Washington, D.C.

The data reported in this pre-clinical study demonstrated that transplantation of hpSC-derived hepatocytes cells (HLCs) elicits a significant decrease and long-term stabilization of bilirubin levels in the serum of Gunn rats, a well-established animal model of Crigler-Najjar syndrome type 1 (CN1), an inborn error of bilirubin metabolism. Moreover, at four months following treatment no adverse safety signals were detected.

CN1 is a rare inherited liver-based metabolic disorder in which the host liver lacks one hepatic enzyme, UGT1A1, essential for the conjugation and excretion of the toxin bilirubin. This pre-clinical study provides important supportive evidence of the potential safety and efficacy of HLCs which could constitute a reliable source for large numbers of transplantable cells. In the long-term, experience with HLC transplantation for CN1 could potentially be used to develop therapeutic strategies for more common inherited liver diseases.

"Being awarded such a prestigious honor is a testament to the quality of our scientific team at ISCO," said Ruslan Semechkin, Ph.D., Chief Scientific Officer of ISCO. "The data presented at this conference demonstrates the unique nature of our HLCs and their potential efficacy in a clinical setting."

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) hence avoiding ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (Human Cells and Cell Culture Media), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (Stem Cell Skin Care Products | Lifeline Skin Care | Lifeline Skin Care). More information is available at Welcome to International Stem Cell Corporation.

ISCO's lead indication is Parkinson's disease. The Parkinson's disease program uses human parthenogenetic neural stem cells (hPNSC) a novel therapeutic cellular product derived from the company's proprietary histocompatible human pluripotent stem cells. hPNSC are self-renewing mulitpotent cells that are precursors for the major cells of the central nervous system. The ability of hPNSC to (i) differentiate into dopaminergic (DA) neurons and (ii) express neurotrophic factors such as glial derived neurotrophic factor (GDNF) and brain derived neurotrophic factor (BDNF) to protect the nigrostriatal system, offers a new opportunity for the treatment of Parkinson's disease, especially in cases where current small molecule approaches fail to adequately control the symptoms.

To receive ongoing corporate communications via email, visit: Email Alerts

To like our Facebook page or follow us on Twitter for company updates and industry related news, visit: www.facebook.com/InternationalStemCellCorporation and www.twitter.com/intlstemcell

Contact:

International Stem Cell Corporation
Dr. Simon Craw
Executive Vice President
Phone: 760-940-6383
Email: ir@intlstemcell.com

Dr. Ruslan Semechkin
Chief Scientific Officer
Phone: 760-940-6383
Email: ras@intlstemcell.com
 
International Stem Cell Corporation (OTCQB: ISCO) (Welcome to International Stem Cell Corporation), a California-based biotechnology company developing novel stem cell-based therapies and biomedical products, today announced the completion of discussions with the U.S. Food and Drug Administration (FDA) regarding its Parkinson's disease (PD) cell therapy program through a pre-Investigational New Drug (pre-IND) meeting. The meeting provided formal feedback and guidance from the FDA on the proposed pre-clinical plan, manufacturing approach, and clinical study design necessary to file the IND.

"We're pleased with the outcomes of the meeting with the FDA," said Yale School of Medicine Professor D. Eugene Redmond Jr. MD, who is leading ISCO's pharmacology/toxicology study. "The FDA's feedback has provided clear direction for the remaining studies required for the IND."

Following this meeting, ISCO will be working to complete the Good Laboratory Practice (GLP) pharmacology and safety studies, including tumorigenicity, toxicology and tolerability, using the human parthenogenetic neural stem cell (hPNSC) product, a type of self-renewing multipotent cell that is a precursor for the major cells of the central nervous system. To date pre-clinical pilot studies in rodents and primates have shown the hPNSC to be safe, well tolerated, and provide therapeutic benefit by differentiating into dopaminergic neurons and expressing specific neurotrophic factors to protect the nigrostriatal system of the brain. We anticipate being able to report interim primate data before the end of March 2014 and top line final results from these GLP studies later in 2014 and expect to file the IND soon thereafter.

"As this will be the first IND for the Company, we're pleased to have completed this critical milestone," said Dr. Ruslan Semechkin, Chief Scientific Officer of ISCO. "Based on data from our pilot studies, along with the guidance from the FDA, we believe that we're well positioned to successfully transition this program to the clinical stage."

According to the Parkinson's Disease Foundation, an estimated seven to 10 million people worldwide live with PD, with as many as one million of those in the United States alone, more than the combined total of people diagnosed with multiple sclerosis, muscular distrophy, and Lou Gehrig's disease. The total direct and indirect cost of Parkinson's disease is estimated to be nearly $25 billion per year in the United States alone.

A more complete description of the hPNSC product and the GMP (21CFR211) manufacturing method was published together with Prof. Evan Y. Snyder, Director of Stem Cell Research Center at Sanford-Burnham Medical Research Institute in early 2013. Importantly, unlike many other stem cell therapy products, ISCO's proprietary hPNSC are cryopreservable, meaning they can be delivered in a frozen state to hospitals and clinics.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) hence avoiding ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCellTM. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (Human Cells and Cell Culture Media), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (Stem Cell Skin Care | Anti-Aging Skin Cream | Lifeline Skin Care). More information is available at Welcome to International Stem Cell Corporation.

ISCO's Parkinson's disease program uses human parthenogenetic neural stem cells (hPNSC), a novel therapeutic cellular product derived from the company's proprietary histocompatible human pluripotent stem cells. hPNSC are self-renewing multipotent cells that are precursors for the major cells of the central nervous system. The ability of hPNSC to (i) differentiate into dopaminergic (DA) neurons and (ii) express neurotrophic factors such as glial derived neurotrophic factor (GDNF) and brain derived neurotrophic factor (BDNF) to protect the nigrostriatal system, offers a new opportunity for the treatment of Parkinson's disease, especially in cases where current small molecule approaches fail to adequately control the symptoms.

To receive ongoing corporate communications via email, visit: Email Alerts

To like our Facebook page or follow us on Twitter for company updates and industry related news, visit: www.facebook.com/InternationalStemCellCorporation and www.twitter.com/intlstemcell



Contacts:

International Stem Cell Corporation
Dr. Simon Craw
Executive Vice President
Phone: 760-940-6383
Email: ir@intlstemcell.com

Dr. Ruslan Semechkin
Chief Scientific Officer
Phone: 760-940-6383
Email: ras@intlstemcell.com
 
CARLSBAD, CA--(Marketwired - Jun 19, 2014) - International Stem Cell Corporation (OTCQB: ISCO) (Welcome to International Stem Cell Corporation) ("ISCO" or "the Company"), a California-based biotechnology company developing novel stem cell based therapies, announced today the completion of the acute toxicity study of the Company's proposed clinical product to treat Parkinson's disease. The recently completed IND-enabling study transplanting rodents with human neural stem cells, derived from ISCO's proprietary parthenogenetic stem cell platform, showed that the cells are well tolerated even at high doses up to the equivalent of 2.2 billion cells in humans. The program continues to progress according to the plan outlined with the FDA at the pre-IND meeting as reported in February 2014. The Company intends to provide a further update early next quarter.

"I'm pleased that we have successfully achieved another important milestone in our Parkinson's disease program. A critical part of the development process, and the preparations for the IND submission, was to establish the highest tolerated dose of our clinical product in rodents," said Dr. Ruslan Semechkin, ISCO's Chief Scientific Officer. "The results of this study show that the doses we will be proposing to the FDA in our phase I clinical study design for the treatment of Parkinson's disease are well below the safety threshold."

The study consisted of 19 immune deficient rodents divided into four cohorts, a control group and three treatment groups receiving escalating doses of human parthenogenetic neural stem cells (hPNSC). Animals received stereotactic injections of hPNSC in the striatum and substantia nigra. The rodents were observed for seven days post transplantation and demonstrated normal appearance and behaviors. Necropsies showed no abnormal tissues or tumors after sacrifice. Detailed immunohistochemical analysis demonstrated that the majority of the implanted cells survived the surgery and engrafted into the host brain tissue.

According to the Parkinson's Disease Foundation, an estimated seven to 10 million people worldwide live with Parkinson's disease, with as many as one million of those in the United States alone, more than the combined total of people diagnosed with multiple sclerosis, muscular dystrophy, and Lou Gehrig's disease. The total direct and indirect cost of Parkinson's disease is estimated to be nearly $25 billion per year in the United States alone.

ISCO's Parkinson's disease program uses human parthenogenetic neural stem cells (hPNSC), a novel therapeutic cellular product derived from the company's proprietary histocompatible human pluripotent stem cells. hPNSC are self-renewing multipotent cells that are precursors for the major cells of the central nervous system. The ability of hPNSC to (i) differentiate into dopaminergic (DA) neurons and (ii) express neurotrophic factors such as glial derived neurotrophic factor (GDNF) and brain derived neurotrophic factor (BDNF) to protect the nigrostriatal system, offers a new opportunity for the treatment of Parkinson's disease, especially in cases where current small molecule approaches fail to adequately control the symptoms.

About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) hence avoiding ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCellTM. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (Human Cells and Cell Culture Media), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (Lifeline Stem Cell Skin Care - Skin Care with Non-embryonic Human Stem Cell. | Lifeline Skin Care). More information is available at Welcome to International Stem Cell Corporation.

ISCO's Parkinson's disease program uses human parthenogenetic neural stem cells (hPNSC), a novel therapeutic cellular product derived from the company's proprietary histocompatible human pluripotent stem cells. hPNSC are self-renewing multipotent cells that are precursors for the major cells of the central nervous system. The ability of hPNSC to (i) differentiate into dopaminergic (DA) neurons and (ii) express neurotrophic factors such as glial derived neurotrophic factor (GDNF) and brain derived neurotrophic factor (BDNF) to protect the nigrostriatal system, offers a new opportunity for the treatment of Parkinson's disease, especially in cases where current small molecule approaches fail to adequately control the symptoms.

To receive ongoing corporate communications via email, visit: Email Alerts

To like our Facebook page or follow us on Twitter for company updates and industry related news, visit: www.facebook.com/InternationalStemCellCorporation and www.twitter.com/intlstemcell

Contact:

International Stem Cell Corporation
Dr. Simon Craw
Executive Vice President
Phone: 760-940-6383
Email: ir@intlstemcell.com
 
sembra che la news, non sia stata recepita in positivo.....:(



Intl Stem Cell Corp (ISCO)


0.0930-0.0071 (-7.09%)
 
ISCO - International Stem Cell Corporation Secures Approval for Core Technology Patents in European Union

Press Releases: International Stem Cell Corporation Secures Approval for Core Technology Patents in European Union

CARLSBAD, CA - International Stem Cell Corporation (OTCQB: ISCO) (Welcome to International Stem Cell Corporation) ("ISCO" or "the Company"), a California-based biotechnology company developing novel stem cell based therapies and biomedical products, received formal opinion from the Advocate General for the European Union Court of Justice (CJEU) in favor of the Company's pending core technology patents.

Dr. Andrey Semechkin, the Company's Co-Chairman and CEO commented: "A favorable ruling by the CJEU in this case would give ISCO a unique advantage. Having the ability to seek patent protection in all 28 counties of the EU would not only enhance our ability to attract partners to develop stem cell therapies, but could also stimulate further investment by pharmaceutical companies who up to this point have been somewhat on the sidelines in part because of the intellectual property risks."

The European Union's highest court was asked to clarify whether its interpretation of the EU Directive on Legal Protection of Biotechnological Inventions ("Biotech Directive") in the 2011 Brüstle vs. Greenpeace case excluded ISCO's core technology -- parthenogenetic stem cells -- from patentability under the EU law. According to the Advocate General's interpretation, the Biotechnology Directive should not prohibit patenting of parthenogenetic stem cells.

Background
At issue in this case are two patent applications (covering production of stem cell lines and corneal tissue from parthenogenetically activated oocytes) that were initially filed by ISCO in the United Kingdom. The UK Intellectual Property Office rejected both applications on the grounds that the disclosed technology, namely parthenogenetic stem cells and methods of making these stem cells, involved the use and destruction of human embryos within the meaning of the Biotechnology Directive and was, therefore, excluded from patentability under the Court of Justice decision in Brüstle v. Greenpeace.

Technology covered by the German patent in the Brüstle case concerned the use of pluripotent embryonic stem cells for producing isolated and purified neural precursor cells which could be used to treat neurological diseases. Greenpeace challenged the patent, citing the Biotechnology Directive that expressly disallowed patent protection for inventions that used human embryos for industrial and commercial purposes. Faced with ambiguities in the language of the Directive, the German court referred the question of what constitutes a 'human embryo' to CJEU. Choosing to interpret the Directive broadly, the EU Court defined 'human embryo' as an organism that is capable of commencing the process of developing into a human being, including within the meaning of the term, an ovum that has been fertilized by sperm, a non-fertilized ovum subjected to somatic-cell nuclear transfer, and, notably, a non-fertilized ovum activated through parthenogenesis.

ISCO appealed the UK IPO's rejection, arguing that CJEU's ruling in Brüstle was incorrect as a matter of scientific fact with respect to parthenogenetic stem cells. In contrast to a fertilized human ovum, which gives rise to totipotent cells and possesses the inherent capacity to develop into human beings given the right environment, chemically activated oocytes or "parthenotes" are pluripotent and, therefore, incapable of ultimately developing into human beings. ISCO maintained further that since the ruling in Brüstle was only intended to ban patents on the use of organisms that could ultimately develop into human beings, parthenotes, which lacked such capacity, should not be regarded as human embryos for purposes of the Biotechnology Directive and should be patentable under the EU law.

Conceding that the Company's position with respect to parthenotes was well supported by scientific evidence, the UK court referred the question of whether parthenotes were 'human embryos' within the meaning of the Biotechnology Directive to the CJEU.

In his opinion, the EU Court's Advocate General concluded that with one technical caveat the question should be answered in the negative. According to the top advisor's reading of the ruling in Brüstle, the key criterion for determining whether an unfertilized ovum is a human embryo is whether the ovum possesses the inherent capacity to develop into a human being. Parthenotes, in the Advocate General's view, cannot be said to possess such inherent capacity given the current scientific knowledge, and as such should not be considered 'human beings' within the meaning of the Biotechnology Directive.

A confirmation of the Advocate General's opinion from the CJEU is expected within the coming months.

About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (Human Cells and Cell Culture Media), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (Lifeline Stem Cell Skin Care - Skin Care with Non-embryonic Human Stem Cell. | Lifeline Skin Care). More information is available at Welcome to International Stem Cell Corporation or follow us on Twitter @intlstemcell.

To receive ongoing corporate communications, please click on the following link: Email Alerts

Forward-looking Statements
Statements pertaining to anticipated developments, the potential benefits of research programs and products, 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," "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, 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 forward-looking statements.


Contact Information

Contact
International Stem Cell Corporation
Dr. Simon Craw
Executive Vice President
Phone: 760-940-6383
Email: ir@intlstemcell.com

Dr. Ruslan Semechkin
Chief Scientific Officer
Phone: 760-940-6383
Email: ras@intlstemcell.com
 
And they have the CEO as well, he just bought 4.8 mil shares at $0.10 about 3 weeks ago.

this is a buy and hold company, just wish they would put the IND on the back burner and focus on all the other things they have going on.

GLTA.

A.H
 
Indietro