ISCO's
Parkinson's disease program was showcased in Seeking Alpha this morning.
Thursday, April 4, 2013
Thursday, March 28, 2013
Patrick Cox Features ISCO's Stem Cell Parkinson's Study
Patrick Cox blogs about ISCO's success in primate study (data presented
at American Academy of Neurology Annual Meeting, March 20th 2013).
Reproduced with the permission of P.Cox.
ISCO Shows Functioning Parthenogenic Stem Cells
in Parkinson's Chimp Study
International Stem Cell Corp. (OTCBB: ISCO) has announced the most important experimental results in the history of the company. Last week, the company confirmed that these nonembryonic stem cells can, in fact, become part of a host primate and function as normal cells.
Now I'm really feeling guilty because this story deserves a lot more attention than I can give it today. Nevertheless, ISCO presented the results of a blinded chimpanzee Parkinson's study at the American Academy of Neurology's 65th annual meeting on March 20.
There's been a lot of skepticism about the potential of human parthenogenic stem cells (hpSCs) for several reasons. First of all, they don't develop naturally into adult cells such as the neuronal cells that were used in this study. Unlike regular cells that have the DNA of both the mother and the father, hpSC DNA consists of two copies of the mother's genome, so they have to be provoked to become specific cell types.
As a result, these hpSCs, which come from immature ova gathered during routine in vitro fertilization procedures, cannot develop into fetuses. Obviously, this is a big plus for those who oppose the use of embryonic stem cells. It raised the possibility, however, that cells derived from hpSCs would not function as normal cells for therapeutic purposes.
We now know that hpSC-derived neuronal cells will engraft, became part of the chimps they were given to and produce the dopamine needed to prevent the symptoms of Parkinson's disease. This is powerful evidence of hpSC efficacy, though I'm not at all surprised by these results.
You should read the press release, which states:
International Stem Cell Corp. (OTCBB: ISCO) has announced the most important experimental results in the history of the company. Last week, the company confirmed that these nonembryonic stem cells can, in fact, become part of a host primate and function as normal cells.
Now I'm really feeling guilty because this story deserves a lot more attention than I can give it today. Nevertheless, ISCO presented the results of a blinded chimpanzee Parkinson's study at the American Academy of Neurology's 65th annual meeting on March 20.
There's been a lot of skepticism about the potential of human parthenogenic stem cells (hpSCs) for several reasons. First of all, they don't develop naturally into adult cells such as the neuronal cells that were used in this study. Unlike regular cells that have the DNA of both the mother and the father, hpSC DNA consists of two copies of the mother's genome, so they have to be provoked to become specific cell types.
As a result, these hpSCs, which come from immature ova gathered during routine in vitro fertilization procedures, cannot develop into fetuses. Obviously, this is a big plus for those who oppose the use of embryonic stem cells. It raised the possibility, however, that cells derived from hpSCs would not function as normal cells for therapeutic purposes.
We now know that hpSC-derived neuronal cells will engraft, became part of the chimps they were given to and produce the dopamine needed to prevent the symptoms of Parkinson's disease. This is powerful evidence of hpSC efficacy, though I'm not at all surprised by these results.
You should read the press release, which states:
"‘This pilot
study represents a first essential step in bringing cell-based therapies for
Parkinson's disease to clinical trials,’ commented co-author of the study
Evan Y. Snyder, MD, Ph.D., director of Stem Cells and Regenerative Biology
Program at Sanford Burnham Medical Research Institute.
“These placebo-controlled studies were designed to demonstrate the viability, fate and functional efficacy of the stem cell-derived neural cells after implantation to the brain. Highly pure populations of neuronal cells were differentiated from human parthenogenetic stem cells (hpSC) according to the protocol developed by International Stem Cell Corp. and recently published in the Nature Publishing Group's Scientific Reports. “The studies employ MPTP-lesioned African green monkeys and 6-OHDA-lesioned rats, the principal models used to study Parkinson's disease. The duration of the primate study was four months and the rodent study six months. In the nonhuman primate model, behavioral endpoints were assessed with Parkinsonian scores. These scores, based on a standardized rating scale, were recorded by observers blinded to whether the primates were in the treatment or control group. Observations were done twice per day, five days per week. In the rodent model, behavioral improvement was assessed using the cylinder test, amphetamine and apomorphine-induced rotation tests. Cell engraftment, viability and phenotype of the implanted cells were determined histologically at the end of the studies. Tumorigenicity and safety of the therapy was assessed at the end of both the rodent and primate studies by gross necropsy, and brain histology. “The primate study consisted of eight asymptomatic monkeys which have the pathology of the disease, low levels of dopamine induced by bilateral injections of the neurotoxin MPTP and lack clinical symptoms. Four of the monkeys were transplanted with hpSC-derived neuronal cells, two monkeys sham transplanted with an equivalent volume of cell-less media thus serving as the placebo control group and two healthy monkeys serving as a positive control. Behavioral endpoints were recorded to evaluate possible adverse effects. “Subsequent to implantation of the neuronal cells, all monkeys in the treatment group had higher levels of dopamine in the brain compared with the control group. Additionally, the rats in the treatment group showed gradual improvements in motor symptoms consistent with cells survival, engraftment and dopamine release. No adverse events, including dyskinesia, deformations, tumors or overgrowth, were observed in the rat or monkey treatment groups. Overall, these results provide evidence to support the hypothesis that hpSC-derived neuronal cells can be safe and have a disease modifying effect. These results, although preliminary, are a strong indication that our approach to Parkinson's disease can succeed. "‘These results are pivotal for our preclinical Parkinson's program showing, as they do, that the hpSC-derived neuronal cells can potentially ameliorate the behavioral symptoms without triggering dyskinesias. This data form the foundation of our discussions with the FDA as we move toward our IND in 2013,’ said Dr. Ruslan Semechkin, principal investigator of this study, head of R&D for International Stem Cell Corp. and Member of the American Academy of Neurology. “These results will be presented and discussed at the 65th American Academy of Neurology annual meeting, one of the world's most important annual events for neurologists and neuroscience professionals and the largest such international meeting of its kind, with more than 12,000 attendees at last year's meeting.” |
Obviously, the company intends to bolster this study with larger primate studies before going into human studies, hopefully early next year. The importance of hpSC therapies, however, shouldn't be overlooked. Not only do they provide a solution to many people's ethical problems with embryonically derived stem cells, they represent an entirely different path to regenerative medicine.
As you know, BioTime (AMEX: BTX) recently consolidated Geron's stem cell IP. BioTime is now the undisputed leader in embryonic and induced pluripotent stem cells. ISCO, however, owns the parthenogenic space. It uses methods of differentiation and cell production that are unique to its own platform. In fact, far more information is available about those technologies in this journal article of Nature's Scientific Reports.
Ultimately, when the company has created its bank of cell lines to match most of the human species, it will be able to provide off-the-shelf therapeutic cells for many conditions that would otherwise require immune suppression or iPS cells. This is a big deal, but it's also in the future. The Parkinson's disease target is ideal for ISCO because there is no immune rejection behind the blood-brain barrier where these cells are required. This enables a path to revenues much sooner than the cell line strategy.
I'll have a lot more on this development in the future. Already, these results have generated more attention in the scientific press than the company has ever before garnered. That will increase as more information is released.
Also, by the way, the company's hpSC cosmetics line, Lifeline Skin Care, is getting serious attention in the beauty and anti-aging press. Products have recently been featured in Elle and Prevention magazines as well as other forums.
Yours for transformational profits,
Patrick Cox
Wednesday, March 20, 2013
International Stem Cell Corporation Announces Positive Stem Cell Data in Parkinson's Disease
Data Presented at the American Academy of Neurology 65th Annual Meeting
"This pilot study represents a first essential step in bringing cell-based therapies for Parkinson's disease to clinical trials," commented co-author of the study Evan Y. Snyder, MD, PhD, Director of Stem Cells and Regenerative Biology Program at Sanford Burnham Medical Research Institute.
These placebo-controlled studies were designed to demonstrate the viability, fate and functional efficacy of the stem cell derived neural cells after implantation to the brain. Highly pure populations of neuronal cells were differentiated from human parthenogenetic stem cells (hpSC) according to the protocol developed by International Stem Cell Corporation and recently published in the Nature Publishing Group's Scientific Reports.
The studies employ MPTP-lesioned African Green monkeys and 6-OHDA-lesioned rats, the principle models used to study Parkinson's disease. The duration of the primate study was four months and the rodent study six months. In the non-human primate model, behavioral endpoints were assessed with parkinsonian scores. These scores, based on a standardized rating scale, were recorded by observers blinded to whether the primates were in the treatment or control group. Observations were done twice per day, five days per week. In the rodent model, behavioral improvement was assessed using the cylinder test, amphetamine and apomorphine induced rotation tests. Cell engraftment, viability and phenotype of the implanted cells were determined histologically at the end of the studies. Tumorigenicity and safety of the therapy was assessed at the end of both the rodent and primate studies by gross necropsy, and brain histology.
The primate study consisted of eight asymptomatic monkeys which have the pathology of the disease, low levels of dopamine induced by bilateral injections of the neurotoxin MPTP, and lack clinical symptoms. Four of the monkeys were transplanted with hpSC-derived neuronal cells, two monkeys sham transplanted with an equivalent volume of cell-less media thus serving as the placebo control group and two healthy monkeys serving as a positive control. Behavioral endpoints were recorded to evaluate possible adverse effects.
Subsequent to implantation of the neuronal cells, all monkeys in the treatment group had higher levels of dopamine in the brain compared with the control group. Additionally, the rats in the treatment group showed gradual improvements in motor symptoms consistent with cells survival, engraftment and dopamine release. No adverse events, including dyskinesia, deformations, tumors or overgrowth, were observed in the rat or monkey treatment groups. Overall, these results provide evidence to support the hypothesis that hpSC-derived neuronal cells can be safe and have a disease modifying effect. These results, although preliminary, are a strong indication that our approach to Parkinson's disease can succeed.
"These results are pivotal for our pre-clinical Parkinson's program showing, as they do, that the hpSC-derived neuronal cells can potentially ameliorate the behavioral symptoms without triggering dyskinesias. This data forms the foundation of our discussions with the FDA as we move towards our IND in 2013," said Dr. Ruslan Semechkin, Principal Investigator of this study, head of R&D for International Stem Cell Corporation and Member of the American Academy of Neurology.
These results will be presented and discussed at the 65th American Academy of Neurology Annual Meeting, one of the world's most important annual events for neurologists and neuroscience professionals and the largest such international meeting of its kind with more than 12,000 attendees at last year's meeting.
Location: San Diego Convention Center, 111 W Harbor Dr., San Diego, CA 92101
Session: Movement Disorders; Parkinson's Disease Therapeutics
Date and time: March 20th, 2013 at 3:30 PM PDT
Parkinson's disease (PD) is a debilitating neurodegenerative disorder characterized by a progressive degeneration of dopamine-producing neurons in the central nervous system. Approximately 60,000 American's are diagnosed with PD every year, world-wide there are thought to be as many as ten million sufferers. Current PD treatments, including small molecule such as Levadopa which replaces the lost dopamine, are useful in the relatively early stage of the disease. As symptoms grow worse, the efficacy of such therapies declines, leaving many patients severely disabled.
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 (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.
To receive ongoing corporate communications via email, visit: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0
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
Safe harbor statement
Statements pertaining to anticipated developments, the potential use of technologies to develop therapeutic products, potential 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" or "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 and the management of collaborations, 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.
Contacts:
International Stem Cell Corporation
Dr. Simon Craw
Executive Vice President
Phone: 760-940-6383
Email: ir@intlstemcell.com
Dr. Ruslan Semechkin
Vice President, R&D
Phone: 760-940-6383
Email: ras@intlstemcell.com
Friday, March 15, 2013
International Stem Cell Corporation Technology for Deriving Neuronal Cell Published by Nature Publishing Group
International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com),
a California-based biotechnology company focused on the therapeutic
applications of human parthenogenetic stem cells, announced today the
publication of its breakthrough method of deriving neuronal cells for
the treatment of Parkinson's disease in Scientific Reports, a primary
research publication from the publishers of Nature.
Parkinson's disease (PD) is a common neurodegenerative disorder caused by a progressive loss of dopamine-producing neurons resulting in gradual dysfunction of the motor system. Pharmacological treatments are useful in the relatively early stage of the disease, but the continuous use of pro-dopaminergic medication eventually becomes ineffective and can worsen some of the motor symptoms. ISCO is developing a treatment for PD based on replacing the lost neurons with new neuronal cells derived from human parthenogenetic stem cells (hpSC). To this end ISCO has developed a sophisticated and efficient manufacturing process for neuronal cells which has now been published in the peer-reviewed journal Scientific Reports.
The paper describes the technology, developed by ISCO's R&D team, for producing highly pure populations of GMP-grade neuronal cells suitable for pre-clinical studies and clinical trials. The neuronal cells created using this approach are further characterized using a number of analytical methods and shown to function in a similar manner to adult cells. Moreover, neuronal cells produced using this new method, express greater levels of dopamine, the neurotransmitter central to PD, than previously reported approaches. Furthermore, these hpSC-derived neuronal cells are cryopreservable and can be stored frozen, and provides a practical route to creating neurons of sufficient quality to be used to treat Parkinson's disease patients.
"It is important that our research is reviewed and validated by the scientific community and being able to publish in a Nature-branded, journal provides confirmation of the quality of ISCO's scientific research," commented Dr. Andrey Semechkin, CEO and Co-Chairman.
The full-text of the publication can be found at http://www.nature.com/srep/2013/130315/srep01463/full/srep01463.html
Contacts:
International Stem Cell Corporation
Dr. Simon Craw
Executive Vice President
Phone: 760-940-6383
Email: ir@intlstemcell.com
Dr. Ruslan Semechkin
Vice President, R&D
Phone: 760-940-6383
Email: ras@intlstemcell.com
Parkinson's disease (PD) is a common neurodegenerative disorder caused by a progressive loss of dopamine-producing neurons resulting in gradual dysfunction of the motor system. Pharmacological treatments are useful in the relatively early stage of the disease, but the continuous use of pro-dopaminergic medication eventually becomes ineffective and can worsen some of the motor symptoms. ISCO is developing a treatment for PD based on replacing the lost neurons with new neuronal cells derived from human parthenogenetic stem cells (hpSC). To this end ISCO has developed a sophisticated and efficient manufacturing process for neuronal cells which has now been published in the peer-reviewed journal Scientific Reports.
The paper describes the technology, developed by ISCO's R&D team, for producing highly pure populations of GMP-grade neuronal cells suitable for pre-clinical studies and clinical trials. The neuronal cells created using this approach are further characterized using a number of analytical methods and shown to function in a similar manner to adult cells. Moreover, neuronal cells produced using this new method, express greater levels of dopamine, the neurotransmitter central to PD, than previously reported approaches. Furthermore, these hpSC-derived neuronal cells are cryopreservable and can be stored frozen, and provides a practical route to creating neurons of sufficient quality to be used to treat Parkinson's disease patients.
"It is important that our research is reviewed and validated by the scientific community and being able to publish in a Nature-branded, journal provides confirmation of the quality of ISCO's scientific research," commented Dr. Andrey Semechkin, CEO and Co-Chairman.
The full-text of the publication can be found at http://www.nature.com/srep/2013/130315/srep01463/full/srep01463.html
Contacts:
International Stem Cell Corporation
Dr. Simon Craw
Executive Vice President
Phone: 760-940-6383
Email: ir@intlstemcell.com
Dr. Ruslan Semechkin
Vice President, R&D
Phone: 760-940-6383
Email: ras@intlstemcell.com
Tuesday, March 12, 2013
International Stem Cell Corporation Demonstrates Positive Animal Efficacy Results in Metabolic Liver Disease Program
International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com)
("ISCO" or "the Company") a California-based biotechnology company,
today announced the conclusions from its study demonstrating the
efficacy and safety of the hepatocyte-like cells (HLC) derived from
human parthenogenetic stem cells (hpSC) in a well-established animal
model of a congenital liver disorder associated with bilirubin
metabolism. The data from this pre-clinical study indicates that
implanting HLC in rodents produced both a significant initial decrease
and the long-term stabilization of bilirubin levels in blood serum.
Criggler-Najjar syndrome type 1 (CN1) is a rare inherited metabolic disorder in which the sufferer's liver lacks a specific enzyme -- UGT1A1, which is essential for the clearance of the toxin bilirubin. The syndrome results in unconjugated hyperbilirubinemia, a disorder characterized by severe neurological complications which, if left untreated, can lead to irreversible acute encephalopathy. Allogenic hepatocyte transplantation (HT) has been used as an alternative therapeutic option for patients with liver-based metabolic diseases including CN1. However, one of the major factors limiting the clinical advancement of human HT is a shortage of mature, functioning human hepatocytes as well as the limited repopulation capacity of grafted adult cells.
The use of HLCs to treat CN1 has several potential advantages over transplantation of primary hepatocytes. Firstly, HLC would circumvent the shortage of primary cells, as they can be produced and expanded in vitro. Secondly, there is evidence to suggest that grafting HLC may yield better long-term repopulation and persistent metabolic activity than using immature fetal hepatocytes. HLCs can also be given before the onset of bilirubin encephalopathy occurs, and can thus provide sufficient amounts of UGT1A1 to allow the liver to metabolize this toxin.
ISCO has previously reported how these HLC engraft in the liver of Gunn rats, a well-validated model of CN1 where the animals lack UGT1A1 and therefore accumulate toxic levels of unconjugated bilirubin. In addition to this result, no adverse safety signals were detected 16 weeks after the implantation of a therapeutic dose of HLC, and serum levels of bilirubin continued to decline, compared with the control group, up to the conclusion of the observation period at week 19. Moreover, the overall structure and morphology of the liver in all rodents in the treatment group appeared to be undamaged, with no apparent inflammation, tumorigenicity or cell rejection observed.
Dr. Ruslan Semechkin, Vice President - head of R&D for ISCO comments: "This study provides important evidence for the use of our HLC product as a viable source of transplantable cells for the treatment of CN1. Having completed this study, we can now discuss with the FDA the requirements for our Investigational New Drug (IND) application and phase 1 clinical trial."
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 (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.
To receive ongoing corporate communications via email, visit: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0
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
Safe harbor statement
Statements pertaining to anticipated developments, the potential use of technologies to develop therapeutic 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" or "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 and the management of collaborations, 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.
Criggler-Najjar syndrome type 1 (CN1) is a rare inherited metabolic disorder in which the sufferer's liver lacks a specific enzyme -- UGT1A1, which is essential for the clearance of the toxin bilirubin. The syndrome results in unconjugated hyperbilirubinemia, a disorder characterized by severe neurological complications which, if left untreated, can lead to irreversible acute encephalopathy. Allogenic hepatocyte transplantation (HT) has been used as an alternative therapeutic option for patients with liver-based metabolic diseases including CN1. However, one of the major factors limiting the clinical advancement of human HT is a shortage of mature, functioning human hepatocytes as well as the limited repopulation capacity of grafted adult cells.
The use of HLCs to treat CN1 has several potential advantages over transplantation of primary hepatocytes. Firstly, HLC would circumvent the shortage of primary cells, as they can be produced and expanded in vitro. Secondly, there is evidence to suggest that grafting HLC may yield better long-term repopulation and persistent metabolic activity than using immature fetal hepatocytes. HLCs can also be given before the onset of bilirubin encephalopathy occurs, and can thus provide sufficient amounts of UGT1A1 to allow the liver to metabolize this toxin.
ISCO has previously reported how these HLC engraft in the liver of Gunn rats, a well-validated model of CN1 where the animals lack UGT1A1 and therefore accumulate toxic levels of unconjugated bilirubin. In addition to this result, no adverse safety signals were detected 16 weeks after the implantation of a therapeutic dose of HLC, and serum levels of bilirubin continued to decline, compared with the control group, up to the conclusion of the observation period at week 19. Moreover, the overall structure and morphology of the liver in all rodents in the treatment group appeared to be undamaged, with no apparent inflammation, tumorigenicity or cell rejection observed.
Dr. Ruslan Semechkin, Vice President - head of R&D for ISCO comments: "This study provides important evidence for the use of our HLC product as a viable source of transplantable cells for the treatment of CN1. Having completed this study, we can now discuss with the FDA the requirements for our Investigational New Drug (IND) application and phase 1 clinical trial."
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 (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.
To receive ongoing corporate communications via email, visit: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0
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
Safe harbor statement
Statements pertaining to anticipated developments, the potential use of technologies to develop therapeutic 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" or "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 and the management of collaborations, 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.
Tuesday, February 5, 2013
Mentioned in Breakthrough Technology Alert
Progress in our Parkinson's disease program was showcased in Breakthrough Technology Alert today. Read here.
Monday, February 4, 2013
International Stem Cell Corporation Announces Positive Results From In Vivo Animal Study of Parkinson's Disease
CARLSBAD, CA -- (Marketwire) -- 02/04/13 -- International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) ("ISCO" or "the Company") a California-based biotechnology company, today announced positive 12-week results from its pre-clinical in vivo Parkinson's disease study. The primary goal of this behavioral study was to demonstrate the therapeutic benefits of neuronal cells derived from human parthenogenetic stem cell (hpSC) line in a rat model of Parkinson's disease (PD).
Parkinson's disease is a common neurodegenerative disorder caused by a progressive degeneration of dopamine-producing neurons resulting in gradual dysfunction of the motor system and can eventually lead to death. Pharmacological treatments are useful in the relatively early stage of the disease, but the continuous use of pro-dopaminergic medication eventually becomes ineffective and can cause some of the motor symptoms to worsen.
Our proprietary technology is based on a homogeneous population of neuronal cells (NCs) derived from homozygous hpSCs through a scalable and efficient method, developed by ISCO's R&D team. These parthenogenetically-derived NCs are cryopreservable and can become neurons once they are implanted into the brain. As such, they hold significant therapeutic potential not only because they can differentiate into dopamine-producing neurons, but also because these cells deliver trophic factors that may be able to provide a level of protection to existing neurons affected by the disease.
The animal model used in this study is the 6-OHDA lesioned rat, a well-established and validated model of PD which has been used extensively in the development and testing of drugs for the treatment of PD. The pharmacological induction of rotational behavior in rats is widely used to assess the effects of lesions and potential of cell therapy to effectively replace the dopaminergic system in the rat brain and thus serves as a model of PD. The experimental rats with unilateral dopamine (6-OHDA) lesions survived the inoculation of cells into the brain and signs of improvement in rotational behavior of these animals were clearly observed. Correlational analysis of rotation intensity demonstrated a difference between the drug effects in the control group vs. experimental (transplanted) group of animals. These interim results demonstrate that a single injection of hpSC-derived neuronal cells into the striatum of rats with induced PD symptoms can lead to a significant slowdown in the progression of the disease.
Dr. Ruslan Semechkin, Vice President - head of R&D, comments: "This is a very important result for our pre-clinical Parkinson's program. The initial in vivo results are very encouraging and show the therapeutic promise of hpSC-derived neuronal cells in the treatment of individuals with Parkinson's disease. Results from this behavioral study will be presented and discussed together with the results of non-human primate study before the end of the first quarter of 2013"
About International Stem Cell CorporationInternational 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 (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.
To receive ongoing corporate communications via email, visit: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0
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
Safe harbor statement Statements pertaining to anticipated developments, the potential use of technologies to develop therapeutic 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" or "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 and the management of collaborations, 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.
Monday, January 7, 2013
International Stem Cell Corporation Announces Positive Animal Efficacy Results in Liver Disease Program
01/07/13 -- International Stem Cell
Corporation (OTCQB: ISCO) (www.internationalstemcell.com) ("ISCO"
or "the Company") a California-based biotechnology company, today
announced positive top line efficacy results from its pre-clinical in vivo
liver study. The primary goal of the efficacy study was to demonstrate the
therapeutic equivalence of human parthenogenetic stem cell (hpSC)-derived hepatocytes
to adult liver cells as a prerequisite for using such cells in the treatment of
metabolic liver diseases including Crigler-Najjar Syndrome.
Crigler-Najjar Syndrome (CNS) is a
rare inherited disorder in which bilirubin, a substance made by the liver,
cannot be broken down by the liver. The build-up of this toxic compound can
lead to damage to the brain, muscles, and nerves and eventually cause death.
Current treatment paradigms for CNS include phototherapy and blood
transfusions, but these do not treat the underlying cause of the disease.
Hepatocyte transplantation has emerged as a therapeutic strategy, and has been
successfully applied to treat patients with CNS, however the extremely limited
availability of human livers and therefore of donated primary hepatocytes makes
a stem cell based approach attractive.
These ISCO study results demonstrate
that the hpSC-derived hepatocytes engraft in the liver of Gunn rats and behave
in a similar manner to primary human hepatocytes. The Gunn rat is a well-established
model of CNS and has been used extensively to study bilirubin toxicity and
hepatocytes transplantation. Additionally, the study indicates that a single
intrasplenic injection of hpSC-derived hepatocytes results in a change in the
plasma indirect bilirubin level equivalent to that achieved by injecting
primary hepatocytes. Establishing the equivalence of hpSC-derived and
donor-derived hepatocytes in their ability to metabolize bilirubin supports the
thesis that hpSC-derived hepatocytes can be used therapeutically as a
substitute for donated primary liver cells.
"Achieving this milestone is
very encouraging," said Dr. Andrey Semechkin, CEO and Co-chairman of ISCO.
"These results suggest that hpSC-derived hepatocytes could be a well
suited alternative to donated primary hepatocytes as a source of cells in
clinical applications including the treatment of Crigler-Najjar Syndrome."
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 (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.
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 (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.
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Safe
harbor statement
Statements pertaining to anticipated developments, the potential use of technologies to develop therapeutic 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" or "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 and the management of collaborations, 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.
Statements pertaining to anticipated developments, the potential use of technologies to develop therapeutic 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" or "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 and the management of collaborations, 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.
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