“The publication of these data in the peer-reviewed and highly-respected journal, Cell Transplantation, brings to a conclusion the preclinical stage of our Parkinson’s disease program. The data clearly support the premise that parthenogenetic neural stem cells can be effective in treating the symptoms of Parkinson’s disease and, along with the previously reported safety data, forms the basis of our decision to move into the clinic,” said Ruslan Semechkin, Ph.D., the Company’s Chief Scientific Officer, “We look forward to providing an update on the status of our regulatory submission to the Australian government in the near future.”
The two studies demonstrated the safety and efficacy of transplanting human parthenogenetic neural stem cells (hpNSC) into animals with induced Parkinson's disease symptoms. No deformations, tumors or involuntary muscle movements (dyskinesia) developed. The studies further show that transplants of human parthenogenetic neural stem cells led to improvement of dopamine levels and increased cytokine levels.
The article and abstract can be found at: http://www.ingentaconnect.com/content/cog/ct/2015/00000024/00000004/art00010
ISCO has built a comprehensive preclinical safety dataset from a series of GLP and non-GLP studies on hpNSC. The Company has submitted a Clinical Trial Exemption (CTX) application to the Australian regulatory authorities and plans to begin the phase 1/2a clinical study within the next few months.
About human parthenogenetic neural stem cell (hpNSC)
hpNSCs are a novel therapeutic cellular product derived from the Company's proprietary human pluripotent stem cells. Neural stem cells work to repair the brain in several ways. The cells are attracted to the site of injury and in response to signals released by the damaged tissue release a range of molecules that reduce inflammation and trigger the recovery process. Neural stem cells also have the ability to generate new cells to replace those that are either dead or dying enabling the formation of new tissue. In this way the hpNSCs act as coordinators of all the various activities necessary to recover brain function.
About Parkinson’s disease
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. Parkinson's disease is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons responsible for producing dopamine, and is characterized by symptoms including tremors at rest, rigidity and impaired movement.
The standard of care for the treatment of PD symptoms is oral levodopa (L-dopa). Oral dosing of L-dopa is associated with wide variability in the timing and amount of L-dopa absorption into the bloodstream, leading to the unreliable control of symptoms resulting in the emergence of off episodes, periods of time during which Parkinson's disease symptoms reemerge despite L-dopa treatment. These off episodes, which increase in frequency and severity during the course of the disease, are experienced by a majority of PD patients and are considered one of the greatest unmet medical needs facing PD patients.
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 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 and companyblog.intlstemcell.com.
To receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0
Safe harbor statement
Statements pertaining to anticipated developments, expected clinical studies (including timing and potential results), 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.
Contacts:
International Stem Cell Corporation
The two studies demonstrated the safety and efficacy of transplanting human parthenogenetic neural stem cells (hpNSC) into animals with induced Parkinson's disease symptoms. No deformations, tumors or involuntary muscle movements (dyskinesia) developed. The studies further show that transplants of human parthenogenetic neural stem cells led to improvement of dopamine levels and increased cytokine levels.
The article and abstract can be found at: http://www.ingentaconnect.com/content/cog/ct/2015/00000024/00000004/art00010
ISCO has built a comprehensive preclinical safety dataset from a series of GLP and non-GLP studies on hpNSC. The Company has submitted a Clinical Trial Exemption (CTX) application to the Australian regulatory authorities and plans to begin the phase 1/2a clinical study within the next few months.
About human parthenogenetic neural stem cell (hpNSC)
hpNSCs are a novel therapeutic cellular product derived from the Company's proprietary human pluripotent stem cells. Neural stem cells work to repair the brain in several ways. The cells are attracted to the site of injury and in response to signals released by the damaged tissue release a range of molecules that reduce inflammation and trigger the recovery process. Neural stem cells also have the ability to generate new cells to replace those that are either dead or dying enabling the formation of new tissue. In this way the hpNSCs act as coordinators of all the various activities necessary to recover brain function.
About Parkinson’s disease
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. Parkinson's disease is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons responsible for producing dopamine, and is characterized by symptoms including tremors at rest, rigidity and impaired movement.
The standard of care for the treatment of PD symptoms is oral levodopa (L-dopa). Oral dosing of L-dopa is associated with wide variability in the timing and amount of L-dopa absorption into the bloodstream, leading to the unreliable control of symptoms resulting in the emergence of off episodes, periods of time during which Parkinson's disease symptoms reemerge despite L-dopa treatment. These off episodes, which increase in frequency and severity during the course of the disease, are experienced by a majority of PD patients and are considered one of the greatest unmet medical needs facing PD patients.
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 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 and companyblog.intlstemcell.com.
To receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0
Safe harbor statement
Statements pertaining to anticipated developments, expected clinical studies (including timing and potential results), 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.
Contacts:
International Stem Cell Corporation
Simon Craw, Ph.D., Executive Vice President
Phone: 760-940-6383
Email: ir@intlstemcell.com
Ruslan Semechkin, Ph.D., Chief Scientific Officer
Phone: 760-940-6383
Email: ras@intlstemcell.com
Media
Tony Russo, Ph.D.
Phone: 212-845-4251
Email: tony.russo@russopartnersllc.com
Christopher Hippolyte
Phone: (646)942-5634
Email: chris.hippolyte@russopartnersllc.com
Phone: 760-940-6383
Email: ir@intlstemcell.com
Ruslan Semechkin, Ph.D., Chief Scientific Officer
Phone: 760-940-6383
Email: ras@intlstemcell.com
Media
Tony Russo, Ph.D.
Phone: 212-845-4251
Email: tony.russo@russopartnersllc.com
Christopher Hippolyte
Phone: (646)942-5634
Email: chris.hippolyte@russopartnersllc.com
