International Stem Cell Corporation (ISCO) Commenc
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Posted On: 03/07/2016 4:31:43 PM
International Stem Cell Corporation (ISCO) Commences Enrollment of Phase I Trial of ISC-hpNSC
Before the opening bell, International Stem Cell Corporation (OTCQB: ISCO) took a major step in the development of its human parthenogenetic stem cell-derived neural stem cells (ISC-hpNSC) for the treatment of moderate to severe Parkinson’s disease when it announced the commencement of enrollment for its upcoming phase I clinical trial. This announcement followed the Melbourne Health Human Research Ethics Committee’s (HREC) recent decision to grant approval of the phase I clinical trial in patients with moderate to severe Parkinson’s disease. The trial is scheduled to take place at the Royal Melbourne Hospital in Australia.
“Enrollment in this trial is an important milestone,” Dr. Russell Kern, executive vice president and chief scientific officer of ISCO, stated in this morning’s release. “Promising preclinical results support our expectation that ISC-hpNSC will bring a long-needed solution for patients suffering from Parkinson’s disease.”
Following completion of enrollment, ISCO will commence a dose escalation safety and preliminary efficacy study of its proprietary ISC-hpNSC. The clinical trial will involve intracranial transplantation of the stem cells into patients with moderate to severe Parkinson’s disease. A total of 12 patients are expected to participate in the trial, with three different dose regimens being studied. Following transplantation, the patients will be monitored at specified intervals for one year, with PET scans being performed as part of the screening assessment. The study’s submission will be overseen by Cyto Therapeutics Pty Ltd., a subsidiary of ISCO.
ISC-hpNSC have demonstrated promising results in preclinical studies. In both rodents and non-human primates, the highly pure stem cells have supported improvement in Parkinson’s symptoms and increases in brain dopamine levels. Additionally, ISC-hpNSC have been safe, well-tolerated and free from adverse side effects such as dyskinesia, systemic toxicity and tumors in preclinical models.
If approved, ISCO’s groundbreaking approach to the treatment of Parkinson’s disease could revolutionize an expansive treatment market. Currently, medications used to treat Parkinson’s, including L-DOPA and dopamine agonists, serve only to improve the early symptoms associated with the disease. As the illness progresses, the loss of dopaminergic neurons eventually renders these drugs ineffective while at the same time producing a complication marked by involuntary writhing movements. In recent years, incidence of Parkinson’s has been on the rise. In 2013, the disease resulted in roughly 103,000 deaths globally, up from about 44,000 deaths in 1990.
For more information, visit www.internationalstemcell.com
Please read full disclaimers at http://disclaimer.missionir.com
Before the opening bell, International Stem Cell Corporation (OTCQB: ISCO) took a major step in the development of its human parthenogenetic stem cell-derived neural stem cells (ISC-hpNSC) for the treatment of moderate to severe Parkinson’s disease when it announced the commencement of enrollment for its upcoming phase I clinical trial. This announcement followed the Melbourne Health Human Research Ethics Committee’s (HREC) recent decision to grant approval of the phase I clinical trial in patients with moderate to severe Parkinson’s disease. The trial is scheduled to take place at the Royal Melbourne Hospital in Australia.
“Enrollment in this trial is an important milestone,” Dr. Russell Kern, executive vice president and chief scientific officer of ISCO, stated in this morning’s release. “Promising preclinical results support our expectation that ISC-hpNSC will bring a long-needed solution for patients suffering from Parkinson’s disease.”
Following completion of enrollment, ISCO will commence a dose escalation safety and preliminary efficacy study of its proprietary ISC-hpNSC. The clinical trial will involve intracranial transplantation of the stem cells into patients with moderate to severe Parkinson’s disease. A total of 12 patients are expected to participate in the trial, with three different dose regimens being studied. Following transplantation, the patients will be monitored at specified intervals for one year, with PET scans being performed as part of the screening assessment. The study’s submission will be overseen by Cyto Therapeutics Pty Ltd., a subsidiary of ISCO.
ISC-hpNSC have demonstrated promising results in preclinical studies. In both rodents and non-human primates, the highly pure stem cells have supported improvement in Parkinson’s symptoms and increases in brain dopamine levels. Additionally, ISC-hpNSC have been safe, well-tolerated and free from adverse side effects such as dyskinesia, systemic toxicity and tumors in preclinical models.
If approved, ISCO’s groundbreaking approach to the treatment of Parkinson’s disease could revolutionize an expansive treatment market. Currently, medications used to treat Parkinson’s, including L-DOPA and dopamine agonists, serve only to improve the early symptoms associated with the disease. As the illness progresses, the loss of dopaminergic neurons eventually renders these drugs ineffective while at the same time producing a complication marked by involuntary writhing movements. In recent years, incidence of Parkinson’s has been on the rise. In 2013, the disease resulted in roughly 103,000 deaths globally, up from about 44,000 deaths in 1990.
For more information, visit www.internationalstemcell.com
Please read full disclaimers at http://disclaimer.missionir.com
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