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Press Release

International Stem Cell Corporation Doses 7th Patient in Clinical Trial for Parkinson's Disease


Posted on: 29 Nov 17

CARLSBAD, Calif., Nov. 29, 2017 (GLOBE NEWSWIRE) -- International Stem Cell Corporation (OTCQB:ISCO) (www.internationalstemcell.com) (“ISCO” or “the Company”), a California-based clinical stage biotechnology company developing novel stem cell-based therapies and biomedical products reported today that a third patient of the second cohort with Parkinson's disease was successfully transplanted with ISCO's proprietary ISC-hpNSC® cells. The operation was successfully performed by the team of the Royal Melbourne Hospital’s neurosurgeons without complications.

"We are very encouraged by how the clinical trial is progressing," commented Russell Kern, PhD, ISCO's Executive Vice President and Chief Scientific Officer. "We anticipated positive results from the beginning and this trial continues to meet our high expectations. We foresee only promising results in the months to come” he continued.

About the Clinical Study

The Phase I clinical study is a dose-escalation safety and preliminary efficacy study of ISC-hpNSC®, intracranially transplanted into 12 patients who have moderate-to-severe Parkinson's disease. The open-label, single center, uncontrolled clinical trial will evaluate three different dose regimens of 30 million to 70 million neural cells. Following transplantation, the patients will be monitored for 12 months at specified intervals to evaluate the safety and biologic activity of ISC-hpNSC®. PET scan will be performed at baseline as part of the screening assessment, and at six and 12 months after surgical intervention. Clinical responses compared to baseline after the administration of ISC-hpNSC® will be evaluated using various neurological assessments, such as the Unified Parkinson Disease Rating Scale (UPDRS), Hoehn and Yahr, among others. Patients will be followed for 5 additional years to monitor safety and progression in neurological assessments.

About Parkinson's Disease

Parkinson's disease (PD) is a degenerative disorder of the central nervous system, mainly affecting the motor system. The motor symptoms of PD result from the death of dopamine-generating cells in the substantia nigra, a region of the midbrain. Early in the course of the disease, the most obvious symptoms are movement-related. These symptoms include shaking, rigidity, slowness of movement, and difficulty walking. Later, thinking and behavioral problems may arise, with dementia commonly occurring in the advanced stages of the disease, with depression being the most common psychiatric symptom. PD most commonly occurs with people over the age of 50.

Currently, medications typically used in the treatment of PD, L-DOPA and dopamine agonists, improve only early symptoms of the disease. As the disease progresses and dopaminergic neurons continue to diminish, drugs eventually become ineffective while at the same time, frequently producing a complication marked by involuntary fidgeting movements. In 2013, PD resulted in about 103,000 deaths globally, up from 44,000 deaths in 1990.

About ISC-hpNSC®

ISCO's proprietary ISC-hpNSC® consists of a highly pure population of neural stem cells derived from human parthenogenetic stem cells. ISC-hpNSC® is a suspension of clinical grade cells manufactured under cGMP conditions that have undergone stringent quality control measures and are clear of any microbial and viral contaminants. Preclinical studies in rodents and non-human primates have shown improvement in Parkinson's disease symptoms and increase in brain dopamine levels, following the intracranial administration of ISC-hpNSC®. ISC-hpNSC® provides neurotrophic support and cell replacement to the dying dopaminergic neurons of the recipient PD brain. Additionally, ISC-hpNSC® is safe, well-tolerated, and does not cause adverse events such as dyskinesia, systemic toxicity, or tumors in preclinical models. ISCO believes that ISC-hpNSC® may have broad therapeutic applications for many neurological diseases affecting the brain, the spinal cord, and the eye.

About International Stem Cell Corporation

International Stem Cell Corporation (ISCO) 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 backgrounds 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, expected results of clinical studies, potential applications of ISC-hpNSC® to other diseases, progress of research and development initiatives, 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," “foresee,” "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 (including clinical trial results that differ from expectations based on earlier studies), 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.

International Stem Cell Corporation
Dr. Russell Kern
EVP, Chief Scientific Officer
(760) 940-6383
ir@intlstemcell.com

 

GlobeNewswire
globenewswire.com

Last updated on: 30/11/2017

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