CARLSBAD, CA – (Marketwired) – 08/21/13 – International
Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) a
California-based biotechnology company developing novel stem cell-based
therapies, announced today that it has entered into a master clinical research agreement
with Duke University to conduct clinical trials research in Parkinson’s disease
using ISCO’s innovative neural stem cell product.
Mark Stacy, M.D., Vice Dean for Clinical Research,
Neurology at Duke University School of Medicine and an internationally
recognized leader in the field of Movement Disorders, including Parkinson’s
disease, will be the study’s principal investigator. The research will be
coordinated by the Duke Clinical
Research Institute (DCRI), the world's largest academic clinical
research organization, which is internationally recognized for conducting
groundbreaking clinical trials.
“We are pleased
to have the opportunity to conduct the clinical trials related to ISCO’s investigation stem cell therapy in Parkinson’s disease patients,” said Stacy.
“Duke has an exceptional clinical trials team and we look forward to
characterizing and understanding the safety and efficacy profile of this agent
in the clinical trials setting.”
“We’re tremendously excited to be working with such a world-class
clinical research organization as Duke University,” commented Dr. Ruslan
Semechkin, Vice President of Research and Development at International Stem
Cell Corporation. “Dr. Stacy and his team have made numerous significant
contributions in the field of Parkinson’s disease research which together with
Duke’s extensive clinical expertise in cell therapy clinical trials and the
extensive patient population, gives us an outstanding
opportunity to evaluate our revolutionary stem cell therapy.”
Stacy has extensive clinical trials experience,
primarily involving neuro-protective and neuro-regenerative therapies and
developing biomarkers for early diagnosis in Parkinson’s disease. He has
published more than 100 peer-reviewed scientific papers in the field and has
served as an advisor to a number of companies. He has participated in more than
100 clinical trials.
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. The hPNSC
are self-renewing mulitpotent cells that are precursors for the major cells of
the central nervous system. The ability of hPNSC to (1) differentiate into
dopaminergic neurons and (2) express neurotrophic factors such as glial derived
neurotrophic factor (GDNF) and brain-derived neurotrophic factor (BDNF) to
protect the nigrostriatal system, offers a new and revolutionary opportunity for
the treatment of Parkinson’s disease, especially in cases where current dopamine-replacement
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, 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.
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.
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
Investor
Relations:
MZ
Group
Mark
McPartland
Senior
Vice President
Phone:
212-301-7130
Email:
markmcp@mzgroup.us
