Today before the opening bell, ISCO announced that it had completed a
pre-investigational new drug meeting (pre-IND) with the US FDA, thereby
completing its discussions with the administration about the company’s
Parkinson’s disease cell therapy. The company received feedback and input from
the FDA on its proposed pre-clinical plan, manufacturing approach, and clinical
study design necessary to file the IND.
We’re pleased with the outcomes of the meeting with the FDA,” said Yale
School of Medicine Professor D. Eugene Redmond Jr. MD, who is leading ISCO’s
pharmacology/toxicology study. “The FDA’s feedback has provided clear direction
for the remaining studies required for the IND.”
“As this will be the first IND for the Company, we’re pleased to have
completed this critical milestone,” said Dr. Ruslan Semechkin, Chief Scientific
Officer of ISCO. “Based on data from our pilot studies, along with the guidance
from the FDA, we believe that we’re well positioned to successfully transition
this program to the clinical stage.”
According to the Parkinson’s Disease Foundation, some 7-10 million people
worldwide live with Parkinson’s disease. Around 1 million of these people live
in the United States alone, more than the combined amount of people diagnosed
with multiple sclerosis, muscular distrophy, and Lou Gehrig’s disease. Direct
and indirect costs attributed to Parkinson’s disease within the United States
are estimated to be nearly $25 billion per year.
With the pre-IND meeting complete, ISCO will be working toward completion
of the Good Laboratory Practice pharmacology and safety studies, including
tumorigenicity, toxicology, and tolerability, via use of the human
parthenogenetic neural stem cell (hPNSC) product. From the wording in the
company’s news release, this product is a “type of self-renewing multipotent
cell that is a precursor for the major cells of the central nervous system.”
Pre-clinical pilot studies in rodents and primates have shown that the
product’s safety, tolerability, and therapeutic benefit. Unlike other stem cell
therapies, ISCO’s hPNSC product can be delivered in a frozen state to hospitals
and other healthcare provider centers. ISCO anticipates the release of interim
primate data before the end of March 2014 and top-line final results from these
GLP studies later in 2014. From there, it expects to file the IND soon
thereafter.
A comprehensive description of ISCO’s hPNSC product and the GMP
manufacturing method was published in early 2013 with Prof. Evan Y. Snyder,
Director of Stem Cell Research Center at Sanford-Burnham Medical Research
Institute.
For more information, visit: www.internationalstemcell.com
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