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StemCells (STEM) FDA Authorization for Age-Related Macular Degeneration Clinical Trial
STEM initiates a P1/2 clinical trial of its proprietary HuCNS-SC® product candidate (purified human neural stem cells) in dry age-related macular degeneration (AMD).
The P1/2 trial will evaluate the safety and preliminary efficacy of HuCNS-SC cells as a treatment for dry AMD. The trial will be an open-label, dose-escalation study, and is expected to enroll a total of 16 patients.
- The HuCNS-SC cells will be administered by a single injection into the space beneath the retina. Patients’ vision will be evaluated using conventional methods of ophthalmological assessment at predetermined intervals over a 1 year period;
- A summary of the preclinical data was published in the 2/12 issue of the international peer-reviewed European Journal of Neuroscience, and is available online at http://onlinelibrary.wiley.com/doi/10.1111/j.1460-9568.2011.07970.x/abstract.
The Bottom Line: Preclinical data submitted as part of the IND application demonstrated that HuCNS-SC cells protect host photoreceptors and preserve vision in a well-established animal model of retinal disease that is relevant to dry AMD. STEM’s approach is to provide durable protection of photoreceptors, thereby preserving vision, as opposed to approaches that aim to replace photoreceptors or the retinal pigmented epithelial cells. Furthermore, preclinical data supports a single transplant in AMD patients. A crowding stem cell universe of applications is targeting the ophthalmology market, but the question is still the delivery …
- STEM is UP +$0.07 <+7.14%> to $1.05 in opening trading …
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