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TOPIC: STEM reports early results in AMD

STEM reports early results in AMD 19 Jun 2014 09:43 #1805

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NEWARK, Calif., June 19, 2014 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) reported positive interim results from its Phase I/II clinical trial of the Company's proprietary HuCNS-SC(R) human neural stem cell platform in dry age-related macular degeneration (AMD) yesterday evening at the 12th annual meeting of the International Society for Stem Cell Research (ISSCR) in Vancouver, Canada.

Interim trial results show a 65 percent reduction in the rate of geographic atrophy (GA) in the study eye when compared to the expected natural history of the disease as well as a 70 percent reduction in the rate of GA when compared to the control eye.
GA is the progressive loss of two important retinal tissue layers, the photoreceptors and the retinal pigmented epithelium. This degeneration is the cause of vision loss in dry AMD.
Interim results also indicate improvements in visual function, as measured by the ability to distinguish shades of light versus dark, also referred to as "contrast sensitivity."
Contrast sensitivity was improved in four of the seven patients and remained stable in the other three patients.
The interim analysis is based on a minimum follow up of at least 6 months and demonstrates a favorable safety profile for administration of the HuCNS-SC cells into the sub-retinal space of the study eye.
"The interim data are very encouraging from two separate perspectives. First, the reduction in the rate of geographic atrophy suggests the HuCNS-SC cells are affecting the underlying cause of AMD. Secondly, the data demonstrates there are increases in contrast sensitivity, which is a vital aspect of visual function," said Stephen Huhn, M.D., FACS, FAAP, vice president, CNS clinical research and chief medical officer at StemCells, Inc. "Impacting the progression of GA and enhancing visual function could have a very meaningful impact on the quality of life for AMD patients and the results to date strongly support our plans to initiate a randomized, controlled, Phase II proof-of-concept trial later this year."

"These interim results have exceeded our expectations at this stage of the trial," said David Birch, Ph.D., chief scientific and executive officer of the Retina Foundation of the Southwest in Dallas, Texas. "These results are particularly interesting given that the first cohort of patients had significant visual impairment and baseline GA. The next cohort of patients will have less impairment and we look forward to learning even more as we analyze data from the patients in the second half of the trial."

StemCells, Inc. will host a conference call and webcast to discuss the interim results from the Phase I/II clinical trial of HuCNS-SC cells in dry AMD, after market close today, Thursday, June 19, at 4:30 p.m. Eastern Daylight Time (1:30 p.m. Pacific Daylight Time).
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STEM reports early results in AMD 19 Jun 2014 14:31 #1811

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Hedge, Its good to see some progress in this sector. Osiris is still the leader at this point and they were smart enough to sidetrack the FDA with their wound healing therapy.


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