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Stock Market & Financial Investment News

News Breaks
August 12, 2014
08:04 EDTBTXBioTime reports Q2 EPS (16c) vs (14c) last year
Reports Q2 revenue $1.11M, vs. $1.22M last year
News For BTX From The Last 14 Days
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February 24, 2015
09:15 EDTBTXBioTime announces treatment of first patient in European Renevia trial
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February 19, 2015
11:19 EDTBTXBioTime management to meet with Jefferies
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February 17, 2015
08:47 EDTBTXBioTime provides update on Cell Cure's product development, partnering
BioTime (BTX) and its subsidiary Cell Cure Neurosciences provided an update on Cell Cure’s product development and partnering activities. On February 16, Cell Cure opened the clinical trial of OpRegen titled “Phase I/IIa Dose Escalation Safety and Efficacy Study of Human Embryonic Stem Cell-Derived Retinal Pigment Epithelium Cells Transplanted Subretinally in Patients with Advanced Dry-Form Age-Related Macular Degeneration with Geographic Atrophy” at Hadassah University Medical Center in Jerusalem, Israel. Patient enrollment is expected to begin shortly. OpRegen consists of animal product-free retinal pigment epithelial cells with high purity and potency. On October 31, 2014, the FDA cleared Cell Cure's Investigational New Drug application to initiate the clinical trial of OpRegen in patients with the severe form of age-related macular degeneration with geographic atrophy.The Phase I/IIa clinical trial, will evaluate three different dose regimens of OpRegen. Following transplantation, the patients will be followed for 12 months at specified intervals, to evaluate the safety and tolerability of the product. Following the initial 12 month period, patients will continue to be monitored at longer intervals for an additional period of time. A secondary objective of the clinical trial will be to examine the ability of transplanted OpRegen to engraft, survive, and moderate disease progression in the patients. In addition to thorough characterization of visual function, a battery of ophthalmic imaging modalities will be used to quantify structural changes and rate of GA expansion. Cell Cure also announced that the option granted to Teva (TEVA) under a Research and Exclusive Option Agreement of October 7, 2010 to license-in rights to its OpRegen product has expired without having been exercised by Teva. Cell Cure will therefore be continuing the clinical development of OpRegen on its own and pursuing discussions with other potential strategic partners, including those that have already indicated interest in participating in development and commercialization of the product. Cell Cure also announced that US patent No. 8,956,866 relating to a proprietary method of manufacturing RPE cells is expected to issue on February 17. This patent combined with other patents and patent applications in the BioTime family of companies provides significant patent protection for this novel therapeutic modality for AMD.

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