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July 31, 2014
09:03 EDTBTXBioTime unit expands clinical development of bladder cancer test
BioTime and its subsidiary OncoCyte announced that OncoCyte has expanded the clinical development of its urine-based bladder cancer diagnostic test by initiating a multi-site clinical trial. The trial, which will involve up to 1,200 patient samples obtained from at least four large urology clinics located throughout the U.S., has received Institutional Review Board approval at multiple sites and should begin enrolling patients within the next week. OncoCyte’s initial clinical study of its bladder cancer diagnostic test began in January and involves pathology specimens being collected at a leading medical institution with an international reputation for excellence and discovery. The multi-site clinical trial is designed to expand the potential use of the PanC-Dx bladder cancer test beyond pathology laboratories and into urologic practices at the point of cystoscopy. Cystoscopy along with urine cytopathology, are the standard methods utilized for bladder cancer screening and diagnosis. The multi-site clinical trial should be completed within 12 months. The goal of the current clinical trial is to compare the performance of OncoCyte’s proprietary PanC-Dx bladder cancer markers to the performance of cystoscopy.
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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