-Asterias Biotherapeutics approved for listing on NYSE MKT
-Asterias' AST-OPC1 cleared by FDA for Phase 1/2a dose escalation clinical trial for spinal cord injury
-Cell Cure Neuroscience's OpRegen® cleared by FDA for Phase 1/2a dose escalation clinical trial for the dry form of age-related macular degeneration
-ReneviaTM cleared for pivotal trial in Europe for treatment of HIV-related lipoatrophy
-PremviaTM cleared by FDA as Class II medical device for wound management
-BioTime and its subsidiaries end October with $35 million in cash to fund additional milestone achievements in 2015
ALAMEDA, Calif.--(BUSINESS WIRE)--Nov. 10, 2014-- BioTime, Inc. (NYSE MKT: BTX), the leader in developing pluripotent stem-cell therapies and other technologies designed to address major unmet medical needs, today reported financial results for the third quarter and the nine months ended September 30, 2014, and highlighted recent corporate accomplishments.
"BioTime and its subsidiaries set in motion a rapid cadence of milestone achievements in our clinical development of therapeutic and diagnostic products during the third quarter," said Dr. Michael D. West, CEO. "We recently obtained authorization to begin our pivotal trial of ReneviaTM in Europe for HIV-related lipoatrophy; our subsidiary Asterias Biotherapeutics received clearance from the FDA to initiate a Phase 1/2a dose escalation clinical trial of its product, AST-OPC1, in patients with complete cervical spinal cord injury; our subsidiary Cell Cure Neurosciences received clearance from the FDA for a Phase 1/2a dose escalation clinical trial of its product, OpRegen®, in patients with the dry form of age related macular degeneration; and the FDA cleared BioTime's PremviaTM as a Class II medical device for the management of wounds. Also, BioTime's subsidiary OncoCyte expanded its large clinical studies of PanC-DxTM biomarkers in the diagnosis of breast, bladder, and lung cancer. In total, we now have six products for which seven clinical
BTX products in development in many hospitals around the globe. Should be some positive news in the next 6 months, and insiders starting to buy in before news hits the streets.
Now approaching two years since OrthoCyte announced the isolation of 7 hESC cartilage, tendon and bone stem cell lines. I would also think we will hear more on the development of these 'off the shelf' OrthoCyte products in 2015.
Over the last two years BTX has been focusing on their cancer diagnostic product PanC-DX which will be on the market in a years time and probably along with their 2nd IPO(OncoCyte)to boot.
But for the most part PanC-DX development is finished and they are in the final stages of testing it's accuracy on patients at Weil Cornel and Wistar. So with AST in order and OncoCyte on the straight and narrow, next up LifeMaps medical app 1.0 as well as some other technologies that have been put on the back burner.
I'd also think we are due for an update on BTX subsidiary OrthoCyte and their cartilage , tendon, and bone regen development.
All is well in Biotime land!
Icono, any idea how many cells were given to the Bulgarian patient in the UK study?
Very cool news, everyone I know has been talking about this story. Biotimes is not far behind with spine trials will start within months. For those who don't know BTX has acquired Gerons hESC ip and will restart trials where Geron left off. Gerons phase 1 have been proven safe and effective in the early stage, and so Biotime will continue treating patients starting in January of 2015, By the end of 2015 we should know if the treatment is successful as this smelling sensory neural cells study. Just one more potential billion dollar product in development.
There is a diagnostic company BTX could acquire that would be a great addition to OncoCytes product line. Sept 29th could yield some surprises.