ALAMEDA, Calif.--(BUSINESS WIRE)--BioTime, Inc. (NYSE American: BTX), a late-stage, clinical biotechnology company developing and commercializing products addressing degenerative diseases, today announced the issuance of 41 new patents over the past 12 months that are owned by or licensed to BioTime. These new patents add to the over 800 issued or pending patents worldwide and address many of BioTime’s key programs, including OpRegen®, which is in a Phase I/IIa trial for dry-AMD; stroke and orthopedics, which are in early stages of development; and cell culture methods that are applicable across the pluripotent cell platform that enables robust manufacturing processes for many of the products.
“These 41 new patents are significant because they expand and strengthen our intellectual property portfolio, which is an integral aspect of BioTime’s clinical development and commercialization strategy,” said Adi Mohanty, Co-Chief Executive Officer of BioTime.
- OpRegen® – 3 patents issued that provide protection for OpRegen® in the U.S., Canada, and Hong Kong through 2031.
- Stroke – 1 new patent provides protection in the U.S. through 2031.
- Pluripotent Cell Technology – 34 patents provide protection in the U.S., Japan, Singapore, India and several countries in Europe of pluripotent cell technologies, including cell culture techniques, equipment and differentiation methods.
- Orthopedics – 3 new patents provide protection in the U.S. and Japan through 2029.
OpRegen®, which is in a Phase I/IIa trial for the treatment of the dry form of AMD, consists of a suspension of Retinal Pigment Epithelial (RPE) cells that are delivered subretinally during a simple intraocular injection. RPE cells are essential components of the back lining of the retina, and function to help nourish the retina including photoreceptors. A proprietary process that drives the differentiation of human pluripotent stem cells is used to generate high purity OpRegen® RPE cells. OpRegen® RPE cells are also “xeno-free," meaning that no animal products are used at any point in the derivation and production process. The avoidance of the use of animal products eliminates some potential safety concerns. Preclinical studies in rats have shown that following a single subretinal injection of OpRegen®, the cells can rapidly organize into its natural monolayer structure in the subretinal space and survive throughout the lifetime of the animal. OpRegen® is designed to be an “off-the-shelf” allogeneic (non-patient specific) product. Unlike treatments that require multiple, frequent injections into the eye, it is expected that OpRegen® would be administered in a single procedure. OpRegen® was granted Fast Track designation from the FDA, which allows more frequent interactions with the agency, and eligibility for accelerated approval and priority review. OpRegen® is a registered trademark of Cell Cure Neurosciences Ltd., a majority-owned subsidiary of BioTime, Inc.
About BioTime, Inc.
BioTime is a late-stage clinical biotechnology company focused on developing and commercializing products addressing degenerative diseases. The Company’s current clinical programs are targeting three primary sectors, aesthetics, ophthalmology and cell and drug delivery. Its clinical programs are based on two platform technologies: pluripotent cells, which can become any type of cell in the human body, and cell/drug delivery. Renevia®, a cell delivery product, met its primary endpoint in an EU pivotal clinical trial for the treatment of facial lipoatrophy in HIV patients earlier this year. Submission for approval of Renevia® in the EU is expected to be early 2018, with possible approval and commercial launch in 2018. There were no device related serious adverse events reported. OpRegen®, a retinal pigment epithelium transplant therapy, is in a Phase I/IIa multicenter trial for the treatment of dry age-related macular degeneration, the leading cause of blindness in developing countries. There were no related serious adverse events reported. BioTime also has significant equity holdings in two publicly traded companies, Asterias Biotherapeutics, Inc. (NYSE American: AST) and OncoCyte Corporation (NYSE American: OCX), and a private company, AgeX Therapeutics, Inc.
BioTime common stock is traded on the NYSE American and TASE under the symbol BTX. For more information, please visit www.biotime.com or connect with the company on Twitter, LinkedIn, Facebook, YouTube, and Google+.
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