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BioTimeexpands and strengthens patent estate covering OpRegen® through 2031
- Expanded and strengthened patent coverage of pluripotent cell technology
“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
OpRegen® – 3 patents issued that provide protection for
OpRegen® in the U.S.,
Canada, and Hong Kongthrough 2031.
- Stroke – 1 new patent provides protection in the U.S. through 2031.
Pluripotent Cell Technology – 34 patents provide protection in the
Japan, Singapore, Indiaand several countries in Europeof pluripotent cell technologies, including cell culture techniques, equipment and differentiation methods.
Orthopedics – 3 new patents provide protection in the U.S. and
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.
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
BioTime common stock is traded on the NYSE American and TASE under the
symbol BTX. For more information, please visit www.biotime.com or
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