ALAMEDA, Calif. & JERUSALEM--(BUSINESS WIRE)--BioTime, Inc. (NYSE MKT and TASE: BTX), a clinical-stage regenerative medicine company with a focus on pluripotent stem cell technology, and its subsidiary Cell Cure Neurosciences Ltd. (“Cell Cure”) today announced that Cell Cure has been awarded a new grant for 2016 of 8.4 million shekels (approximately $2.2 million) from the Israel Innovation Authority (“IIA,” formerly the Office of the Chief Scientist) of the Ministry of Economy and Industry. The grant provides continuing funding for the development of OpRegen®, a cell-based therapeutic product that consists of animal product-free retinal pigment epithelial (RPE) cells with high purity and potency.
OpRegen® is currently in a Phase I/IIa dose-escalation clinical study evaluating the safety and efficacy of OpRegen® for geographic atrophy (GA), the severe stage of the dry form of age-related macular degeneration (dry-AMD). Dry-AMD is a leading cause of blindness in people over age 60, for which there is no currently approved therapy.
“We are proud to be one of Israel’s innovative life science companies, and we want to thank the Israel Innovation Authority for its ongoing commitment and continuing support of our development of a cell therapy-based treatment for this major disease of aging,” said Charles Irving, Ph.D., Chief Executive Officer of Cell Cure.
The IIA has to date provided grants of approximately $9.6 million to Cell Cure. Under the grant award agreement, Cell Cure is obligated to pay a 3.5% royalty to the IIA on revenues from OpRegen® up to an amount equal to 100% of the grants received plus interest at a LIBOR rate.
About Dry Age-Related Macular Degeneration (Dry–AMD)
Dry-AMD is the most common type of macular degeneration and affects approximately 90% of people with the disorder. In dry-AMD, there is a loss or dysfunction of the layer of retinal pigment epithelial (RPE) cells generally in the region of the eye called the macula, which is the part of the retina responsible for sharp, central vision that is important for facial recognition, reading and driving. These RPE cells support the light detecting photoreceptor cells that are so critical to vision. When we look at something, the photoreceptors (rods and cones) detect the light and send the information to the brain allowing us to perceive our surroundings. The age-dependent loss of the RPE cells therefore leads to degeneration of nearby photoreceptors and this can lead to severe vision loss or even blindness. Generally, the damage caused by the “dry” form is not as severe or rapid as that of the “wet” form. However, over time, it can cause profound vision loss. The more advanced stage of dry macular degeneration is called geographic atrophy. While there are therapeutics available to treat the wet form of AMD, there are currently no FDA-approved therapies for dry-AMD.
OpRegen® consists of retinal pigment epithelial (RPE) cells that are produced using a proprietary process that drives the differentiation of human embryonic stem cells into high purity RPE cells. OpRegen® is also “xeno-free," meaning that no animal products were used either in the derivation and expansion of the human embryonic stem cells or in the directed differentiation process. The avoidance of the use of animal products eliminates some safety concerns. OpRegen® is formulated as a suspension of RPE cells. Preclinical studies in mice have shown that following a single subretinal injection of OpRegen®, as a suspension of cells, the cells can rapidly organize into its natural monolayer structure 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.
BioTime, Inc. is a clinical-stage biotechnology company focused on developing and commercializing novel therapies developed from what we believe to be the world’s premier collection of pluripotent cell assets. The foundation of our core therapeutic technology platform is pluripotent cells that are capable of becoming any of the cell types in the human body. Pluripotent cells have potential application in many areas of medicine with large unmet patient needs, including various age-related degenerative diseases and degenerative conditions for which there presently are no cures. Unlike pharmaceuticals that require a molecular target, therapeutic strategies based on the use of pluripotent cells are generally aimed at regenerating or replacing affected cells and tissues, and therefore may have broader applicability than pharmaceutical products.
In addition to the development of therapeutics, BioTime’s research and other activities have resulted, over time, in the creation of other subsidiaries that address other non-therapeutic market opportunities such as cancer diagnostics, drug development and cell research products, and mobile health software applications.
BioTime common stock is traded on the NYSE MKT and TASE under the symbol BTX. For more information, please visit www.biotimeinc.com or connect with the company on Twitter, LinkedIn, Facebook, YouTube, and Google+.
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