10 June 2016 - - US-based regenerative medicine company BioTime, Inc.'s (NYSE MKT: BTX) (TASE: BTX) Cell Cure Neurosciences Ltd. subsidiary has been awarded a new grant for 2016 of INS 8.4m (approximately USD 2.2m) from the Israel Innovation Authority 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 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, 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.

The IIA has to date provided grants of approximately USD 9.6m 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.

Dry Age-Related Macular Degeneration (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 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 cells that are produced using a proprietary process that drives the differentiation of human embryonic stem cells into high purity RPE cells. 

It 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 organise 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 is focused on developing and commercializing novel therapies developed from what we believe to be the world's premier collection of pluripotent cell assets.