BioTime Announces $2.2 Million Grant for Further Development of Dry-AMD Program

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.
About OpRegen^®
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.
About BioTime
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
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