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- Safety Confirmed with No Concerns Reported in Cohort 1 -
- Approval to Immediately Proceed to Cohort 2 -
“The positive DSMB recommendation confirms the acceptable safety profile of OpRegen® in the initial low-dose cohort, and allows us to proceed with the second cohort,” said
The Phase I/IIa clinical trial is evaluating the safety and efficacy of three different dose regimens of OpRegen® in the advanced form of dry-AMD, the leading cause of blindness in an aging population over the age of 60, and a condition for which there is currently no
“The successful completion of the DSMB's review of the first dose escalation cohort represents an important milestone in the clinical development of OpRegen®,” said Dr. Eyal Banin, Director of the
Details of the trial and about a patient’s eligibility are available at https://clinicaltrials.gov/, with the following Identifier: NCT02286089 (dry AMD).
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
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.
Established in 2005, Cell Cure is located in
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.
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