Treatment offered by Cell Cure Neurosciences has fast track approval for further trials from the FDA
Age Related Macular Degeneration (AMD) is responsible for impaired vision and total vision loss in millions of people world wide: in fact, AMD is the leading cause of blindness in those over age 60. Given the magnitude of people affected and limited treatment options currently available, much attention is being given to research in the hopes of finding a cure. One of the companies currently involved in discovering new options to successfully treat AMD is Cell Cure Neurosciences of Israel.
The focus of Cell Cure Neuroscience’s treatment is OpRegen®, a cell-based therapeutic product consisting of retinal pigment epithelial (RPE) cells, which are produced from pluripotent stem cells using their proprietary technology. OpRegen® is injected into the eye, with the goal of stopping the progression of the severe dry form of AMD, which is the most common type, and is currently not treatable. In a recent news release, the company outlines the function of RPE cells, and progression of dry AMD:
Dry AMD is the most common type of macular degeneration and affects approximately 90% of people with the disorder. In the dry form, 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. 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.
In a recent interview with Israel21c, Cell Cure CEO Charles Irving, says:
“The photoreceptor cells can only make it a little longer on their own before dying, and that’s irreversible. Our goal is to enable, for the first time, transplantation with new RPE cells so we can save the photoreceptors that haven’t already died and stop the progression of the disease.”
In the interview, Irving proceeds to describe the progression of AMD, likening it to a forest fire burning in the retina, with the damage being tolerated until it reaches the “houses in the village”- in this case, being the macula’s minute fovea.
“If disease reaches the fovea, you have essentially lost central and color vision. We want to stop the ‘fire’ before it reaches the fovea. We do that by putting in young cells not susceptible to the aging process,” said Irving.
Clinical trials are now underway, and volunteers are currently being recruited for upcoming phases. In a recent news release, the current trials are described as follows:
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 FDA-approved therapy. The first cohort was successfully dosed earlier this year. Enrollment in the second cohort is expected to be completed in 2016 and, if the data are positive, it is anticipated that DSMB approval to proceed to the third cohort will be received by the end of 2016.
Commenting on the trials underway, CEO Irving told Israel21,
“These first studies are to show there is no harm in putting the new cells into the retina and that they will engraft properly and organize themselves to support the photoreceptor cells,” Irving says. “The next studies will look at whether they do their job to stop the progression of the disease.”
Additional information on the clinicial trials and enrollment criteria is available on their website, at www.cellcureneurosciences.com.