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The approval was based on the continued safety observed throughout the
first three cohorts. Although safety will remain the main focus of
cohort 4, the fourth cohort will include earlier stage dry-AMD patients
with better vision than the previous three cohorts. Cohort 4 will also
include a wide range of preliminary functional assessments, such as best
corrected visual acuity. These earlier stage patients, would likely be
the target patient population for this therapy.
“This DSMB approval, which now includes enrollment of patients in
earlier stages of dry-AMD, is an important milestone for the OpRegen
The Company recently announced that interim data from the Phase I/IIa
OpRegen® trial would be presented at the upcoming
OpRegen®, which is being studied for the treatment of the dry
form of AMD, consists of a suspension of Retinal Pigment Epithelial
(RPE) cells that are delivered subretinally during a simple intraocular
injection. RPE cells are essential components of the back lining of the
retina, and function to help nourish the retina including
photoreceptors. A proprietary process that drives the differentiation of
human pluripotent stem cells is used to generate high purity OpRegen® RPE
cells. OpRegen® RPE cells are also “xeno-free," meaning that
no animal products are used at any point in the derivation and
production process. The avoidance of the use of animal products
eliminates some potential safety concerns. Preclinical studies in rats
have shown that following a single subretinal injection of OpRegen®,
the cells can rapidly organize into its natural monolayer structure in
the subretinal space 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. OpRegen® was granted
Fast Track designation from the FDA, which allows more frequent
interactions with the agency, and eligibility for accelerated approval
and priority review. OpRegen® is a registered trademark of
BioTime is a clinical-stage biotechnology company focused on degenerative diseases. Its clinical programs are based on two platform technologies: cell replacement and cell/drug delivery. With its cell replacement platform, BioTime is creating new cells and tissues with its proprietary pluripotent cell technologies. These cells and tissues are developed to replace those that are either rendered dysfunctional or lost due to degenerative diseases. BioTime’s cell/drug delivery programs are based upon its proprietary HyStem® cell and drug delivery matrix technology. HyStem® was designed to provide for the transfer, retention, engraftment and metabolic support of cellular replacement therapy. BioTime’s lead cell delivery clinical program, Renevia®, which consists of our proprietary HyStem® cell-transplantation delivery matrix combined with the patient's own adipose progenitor cells (Fat), met its primary endpoint in an EU pivotal clinical trial for the treatment of facial lipoatrophy in HIV patients in 2017. Submission for approval of Renevia® in the EU is expected to be early 2018, with possible approval in 2018. There were no device related serious adverse events reported to date. Our lead cell replacement clinical program, OpRegen®, which is a retinal pigment epithelium transplant therapy, is in a Phase I/IIa multicenter trial for the treatment of dry age-related macular degeneration, the leading cause of blindness in developing countries. There were no related serious adverse events reported to date. BioTime also has significant equity holdings in two publicly traded companies, Asterias Biotherapeutics, Inc. (NYSE American: AST) and OncoCyte Corporation (NYSE American: OCX), and a private company, AgeX Therapeutics, Inc.
BioTime common stock is traded on the NYSE American and TASE under the
symbol BTX. For more information, please visit www.biotime.com or
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