BioTime Inc. (NYSE:BTX) said today that it expanded its OpRegen Phase I/IIa trial into the U.S. with 2 new trial sites. The company’s study is evaluating its OpRegen cell therapy in patients with advanced dry form age-related macular degeneration.
The 2 U.S.-based trial sites will include ophthalmologists Dr. David Boyer from the Retina-Vitreous Associates Medical Group and Dr. Richard McDonald from the West Coast Retina Medical Group.
“The addition of U.S. clinical trial sites is an important step in the acceleration of our clinical development program for OpRegen,” co-CEO Adi Mohanty said in prepared remarks. “We are honored to be working with 2 of the leading U.S. clinicians in ophthalmology, Dr. David Boyer and Dr. Richard McDonald. The sites are currently going through the set-up process, and we anticipate enrolling and treating U.S.-based patients by the end of the 2nd quarter.”
Alameda, Calif.-based BioTime is developing OpRegen, an investigational therapy that delivers retinal pigment epithelial cells into the subretinal space to replace lost RPE cells. The company’s ongoing trial is a dose escalation study evaluating the safety and efficacy of 3 dose regimens of OpRegen in patients with the advanced form of dry-AMD with geographic atrophy.
The company presented data from the 1st patient cohort in December and February demonstrating that the 1st dose of OpRegen caused no serious adverse events and that the transplanted cells survived in the subretinal space for up to 1 year.
“I am excited about the potential of BioTime’s OpRegen for the treatment of dry-AMD, the leading cause of blindness in the elderly,” Boyer said. “In my practice I routinely encounter patients who are suffering from various stages of dry-AMD, a debilitating condition for which no currently approved therapy exists. I would like nothing more than to be able to offer my patients an effective treatment for it, especially 1 that may be able to preserve and possibly even help restore function. Data on the 1st patient cohort and progress to date is very encouraging, and I am eagerly anticipating treating patients.”
“Dry-AMD is the only major eye disease for which no treatment is available and it affects a significantly higher number of people than the wet form of AMD. I look forward to the initiation of this important clinical trial to see if this treatment can arrest and potentially reverse the course of this disease, which inevitably leads to blindness,” McDonald added.
In January, BioTime and its subsidiary Cell Cure Neurosciences said that it is establishing an 800 square meter cell manufacturing facility at the Hadassah University Hospital in Jerusalem.
The manufacturing center will be staffed initially by 30 employees, according to the companies, and will be prepared to produce OpRegen for BioTime’s ongoing clinical trial program.