BioTime announced that the independent Data Safety Monitoring Board (DSMB) has approved initiation of the fourth cohort for the ongoing OpRegen clinical trial. The DSMB is an independent group of medical experts closely monitoring the phase 1/2a OpRegen clinical trial.
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. BioTime expects to share initial data from cohort 4 in Q4 2018.
“This DSMB approval, which now includes enrollment of patients in earlier stages of dry-AMD, is an important milestone for the OpRegen study,” Adi Mohanty, Co-Chief Executive Officer at BioTime, said in a company news release. “We are excited to move towards this expected target patient population and look forward to sharing data from cohort 4 later this year. We are happy with the continued progress of OpRegen, as dry-AMD is estimated to affect more than 25 million worldwide and is one of the leading causes of blindness in people over the age of 60.”
The company recently announced that interim data from the phase 1/2a OpRegen trial would be presented at the upcoming Association for Research in Vision and Ophthalmology meeting taking place from April 29–May 3, 2018 in Honolulu, Hawaii. The poster presentation will take place on April 29, 2018 from 8:15 am – 10 am local time at the Hawaii Convention Center.