BioTime (BTX) Announces Presentation of OpRegen Phase 1/2a Data in Dry-AMD at ISOPT Symposium
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BioTime, Inc. (NYSE: BTX) reported that data from the first patient cohort of the Phase I/IIa clinical trial of OpRegen® in the advanced form of dry age-related macular degeneration (dry-AMD) will be presented at the International Symposium on Ocular Pharmacology and Therapeutics (ISOPT) on Friday, December 2, 2016, in Rome, Italy.
The Phase I/IIa clinical trial, which is being conducted by BioTime’s subsidiary, Cell Cure Neurosciences Ltd., is evaluating the safety of three different dose regimens of OpRegen in the advanced form of dry-AMD that is accompanied by geographic atrophy. The first Phase I/IIa patient cohort received an initial targeted dose of 50,000 cells.
“The primary focus of this cohort is safety. OpRegen was successfully administered with no serious adverse events,” commented Prof. Eyal Banin, Director of the Center for Retinal and Macular Degenerations at Hadassah Medical Center, where the trial is being conducted. “Importantly, retinal imaging suggests that OpRegen RPE cells are able to engraft. Imaging from the first patient, who just completed one-year of post-treatment clinical assessment, may indicate that the graft can survive for at least 12 months. We are encouraged by these data and our continued progress in this important trial.”
“OpRegen RPE cells were created without the use of animal-derived products through a proprietary directed differentiation process to produce a highly purified population of RPE cells,” said Prof. Benjamin Reubinoff, Chief Scientific Officer of Cell Cure Neurosciences Ltd. and director of Hadassah's Stem Cell Research Center. “We are pleased that OpRegen did not cause serious adverse events in the first cohort of patients.”
The safety profile of the first cohort of subjects was thoroughly assessed by the Data Safety Monitoring Board (DSMB), an independent group of physicians and medical experts closely monitoring the clinical trial, before it gave its recommendation that the company continue the trial with the second cohort at a higher dose of 200,000 cells. The company expects a similar review by the DSMB at the end of the second cohort.
“We are looking forward to the opportunity to present data from the first patient cohort at ISOPT,” said Adi Mohanty, Co-Chief Executive Officer of BioTime. “OpRegen’s progress in the clinic is gaining momentum and we have already treated patients with 200,000 cell doses. It is in these higher cell dose cohorts where we believe OpRegen has the potential to demonstrate more meaningful clinical outcomes and we expect to start reporting on these data in early 2017. Our goal is to develop a treatment that can serve the millions of dry-AMD patients for whom there are currently no FDA-approved therapies.”
Enrollment in the second cohort is expected to be completed in 2016. Depending on the outcome of the DSMB’s review of the second patient cohort, approval to begin administering the 500,000 cell dosage to the third patient cohort could be provided by the end of the current year. The first OpRegen clinical trial site in the United States is expected to be selected in the near future.
OpRegen has received Fast Track designation from the FDA for treatment of the advanced form of dry-AMD. Details of the trial and about a patient’s eligibility are available at https://clinicaltrials.gov/ with the following Identifier: NCT02286089 (dry-AMD).
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