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- OpRegen at the first dose caused no serious adverse events in the first patient cohort -
- Retinal imaging suggests presence and survival of the transplanted cells in the subretinal space for up to one year -
The Phase I/IIa clinical trial, which is being conducted by BioTime’s subsidiary,
“The primary focus of this cohort is safety. OpRegen was successfully administered with no serious adverse events,” commented Prof.
“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.
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
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
OpRegen has received Fast Track designation from the
About the ISOPT Clinical Symposium
The ISOPT Clinical Symposium is an annual symposium focusing on clinical drug treatments in ophthalmology via a pragmatic clinical angle. Symposium participants are clinicians, clinical investigators, academy based researchers and members of the industry. The ISOPT Clinical board has two major missions: 1) To provide updates on current paradigms of therapy for common ophthalmic diseases with profound risk / benefit coverage, and 2) To assess expected therapeutic paradigm shifts in the near future as reflected in current clinical research. The ISOPT Clinical meeting will focus on case presentations as they demonstrate current treatment options. This year’s symposium will take place
About Dry Age-Related Macular Degeneration (Dry–AMD)
Macular degeneration affects approximately 11 million people in the U.S. and is the leading cause of blindness in people over the age of 60. Approximately 90 percent of these patients suffer from the dry form, for which there are no
OpRegen consists of RPE cells that are produced using a proprietary process that drives the differentiation of human embryonic stem cells into high purity RPE cells. OpRegen is also “xeno-free," meaning that no animal products were used either in the derivation and expansion of the human embryonic stem cells or in the directed differentiation process. The avoidance of the use of animal products eliminates some safety concerns. OpRegen is formulated as a suspension of RPE cells. Preclinical studies in rats have shown that following a single subretinal injection of OpRegen, as a suspension of cells, the cells can rapidly organize into its natural monolayer structure 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® is a registered trademark of
In addition to the development of therapeutics, BioTime’s research and other activities have resulted, over time, in the creation of other subsidiaries that address other non-therapeutic market opportunities such as cancer diagnostics, drug development and cell research products, and mobile health software applications.
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