ACT Announces Approval To Treat Additional Stargardt’s Disease Patients With Higher RPE Dosage In Both U.S. And European Clinical Trials
Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Data and Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring the Company’s three ongoing clinical trials, has authorized the Company to move forward with enrollment and treatment of second and third additional patients with Stargardt’s macular dystrophy (SMD) in the second patient cohort of its U.S. trial for the condition. Additionally, the DSMB has authorized the Company to treat all three patients in the second cohort of its European trial for SMD.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) recently approved a protocol modification to the DSMB review, streamlining the process, allowing the company to treat the first patient in a new cohort if the DSMB has allowed this in the US study, and once clearance has been received in the US trial to treat the next two patients in the US cohort. This would also allow for treatment of the UK patients without an additional review by the DSMB. Moreover, according to the protocol for both trials, each patient in the second cohort will be injected with 100,000 human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells, up from 50,000 in the first cohort.
“This authorization to treat the next five patients in the second, higher-dosage cohort in both our clinical trials for SMD represents a significant step forward for our clinical programs,” commented Gary Rabin, chairman and CEO of ACT. “We are also encouraged with the MHRA’s approval of the DSMB’s streamlined review process. Clearly this has the potential to help accelerate the pace of our European trial.”
ACT is conducting three clinical trials in the U.S. and Europe using hESC-derived RPE cells to treat forms of macular degeneration, SMD and dry age-related macular degeneration (dry AMD). Each trial will enroll a total of 12 patients, with cohorts of three patients each in an ascending dosage format, from 50,000 hESC-derived RPE cells in the first patient cohort to 200,000 in the last and final cohort. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry-AMD or SMD at 12 months, the study’s primary endpoint.
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