Data and Safety Monitoring Board (DSMB) Process Streamlined in the Protocol; Could Accelerate Patient Enrollment and Treatment in European Trial
MARLBOROUGH, Mass.--(BUSINESS WIRE)-- 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.
“We are eagerly anticipating treating these final two patients in the second cohort of our U.S. trial for SMD, and all three patients in the second cohort of our E.U. trial,” commented Robert Lanza, M.D., ACT’s chief scientific officer. “We are encouraged by the preliminary data in the first patient in this second, higher-dosage cohort and look forward to gathering more data.”
Further information about patient eligibility for ACT’s SMD studies in the U.S. and E.U. as well as its dry AMD study are available at www.clinicaltrials.gov, with the following Identifiers: NCT01345006 (U.S. SMD), NCT01469832 (E.U. SMD), and NCT01344993 (dry AMD).
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit www.advancedcell.com.
Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company’s periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Company’s clinical trials will be successful.
James Young, 212-732-4300
ACT Corporate Communications
Bill Douglass, 646-450-3615
Martina Schwarzkopf, Ph.D., 212-845-4292
Source: Advanced Cell Technology, Inc.