ACT Announces Data and Safety Monitoring Board (DSMB) Approval to Complete Second Patient Cohort in Clinical Trial for Dry AMD
Patients Five and Six to be Treated with 100,000 Human Embryonic Stem Cell (hESC)-Derived RPE Cells, Completing Second Cohort of Trial
MARLBOROUGH, Mass. – November 1, 2012 - 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 two additional patients with dry age-related macular degeneration (dry AMD). ACT will screen and enroll the second and third patients of the three-patient second cohort in the trial. Per trial protocol, each patient will be injected with 100,000 human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells.
“Dry AMD represents one of the largest unmet medical needs in the world, and we are thrilled to be making steady progress in our clinical trial for this condition,” commented Gary Rabin, ACT’s chairman and CEO. “We are well on our way to the halfway point of all three of our clinical trials. We also recently secured DSMB approval to complete the second cohort of our two trials for Stargardt’s Macular Dystrophy.”
ACT is conducting three clinical trials in the U.S. and Europe using hESC-derived RPE cells to treat forms of macular degeneration, dry AMD and Stargardt’s Macular Dystrophy (SMD). Each trial will enroll a total of 12 patients, with cohorts of three patients each in an ascending dosage format, from 50,000 to 200,000 hESC-derived RPE cells. 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.
“This authorization to treat the next two patients in the second, higher-dosage cohort of our trial for dry AMD represents a notable milestone for our clinical programs,” commented Robert Lanza, M.D., ACT’s chief scientific officer. “We look forward to treating these two patients and moving on to the third cohort in good time.”
Further information about patient eligibility for ACT’s SMD studies in the U.S. and E.U. as well as its dry AMD study in the U.S. 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 .
Forward-Looking Statements
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.
Contact:
Investors:
CEOcast, Inc., James Young, 212-732-4300
Press:
ACT Corporate Communications, Bill Douglass, 646-450-3615
or:
Russo Partners, Martina Schwarzkopf, Ph.D., 212-845-4292
