ACT Secures Approval from Data Safety Monitoring Board to Complete Third Patient Cohort in All Three
ACT Secures Approval from Data Safety Monitoring Board to Complete Third Patient Cohort in All Three Clinical Trials
Patients Already Screened to be Treated with 150,000 Human Embryonic Stem Cell (hESC)-Derived RPE Cells, Completing Third Cohort of Trial
Four Patients with Better Vision Already Treated in Cohort 2a of U.S. Clinical Trials with 100,000 Human Embryonic Stem Cell (hESC)-Derived RPE Cells
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 remaining two patients in the third cohort of each of the three clinical trials. The decision follows an interim review by the DSMB six weeks after the first patient was treated in the third cohort of each trial. ACT will proceed with screening and enrollment for the patients who, in keeping with trial protocol, will be injected with 150,000 retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).
"We are pleased that the first patients treated with the higher dose of RPE cells are doing well and the DSMB sees fit for enrollment to continue in all three clinical trials," commented Gary Rabin, chairman and CEO of ACT. "Even with several patients failing laboratory evaluations late in the inclusion/exclusion review process, which is not atypical in clinical trials, we have four of the six patient surgeries for the third cohorts scheduled, with two remaining to complete screening. We are confident that all surgeries will be performed in ample time for a complete data review at the company's Ophthalmic Advisory Board meeting in early October, where Phase 2 trial designs will be discussed."
ACT's three clinical trials in the U.S. and Europe use hESC-derived RPE cells to treat forms of macular degeneration, dry AMD and Stargardt's Macular Dystrophy (SMD). Each trial will enroll four cohorts, with three patients each, in an ascending dosage format from 50,000 to 200,000 hESC-derived RPE cells. The U.S.-based clinical trials in AMD and SMD are currently enrolling a cohort of four patients with better vision receiving 100,000 hESC-derived RPE cells, referred to as "Cohort 2a". To date, the company has treated four patients in Cohort 2a, with two more surgeries scheduled. 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.
Robert Lanza, M.D., chief scientific officer of ACT, added, "The DSMB approval is an important milestone, especially as we continue to significantly increase the RPE dosage in all three of our clinical trials. This independent review of safety comes on the two year anniversary of the treatment of our first two patients in July 2011. Those original patients continue to do well, and the gains in visual acuity we first reported in The Lancet in January 2012, have persisted. We are excited to enroll the next patients in these cohorts, as well as the better vision patients in Cohort 2a of the U.S. trials."
Further information about patient eligibility for ACT's dry AMD study and the company's concurrent SMD studies in the U.S. and E.U. is available at www.clinicaltrials.gov, with the following Identifiers: NCT01344993 (dry AMD), NCT01345006 (U.S. SMD), and NCT01469832 (E.U. SMD).
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, 2012. 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.
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