Two Clinical Trial Sites Now Approved to Participate in Clinical Trial for Dry AMD
MARLBOROUGH, Mass. — April 16, 2012 – Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the second patient was dosed in the Company’s Phase I/II trial for dry age-related macular degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patient is recovering uneventfully.
“We are very pleased to announce that the treatment of the second dry AMD patient went very well, without any complications,” said Gary Rabin, chairman and CEO of ACT. “We are delighted with our ongoing progress in all of our clinical trials using our stem cell-derived RPE cells to treat forms of macular degeneration. So far, there have not been any complications or side effects due to the stem cell-derived RPE cells, and we will continue monitoring the patients for safety, tolerability and efficacy of this therapy.”
The dry AMD trial is one of three clinical trials being carried out by the company in the U.S. and in Europe. Each trial will enroll 12 patients, with cohorts of three patients in an ascending dosage format. 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 Stargardt’s macular dystrophy (SMD) at 12 months, the study’s primary endpoint. Preliminary results relating to both early safety and biological function for the first two patients in the United States, one SMD patient and one dry AMD patient, were recently reported in The Lancet.
Further information about patient eligibility for the dry AMD study and the concurrent study on SMD is also available on www.clinicaltrials.gov; ClinicalTrials.gov Identifiers: NCT01345006 and NCT01344993.
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.
CEOcast, Inc., James Young, 212-732-4300
ACT Corporate Communications, Bill Douglass, 646-450-3615
Russo Partners, Martina Schwarzkopf, Ph.D., 212-845-4292
Advanced Cell Technology, Matthew Vincent, Ph.D., email@example.com