ACT's European Clinical Trial Advances to First Patient Treatment with Higher Dosage of Embryonic Stem Cell-Derived Retinal Pigment Epithelial Cells
First Patient of Second Cohort Injected with 100,000 RPE Cells
MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the fourth patient, the first in the second patient cohort, in its European clinical trial for Stargardt's Macular Dystrophy (SMD). The patient was injected with 100,000 human embryonic stem cell-derived retinal pigment epithelial (RPE) cells, as compared with 50,000 cells in the three patients comprising the first cohort. The outpatient transplantation surgery was performed successfully and the patient is recovering uneventfully.
"Our progress continues in our European clinical trial and both our trials in the U.S., as seen most recently with last week's announcement of treatment of the second patient in the second patient cohort of our U.S. trial for SMD," said Gary Rabin, chairman and CEO of ACT. "As I mentioned last week, we have mapped out the series of patients to complete the second cohort of both our trials for SMD, as well as for our trial for dry age-related macular degeneration (dry AMD), pending DSMB review, and we anticipate generating patient data at a faster pace."
Initiated in January of this year, the Phase I/II trial is designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation in patients with SMD at 12 months, the study's primary endpoint. It will involve a total of 12 patients, with cohorts of three patients each in an ascending dosage format. The company is concurrently conducting another trial for SMD and one for dry AMD, both in the U.S.
"We are very gratified to be initiating the first treatment of the second patient cohort in our European clinical trial, having just started it this year," commented Robert Lanza, M.D., ACT's chief scientific officer. "Our two U.S. trials also continue to move steadily forward."
Further information about patient eligibility for ACT's SMD study and the concurrent studies in the U.S. and Europe (for dry age-related macular degeneration and SMD, respectively) are available at www.clinicaltrials.gov, with the following Identifiers: NCT01469832 (E.U. SMD), NCT01345006 (U.S. SMD), and NCT01344993 (dry AMD).
About Stargardt's Disease
Stargardt's disease or Stargardt's Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.
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 http://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
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