Patient Injected with 100,000 RPE Cells at Wills Eye Institute
MARLBOROUGH, Mass. — July 12, 2012 – 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 U.S. clinical trial for Stargardt’s Macular Dystrophy (SMD). The surgery was performed on Wednesday, July 11 at Wills Eye Institute in Philadelphia, by a surgical team lead by Carl D. Regillo, MD, FACS, director of the Wills Eye Clinical Retina Research Unit, attending surgeon in the Wills Eye Retina Service at the Wills Eye Institute, and professor of ophthalmology at Thomas Jefferson University. In keeping with trial protocol, the patient was injected with 100,000 human embryonic stem cell-derived retinal pigment epithelial (RPE) cells, as compared with the 50,000 cell dose used in the three patients of the first cohort. The outpatient transplantation surgery was performed successfully and the patient is recovering uneventfully.
“It is very gratifying to have second cohort, higher-dosage patient treatment underway in our U.S. clinical trial for SMD,” commented Gary Rabin, chairman and CEO of ACT. “We are also pleased to be working with Dr. Regillo and his team at Wills Eye Institute, a truly first-class institution that is ranked as one of the best ophthalmology hospitals in the country by U.S. News & World Report.”
Initiated in July of last 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. As part of its RPE clinical program, the company is concurrently conducting a clinical trial for dry age-related macular degeneration and second trial for SMD in the United Kingdom.
“Doubling the cell dosage marks an important milestone in our clinical programs,” said Robert Lanza, MD, ACT’s chief scientific officer. “We look forward to continued progress and safety findings in the coming months, in both our U.S. and European trials.”
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: NCT01345006 (U.S. SMD), NCT01344993 (dry AMD), and NCT01469832 (E.U. SMD).
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 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