ACT Announces First Dry AMD Patient Treated with Higher Dosage of Embryonic Stem Cell-Derived RPE Cells

Home/Blindness, Clinical Trials, Disease Specific, Macular Degeneration/ACT Announces First Dry AMD Patient Treated with Higher Dosage of Embryonic Stem Cell-Derived RPE Cells

ACT Announces First Dry AMD Patient Treated with Higher Dosage of Embryonic Stem Cell-Derived RPE Cells

Thursday, August 2, 2012

By: Market Watch Wall Street Journal

Patient with Dry Age-Related Macular Degeneration Injected with 100,000 Retinal Pigment Epithelial Cells at Wills Eye Institute in Philadelphia.

MARLBOROUGH, Mass., Aug 02, 2012 (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 the company’s Phase I/II clinical trial for dry age-related macular

degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from

human embryonic stem cells (hESCs). The surgery was performed on Wednesday, Aug.

1 at Wills Eye Institute in Philadelphia, by a surgical team lead by Carl D.

Regillo, M.D., Chief of the Wills Eye Institute Retina Service, and professor of

ophthalmology at Thomas Jefferson University. The patient was injected with

100,000 hESC-derived RPE cells and is recovering uneventfully.

“We are very pleased to have the second dose cohort in both of our U.S.

clinical trials underway,” commented Gary Rabin, chairman and CEO of ACT. “We

are encouraged by our ongoing progress in all three of our clinical trials using

our hESC-derived RPE cells to treat forms of macular degeneration. We have not

observed any complications or side effects from the stem cell-derived RPE cells,

and we will continue to monitor 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 from the two U.S. trials were

reported in The Lancet earlier this year.

“Doubling the cell dosage in both our U.S. trials is an important step

forward in our clinical programs,” said Robert Lanza, M.D., ACT’s chief

scientific officer. “We anticipate continued progress and safety findings in

both our U.S. trials as well as our concurrent European trial.”

“Dry AMD is the most common cause of vision loss in patients over 50 years

and affects around 30 million people worldwide,” said Dr. Regillo. “Dry AMD is a

form of macular degeneration with no approved drug treatment available to date.

ACT’s hESC-derived RPE cells could address the unmet medical need of combating

dry AMD and other macular degenerations such as Stargardt’s disease. We are

looking forward to analyzing the safety and efficacy data.”

Further information about patient eligibility for ACT’s dry AMD study and the

concurrent studies in the U.S. and the E.U. for SMD is available at

www.clinicaltrials.gov , with the following Identifiers: NCT01344993 (dry AMD),

NCT01345006 (U.S. SMD), and NCT01469832 (E.U. SMD).

About dry AMD

Degenerative diseases of the retina are among the most common causes of

untreatable blindness in the world. Age-related macular degeneration (AMD) is

the leading cause of blindness in people over age 60 in the United States, and

the vast majority of cases of AMD are of the “dry” form, which is currently

untreatable.

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 .

About Wills Eye Institute

Wills Eye Institute is a global leader in ophthalmology, established in 1832

as the nation’s first hospital specializing in eye care. U.S. News & World

Report has consistently ranked Wills Eye as one of America’s top three

ophthalmology centers since the survey began in 1990. Wills Eye is a premier

training site for all levels of medical education. Its resident and

post-graduate training programs are among the most competitive in the country.

One of the core strengths of Wills is the close connection between innovative

research and advanced patient care. Wills provides the full range of primary and

subspecialty eye care for improving and preserving sight, including cataract,

cornea, retina, emergency care, glaucoma, neuro-ophthalmology, ocular oncology,

oculoplastics, pathology, pediatric ophthalmology and ocular genetics, and

refractive surgery. Ocular Services include the Wills Laser Correction Center,

Low Vision Service, and Diagnostic Center. Its 24/7 Emergency Service is the

only one of its kind in the region. Wills Eye also has a network of nine

multi-specialty, ambulatory surgery centers throughout the tri-state area. To

learn more, please visit www.willseye.org

 

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.

SOURCE: Advanced Cell Technology, Inc.

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