ACT Announces Completion of Higher-Dosage Cohort in Both U.S. Clinical Trials

Wed Nov 28, 2012 8:30am EST

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ACT Announces Completion of Higher-Dosage Cohort in Both U.S. Clinical Trials

Three Patients with Forms of Macular Degeneration Injected with 100,000 hESC-Derived RPE Cells, Successfully Completing Second Cohort

Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC or the “Company”), a leader in the field of regenerative medicine, today announced treatment of three additional patients in the company’s two U.S. trials using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The fifth and sixth patients in the company’s Phase I/II clinical trial for dry age-related macular degeneration (dry AMD) were treated, completing the second patient cohort. The fifth patient was treated at Massachusetts Eye and Ear Infirmary, a Harvard Medical School affiliate, by a surgical team led by Dean Eliott, M.D., a full-time retina surgeon, scientist and associate director of the Retina Service at Mass. Eye and Ear. Additionally, the sixth patient in the company’s clinical trial for Stargardt’s Macular Dystrophy (SMD) was treated, also completing that second cohort. All three patients were injected with 100,000 hESC-derived RPE cells and are recovering uneventfully.

“We could not be more pleased to have now completed the second, higher-dose patient cohort in both of our U.S. clinical trials,” commented Gary Rabin, chairman and CEO of ACT. “We continue to be encouraged by our progress in all three of our clinical trials and are eagerly anticipating proceeding to the third, 150,000-cell patient cohort.”

The company is conducting a total of three clinical trials in the U.S. and Europe. Each trial will enroll a total of 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 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.

“Completing the higher-cell dosage in both our U.S. trials is an important milestone in our clinical programs,” said Robert Lanza, M.D., ACT’s chief scientific officer. “We are now halfway through both U.S. trials, and look forward to treating the remaining two patient cohorts in the coming year.”

Added Dr. Eliott, “Dry AMD affects upwards of 30 million people worldwide. Moreover, it has no approved drug treatment available to date. ACT’s hESC-derived RPE cells could address this considerable unmet need and also point the way towards treatments of other forms of macular degeneration. We are pleased to be a part of this important clinical trial.”

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 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 Mass. Eye and Ear

Mass. Eye and Ear clinicians and scientists are driven by a mission to find cures for blindness, deafness and diseases of the head and neck. After uniting with Schepens Eye Research Institute in 2011, Mass. Eye and Ear in Boston became the world's largest vision and hearing research center, offering hope and healing to patients everywhere through discovery and innovation. Mass. Eye and Ear is a Harvard Medical School teaching hospital and trains future medical leaders in ophthalmology and otolaryngology, through residency as well as clinical and research fellowships. Internationally acclaimed since its founding in 1824, Mass. Eye and Ear employs full-time, board-certified physicians who offer high-quality and affordable specialty care that ranges from the routine to the very complex. U.S. News & World Report’s “Best Hospitals Survey” has consistently ranked the Mass. Eye and Ear Departments of Otolaryngology and Ophthalmology as top five in the nation. Mass. Eye and Ear is home to the Ocular Genomics Institute which aims to translate the promise of personalized genomic medicine into clinical care for ophthalmic disorders. For more information, visit MassEyeAndEar.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.

Investors:
CEOcast, Inc.
James Young, 212-732-4300
or
Press:
ACT Corporate Communications
Bill Douglass, 646-450-3615
or
Russo Partners
Martina Schwarzkopf, Ph.D., 212-845-4292

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