차바이오앤[085660] - 미국act사와 공동연구개발중, ACT 황반변성 배아줄기세포 2임상 미국IRB(임상심사위원회)승인

[불스탁분석팀]

차바이오앤[085660]
미국act사와 공동연구개발중

미국 act 주가 급등
ACT 황반변성 배아줄기세포 2임상 미국IRB(임상심사위원회)승인
Leading Eye Institute to Participate in ACT’s Embryonic Stem Cell Clinical Trial for Macular Degeneration
Wills Eye Institute receives IRB approval to treat dry-AMD using ACT’s hESC-derived retinal pigment epithelial (RPE) cells
MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced that the Wills Eye Institute in Philadelphia has received institutional review board (IRB) approval as a site for the Phase 1/2 clinical trial for dry age-related macular degeneration (dry AMD) using human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells.

“The participation of Wills Eye Institute in this trial will significantly enhance our clinical program,” said Robert Lanza, M.D., ACT's chief scientific officer. “Wills Eye Institute is the oldest eye-care facility in the United States and is consistently ranked as one of the best ophthalmology hospitals in the country by the U.S. News & World Report. We are looking forward to working with Dr. Regillo and his team to address the unmet medical needs of degenerative diseases of the retina. With this latest approval, the company continues to assemble a clinical team that includes the best eye hospitals and surgeons in the world in our effort to find an effective therapy for this devastating eye disease.”

The Phase 1/2 trial for dry AMD is a prospective, open-label study designed to determine the safety and tolerability of the hESC-derived RPE cells following sub-retinal transplantation into patients with dry AMD. The trial will ultimately enroll 12 patients, with cohorts of three patients each in an ascending dosage format. Which patients will be enrolled at the Wills Eye Institute will be determined in the near future.

“Degenerative diseases of the retina often lead to a significant visual impairment,” said Carl Regillo, M.D., director of clinical retina research at Wills Eye Institute and professor of ophthalmology at Thomas Jefferson University. “Replacing lost or damaged cells with functional and healthy cells may provide a treatment option that could slow vision loss, and perhaps even reverse the effects of disease. We are looking forward to collaborating with ACT to eval‎uate the potential of the stem cell-derived RPE cells for debilitating diseases such as Stargardt’s macular dystrophy and dry AMD.”

Dry AMD, or “central geographic atrophy,” is the “dry” form of advanced age-related macular degeneration. Dry AMD occurs when the light-sensitive cells (photoreceptors) in the macula slowly break down, gradually blurring central vision in the affected eye. Over time, as less of the macula functions, central vision is gradually lost in the affected eye, often progressing to blindness. The loss of photoreceptors is a direct result of a preceding degeneration of the retinal pigment epithelial (RPE) layer of cells just below the retina. As many as 30 million people in the United States and Europe suffer from macular degeneration, which represents a $25-30 billion worldwide market that has yet to be effectively addressed. Approximately 10% of people ages 66 to 74 will have symptoms of macular degeneration, the vast majority suffering from the “dry” form of AMD - which is currently untreatable. The preval‎ence increases to 30% in patients 75 to 85 years of age.

“We are honored to have the opportunity to work with one of the foremost eye care centers in the world”, said Gary Rabin, chairman and chief executive officer of ACT. “This clinical trial represents the culmination of years of innovation and hard work by ACT’s scientific team. The whole world is focused on our trials, most especially patients suffering from dry AMD and other forms of macular degeneration. Wills Eye Institute has a strong tradition of innovation and discovery, and we are excited at their participation in bringing this cutting-edge technology through the clinic.”

Additional details about these studies, for which the Jules Stein Institute at the University of California, Los Angeles has also received IRB approval, can be found at http://clinicaltrials.gov/; ClinicalTrials.gov Identifier: NCT01345006 and NCT01344993.

About hESC-derived RPE Cells
The retinal pigment epithelium (RPE) is a highly specialized tissue located between the choroids and the neural retina. RPE cells support, protect and provide nutrition for the light-sensitive photoreceptors. Human embryonic stem cells differentiate into any cell type, including RPE cells, and have a similar expression‎ of RPE-specific genes compared to human RPE cells and demonstrate the full transition from the hESC state.

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.

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, refractive surgery and retina. 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, 2010. 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.
http://finance.yahoo.com/news/Leading-Eye-Institute-bw-653807741.html?x=0

참고자료
차바이오앤 (11,950원 350 -2.9%)디오스텍(대표 황영기)은 동종배아줄기세포 유래 망막색소상피세포를 이용한 건성 노인성 황반변성증에 대한 임상1상 시험과 2상 시험 신청서를 식품의약품안전청에 제출했다고 16일 밝혔다.

이번 임상 시험 신청은 배아줄기세포치료제로는 지난 5월 이미 임상시험 승인을 받은 바 있는 희귀실명질환인 스타가르트병에 이어 두 번째다.

차바이오앤은 이번에 신청한 건성 노인성황반변성증의 경우 최근 환자가 급증하고 있지만 치료제가 전무한 질환이라 상용화 될 경우 상당한 파급력을 가져 올 것으로 기대하고 있다.

차바이오앤의 황반변성 줄기세포치료제는 미국 ACT(Advanced Cell Technology)사와의 공동연구개발의 성과다.

http://www.mt.co.kr/view/mtview.php?type=1&no=2011091610530553629&outlink=1