WORCESTER, Mass., Sept 22 (BUSINESS WIRE)—Advanced Cell Technology, Inc. (OTCBB:ACTC.PK–News) provided an update on pre-clinical activities in preparation of its first IND filing with the Food and Drug Administration for its retinal pigment epithelium (RPE) cell program for the treatment of various eye diseases. In the next few weeks, the Company will be completing the preclinical work necessary for filing the IND. To date, no adverse events have occurred in testing. The results will be part of the submission which Advanced Cell expects to submit to the FDA prior to the end of the year.
“We are very pleased with the long-term safety and efficacy data,” said Dr. Robert Lanza, ACT’s Chief Scientific Officer. “We have carried out pre-clinical studies using these cells in multiple animal models, and to-date have not seen any teratoma formation or untoward pathological reactions. We are optimistic that human embryonic stem cells (hESCs) will serve as a potentially safe and inexhaustible source of RPE for the treatment of a range of macular degenerative diseases.”
“We are pleased with the progress we have made in preparation for the FDA submission,” said William M. Caldwell IV, Advanced Cell’s Chairman and CEO. “In the retina, compromised RPE function can lead to deteriorated vision and photoreceptor loss in both age-related macular degeneration and other forms of degenerative eye disease. We look forward to further studying the role that our RPE cells can play in providing a potential solution to this problem.”
WORCESTER, Mass., Sept. 21 (PRNewswire)—Advanced Cell Technology, Inc. (OTCBB:ACTC.PK–News)announced today that Dr. Robert Lanza, its Chief Scientific Officer, will be featured this week on “Explorations in Science” with Dr. Michio Kaku, an hour long radio program on science, technology, politics, and the environment. It is broadcast each week on public radio in New York City (WBAI 99.5 FM), and re-aired in Los Angeles, San Francisco, Tampa, Houston, and stations across the country. Explorations can also be heard around the world via the web at www.kpfa.org/archive/show/51. The show focuses on Dr. Lanza’s research on cloning, stem cells, and his new book “Biocentrism.”
Dr. Lanza is also scheduled to appear on Dr. Kaku’s commercial radio show “Science Fantastic,” which airs in 127 cities around the country, making it the largest nationally syndicated science radio show on commercial radio. The program focuses the future of science. Past featured guests include Nobel laureates and top researchers on the topics of string theory, time travel, black holes, gene therapy, aging, space travel, artificial intelligence and SETI.
Dr. Kaku holds the Henry Semat Chair and Professorship in theoretical physics at City College of New York. He is the co-founder of string field theory, and is currently engaged in defining the “Theory of Everything,” which seeks to unify the fundamental forces of the universe. In addition to authoring textbooks on string theory and quantum field theory, Dr. Kaku is also the best- selling author of popular books, such as “Hyperspace,” “Beyond Einstein,” and “Physics of the Impossible” (which is currently on the New York Times top 10 bestseller list). On his show, Lanza discusses the cutting edge of cloning (including the cloning of endangered/extinct species and cells for medical therapy), as well as the future of regenerative medicine using stem cells to grow organs and to treat human disease.
Drs. Lanza and Kaku also discuss “Biocentrism: How life and consciousness are the keys to understanding the true nature of the universe.” “We think life is an accident of physics and chemistry,” explains Lanza. “But a long list of experiments suggests just the opposite. Amazingly, if you add life to the equation, you can explain some of the biggest puzzles of science. For instance, it becomes clear why space and time—and even the properties of matter itself—depend on the observer. Biocentrism even explains why the laws of the universe are fine-tuned for the existence of life.”
Click here for a complete list of stations carrying the show: www.mkaku.org
WORCESTER, Mass.—(BUSINESS WIRE)—Advanced Cell Technology, Inc. (OTCBB:ACTC.PK–News), announced today that it has hired Edmund Mickunas as Vice President Regulatory. Mr. Mickunas will be in charge of spearheading the company’s effort to translate its cutting edge research into FDA approved therapies ready for clinical trials. Specifically, Mr. Mickunas will work with Dr. Robert Lanza and ACT’s Development Team to finalize and submit an IND for the RPE program to the FDA for approval to commence a Phase I Clinical Trial. Mr. Mickunas has over 28 years of experience across a breadth of disciplines including the biotechnology, medical device and pharmaceutical fields. During his career he has worked in preclinical program development, clinical affairs, regulatory affairs/compliance and quality assurance, and has worked closely with all disciplines involved in product development. Prior to joining Advanced Cell, Mr. Mickunas was Executive Director, Regulatory Affairs and Quality Assurance for Applied Genetic Technologies Corporation, a privately held gene therapy and genomics-focused biotech company.
Before joining Applied Genetic Technologies, he was Vice President, Regulatory, Quality and Clinical Affairs for Oragenics, a company engaged in the development of vaccines, biologics and pharmaceuticals. Mr. Mickunas was previously Senior Director of Regulatory Affairs and Compliance for Control Delivery Systems, Inc., where he managed the submissions of IND filings, among other responsibilities. He also held senior regulatory positions at Bioheart, Inc., Cytomed and Del Laboratories. He received his B.S. and pursued graduate studies in human biochemistry at Fairleigh Dickinson University, as well as a Masters Degree from Fairfield University.
“We are pleased that Ed has elected to join us as his extensive regulatory expertise and experience in filing IND’s will be invaluable as we prepare to file our first IND with the FDA in the second half of this year,” said William M. Caldwell IV, Chairman & CEO of Advanced Cell. “Ed’s most recent assignment focused on retinal programs. He has strong relations with the Ophthalmology Departments of our clinical advisors as well as recent first hand experience with processing retinal IND applications through the FDA. We look forward to his input and to his role in helping to move our stem cell therapeutic programs into and through the clinical process.”
Before joining Applied Genetic Technologies, he was Vice President, Regulatory, Quality and Clinical Affairs for Oragenics, a company engaged in the development of vaccines, biologics and pharmaceuticals. Mr. Mickunas was previously Senior Director of Regulatory Affairs and Compliance for Control Delivery Systems, Inc., where he managed the submissions of IND filings, among other responsibilities. He also held senior regulatory positions at Bioheart, Inc., Cytomed and Del Laboratories. He received his B.S. and pursued graduate studies in human biochemistry at Fairleigh Dickinson University, as well as a Masters Degree from Fairfield University.
“I look forward to joining ACT at such an exciting time in the Company’s development,” said Mr. Mickunas. “I am impressed that despite a challenging economic and political environment, the Company has been able to acquire and develop such a promising regenerative medicine platform and to advance it to an industry leading stage of clinical development. I feel very privileged to be working with Dr. Lanza, a well respected leader in the field of regenerative medicine and Mr. Caldwell, whose financial experience is setting the Company on sound footing to make the clinical development of these very significant biotechnology platforms possible.”
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-QSB for the quarter ended September 30, 2007. 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.
WORCESTER, Mass., Aug. 13 /PRNewswire-FirstCall/—Advanced Cell Technology, Inc. (OTCBB:ACTC.PK–News) announced today that Dr. Robert Lanza, its Chief Scientific Officer, is featured on Deepak Chopra’s Wellness Radio airing Saturday on Sirius/XM Stars, Channels 102 and 55 [Live Saturday 12 pm – 1 pm ET; Replays 1 pm – 4 am (Sunday) ET, and throughout the week]. The show focuses on Dr. Lanza’s research at ACTC and his new book “Biocentrism.” SIRIUS XM Stars Channel is the flagship satellite talk station featuring unique and diverse programs, including Deepak Chopra and broadcasting legend Barbara Walters, among others. It has a listenership of approximately 9 million people.
Chopra is a prolific author of over fifty-five books on topics ranging from health to consciousness and quantum mechanics, and was heralded by Time Magazine as one of the top heroes and icons of the century. On his show, Lanza discusses the cutting edge of regenerative medicine, including ACTC’s efforts to use stem cells to treat blindness, vascular damage, and heart disease. ACTC hopes to file at least one application with the FDA this year to begin human clinical trials using retinal pigment epithelium (RPE) cells to treat macular degeneration and other retinal degenerative diseases.
Lanza and Chopra also discuss “Biocentrism,” and how life and consciousness are the keys to understanding the true nature of the universe. “We think life is an accident of physics,” explains Lanza. “But a long list of experiments suggests just the opposite. Amazingly, if you add life to the equation, you can explain some of the biggest puzzles of science. ”
Deepak Chopra stated, “Having interviewed some of the most brilliant minds in the scientific world, I found Dr. Robert Lanza’s insights into the nature of consciousness original and exciting. His theory of biocentrism is consistent with the most ancient wisdom traditions of the world which says that consciousness conceives, governs, and becomes a physical world. It is the ground of our Being in which both subjective and objective reality come into existence. I hope to have Dr. Lanza continue this conversation on Sirius XM satellite radio in the future.”
“We believe that Dr. Lanza has contributed significantly to the understanding of the key role stem cells play in the field of regenerative medicine,” said William M. Caldwell IV, Chairman and CEO of ACTC. “Through his scientific leadership the field is on the verge of therapeutically validating a new platform for regenerative medicine.”
Click this link to listen to the Sirius/XM radio broadcast: http://www.sirius.com/siriusxmstars
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-QSB for the quarter ended September 30, 2007. 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.
WORCESTER, Mass.—(BUSINESS WIRE)—Advanced Cell Technology, Inc. (Advanced Cell, ACT) (OTC: ACTC) announced today that it has filed its Form 10-Q for the first quarter ended March 31, 2009. The filing brings the Company’s financial statements current. The Company plans to seek relisting on the Over-the-Counter Bulletin Board.
“We are pleased that we have been able to bring our financial statements current, which represents an important step in relisting on the Over-the-Counter Bulletin Board and in providing the investment community with up-to-date information on the Company’s financial condition,” said William Caldwell, CEO of Advanced Cell. “I also want to express my gratitude to the Company’s employees for their tireless efforts in helping the Company compile the requisite financial information, and to Dr. Robert Lanza, Advanced Cell’s Chief Scientific Officer, and his research and development team who have made significant scientific progress, despite the Company and industry’s financial challenges. Through their efforts ACT is on track to file an IND with the Food and Drug Administration for its retinal pigment epithelium cell therapeutic program for the treatment of diseases of the eye the second half of this year.”
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 ability to draw on the credit Facility, 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: the Company’s ability to meet all of the conditions to allow it to access the entire amount available under the credit Facility discussed in this press release, 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-QSB for the quarter ended September 30, 2007. 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.
Advanced Cell Technology
Dan Schustack
CEOcast, Inc. for Advanced Cell Technology
212-732-4300
WORCESTER, Mass.—(BUSINESS WIRE)—Advanced Cell Technology, Inc. (OTC:ACTC) and its collaborators at OHSU reported today the long-term safety and efficacy of human embryonic stem cell (hESC)-derived retinal pigment epithelium (RPE) produced under manufacturing conditions suitable for human clinical trials. Two important early potential hESC applications are the use of RPE for the treatment of age-related macular degeneration and Stargardt disease, an untreatable form of eye disease that leads to early-onset blindness. The research, which appears online ahead of print in the journal Stem Cells, shows long-term functional rescue using hESC-derived cells in both the RCS rat and Elov14 mouse, animal models of retinal degeneration and Stargardt, respectively. The cells survived transplantation for prolonged periods (>220 days) and sustained visual function without tumor formation or untoward pathological reactions. Near-normal functional rescue was also achieved in the ‘Stargardt’ mouse. To further address safety concerns, a study was carried out in the NIH III immune deficient mouse model. Long-term data (spanning the life of the animals) revealed no evidence of tumor formation after transplantation.
“We’re delighted with these results,” said Robert Lanza, Chief Scientific Officer at ACT, and co-senior author of the study. “Everything looks great so far. Based on these and other studies, we’re on schedule to file an IND with the FDA to begin human clinical trials sometime in the next 3 or 4 months. Barring any surprises, Stargardt disease and macular degeneration are likely to be the next two clinical applications of ES technology.
Since their discovery over a decade ago, hESCs have been considered a promising source of replacement cells for clinical studies. However, problems continue to plague clinical translation, including the risk of teratoma formation and the need for powerful drugs to overcome the problem of immune rejection. Until induced pluripotent stem (iPS) cell technology is further developed, hESC-derived therapies are likely to be limited to immunoprivileged sites such as the central nervous system and the eye. In the retina, compromised RPE function can lead to deteriorated vision and photoreceptor loss in both age-related macular degeneration and other forms of degenerative eye disease. In this study, the cell manufacturing and documentation process complied with the guidelines set forth by the FDA, collectively referred to as Good Manufacturing (GMP) and Good Tissue Practices.
The cells were prepared for clinical application and tested for safety and efficacy in several different in vitro and animal models in collaboration with researchers at the Casey Eye Institute at Oregon Health and Science University (OHSU) headed by Dr. Raymond Lund. Dr. Lund, co-senior author of the paper, is widely considered one of the world’s foremost experts in retinal cell physiology and vision restoration. RPE from different hESC lines were tested in the RCS rat, an animal in which vision deteriorates over several months due to an RPE functional defect. The studies focused on longevity of effect, dosing effect, and evidence of untoward pathology. After three months, the treated retina had 5-6 layers of photoreceptors, whereas the untreated animals only had a single layer of cells remaining (they were essentially blind). Based on these data, a cell batch was chosen for a GLP safety study using the NIH III mouse model, an immune deficient animal model. Importantly, we also showed that vision can be rescued in a mouse model of Stargardt’s disease, which is a form of early-onset macular dystrophy that leads to blindness despite an intact Bruch’s membrane (critical for RPE cell attachment and potential clinical efficacy).
“We have worked with Dr. Lund and his team for over three years investigating the safety and efficacy of our RPE cell therapy,” stated William M. Caldwell IV, Chairman and CEO of ACTC. “We are now completing the finishing touches to seek FDA approval to conduct human clinical trials with a cell therapy that may be able to address many of the 200 plus known retinal diseases.”
The researchers of the paper from Advanced Cell Technology, collaborated with scientists from Casey Eye Institute at the Oregon Health & Science University, Portland, Oregon. The paper’s other authors are Bin Lu (co-equal first author), Shaomei Wang (co-equal first author), Sergej Girman, and Peter Francis at OHSU; and Christopher Malcuit (co-equal first author) and Linda Lemieux of ACT.
Link to article: http://www3.interscience.wiley.com/cgi-bin/fulltext/122455604/PDFSTART
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-QSB for the quarter ended September 30, 2007. 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.
Advanced Cell Technology
Kathy Singh, 508-756-1212×653
or
CEOcast, Inc. for Advanced Cell Technology
Dan Schustack, 212-732-4300
WORCESTER, Mass.—(BUSINESS WIRE)—Advanced Cell Technology, Inc. (Advanced Cell, ACT) (OTC: ACTC – News) and a leading leading Korea-based stem cell company, CHA Bio & Diostech Co., Ltd. (CHA Bio), formerly known as CHA Biotech, Co., Ltd. and whose shares are publicly traded on KOSDAQ, announced today that the parties have entered into a licensing agreement under which Advanced Cell will license its proprietary single blastomere technology, which has the potential to generate stable cell lines, including retinal pigment epithelium (RPE) cells for the treatment of diseases of the eye, to CHA Bio for development and commercialization exclusively in Korea. ACT received an undisclosed up-front license fee. The Company believes there are some 200 different retinal diseases that may be impacted by this stem cell derived therapy including macular degeneration, which represents a $28 billion dollar market. Age-related macular degeneration (AMD) affects more than 30 million people worldwide and is the leading cause of blindness in people over 60 years of age in the United States.
We are pleased to acquire the Korean rights to a promising technology platform which could provide a solution to diseases of the eye, which represent a large market opportunity in Korea, said Moon, ByungWoo, the CEO for CHA Bio. As a result of the acquisition of this license, we believe we have a way to produce cell lines that appear to be identical to hESC lines derived from later stage embryos using techniques that does not destroy the embryos developmental potential. If so, we believe it may represent a solution to the ethical and moral dilemma facing many regarding embryonic stem cell destruction.
We are pleased to further expand our relationship with CHA Bio and to grant a license to develop our blastomere technology for development exclusively in Korea only, said William Caldwell, CEO of Advanced Cell. We expect that our collaborative efforts will accelerate the technology of regenerative medicine therapies internationally. Granting CHA exclusive rights to develop the technology in Korea while ACT retains the right to develop it in the rest of the world, positions ACT to benefit from a relationship with a well-capitalized and successful stem cell company, which allows the Company to expand its knowledge base surrounding this promise technology platform.
Previously, ACT demonstrated the ability to rescue visual function in rats through implantation of RPE cells derived from human embryonic stem cells. In collaboration with Dr Raymond Lund, then at the Moran Eye Institute at the University of Utah and currently working at the Casey Eye Institute at the Oregon Health and Science University, the Company performed RPE cell transplantation into the sub-retinal space in the eyes of RCS rats that naturally become blind in several weeks due to RPE degeneration and photoreceptor death. In the experiments sponsored by the Company, the rats were injected with embryonic stem derived RPE cells into the sub-retinal space of the eye at 21 days after their birth—an age at which photoreceptor degeneration has not yet occurred. As control measures, some rats received injections of cell culture medium alone or were not injected at all. Subsequently, tests for visual function were performed at 60 and 90 days after birth—times at which loss of photoreceptor cell has produced characteristic vision deficits. The results represented a major breakthrough. The injected RPE cells grew normally without forming teratomas (tumors). Soon, the rats were able to follow light with their eyes and attained approximately 70% of the spatial acuity of a normal, healthy rat. Necropsy revealed that the eyes had grown layers of the retinal cells. The experiment demonstrated that animals receiving the human embryonic stem cell-derived RPE cells performed significantly better than medium-only treated (50% improvement), or untreated (100% improvement) controls in visual performance. In addition, the human embryonic stem cell-derived RPE cells did not appear to cause any side effects in the animals. The research was published in Cloning and Stem Cells and was also referenced in Scientific American.
The license between ACT and Cha Bio is a part of continuing cooperation and collaboration between the two companies, including a joint venture regarding hemangioblast technology. In March, the Company also announced that it licensed its retinal pigment epithelium (RPE) technology, for the treatment of diseases of the eye, to CHA Bio for development and commercialization exclusively in Korea. ACT is eligible to receive up to a total of $1.9 million in fees based upon the parties achieving certain milestones, including ACT making an IND submission to the US FDA to commence clinical trials in humans using the technology, which ACT currently plans to do during the second half of 2009.
About CHA Bio & Diostech
CHA Bio & Diostech, a leading stem cell company in Korea, was established in September 2000 by CHA University and CHA General Hospital Group to create a central, multidisciplinary research facility where the universitys scientists and hospital physicians could come together and focus their efforts on developing stem cell, gene therapy and regenerative medicine technology. The company is one of the largest companies in terms of its market value on KOSDAQ, the Korean equivalent of NASDAQ.
CHA Bio presently operates the largest stem cell research institute in Korea occupying a modern 130,000 sq. ft., state-of-the-art facility staffed with 28 professors and involving 180 of the most prominent research scientists. The Company also successfully operates CHA i-Cord, a cord blood bank, and a mobile healthcare unit called CHA Paramedic Service, both of which were rated #1 in consumer reliability surveys in Korea. As part of its global business strategy, CHA Bio expanded its operations to the United States in 2002 with the opening of CHA Fertility Center in Los Angeles followed by the 2005 acquisition of Hollywood Presbyterian Medical Center, a 434-bed general, acute-care hospital also located in LA.
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine with its laboratory located in Worcester, Massachusetts.
Forward-Looking Statements
Statements in this news release regarding future ability to draw on the credit Facility, 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: the Companys ability to meet all of the conditions to allow it to access the entire amount available under the credit Facility discussed in a previous press release, limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of 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 Companys periodic reports, including the report on Form 10-QSB for the quarter ended September 30, 2007. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys 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 companys 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
For more information, visit www.advancedcell.com
WORCESTER, Mass.—(BUSINESS WIRE)—Advanced Cell Technology, Inc. (OTCBB:ACTC.PK–News announced today that it has filed its Form 10-Q for its 2008 second and third quarters for the three months ended June 30, 2008 and September 30, 2008. The Company anticipates filing its Form 10-K for the year-ended December 31, 2008 and Form10-Q for the first quarter ended March 31, 2009 prior to the end of this quarter. Upon completing those filings, the Company intends to file for relisting on the Over-the-Counter Bulletin Board as its financial statements will be current.
We recognize the importance of transparency and the need to become current in our financial reporting and are working diligently with our auditors to achieve this, said William Caldwell, CEO of Advanced Cell. Filing the 10-Qs for two quarters last year is the first step in the process that will hopefully lead to a listing on the Bulletin Board. We believe such a listing should increase interest among the investment community in the significant progress we have made in developing our scientific platform, and our IND filing later this year when we will seek approval to commence human clinical trials for our retinal pigment epithelium (RPE) technology.
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.
Forward-Looking Statements
Statements in this news release regarding future ability to draw on the credit Facility, 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: the Companys ability to meet all of the conditions to allow it to access the entire amount available under the credit Facility discussed in this press release, 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 companys periodic reports, including the report on Form 10-QSB for the quarter ended September 30, 2007. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys 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 companys 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.
Monday February 2, 1:00 pm ET
Worcester, MA February 2, 2009 (PR Newswire)—Advanced Cell Technology, Inc. (OTC: http://finance.yahoo.com/q?s=actc.pk&d=t) and its collaborators reported today that human oocytes (or ‘eggs’) have the capacity to extensively reprogram adult human cells. The research, which appears online ahead of print in the journal Cloning and Stem Cells (Editor-in-Chief: Sir Ian Wilmut; published by Mary Ann Liebert, Inc.) demonstrates that although human-to-human clones (human clones) and human-to-animal clones (hybrids) appear similar, the pattern of reprogramming of the donor human cell is dramatically different. In contrast to the human-animal hybrids, the gene expression pattern of the human clones was highly similar to normal human embryos. The paper is available free online at www.liebertpub.com/clo.
Since the cloning of Dolly the Sheep over a decade ago, somatic cell nuclear transfer (SCNT) has been considered a promising way to generate personalized stem cells to repair the body without fear of tissue rejection. Due to the serious shortage of human donor eggs, cows, rabbits, and other animals have long been considered an attractive surrogate source of eggs. Although previous reports have documented the formation of cloned embryos using both human and animal eggs, to-date, there has been no data indicating whether –and to what extent − the donor DNA was reprogrammed.
This new study looked at the reprogramming of human cells using eggs obtained from human and animal sources, and shows for the first time that the donor DNA in the cloned human embryos is extensively reprogrammed through extensive up-regulation (‘turning on’ of genes) with similar expression patterns to normal human embryos. Nearly all of the key differentially-expressed genes were activated in the human clones. In distinct contrast, the majority of these genes were down-regulated or silenced in the human-animal hybrids.
“We examined the factors recently used to reprogram skin cells (to induce pluripotent stem cells),” said Robert Lanza, MD, Chief Scientific Officer at ACT, and senior author of the study. “At the center of cellular reprogramming lies the activation of the transcription factors Oct4, Sox2, and nanog. These core factors were activated in both the normal and cloned human embryos. In striking contrast, the human-animal hybrids showed no difference or a down-regulation of these critical pluripotency genes −effectively silencing them—thus making the generation of stem cells impossible. Without appropriate reprogramming, these data call into question the potential use of animal egg sources to generate patient-specific stem cells. It also renders the moral controversy surrounding the use of human-animal hybrids mute.”
Previous studies have confirmed the ability of animal eggs to support interspecies cell division to the embryo stage, and in a few closely-related bovid species, successful development to term. However, there are clear differences in compatibility. Distantly-related animal combinations generally arrest at the cleavage-stage, although there have been reports of blastocyst formation. Our group and others have successfully used eggs to clone closely-related species (for instance, we cloned two endangered species – the guar and banteng − using cow eggs). Rabbit eggs have also been used to generate embryos using cells from cats and panda, among others. However, it remains unknown whether the DNA in the later combinations was fully reprogrammed. Importantly, except for a study carried out in China (which to-date has proven irreproducible despite attempts by numerous groups in the last half-decade), there is no evidence that patient-specific stem cells can be generated using animal eggs. This is consistent with studies that indicate that eggs support nuclear remodeling, but not reprogramming of discordant animal combinations. Studies using cow and rabbit eggs clearly suggest that DNA methylation/demethylation of the donor DNA occurs in a species-specific way, and that the eggs might lack the ability to demethylate repetitive sequences from other species. While cleavage division relies on maternal factors in the egg, further development requires activation of the embryonic genome to ensure correct progression of the cell cycle. These new results suggest that while bovine and rabbit eggs are capable of supporting limited cell division, specific reprogramming towards the normal human embryonic state does not occur.
Wide scale application of stem cell technology will require a solution to the problem of rejection. This report suggests that adult cells can be successfully reprogrammed using human eggs, and that scientists may soon have two ways (SCNT and induced pluripotent stem cell technology) to reprogram adult cells into stem cells. However, until this is achieved, clinical trials are likely to be limited to immune-privileged sites in the body, such as the use of cells in the central nervous system, or the transplantation of ACT’s retinal cells into the eye to prevent blindness.
“Producing millions of patient-specific stem cell lines is commercially unviable,” stated William M. Caldwell, CEO and Chairman of ACTC. “However, we are optimistic that we will soon have at least two different methods to create stem cells banks to match patients. We estimate that a bank of 100 different lines could furnish a complete tissue (HLA haplotype) match for half of the US population. This will allow us to expand the range of possible clinical therapies to include diseases such as diabetes and heart disease.”
The paper’s other authors are Young Chung (first author), Vladislav Sandler, Sandy Becker, Irina Klimanskaya, Shi-Jiang Lu & Marc Maserati of ACT; Colin Bishop, Stephen Walker & Anthony Atala at Wake Forest University School of Medicine; Nathan Treff, Jing Su & Richard Scott at Reproductive Medicine Associates of New Jersey; Randall Dunn at Fertility Specialists of Houston; Wan-Song Wun, Rebecca Hall & Ralph Dittman at Stem Cell Source; and Young-Ho Choi at Texas A&M University.
Link to article: www.liebertpub.com/clo
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.
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-QSB for the quarter ended September 30, 2007. 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.
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WORCESTER, Mass.—(BUSINESS WIRE)—Advanced Cell Technology, Inc. (OTCBB: ACTC.PK – News) reported that it is feasible to differentiate human embryonic stem cells (hESCs) into functional human vasculature. The research, which appears in the January issue of the journal Regenerative Medicine, shows for the first time that human progenitor cells –known as hemangioblasts– have the potential for both endothelial cell (EC) and vascular smooth muscle cell (SMC) lineage differentiation. This dual potentiality is critical for the effective treatment of human vascular disease, especially the repair and formation of mature and larger-size (non-capillary) vessels.
“The cells participated in the formation of new blood vessels –both capillaries and larger vessels—and were capable of repairing damaged vessels in multiple vasculatures,” said Robert Lanza, M.D., Chief Scientific Officer at ACT, and senior author of the study. “The cells restored blood flow in ischemic limbs to near normal levels. They also showed a similar regenerative capacity after myocardial infarction and participated in the repair of vascular injury in diabetic animals. The formation of mature and functional vasculature, except for capillary vessels, requires the interaction of endothelial and smooth muscle cells, the later playing a critical role in the structural and functional support of the vascular network. Thus, the ability to generate large numbers of these progenitor cells makes them an ideal source of cells for the treatment of human diseases caused by deficient vessel growth.”
Although endothelial cells play an essential role in vasculogenesis and angiogenesis and form capillary vasculatures, they alone cannot complete the process of vessel growth and development. Vascular smooth muscle cells play a critical role in the support of the vascular network by stabilizing nascent endothelial vessels during vascular development and blood vessel growth. This outer layer of cells also protects the fragile channels from rupture and helps control blood flow.
Until now there was no evidence that blast cells (hemangioblasts) or their equivalents generated from hESCs possessed the ability to differentiate into smooth muscle cells. ”The hESC-derived smooth muscle expressed SMC-specific markers (α-SM actin and calponin) and contracted upon stimulation with carbachol,” stated Shi-Jiang Lu, first author of the paper. “When implanted in nude mice, the cells formed microvasculature with endothelial cells in Matrigel. The cells differentiated into both ECs and SMCs, and incorporated into blood vessels after injection into ischemic tissues, indicating that these cells are functional both in vitro and in vivo.”
“We believe these cells could play an important future therapeutic role for patients with vascular disease,” stated William M. Caldwell, CEO and Chairman of ACTC. “We are pleased to continue this work through our new joint venture with CHA Biotech Co, Ltd. (CHA). ACT scientists will work with the new company “Stem Cell & Regenerative Medicine International” to help translate this research into clinical therapies.”
The paper’s other researchers are Yordanka Ivanova, Qiang Feng, and Chenmei Luo.
Link to article: http://www.futuremedicine.com/doi/abs/10.2217/17460751.4.1.37
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.
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-QSB for the quarter ended September 30, 2007. 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.
Michael Wachs
(212 )732-4300
Michael Wachs
(212 )732-4300
Michael Wachs
(212 )732-4300
Michael Wachs
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Dan Schustack
212-732-4300
Michael Wachs
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Daniel Schustack
212-732-4300
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