WORCESTER—Advanced Cell Technology, Inc. (OTCBB: ACTC – News), a biotechnology company applying cellular technology in the field of regenerative medicine, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the company’s MA09-hRPE cells for use in the treatment of Stargardt’s Macular Dystrophy (SMD). As a result, the company is eligible to receive a number of benefits, including tax credits, access to grant funding for clinical trials, accelerated FDA approval and allowance for marketing exclusivity after drug approval for a period of as long as seven years.
“We are pleased that the FDA has, for the first time, granted orphan drug status for the use of an embryonic stem cell derived therapy in treating an unmet medical need,” said Edmund Mickunas, Vice President Regulatory. “We believe that our terminally differentiated RPE cells represent a promising treatment for patients with SMD and expect to be in a position to accelerate clinical development and hopefully make RPE cellular therapy available to the majority of patients sooner.”
US orphan drug designation is granted to companies with products aimed at treatment of a rare disease or condition that affects fewer than 200,000 Americans. The National Institutes of Health (NIH) recently proposed broadening the definition of a human embryonic stem cell to include ACT’s “single blastomere technology platform” which was used to derive ACT’s MA09-hRPE cells. The Company believes that the SMD program should be eligible for federal funding once the change is published in the Federal Register.
Degenerative diseases of the retina are among the most common causes of untreatable blindness in the world, and as many as ten million people in the United States have photoreceptor degenerative disease. While most of these patients have Age-Related Macular Degeneration (AMD), a smaller number have Stargardt’s, an Orphan disease and to date an untreatable form of juvenile macular degeneration leading to blindness in a much younger group of patients than are affected by AMD. ACT’s treatment for eye disease uses stem cells to re-create a type of cell in the retina that supports the photoreceptors needed for vision. These cells, called retinal pigment epithelium (RPE), are often the first to die off in SMD and AMD, which in turn leads to loss of vision.
While there is currently no treatment for SMD, several years ago ACT and its collaborators discovered that human embryonic stem cells could be a source of RPE cells. Subsequent studies found that the cells could restore vision in animal models of macular degeneration. In a Royal College of Surgeons (RCS) rat model, implantation of RPE cells resulted in 100% improvement in visual performance over untreated controls, without any adverse effects. The cells survived for more than 220 days and sustained extensive photoreceptor rescue. Functional rescue was also achieved in the ‘Stargardt’s’ mouse with near-normal functional measurements recorded at more than 70 days.
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, 2009. 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 or “ACT” (OTCBB: ACTC – News announced today that its research involving therapeutic cell types obtained from induced pluripotent stem (iPS) cells has been featured in several leading news media outlets: Scientific American, USA Today and Newsweek. The coverage highlights a recent paper in the journal Stem Cells co-authored by ACT lead by its Chief Scientific Officer, Dr. Robert Lanza MD, and its collaborators. The paper reports that iPS cells exhibit abnormal expansion and early cellular aging, raising important questions about the future prospects for iPS cell-based therapies and supporting the use of ACT’s embryo-safe single blastomere-derived human embryonic stem cell lines, which do not exhibit these problems.
The Scientific American article, “Cell-Off: Induced Pluripotent Stem Cells Fall Short of Potential Found in Embryonic Version” includes the following passage: “The act of reprogramming cells to make them as capable as ones from embryos apparently can result in aberrant cells that age and die abnormally, suggesting there is a long way to go to prove such cells are really like embryonic stem cells and can find use in therapies.” The story is available here.
The USA Today article is headlined, “Stem Cell Articles Show Early Aging Abnormalities.” In the story, Maria Blasco, of the Spanish National Cancer Center of Madrid, who was not part of the study, is quoted as saying, “the authors [of the article] show that induced stem cells are not of the same ‘quality’ as embryonic stem cells, and that induced-derived cell types tend to age and die earlier than those derived from embryonic stem cells.” It is available here.
The Newsweek story, “Still No Truce in the Stem Cell Wars,” discusses the “bad news” heralded by ACT’s study for theoretical uses for iPS cells with stem cells produced by adults. ACT’s technology platform uses embryonic stem cells. The article is available here.
“This study, published in Stem Cells, highlights the challenges often faced in attempting to translate promising science into clinical results,” said William M. Caldwell, IV, Chairman and CEO of Advanced Cell. “We are currently working on a solution to the problems raised by this research, and hope to be able to provide details shortly. We believe this study further validates the need to commercialize our blastomere technology, which is still on schedule to begin clinical trials in humans during the 2010 third quarter.”
ACT’s collaborators on the study published in Stem Cells were McLean Hospital/Harvard Medical School, the University of Illinois at Chicago, and Stem Cell & Regenerative Medicine International (SCRMI), a joint venture between ACT and Korean biotech firm CHA.
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visithttp://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 endedSeptember 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, MA –February 11, 2010 (PR Newswire). Advanced Cell Technology, Inc. or “ACT” (OTCBB: ACTC – News reported that a range of therapeutic cell types obtained from induced pluripotent stem (iPS) cells exhibit abnormal expansion and early cellular aging. The research, which appears online (published- ahead-of- print) in the journal STEM CELLS by ACT and its collaborators at Stem International (SCRMI), Harvard Medical School, and the University of Illinois, compares a variety of replacement cell types derived from human iPS cells with their embryonic stem (ES) cell counterparts. The findings support the use of ACT’s single blastomere-derived human embryonic stem cell lines which do not display early aging.
(Download the Paper by clicking here.)
The research shows that human iPS cells can generate blood, vascular and retinal cells with characteristics similar to those derived from ES cells, but with a dramatic decreased efficiency. However, in distinct contrast to the ES cell derivatives, major differences were observed in cells derived from iPS cells, including significantly increased cell death (apoptosis), severely limited growth and expansion capability, as well as a substantially decreased capacity to generate blood progenitors. After further differentiation into red blood cells, over a thousand-fold difference in expansion capability was observed in iPS cells versus ES cell progenitors. Although vascular cells derived from iPS cells were capable of forming capillary-like structures, the cells also demonstrated early cell aging (senescence). Similarly, retinal cells derived from iPS cells also displayed early signs of aging.
“Before clinical application, it will be necessary to determine the cause and extent of such abnormalities, and whether they also occur in stem cells generated using different reprogramming methods” said Robert Lanza, M.D., Chief Scientific Officer at ACT, and senior author of the study. “Fortunately, we think the problem may be related to the use of viruses. Preliminary results suggest that these abnormalities are significantly reduced using stem cells generated using proteins (without the use of viruses or genetic manipulation). Although there is excitement that iPS cells can serve as an embryo-free source of stem cells, it would premature to abandon research using embryonic stem cells until we fully understand what’s causing these problems.”
Rapid progress is being made towards controlled differentiation of human iPS cells into specific tissue types, such as heart, liver, and eye including retinal pigment epithelium (RPE). Although these studies clearly suggest a similar differentiation potential between iPS and embryonic stem cells, it is unclear whether they can be expanded into homogeneous cell populations suitable for use in drug discovery and clinical translation.
“A major hallmark of ES-derived cells is the high recovery and proliferative capability of the cells,” stated Shi- Jiang Lu, Ph.D., Senior Director of Stem International and co-senior author of the paper. “We compared the characteristics of cells derived from iPS and ES cells, and found that blood and vascular derivatives from iPS cells display abnormal molecular and/or cellular processes compared to their corresponding ESC counterparts. Similarly, RPE cells derived from iPS cells began senescing in the first passage, indicating the observed phenomenon is not limited to hemangioblastic lineages.”
“This study further supports our single blastomere-derived human embryonic stem cell technology platform, “stated William M. Caldwell, CEO and Chairman of ACTC. “More research is clearly needed before we can advance iPS cell technology into the clinic. However, until this technology is perfected, we believe embryonic stem cells will play an important role in helping patients suffering from a range of debilitating diseases.”
The researchers of the paper from Advanced Cell Technology collaborated with scientists from Stem Cell and Regenerative Medicine International (SCRMI), McLean Hospital/Harvard Medical School, and the University of Illinois at Chicago. The paper’s other authors are Qiang Feng (first author) and Young Chung of SCRMI, Irina Klimanskaya at ACT, Ignatius Gomes and George Honig at the University of Illinois at Chicago, and Kwang-Soo at McLean Hospital/Harvard Medical School.
(Download the Paper by clicking here.)
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.
Please contact: Rita Parker at 508-756-1212×654
WORCESTER, MA –November 19, 2009 (BUSINESS WIRE). Advanced Cell Technology, Inc. (OTCBB: ACTC – News announced today that it filed an Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA) to initiate a Phase I/II multicenter study using embryonic stem cell derived retinal cells to treat patients with Stargardt’s Macular Dystrophy (SMD). Among the most common causes of untreatable blindness in the world are degenerative diseases of the retina. As many as 10 million people in the United States have photoreceptor degenerative disease. While most of these patients have Age-Related Macular Degeneration (AMD), a smaller number of patients have Stargardt’s, an Orphan disease and one of the most common forms of juvenile macular blindness. The treatment for eye disease uses stem cells to re-create a type of cell in the retina that supports the photoreceptors needed for vision. These cells, called retinal pigment epithelium (RPE), are often the first to die off in SMD and AMD, which in turn leads to loss of vision.
While there is currently no treatment for SMD, several years ago ACT and its collaborators found that human embryonic stem cells could be a source of RPE cells. Subsequent studies found that the cells could restore vision in animal models of macular degeneration. In the Royal College of Surgeon (RCS) rat model, implantation of RPE cells resulted in 100% improvement in visual performance over untreated controls without any adverse effects. The cells survived for more than 220 days and sustained extensive photoreceptor rescue. Functional rescue was also achieved in the ‘Stargardt’s’ mouse with near-normal functional measurements recorded at more than 70 days.
“It has been over a decade since human embryonic stem cells were first discovered,” said Dr. Robert Lanza, ACT’s Chief Scientific Officer. “The field desperately needs a big clinical success. After years of research and political debate, we’re finally on the verge of showing the potential clinical value of embryonic stem cell research. Our research clearly shows that stem cell-derived retinal cells can rescue visual function in animals that otherwise would have gone blind. We are hopeful that the cells will be similarly efficacious in patients.”
The Phase I/II trial will be a prospective, open-label study that is designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation to advanced patients with SMD. A total of twelve patients will be enrolled into the study at three clinical sites, including the Casey Eye Institute in Portland, Oregon (headed by Dr. Peter Francis of the Oregon Health & Sciences University); the University of Massachusetts Memorial Medical Center, Worcester, Massachusetts (headed by Dr. Shalesh Kaushal, Chair of the Department of Ophthalmology); and the UMDNJ – New Jersey Medical School, Newark, New Jersey (headed by Dr. Marco Zarbin, Chair, Institute of Ophthalmology and Visual Science). “It is an honor for us to be working with ophthalmology researchers of such high caliber,” said Edmund V. Mickunas, Advanced Cell’s Vice President of Regulatory Affairs. “They have been instrumental as collaborators on the clinical trial design and their input has been invaluable.”
“The filing of this IND places Advanced Cell Technology in position to help lead the industry in validating the stem cell platform.” said William M. Caldwell IV, Advanced Cell’s Chairman and CEO. “Over the past year, we have taken important steps to advance our RPE program while overcoming significant financial challenges. Advanced Cell today is uniquely positioned within the regenerative medicine industry; as it has the technology, a renown scientific and development team and access to capital to become one of the first companies to make the use of an embryonic stem cell derived therapy a reality in treating a major unmet medical need.”
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.
Please contact: Rita Parker at 508-756-1212×654
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
Bill Douglass
(646) 450-3615
Bill Douglass
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Rita Parker
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Rita Parker
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Michael Wachs
(212 )732-4300
Michael Wachs
(212 )732-4300
Michael Wachs
(212 )732-4300
Michael Wachs
(212 )732-4300
Dan Schustack
212-732-4300
Michael Wachs
(212 )732-4300