Tuesday August 19, 3:09 pm ET
WORCESTER, Mass.—(BUSINESS WIRE)—Advanced Cell Technology, Inc. (“ACT”) (OTC: ACTC.PK) reported that it is feasible to differentiate and mature human embryonic stem cells (hESCs) into functional oxygen-carrying red blood cells (RBCs) under conditions suitable for scale-up. The research, which appears online (pre-published ahead of print) in the journal Blood –the leading publication in the field—by ACTC and its collaborators at the Mayo Clinic and the University of Illinois, shows for the first time that the oxygen-carrying capacity of hESC-derived blood cells is comparable to normal transfusable RBCs, and that the cells respond to biochemical changes in a physiologically effective manner.
“Limitations in the supply of blood can have potentially life-threatening consequences for patients with massive blood loss,” said Robert Lanza, M.D., Chief Scientific Officer at ACT, and senior author of the study. “Embryonic stem cells represent a new source of cells that can be propagated and expanded indefinitely, providing a potentially inexhaustible source of red blood cells for human therapy. We can currently generate 10 to 100 billion red blood cells from a single six-well plate of stem cells. The identification of a stem cell line with “O -“ blood-type would permit the production of compatible “universal donor” blood. We also have work underway to generate reprogrammed (iPS) stem cells from individuals with universal-donor blood.”
The efficient and controlled differentiation of hESCs into homogeneous RBC populations has not been previously achieved. This paper describes for the first time the generation of RBCs from hESCs with oxygen-transporting capacity, and that the functional properties of these cells are similar to those of normal erythrocytes. Multiple stem cell lines were stimulated to undergo differentiation in vitro to form functional RBCs (blood types A, B, O, and both RhD+ and RhD-) on a large scale under conditions suitable for scale-up and clinical translation. Although alternative sources of progenitors for the generation of large-scale transfusable RBCs have been investigated, including cord blood, bone marrow and peripheral blood, it is clear that even after expansion and differentiation, these sources represent donor-limited sources of RBCs. Moreover, the low prevalence of O(-) type blood in the general population further intensifies the consequences of blood shortages for emergency situations and battlefield trauma care, where the need for blood typing can imposes serious delays in initiating transfusions
Another critical issue for clinical utilization of hESC-derived RBCs is whether they can be enucleated in vitro. “We show that up to 65% of the blood cells underwent multiple maturation events that resulted in the extrusion of the nucleus,” stated Shi-Jiang Lu, Ph.D., Director of Differentiation at ACT and first author of the paper. “They formed enucleated erythrocytes with a diameter of 6-8 μm, which is similar to normal red blood cells. We also showed that the cells could express adult β-globin and respond normally to biochemical changes.”
“We believe this breakthrough could potentially benefit many Americans,” stated William M. Caldwell, CEO and Chairman of ACTC. “Although more work is required before this can move into the clinic, we are pleased with the rapid progress that is being made by our scientists and others. We are optimistic about the potential future role for stem cells as a donorless source of blood for transfusion”
The researchers of the paper from Advanced Cell Technology collaborated with scientists from the University of Illinois at Chicago, and the Mayo Clinic, Rochester, Minnesota. The paper’s other authors are Qiang Feng and Jennifer Park of ACT, Loyda Vida, Bao-Shiang Lee, and George Honig at the University of Florida, and Michael Strausbauch and Peter Wettstein at the Mayo Clinic.
Link to article (Open Access): Click to Open
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging 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.
CEOcast, Inc. for Advanced Cell Technology
Daniel Schustack, 212-732-4300
ALAMEDA, Calif.—(BUSINESS WIRE)—Advanced Cell Technology, Inc. (OTCBB: ACTC – News)announced today that Jonathan H. Dinsmore Ph.D., Senior Vice President – Regulatory and Clinical, has been invited to present to the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research Advisory Committee on Cellular, Tissue and Gene Therapies. Dr. Dinsmore will deliver a presentation today titled, “Safety Considerations for the Clinical Application of Human Embryonic Stem Cells” to the FDA panel, which will convene at the Hilton Hotel in Gaithersburg, Maryland. The presentation is scheduled for 10 a.m. eastern time. The panel is expected to conduct hearings on Cellular Therapies Derived from Human Embryonic Stem Cells Scientific Considerations for Pre-Clinical Safety Testing. Other companies invited to present include Geron Corporation (NASDAQ: GERN – News) and Novocell, Inc.
During Dr. Dinsmore’s presentation, he is expected to discuss cell sourcing, manufacturing and delivery of human embryonic stem cells. He will also present certain conclusions from pre-clinical activities surrounding the company’s retinal pigmented epithelial (RPE) cell therapy. Advanced Cell recently completed discussions with the FDA regarding this program through a type B, pre-Investigational New Drug (pre-IND) meeting concerning the regulatory pathway and requirements to file an IND to initiate human clinical trials. The entire presentation will be available on the company’s web site by clicking here after 11 a.m. eastern time today.
“We are honored that the FDA has invited us to participate in this panel, which could be influential in shaping the clinical pathway for the testing of embryonic stem cells,” said William M. Caldwell IV, Chairman and CEO of Advanced Cell Technology, Inc. “As one of the few stem cell companies that is preparing for later-stage clinical trials, we are pleased that we will be able to share our views with FDA executives and other distinguished members of the scientific community on the safety issues surrounding human embryonic stem cell development.”
Additional details on the FDA meeting may be found by clicking here to the FDA website.
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.
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.
CEOcast, Inc. for Advanced Cell Technology
Daniel Schustack, 212-732-4300
ALAMEDA, Calif.—(BUSINESS WIRE)—Advanced Cell Technology, Inc. (OTCBB: ACTC – News) reported today on a large-scale differentiation process that has generated panels of differentiating human progenitor cell lines from human embryonic stem cells (hESCs). The research will be published in the April issue of Regenerative Medicine (Vol. 33 e-pub ahead of print) and will be freely available by clicking here.
Since the first isolation of hESCs, scientists and industry alike have been working to harness the power of these cells for the purpose of restoring and regenerating body systems that have been damaged by disease or injury.
One of the hurdles has been a commercially viable means for the expansion of sufficient numbers of the cell types needed for tissue regeneration. With the publication of work entitled “The ACTCellerate Initiative: large-scale combinatorial cloning of novel human embryonic stem cell derivatives,” ACT scientists have solved some of these problems. The paper describes a system that was established to isolate and clonally expand tissue specific precursors that heretofore could only be isolated from aborted human fetal tissue.
Dr Chris Mason (UCL), Associate Editor of Regenerative Medicine said, “This is an enormously exciting development for the regen sector. The research reported… represents a quantum leap forward in embryonics, the mapping and characterization of the cells of early human development. Without any doubt, the ACTCellerate technology will greatly hasten the translation of human embryonic stem cell-based therapies into safe and effective products for routine clinical practice.”
The benefits of the ACTCellerate technology transcend therapeutics and extend as well into revolutionary applications for drug discovery, drug toxicity testing, and cancer research. This advance holds great promise for future research and may one day lead to many new cell-based therapies in the emerging field of regenerative medicine.
Another important finding in this publication is that these normal embryonic progenitor cell types show the expression of certain genes (such as oncofetal markers) often associated in the literature with malignant cancer. However, when these progenitor cells were injected into supportive mice, no malignant tumors could be observed. This indicates that expression of such genes is a function of these cells’ normal primitive stage of differentiation and not linked to any disease potential.
William M. Caldwell IV, Chairman and CEO of Advanced Cell Technology, Inc., stated, “We are greatly indebted to Mike West for his insight in initiating this program during his tenure with ACT and to the entire ACT scientific team for their perseverance in bringing this groundbreaking research to the conclusions described in this publication. ACT has taken great strides in identifying both clinical applications for this approach as well as for the ACTCellerate cell line library for drug target discovery, assay development, and direct therapeutics development across a wide spectrum of clinical indications. We are now in a position to offer our refined technology and know-how to potential partners and licensees.”
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.
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.
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Chad Griffin Consulting, Inc.
Jordan Markwith, 310-888-3523
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CEOcast, Inc.
Daniel Schustack, 212-732-4300
LOS ANGELES—(BUSINESS WIRE)—Advanced Cell Technology, Inc. (OTCBB: ACTC – News) announced today that an ABC Television’s special report titled, “Live to 150, Can You Do It? Secrets to Living Longer,” which aired last night and was hosted by Barbara Walters, highlighted the role that the company’s blastomere program for creating human embryonic stem cell (hESC) lines without impacting the developmental potential of embryos could play in extending life and slowing down the aging process. The special also highlighted Advanced Cell Technology’s research into developing a universal O negative red blood cell bank using human embryonic stem cell science. The report, which included an interview with Dr. Robert Lanza, MD, Chief Scientific Officer at Advanced Cell Technology, featured the company’s research platforms and included a discussion of the role that the company’s stem cell science could play in treating various diseases.
The show profiled the lives of several people who are currently 100 years old or older and described some of the most promising scientific developments that could extend life. Advanced Cell Technology’s technology platform was included among the scientific breakthroughs.
In August 2006, Advanced Cell Technology reported in the journal Nature that company scientists had successfully generated hESCs using its blastomere technology, an approach that does not destroy the developmental potential of embryos. The blastomere technology has been reproduced and peer-reviewed on several occasions. In June 2007, ACT announced at the fifth annual meeting of the International Society for Stem Cell Research in Cairns, Australia, that it had reproduced its work by successfully producing an hESC line without destroying an embryo at its lab in Worcester, Massachusetts. In January 2008, ACT together with colleagues announced the development of five hESC lines without the destruction of embryos. The method was published in the journal Cell Stem Cells, published by Cell Press. The peer-reviewed technique was initially carried out by ACT scientists under the direction of Dr. Lanza and then independently replicated by scientists on the West Coast. In addition, the NIH announced in 2007 that it would begin implementing President George W. Bush’s Executive Order to explore methods to expand the number of approved pluripotent stem cell lines “without creating a human embryo for research purposes or destroying, discarding, or subjecting to harm a human embryo or fetus.” ACT’s blastomere program was cited by the NIH as an alternative method in its implementation plan; therefore, should the company’s blastomere technique satisfy NIH qualifications, ACT could qualify for federal funding from the NIH.
In addition to its blastomere research platform, Advanced Cell Technology has made progress on the therapeutic front. ACT published positive data in the journal NATURE Methods for its HG (hemangioblast) cell program for the treatment of blood and cardiovascular diseases. The company published positive data from animal studies for its RPE (retinal pigment epithelial) cell program for the treatment of retinal degenerative disorders completed in collaboration with the Casey Eye Institute at Oregon Health and Science University. The company also has GLP Safety Studies in process for its RPE Program. Finally, ACT’s Myoblast program, an autologous adult stem cell therapy for the treatment of heart disease, has successfully completed four Phase I clinical trials and has clearance from the FDA to begin Phase II trials shortly.
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.
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.
Media:
Chad Griffin Consulting, Inc.
Jordan Markwith, 310-888-3523
or
Investors:
CEOcast, Inc.
Daniel Schustack, 212-732-4300
LOS ANGELES—(BUSINESS WIRE)—Advanced Cell Technology, Inc. (OTCBB: ACTC – News) announced today that the company will be featured on ABC Television’s special report titled, “Live to 150, Can You Do It? Secrets to Living Longer,” hosted by Barbara Walters. The report is scheduled to air tonight on ABC Television throughout the country at 10 PM eastern time. The report will include an interview with Dr. Robert Lanza, MD, Chief Scientific Officer at Advanced Cell Technology. During the interview, Dr. Lanza and Ms. Walters will discuss a number of Advanced Cell Technology’s research platforms including its blastomere program for creating human embryonic stem cell (hESC) lines without impacting the developmental potential of embryos as well as the company’s research into developing a universal O negative red blood cell bank using human embryonic stem cell science.
Additional details on the show can be found by clicking here
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.
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.
Media:
Chad Griffin Consulting, Inc.
Jordan Markwith, 310-888-3523
or
Investors:
CEOcast, Inc.
Daniel Schustack, 212-732-4300
LOS ANGELES, Calif. (March 12, 2008) – Advanced Cell Technology, Inc. (OTCBB: ACTC – News) announced today that it has signed a clinical trial agreement with Chandler Regional Medical Center and Mercy Gilbert Medical Center, members of Catholic Healthcare West (CHW), the nation’s eighth largest healthcare system, to become ACT’s first clinical trial sites for the Phase II myoblast study. In addition, CHW has received Institutional Review Board approval for the clinical trial, which is expected to begin soon. ACT’s myoblast program is an autologous adult stem cell therapy for the treatment of heart disease that has successfully completed four Phase I clinical trials and received clearance from the Food and Drug Administration to begin Phase II trials.
In November 2007, ACT and CHW announced that the two parties had entered into a letter of intent for a proposed exclusive business arrangement to establish a clinical trial research site and a North American regenerative medicine interventional cardiology training center for the Phase II clinical trial. The study, which will utilize 3-Dimensional Guided Catheter-Based Delivery of Autologous Skeletal Myoblasts for Ishemic Cardiomyopathy (CAuSMIC), will soon be open for enrollment. Led by principal investigator Nabil Dib, M.D., M.Sc., F.A.C.C., director of Cardiovascular Research for Chandler Regional Medical Center and Mercy Gilbert Medical Center, enrollment in the CAuSMIC trial will focus on patients who are not eligible for angioplasty or coronary artery bypass surgery, and who continue to have poor quality of life despite receiving optimal medical therapy or cardiac resynchronization therapy with a pacemaker or defibrillator device.
“The agreement with CHW signifies our readiness to begin the Phase II clinical trial,” said William M. Caldwell, IV, chairman and CEO of ACT. “We are excited to begin the trial, which has the potential to be a major advance for the field of regenerative medicine and, more importantly, to patients in need of care. We look forward to working with such a prominent healthcare group.”
“Currently, there are no treatment options available to correct heart failure, only those that can slow its progression,” said David G. Covert, president and CEO of the CHW East Valley Service Area and Chandler Regional Medical Center. According to Covert, Dr. Dib’s findings are the culmination of seven years of prior clinical work to demonstrate the safety and utility of taking a patient’s own muscle stem cells to repair heart muscle damage. “Chandler Regional Medical Center and Mercy Gilbert Medical Center are proud to participate in developing this innovative treatment option for people living with heart failure. As we continue to develop our research program, our main focus is to translate this type of research into bedside standard of care.”
Catholic Healthcare West (CHW) is the eighth largest hospital system in the nation and one of the largest not-for-profit hospital providers in the West. Founded in 1986, the CHW network of more than 8,500 physicians and approximately 50,000 employees serve a population spanning 22 million people at 43 hospitals across California, Arizona, and Nevada. CHW is committed to delivering compassionate, high-quality, affordable healthcare services with special attention to the poor and underserved. In fiscal year 2007, CHW provided $922 million in charity care, community benefits, and unreimbursed patient care. CHW facilities in Arizona include Chandler Regional Medical Center, Mercy Gilbert Medical Center, St. Joseph’s Hospital and Medical Center and Barrow Neurological Institute, CHW Urgent Cares in Ahwatukee, Gilbert and Queen Creek, Sun Lakes Laboratory, Warner Outpatient Surgery and the Arizona Orthopedic Surgical Hospital. For more information, please visit our Website at www.chwHEALTH.org.
Chandler Regional Medical Center is a 225-bed, acute-care, non-for-profit provider of emergency care, maternal child services, cardiovascular services, wound healing, cancer treatment, diabetes treatment, and diagnostic services. It is located at 475 S. Dobson Road (corner of Dobson Road and Frye Road) in Chandler. For more information, please visit www.chandlerregional.org or call (480) 728-3000. Chandler Regional Medical Center is an Equal Opportunity Employer (EOE). For employment opportunities please contact the Human Resources Department at (480) 728-3424.
Mercy Gilbert Medical Center is located at the intersection of Val Vista Drive and Loop 202 (south of Pecos Road and east of Val Vista Drive). Mercy Gilbert Medical Center is a four-story, full-service acute-care facility with 182 beds. For more information, please visit www.mercygilbert.org or call (480) 728-8000. Mercy Gilbert Medical Center is an Equal Opportunity Employer (EOE). For employment opportunities please contact the Human Resources Department at (480) 728-8396.
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.
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.
Media:
Jordan Markwith
Chad Griffin Consulting, Inc.
(310) 888-3523
Investors:
Daniel Schustack
CEOcast, Inc.
(212) 732-4300
Los Angeles, CA, March 5, 2008 – Advanced Cell Technology, Inc. (OTCBB: ACTC – News) announced today that it has reached a supply agreement with Biologics Delivery Systems Group, Cordis Corporation (a Johnson & Johnson company), in which Biologics Delivery Systems will supply catheters for the Phase II human clinical trial of ACT’s myoblast therapy for the treatment of heart failure. Advanced Cell Technology’s myoblast therapy successfully completed Phase I human clinical trials in 2007 utilizing the therapy safely in more than forty patients. Safety of the therapy was demonstrated in four independent studies. The U.S. Food and Drug Administration has given the company clearance to proceed with Phase II human clinical trials. The company expects its Phase II human clinical trial (CAuSMIC II) to begin shortly.
ACT’s myoblast therapy involves the transplantation of expanded autologous myoblasts (adult progenitor stem cells) derived from a small biopsy of skeletal muscle from a patient’s leg. The technology allows for the expansion of myoblasts into hundreds of millions of cells over a period of two to three weeks. The resulting myoblasts are then transplanted back into the patient’s scarred heart tissue through the use of a catheter-based procedure. Over one million new patients with heart attacks are treated annually in the United States alone, representing a multi-billion dollar market opportunity. Current therapies do not result in rebuilding of heart muscle and do not prevent progression of congestive heart failure, poor quality of life, and long-term deterioration. According to the National Heart, Lung, and Blood Institute, a division of the National Institutes of Health, approximately 5 million people in the United States have congestive heart failure and an estimated 400,000 new cases are diagnosed each year. Roughly 50% of CHF patients die within 5 years.
The Phase II human clinical trial will be a multi-center study following a similar protocol to the one used in the company’s Phase I study. That study demonstrated safety and evidence of significant heart function improvement in congestive heart failure patients as a result of the implantation of the ACT’s proprietary autologous skeletal myoblasts using the Biologics Delivery Systems NOGA® Cardiac Navigation System and MyoStar® Injection Catheter. “The NOGA® System created highly precise, three-dimensional images of the heart. These images gave us a clear ‘map’ that helped us to successfully deliver the adult stem cells where we intended them to go,” commented Dr. Nabil Dib, the lead investigator for the myoblast phase I study. “This imaging technology was critical to making this study possible.” The Phase II human clinical trial will use the latest generation catheters provided as a result of ACT’s ongoing relationship with the Biologics Delivery Systems.
“The supply commitment for NOGA mapping and Myostar injection catheters from Biologics Delivery Systems Group represents another step toward commercializing our myoblast therapy and bringing novel treatment to patients with few effective alternatives,” commented William M. Caldwell IV, Chairman and CEO of Advanced Cell Technology. “We are excited to commence our Phase II human clinical trials soon.”
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.
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. _
Media:
Jordan Markwith
Chad Griffin Consulting, Inc.
(310) 888-3523
Investors:
Daniel Schustack
CEOcast, Inc.
(212) 732-4300
LOS ANGELES—(BUSINESS WIRE)—Advanced Cell Technology, Inc.(OTCBB: ACTC – News) announced today that it has entered into an agreement with Pharming Group N.V. giving Pharming an exclusive, global license to non-human use of certain patents associated with but not limited to oocyte activation patents held by Advanced Cell Technology. According to the terms of the license agreement, Pharming will pay Advanced Cell Technology a one-time license fee. Prior, Pharming had a nonexclusive license to these patents. Based in the Netherlands, Pharming Group N.V. is focused on developing treatments for genetic and aging diseases, specialty products for surgical indications, and intermediates for various applications and nutritional products.
Advanced Cell Technology has been focused on building a broad intellectual property portfolio since its inception. In early 2007, the company strengthened its IP portfolio by acquiring the intellectual property assets of its former competitor Infigen, Inc. relating to somatic cell nuclear transfer, parthenogenesis, and other related technologies. Upon the closing of its Mytogen, Inc. acquisition later that year, ACT absorbed Mytogen’s patent portfolio as well. Advanced Cell Technology now owns or has exclusive licenses to over 380 patents and patent applications worldwide in the field of regenerative medicine and stem cell therapy. In addition, ACT has non-exclusive rights to a portfolio of patents and patent applications that support its core intellectual property.
“We are pleased to be able to monetize our intellectual property portfolio in a number of ways,” stated William M. Caldwell IV, Chairman and CEO of Advanced Cell Technology. “Our intellectual property and the research and science that our employees perform remain the foundation of our company. Using this foundation as a basis for developing commercial therapeutics and entering into licensing agreements allows us to finance the company in profitable and nondilutive manners. We plan on continuing to leverage our IP portfolio.”
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.
For more information, visit 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.
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Chad Griffin Consulting, Inc.
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Source: Advanced Cell Technology, Inc.
Worcester, MA, February 21, 2008 – Advanced Cell Technology, Inc.(OTCBB: ACTC – News) reported today for the first time a robust and highly efficient process for the generation of high-purity hepatocytes (liver cells). The research, described online (ahead of print) in the journal STEM CELLS, signifies a significant step towards the efficient generation of hepatocytes for use in regenerative medicine and drug discovery. (Click Here to link to the Paper) Moreover, the research represents another one of Advanced Cell Technology’s efforts aimed at the large-scale differentiation of human embryonic stem cells (hESCs) into critical replacement cell types. In addition to demonstrating the efficient generation of hepatocytes in research published today, the company has made significant progress in the generation of retinal pigmented epithelial (RPE) cells to treat retinal degenerative diseases and the generation of hemangioblasts to treat vascular disease as well as to create a large-scale and donorless source of red blood cells and platelets.
Two hallmarks of embryonic stem cells, their versatility and capacity for unlimited self renewal, suggest the cells could serve as a potentially inexhaustible source of cells for replacement therapy. As with other tissues, there is a scarcity of donor livers and hepatocytes, which is compounded by the low recovery and proliferative capacity of adult hepatocytes. In addition to the cells’ potential use for the treatment of liver disease, hESC-derived hepatocytes could also provide a valuable model for novel pharmaceutical drug discovery assays as well as new drug metabolism and cytotoxicity screens, particularly because the liver is a major site for detoxification.
“We have established a highly-efficient method for deriving hepatocytes from stem cells that mirrors events in embryonic development,” said Robert Lanza, M.D., Chief Scientific Officer at Advanced Cell Technology, Inc. and senior author of the study. “Large scale production of hepatocytes using this method should greatly bolster their applications in basic research, clinical medicine and preclinical drug discovery.”
The method reported yielded synchronous populations of hepatocytes that were generated in clinically preferred conditions with minimum use of serum and cell feeders. Highly enriched populations of definitive endoderm (DE) were generated from hESCs and then induced to differentiate along the hepatic lineage by the sequential addition of inducing factors implicated in physiological hepatogenesis. The differentiation process was largely uniform with cell cultures progressively expressing increasing numbers of hepatic lineage markers. The hepatocytes exhibited functional hepatic characteristics such as glycogen storage, indocyanine green uptake and release, and albumin secretion. In an animal model of acute liver injury, the hESC-DE cells differentiated into hepatocytes and successfully repopulated the damaged liver.
“I am delighted with the tremendous progress our scientists are making to generate a variety of important functional cells types and refine our cell differentiation process,” stated William M. Caldwell IV, CEO and Chairman of Advanced Cell Technology. “These cells have the potential to benefit many Americans suffering from serious and potentially life-threatening diseases with few if any alternatives. We are committed to developing new methods to help translate our stem cell technology into the clinic and are seeking partners for some of our newest scientific advances.”
Other authors on the paper were Dr. Sadhana Agarwal (first author of the study) and Katherine Holton, a senior research associate at Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.
For more information, visit 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.
Media
Jordan Markwith
Chad Griffin Consulting, Inc.
(310) 888-3523
Investors
Daniel Schustack
CEOcast, Inc.
(212) 732-4300
LOS ANGELES—(BUSINESS WIRE)—Advanced Cell Technology, Inc. (OTCBB: ACTC – News) announced today that principal investigator Dr. Nabil Dib, M.D., M.Sc., FACC, presented results from a 23-patient study of ACT’s myoblast therapy for the treatment of congestive heart failure (CHF) over the weekend at the International Society for Cardiovascular Translational Research (ISCTR) World Symposium in San Diego, CA. Dr. Dib presented the results as a case study of the successful translation of a therapy from scientific research to the bedside. The results of the study demonstrate long term cell survival in heart failure patients as well as strong quality of life improvements as measured by the New York Heart Association third party questionnaire, the Minnesota Living with Heart Failure Questionnaire, and the 6 minute walk results (compared to continued deterioration by the control group). Moreover, ACT’s myoblast trial has been the only cell-based, FDA-approved human clinical trial that has not required the administration of anti-arrhythmic drugs or assist devices, which is in contrast to trials for bone marrow-derived and other adult stem cell therapies.
ISCTR is an annual meeting for basic and clinical scientist practicing cardiovascular disease research sponsored by the University California, San Diego, Catholic Healthcare West and the International Society for Cardiovascular Translational Research. Dr. Dib is Director, Clinical Cardiovascular Cell Therapy, University of California, San Diego, and Director of Cardiovascular Research of Catholic Health Care West’s Chandler Regional Hospital and Mercy Gilbert Medical Center near, Phoenix, Arizona.
Dr. Dib enrolled 23 patients at Arizona Heart Institute with poor heart function and congestive heart failure. The control group consisted of 11 patients on standard drug therapy while the treatment group was given varying doses of 30, 100, 300, or 600 million autologous skeletal myoblast (ASM) cells. After one year, the myoblast therapy showed a favorable safety profile as compared to the control group. Likewise, secondary measures showed improvements in quality of life measures, improvements in measures of tissue regrowth and potential improvement in heart function, while the control group showed signs of heart failure progression on the same measures. The data from the study support conducting larger double-blind, placebo controlled studies. A Phase II human clinical trial has been reviewed and cleared to commence by the FDA. The planned Phase II trial will be conducted at multiple clinical centers across the country including in Arizona and California.
Patients with CHF due to myocardial infarction (damage in heart muscle) often have scar tissue in the heart, which limits the heart’s ability to pump blood. In spite of optimal medical therapy and other current heart failure treatments, in the United States alone 2 million patients per year are admitted to the hospital for CHF and almost one-half million die annually. Doctors may now have the opportunity to successfully replace scarred heart tissue with healthy muscle via intracardiac injections of ASM stem cells from the skeletal muscle.
“In this study, we learned that ASM cell transplantation using a minimally invasive catheter system is safe, showed improvement in measures of quality of life, and may have the potential to improve cardiac function and electrical activity,” said Dr. Dib. By using a catheter and transplanting ASM cells into scarred tissue, new living muscle can potentially be formed with limited risk to the patient. Since the transplanted stem cells are harvested from the patient’s own skeletal muscles, the cells are compatible with the body, avoiding possible immune system and tissue compatibility complications. The procedure poses less risk than surgical procedures because no anesthesia is required and only a small incision is necessary for catheter access. Patients can be discharged within 24 hours of the procedure.
“We are honored that the ISCTR chose our myoblast therapy as the centerpiece for discussing how best to translate research from the bench to the bedside,” stated William M. Caldwell, IV, Chairman and CEO of Advanced Cell Technology, Inc. “We remain encouraged by the data Dr. Dib presented and believe the positive 12-month data represent another step in our process of initiating a Phase II human clinical trial for our myoblast therapy. We look forward to moving the myoblast and other stem cell therapies through the clinic and ultimately to patients in need of treatment.” In addition to nearing the commencement of Phase II human clinical trials for the myoblast therapy, ACT recently completed a pre-IND meeting with the FDA for its RPE program for the treatment of retinal degenerative disease. Should ACT successfully file an IND for its RPE therapy, the company plans to move forward with Phase I human clinical trials, which would position ACT with two therapies in human clinical trials as well as a third, the hemangioblast program for the treatment of blood and cardiovascular indications, in preclinical trials.
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.
For more information, visit 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.
Chad Griffin Consulting, Inc.
Media:
Jordan Markwith, 310-888-3523
or
Investors:
CEOcast, Inc.
Daniel Schustack, 212-732-4300
Daniel Schustack
212-732-4300
Daniel Schustack
212-732-4300
Jordan Markwith
310-888-3523
Jordan Markwith
310-888-3523
Jordan Markwith
310-888-3523
Jordan Markwith
310-888-3523
Jordan Markwith
310-888-3523
Jordan Markwith
310-888-3523
Jordan Markwith
310-888-3523
Jordan Markwith
310-888-3523