CHW Researcher Presents Results of ACT-Sponsored Trial Demonstrating Efficacy of ACT Myoblast Therapy for Heart Failure at AHA MeetingORLANDO, Fla.--(BUSINESS WIRE)--Nov 7, 2007 - Advanced Cell Technology, Inc. (OTCBB: ACTC) today announced that a controlled, randomized clinical trial led by Catholic Healthcare West's Dr. Nabil Dib, M.D., M.Sc., F.A.C.C., using ACT's myoblast therapy demonstrated marked improvement in heart failure symptoms after both six and twelve months. The trial also showed evidence that the hearts of the patients that received the therapy showed less cardiac remodeling (an increase in the size of the heart that signifies worsening of function) than did control patients. Dr. Dib presented the results of the trial today in a Late Breaking Clinical Trial Session at the American Heart Association's annual meeting in Orlando, Florida.
The Phase 1 trial marks the first time in the United States that scientists performed a controlled, randomized clinical trial using catheter-delivered muscle stem cells to treat congestive heart failure, a condition marked by progressive weakening of the heart and failure of the heart to pump blood properly. Patients with congestive heart failure often have scar tissue in the heart, which limits the heart's ability to pump blood and contributes to continued atrophy of the heart. Standard multi-drug therapy and surgery can help slow but not stop the decline in heart function. Using these existing therapies, ultimately patients have no treatment options besides heart transplant or being outfitted with a mechanical pump to assist the heart. The data presented today suggests that by using the ACT technology doctors now have the opportunity to successfully replace scarred heart tissue with healthy muscle via intracardiac injections of autologous skeletal myoblasts (ASMs).
The clinical trial enrolled 23 patients with poor cardiac output and congestive heart failure. The control group consisted of 11 patients on standard drug therapy while the experimental group was given varying doses of 30, 100, 300, or 600 million ASMs. Using a catheter and transplanting ASMs into scarred tissue, the trial suggests that new living muscle may be forming in the hearts of patients in the study. The transplanted stem cells, harvested from the patients' own muscles, are compatible with the body and avoid possible tissue rejection that often accompanies organ transplantation. The procedure uses a minimally invasive catheter approach, which reduces the risk of surgical complications as no anesthesia is required and only a small incision is necessary for catheter access. Patients can be discharged within 24 hours of the procedure.
"In this study, we learned that there is hope for using the body's own reparative cells to help the failing heart," said Dr. Dib, Director, Clinical Cardiovascular Cell Therapy, University of California, San Diego and Director of Cardiovascular Research at CHW's Chandler Regional Medical Center and Mercy Gilbert Medical Center, Phoenix, AZ. "We need to continue research in this area to determine if this kind of procedure is effective in treating a larger, more diverse group of patients."
"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."
Advanced Cell Technology and Catholic Healthcare West today announced that the two parties have entered into a letter of intent (LOI) 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 aforementioned ACT Phase II myoblast cellular transplantation clinical study.
The Phase II human clinical trial is planned and will utilize 3-Dimensional Guided Catheter-Based Delivery of Autologous Skeletal Myoblasts for Ishemic Cardiomyopathy (CAuSMIC). The trial, which will be open for enrollment in the next few months, will be led by principal investigator Dr. Dib and will target patients who are not eligible for angioplasty or coronary artery bypass surgery and who continue to have poor quality of life despite receiving optimal medial therapy or cardiac resynchronization therapy with a pacemaker or defibrillator device.
"We are encouraged by the data Dr. Dib presented from the results of our myoblast trial," noted William M. Caldwell, IV, Chairman and CEO of Advanced Cell Technology, Inc. "The newly established relationship with CHW represents another step in our process of initiating a Phase II human clinical trial for our myoblast therapy. We look forward to working with such a prominent hospital group."
About 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.
About Catholic Healthcare West
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, Warner Outpatient Surgery and the Arizona Orthopedic Surgical Hospital. For more information, please visit our Website at www.chwHEALTH.org.
About Chandler Regional Medical Center
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.
About Mercy Gilbert Medical Center
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 92 beds. Expansion of the second tower is underway and will open in January 2008 adding 90 beds and a pediatric and adolescent unit. 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.
About the American Heart Association
Founded in 1924, the American Heart Association today is the nation's oldest and largest voluntary health organization dedicated to reducing disability and death from diseases of the heart and stroke. These diseases, America's No. 1 and No. 3 killers, and all other cardiovascular diseases claim over 870,000 lives a year. In fiscal year 2005-06 the association invested over $543 million in research, professional and public education, advocacy and community service programs to help all Americans live longer, healthier lives. For more information, please visit www.americanheart.org.
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 June 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
Chad Griffin Consulting, Inc.
Jordan Markwith, 310-888-3523
Andrew Hellman, 212-732-4300
Catholic Healthcare West
Danielle LeBlanc, 480-728-5673 office
Paul Szablowski, 480-728-3568 office
Posted: November 2007