Advanced Cell Technology Enters Into Letter of Intent to Acquire Mytogen, Inc. and Proceed with the Human Clinical Trials Utilizing Myoblasts for the Treatment of Heart Failure
In regard to the Myoblast Program, Mytogen has completed successful Phase I Human Clinical Trials utilizing the therapy safely in over forty patients. The FDA has reviewed the "end-of-Phase I" data and allowed Mytogen to proceed with a Phase II Human Clinical Trial. Upon the close of the acquisition, Advanced Cell Technology plans to commence the Phase II Human Clinical Trial for the treatment of heart failure in approximately 160 patients. If successful, the Company expects to proceed with a pivotal Phase III Trial for the therapy.
The Myoblast Program may prove particularly beneficial for patients who have experienced a serious heart attack and have a high risk of heart failure. The stem cell therapy involves transplantation of expanded autologous Myoblasts (adult progenitor stem cells) derived from a small biopsy of skeletal muscle from a patient's leg. The Mytogen technology allows 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. While the Phase I Human Clinical Trials were focused on the safety of the therapy, the clinical data from those trials suggests that the Myoblasts persist, often improve function in the heart and can lead to a significant increase in quality of life for the patient.
Advanced Cell Technology is interested in the Myoblast Program because of its potential to treat heart attack and heart failure. This is an area of significant focus for Company because of its Hemangioblast program. The catheter-based procedure of the Myoblast Program is similar to procedures that ACTC anticipates using with its Hemangioblast cell therapy. Advanced Cell Technology believes the combination of the Myoblast Program's target indication of heart failure, the catheter method of administration, and the stage of its human clinical trials, will likely generate significant findings and expertise relevant to the Company's Hemangioblast Program. The Company believes that the "here and now" of the autologuous adult stem cell therapy enables the treatment of patients today and importantly will also help deliver on the "promise of tomorrow" of human embryonic stem cell therapies.
Dr. Pedro Huertas, Chief Development Officer of Advanced Cell Technology remarked, "Mytogen has a very experienced team and is the only company that has successfully brought its technology into clinical trials in accordance with FDA regulations. The Myoblast Program takes us directly into Phase II clinical trials and is thoroughly aligned with various applications of our Hemangioblast Program."
William M. Caldwell, IV, Chairman and CEO of Advanced Cell Technology remarked, "We remain fully committed to the field of human embryonic stem cells and we believe that the promise of the Myoblast Program combined with the synergies with our Hemangioblast program provides a diverse technology platform in stem cell therapy focused on the treatment of heart attack and heart failure. We are excited to welcome Dr. Jonathan Dinsmore and the entire Mytogen team who have been together for over ten years to Advanced Cell Technology and look forward to the continued success of the Myoblast Program. We look forward to closing the transaction with Mytogen as quickly as practicable and integrating their technology and scientific team within our organization."
Additional details regarding the letter of intent with Mytogen will be included in a Current Report on Form 8-K to be filed by the Company with the Securities and Exchange Commission.
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc. is a biotechnology company applying embryonic stem cell technology in the emerging field of regenerative medicine. The company operates facilities in Alameda, California and Worcester, Massachusetts.
More information is available at www.advancedcell.com
About Mytogen, Inc.
Mytogen, Inc. is a Massachusetts based company developing autologous myoblast transplantation designed to restore cardiac function in patients with heart failure. The incidence and progressive nature of heart disease make it the leading cause of morbidity and mortality in the U. S. Mytogen is advancing a proprietary formulation of cultured human myoblasts and an optimized delivery system to deliver cells to the site of cardiac damage. Mytogen represents the consolidation of experts in areas including clinical manufacturing of biologics, cell transplantation, and stem cell biology and benefits from intellectual property assets and clinical trial experience acquired from Genvec and Diacrin, Inc. Currently, Mytogen is conducting U.S. human clinical trials of its myoblast therapy with FDA oversight, and is positioned to launch multi-center phase II studies in the near future.
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 March 31, 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.
The Investor Relations Group
James Carbonara or Joseph Kessler, 212-825-3210
Bill Douglass, 212-825-3210
Posted: May 2007