ACTC Prepares to Take Therapy to Phase II Clinical Trials
ALAMEDA, California-- (BUSINESS WIRE)"Advanced Cell Technology, Inc. (OTCBB:ACTC - News) today announced that it has entered into a definitive merger agreement to acquire all of the outstanding capital stock of Mytogen, Inc. In May 2007, the company announced that it had entered into a letter of intent to acquire Mytogen, Inc. and its Myoblast Program for the treatment of heart failure. With the definitive merger agreement approved and executed by both parties, ACT and Mytogen will move quickly to close the transaction, which is signed subject to certain closing conditions. The merger agreement provides for an aggregate purchase price of $5 million payable in ACTC common stock plus the assumption of certain Mytogen liabilities. Mytogen shareholders will also receive a warrant to purchase an additional 1.5 million shares of ACTC common stock at $0.75 subject to the achievement of certain milestones.
Mytogen brings to the company over ten years of experience in clinical trial and FDA experience in developing and advancing cellular therapies including the area of stem cells. Mytogen has successfully completed Phase I human clinical trials utilizing the myoblast 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 closing the acquisition, Advanced Cell Technology plans to begin 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 that have experienced a serious heart attack and have a high risk of heart failure. This 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 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. 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 often improve function in the heart and can lead to a significant increase in quality of life for the patient.
"Advanced Cell Technology has always been on the cutting edge of regenerative medicine and we are excited to join their team,” noted Dr. Jonathan Dinsmore, President and Chief Scientific Officer of Mytogen, Inc. "By merging with Advanced Cell, we can now more rapidly move forward with our clinical trials and bring our novel therapies to cardiac patients in need of treatment.”
William M. Caldwell, IV, Chairman and CEO of Advanced Cell Technology remarked, "We remain committed to the field of human embryonic stem cell research and believe that the promise of the Myoblast Program combined with the synergies with our Hemangioblast Program provide a diverse technology platform in stem cell therapy focused on the treatment of heart attack and heart failure. We are excited about this merger and look forward to focusing our efforts on commencing the Phase II clinical trials. The signing of this definitive agreement signals ACTC's transition from a development stage to a clinical stage company.”
Additional details regarding the definitive merger agreement 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.
For more information, visit "www.advancedcell.com":http://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.
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