Advanced Cell Technology Completes Acquisition Of Mytogen, Inc.
Transaction Significantly Accelerates Stem Cell Clinical Development Activities; Phase II Clinical Trials to Begin Shortly
Los Angeles - Advanced Cell Technology, Inc. today announced that it has completed the acquisition of 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. A definite merger agreement was signed on July 31, 2007 subject to certain closing conditions. ACTC issued a total of approximately 8.2 million restricted shares of common stock, valued at $5 million and assumed certain Mytogen liabilities. Mytogen shareholders also received a warrant to purchase an additional 1.5 million shares of restricted common stock at $0.75 per share 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 use of stem cells. 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. The Myoblast Program has successfully completed Phase I human clinical trials using the myoblast platform, utilizing the therapy safely in over 40 patients. Safety of the company's myoblast therapy has been demonstrated in four independent studies. 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 may lead to a significant increase in quality of life for the patient. The company applied its myoblast therapy without the use of accompanying arrhythmia preventatives mandated by the FDA for similar programs. The FDA has reviewed the "end-of-Phase I" data and will allow Advanced Cell Technology to proceed with a Phase II human clinical trial.
The company 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. The Myoblast Program may prove particularly beneficial for patients that have experienced a serious heart attack and have a high risk of heart failure.
"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 move forward with our clinical trials and bring our therapies to cardiac patients in need of this novel treatment."
William M. Caldwell, IV, Chairman and CEO of Advanced Cell Technology remarked, "The completion of this acquisition marks a transformation for our company, as it significantly advances our clinical development activities, placing the company among the most clinically advanced stem cell companies. We now have three distinct programs in various stages of clinical and preclinical development. Our Myoblast Program for the treatment of heart failure will begin Phase II clinical trials shortly, while two of our human embryonic stem cell programs, our Hemangioblast Program for treating blood and cardiovascular disease and our RPE Program for treating retinal degenerative disorders, are in preclinical studies. We expect to file IND's for those programs next year."
Additional details regarding the definitive merger agreement with Mytogen are included in a Current Report on Form 8-K filed by the Company on August 6, 2007, with the Securities and Exchange Commission.
SOURCE: Advanced Cell Technology, Inc.