>>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."<<
I viewed the initial 1st patient trial of the myoblast therapy web-cast worldwide from the Arizona Heart Institute. The patient was a 51 year old doctor. During the procedure, his heart was mapped using the JNJ/Biosense Webster NOGA imaging apparatus, and the myoblast cells inserted using a catheter from JNJ/Cordis. The patient talked to the surgeon during the procedure. The web-site was www.myoblast.org, now not accessible to me. Stents and deceased heart cells were clearly visible. Three months later, follow-up indicated the patient had great improvement in his condition.
Since then, 40 human patients have undergone the procedure, and the FDA has given the go-ahead for Phase II. Unless I miss my guess, GERN is behind. I have been long in GERN for many years.
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