Advanced Cell Technology, Inc. (OTCBB:ACTC – News) is applying stem cell technology in the field of regenerative medicine to bring effective, patient-specific therapies to the bedside. The company’s Myoblast program is an autologous adult stem cell therapy for the treatment of heart disease. The Myoblast program has successfully completed four Phase I clinical trials and has clearance from the FDA to begin Phase II trials shortly. The company is also rapidly moving towards human clinical trials for its embryonic stem cell therapies including its RPE and HG programs. ACT published positive data from animal studies for its RPE (retinal pigment epithelial) cell program for the treatment of retinal degenerative disorders completed in collaboration with the Casey Eye Institute at Oregon Health and Science University. The company also has GLP Safety Studies in process for its RPE Program. ACT published positive data in the journal NATURE Methods for its HG (hemangioblast) cell program for the treatment of blood and cardiovascular diseases. The company expects to file INDs for its RPE and HG programs in 2008. In August 2006, ACT announced a novel technique to generate embryonic stem cell lines without destroying embryos, a breakthrough in the ethical debate surrounding the industry. Since then, the company has announced on multiple occassions the creation of human embryonic stem cell lines without destroying the developmental potential of the embryos. ACT owns or licenses over 380 patents and patent applications.
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We are currently focused on three product areas.
1) Our myoblast program , which could yield novel therapies for cardiac diseases such as heart failure, successfully completed Phase I human clinical trials. The program has clearance from the FDA to begin Phase II human clinical trials and we expect to commence those trials shortly.
2) Our retinal pigment epithelium (RPE) program , which we believe could yield new therapies for treating indications such as age-related macular degeneration. We announced a collaboration to conduct preclinical trials, completed pre-IND meetings with the FDA, and expect to file an IND in 2008.
3) Our hemangioblast (HG) cell program for which we are currently conducting preclinical research programs investigating the possibility of using the cells to treat cardiovascular disease, stroke, and cancer. Our research , published in Nature Methods, demonstrated success in treating vascular indications such as heart attack and limb loss due to vascular damage. We expect to file an IND in 2008.
The company is led by an experienced management team and scientific experts in the field, including CEO William Caldwell, Chief Scientific Officer Robert Lanza M.D., and SVP, Regulatory and Clinical Jonathan Dinsmore, Ph.D. The company operates GMP capable laboratories in Massachusetts and California.
The company is actively pursuing strategic collaborations in the United States (e.g., in California, where in 2004, the state passed Proposition 71, often referred to as the “Stem Cell Initiative,” which will provide $3.0 billion of funding over the next ten years for stem cell research) and around the world with members of academia, industry and foundations to further accelerate the pace of our research efforts.