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Biotech Investment Blog

This is the official blog for Advanced Cell Technology, Inc.  Investors are encouraged to join for up to date information.

Advanced Cell Technology Company Overview

Advanced Cell Technology, Inc. (OTCBB:ACTC – News) is a biotechnology company that specializes in the development of cellular therapies for the treatment of rare and common diseases that impact millions of people worldwide. The company applies stem cell-based technologies and other proprietary methods in the area of regenerative medicine to bring patient-specific therapies from the lab to the bedside.

The Company is in the final stages of moving toward the initiation of Phase I clinical trials for its Retinal Pigment Epithelial (RPE) program which addresses a number of retinal degenerative disorders. ACT has published positive data from animal studies for the RPE cell program – completed in collaboration with the Casey Eye Institute at Oregon Health and Science University (OHSU) – as well as recently announced promising results – also in collaboration with OHSU- from GLP Safety Studies and long-term efficacy studies for the RPE therapy. Currently ACT is finalizing preclinical studies for the bio-distribution of RPE and expects spiking studies to be finished in the second half of 2009. ACT expects to file the RPE program IND by the end of the year. Advanced Cell also has moved forward rapidly with it Hemangioblast (HG) platform. ACT has published positive data in the journal NATURE Methods for its HG cellular program for the treatment of blood and cardiovascular diseases. Additionally 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.

In recent years ACT has announced the successful development of 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 occasions the successful creation of human embryonic stem cell lines without the destruction or disruption of the developmental potential of the embryos. In support of its research and applications Advanced Cell owns or licenses over 380 patents and patent applications.

We are currently focused on three product areas.

1) Our retinal pigment epithelium (RPE) program , which we believe will yield new therapies for treating disease indications and disorders such as age-related macular degeneration (AMD). Our first therapeutic treatment using our RPE therapy will be a treatment for Stargardt’s Disease. We, along with our collaborators at the Casey Eye Institute at OHSU, just announced successful study results supporting the long-term safety and efficacy of our Retinal Disease therapy. An IND was filed in 2009.

2) Our hemangioblast (HG) cell program which could yield novel therapies for cardiac diseases such as heart failure has successfully completed Phase I human clinical trials. The program has clearance from the FDA to begin Phase II human clinical trials and we are currently seeking funding to support the initiation of a Phase II clinical trial.

3) Our myoblast program , which could yield novel therapies for cardiac diseases such as heart failure has successfully completed Phase I human clinical trials. The program has clearance from the FDA to begin Phase II human clinical trials and we are currently seeking funding to support the initiation of a Phase II clinical trial.

Advanced Cell is led by an experienced management team and world-class scientific team, including CEO William Caldwell, Chief Scientific Officer Robert Lanza M.D., VP of Regulatory Ed Mickunas, Senior Director of Manufacturing Roger Gay PhD and our Director of Operations Rita Parker. The company operates a GMP-capable laboratory in Massachusetts and maintains offices in Southern 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.

Investment Highlights

• Completed acquisition of Mytogen and its Myoblast program, an autologous adult stem cell therapy for treating cardiac disease. Myoblast program successfully completed Phase I clinical trials. Phase II trials to begin shortly.
• Published positive results from HG program demonstrating hemangioblasts’ ability to repair vascular damage in animals. Therapy could be effective for treatment of blood and cardiovascular diseases. Expects to file IND in 2008.
• Made progress in macular degeneration indication by reporting positive data for RPE cell animal study. Entered into collaboration with Casey Eye Institute for preclinical trials. Completed Pre-IND meeting with FDA. Expects to file IND in 2008.
• Developed and demonstrated technique to generate embryonic stems that maintain developmental potential of the embryo and therefore has potential to shift the ethical debate. Announced hESC lines created without destroying an embryo in multiple studies.
• Owns or licenses over 380 patents and patent applications related to stem cell therapy.
• Large Target Market: Regenerative Medicine has potential to treat diseases of the eye, blood disorders, heart disease, neurodegenerative diseases, liver disease, diabetes, and others.
• Led by experienced management team and scientific experts including CEO William Caldwell, Chief Scientific Officer Robert Lanza M.D., and SVP, Regulatory and Clinical Jonathan Dinsmore, Ph.D.

Growing Legislative Support

• CA Prop. 71 provides $3.0 billion in funding over 10 years for stem cell research, with preference given to research that is ineligible for NIH funding.
• Other states (e.g., NJ, CT, FL, IL, MD, NY, MA, and MO) have passed or proposed similar initiatives.
• Political landscape moving in positive direction for stem cell industry.