Awaiting IND Targetting a Twenty-Eight Billion Dollar Market (OTC:ACTC.OB)

November 2, 2009

Advanced Cell Technology, Inc.

(Public, OTC:ACTC.OB)

MiV Investments Inc. has initiated independent research coverage on Advanced Cell Technology Inc. (OTC:ACTC.OB), which is anticipating a filing of an investigational new drug (IND) application which takes on a 28B Age-related macular degeneration (AMD) market, with over 30 million people affected by the disease. The company expects to file the IND prior to the end of Q409. Macular degeneration is a medical condition usually of older adults that results in a loss of vision in the center of the visual field (the macula) because of damage to the retina. It occurs in “dry” and “wet” forms. It is a major cause of visual impairment in the elderly (>50 years). Macular degeneration can make it difficult or impossible to read or recognize faces, although enough peripheral vision remains to allow other activities of daily life. There is no other existing therapeutic treatments which regenrate the lost cells, leaving 90% of Age-related macular degeneration (AMD) patients with dry variety as an unmet need. This condition affects more than 15% of elders aged 75 and above, leaving it as one of the top threats to an elder’s health. The company has also taken major strides, recently moving from the PINK sheets, to the OTC bulletin and sufficing the qualifications needed to be pink sheets compliant. Technicals on the company’s stock have also been highly bullish as of late, sitting at a nine month price low, all the while anticipating news on what could be the beginning of a revolutionary new drug.

The company is in preparation of its first IND filing with the Food and Drug Administration for its retinal pigment epithelium (RPE) cell program for the treatment of various eye diseases. The Company noted that in the next few weeks, it will be completing the preclinical work necessary for filing the IND. To date, no adverse events have occurred in testing. The results will be part of the submission which Advanced Cell expects to submit to the FDA prior to the end of the year.   “We are very pleased with the long-term safety and efficacy data,” said Dr. Robert Lanza, ACT’s Chief Scientific Officer. “We have carried out pre-clinical studies using these cells in multiple animal models, and to-date have not seen any teratoma formation or untoward pathological reactions. We are optimistic that human embryonic stem cells (hESCs) will serve as a potentially safe and inexhaustible source of RPE for the treatment of a range of macular degenerative diseases.”   Existing therapies only treat the condition and do not regenerate cells of the macula that have been damaged. Plus, existing therapies only treat wet AMD, not dry AMD, leaving a significant unmet need for an effective treatment for the 90% of AMD patients who have the dry variety. The company expects to file an IND for its RPE program by end of 2009.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company focused on developing and commercializing human embryonic and adult stem cell technology in the field of regenerative medicine. The Company has acquired, developed and maintain a portfolio of patents and patent applications that form the base for its research and development efforts in the area of embryonic and adult stem cell research. The Company’s technology base, in combination with its know-how, provides an advantage and will facilitate the successful development and commercialization of products for use in treatment of an array of chronic degenerative diseases and in regenerative repair of acute disease, such as trauma, myocardial infarction and burns. The Company’s embryonic stem (ES) cell research programs are divided into three core categories: cellular reprogramming, reduced complexity program, and stem cell differentiation.

Worldwide Recognition

Dr. Robert Lanza, its Chief Scientific Officer, was featured on Deepak Chopra’s Wellness XM Radio and Barbara Walters 20/20 special.  The shows focused on Dr. Lanza’s research at ACTC and his new book “Biocentrism.”  SIRIUS XM Stars Channel is the flagship satellite talk station featuring unique and diverse programs, including Deepak Chopra and broadcasting legend Barbara Walters, among others. It has a listenership of approximately 9 million people.

Chopra is a prolific author of over fifty-five books on topics ranging from health to consciousness and quantum mechanics, and was heralded by Time Magazine as one of the top heroes and icons of the century.  On his show, Lanza discusses the cutting edge of regenerative medicine, including ACTC’s efforts to use stem cells to treat blindness, vascular damage, and heart disease.  ACTC hopes to file at least one application with the FDA this year to begin human clinical trials using retinal pigment epithelium (RPE) cells to treat macular degeneration and other retinal degenerative diseases.

Lanza and Chopra also discuss “Biocentrism,” and how life and consciousness are the keys to understanding the true nature of the universe.   “We think life is an accident of physics,” explains Lanza.  “But a long list of experiments suggests just the opposite.  Amazingly, if you add life to the
equation, you can explain some of the biggest puzzles of science. ”

Deepak Chopra stated, “Having interviewed some of the most brilliant minds in the scientific world, I found Dr. Robert Lanza’s insights into the nature of consciousness original and exciting.  His theory of biocentrism is consistent with the most ancient wisdom traditions of the world which says that consciousness conceives, governs, and becomes a physical world.  It is the ground of our Being in which both subjective and objective reality come into existence.  I hope to have Dr. Lanza continue this conversation on Sirius XM satellite radio in the future.”

“We believe that Dr. Lanza has contributed significantly to the understanding of the key role stem cells play in the field of regenerative medicine,” said William M. Caldwell IV, Chairman and CEO of ACTC.  “Through his scientific leadership the field is on the verge of therapeutically validating a new platform for regenerative medicine.” Source found here

Retinal Pigmented Epithelial Cell Program

Advanced Cell Technology is currently focused on using its proprietary technologies to generate stable cell lines including retinal pigment epithelium (RPE) cells for the treatment of diseases of the eye, including macular degeneration, which represents a $28 billion dollar market. Age-related macular degeneration (AMD) affects more than 30 million people worldwide and is the leading cause of blindness in people over 60 years of age in the United States. AMD is a disorder that affects the macula of the eye that causes decreased visual acuity and possible loss of central vision. The prevalence of AMD begins to increase after the age of 50. Approximately 15% of people over 75 years of age have the condition.

Positive Clinical Trials

ACT demonstrated the ability to rescue visual function in rats through implantations of RPE cells derived from human embryonic stem cells. In collaboration with Raymond Lund at the University of Utah, the company performed RPE transplantation into sub-retinal space of rats that naturally become blind in several weeks due to RPE degeneration and photoreceptor death. In the experiments conducted by the company, the rats were injected with embryonic stem-RPE cells into the sub-retinal space of the eye at 21 days after their birth — an age at which photoreceptor degeneration has not yet occurred. As control measures, some rats received injections of cell culture medium alone or were not injected at all. Subsequently, tests for visual function were performed at 60 and 90 days after birth — times at which loss of photoreceptor cell has produced characteristic vision deficits. The results represented a major breakthrough. The injected RPE cells grew normally without forming teratomas. Soon, the rats were able to follow lights with their eyes and attained approximately 70% of the spatial acuity of a normal, healthy rat. Necropsy revealed that the eyes had grown layers of the retinal cells. The experiment demonstrated that animals receiving the human embryonic stem cell-derived RPE cells performed significantly better than medium-only treated (50% improvement), or untreated (100% improvement) controls in visual performance. In addition, the human embryonic stem cell-derived RPE cells did not appear to cause any side effects in the animals. The research was published in Cloning and Stem Cells and was also referenced in Scientific American. Source found here

Understanding Advanced Cell’s Position

Market Opportunity: Age related macular degeneration (AMD) represents a “tremendous” market opportunity given the size of the patient population and the lack of treatment alternatives. Diseases of the eye affect more than 30 M people worldwide and represent a $20+B market.

• Existing therapies only treat the condition and are not curative but palliative and do not regenerate cells of the macula that have been damaged.  Additionally, existing therapies only treat Wet AMD not Dry AMD hence leaving a significant unmet need for an effective treatment for the 90% of AMD patients who have the dry variety,

• AMD is a common eye disease that leads to deterioration of the macula which is the central area of the retina in the back of the eye, the paper-thin tissue where light-sensitive cells send visual signals to the brain.  In particular, sharp, clear, “straight ahead” vision is processed by the macula.  Injury to the macula results in the formation of blind spots and blurred or distorted vision.  When the macula becomes damaged, many daily activities such as driving and reading become increasingly difficulty,

• AMD most often affects individuals over 50 years of age.  There are two forms of macular degeneration: dry macular degeneration or wet macular degeneration.  Dry AMD takes place when the light-sensitive cells in the macula slowly break down, gradually blurring central vision in the affected eye.  As dry AMD gets worse, the patient may see a blurred spot in the center of their vision.  As the disorder progresses, and less of the macula functions, central vision is gradually lost in the affected eye.  The most common symptom of dry AMD is slightly blurred vision.  The affected individual may need more light for reading and other tasks,

Wet AMD occurs when abnormal blood vessels behind the retina start to grow under the macula.  As the dry form worsens, some people begin to have abnormal blood vessels growing behind the macula.  These new blood vessels tend to be very fragile and often leak blood and fluid (hence ‘wet’ macular degeneration).  The blood and fluid raise the macula from its normal place at the back of the eye.  Damage to the macula occurs rapidly.  With wet AMD, loss of central vision can occur quickly.  Wet AMD is also known as advanced AMD.  It does not have stages like dry AMD.  The wet form is diagnosed in approximately 10 percent of cases; however, it results in 90% of the visual impairment and is considered advanced AMD (there is no early or intermediate stage of wet AMD).  Wet AMD is always preceded by the dry form of the disease.

Investment Highlights

• Currently ACT is finalizing preclinical studies for the bio-distribution of our therapeutic program addressing Retinal Degeneration (i.e. AMD or macular degeneration in the eye) and has completed GLP Safety Studies and long-term efficacy studies for the RPE therapy with positive results.

• The Company expects spiking studies for the RPE product to be finished in the second half of 2009. ACT expects to file the RPE program IND by the end of 2009.

• Working on acquiring funding for Phase II clinical trials for the Company’s Myoblast program, an autologous (meaning “one’s own”) adult stem cell therapy for treating cardiac disease. Historically the Myoblast program successfully completed several Phase I clinical trials.

• 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. Anticipates filing an IND in 2010.

• 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 2009.

• 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., VP of Regulatory Ed Mickunas, Senior Director of Manufacturing Roger Gay PhD and Director of Operations Rita Parker.

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 starting with President Obama new embryonic stem cell directive initiated January 2009. Source found here

FDA News

*Information via BioMedReports’ FDA Calendar

Highly Experienced Leadership

Read this article regarding ACTC’s Chief Scientific Officer within Discover Magazine.

“Whether defying the dean of the University of Pennsylvania Schl. of Medicine so he could publish a book on world health or challenging the titans of cosmology, Robert Lanza has never followed the script. It’s no wonder, then, that this renegade doctor would lead the charge into medicine’s most controversial turf: the creation of cloned embryos for therapy and the engineering of spare human parts.”

William M. Caldwell, IV

Chairman and CEO

Mr. William Caldwell serves as Chairman and Chief Executive Officer of the Company and has a 30-year management career working with emerging technologies and restructuring distressed corporate environments. During his career, he has served in senior executive positions both in marketing and finance. He has worked with Booz Allen and Hamilton; the Flying Tiger Line Inc.; Van Vorst Industries; and Kidder Peabody. He started a firm specializing in corporate financial and strategy planning, which was instrumental in restructuring over $1.0 billion of debt for over twenty companies and partnerships. He was a pioneer in the satellite radio auctions as president of Digital Satellite Broadcasting Corporation; assisted in the financing, and became president and ultimately CEO in the restructuring of CAIS Internet. He has advised corporations, both public and private, in technology, telecommunications, retailing, real estate, hospitality, publishing, and transportation. He received his B.A. degree from the University of Southern California and was a Multinational Enterprise Fellow at the Wharton Graduate School of Finance. He serves as a director of Lee Pharmaceuticals (LPHM.PK) and King Koil Franchising Corp.

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Robert Lanza, M.D.

Chief Scientific Officer

Dr. Lanza joined ACT in 1999. Dr. Lanza has over 25 years of research and industrial experience in the area of stem cells and regenerative medicine. From 1990 to 1998, he was Director of Transplantation Biology at BioHybrid Technologies, Inc., and is currently an Adjunct Professor at the Institute for Regenerative Medicine, Wake Forest University School of Medicine. He has several hundred scientific publications and patents, and has authored/edited 20 books, including the “Handbook of Stem Cells” (as Editor-in-Chief), Principles of Tissue Engineering, XENO, the Yearbook of Cell & Tissue Transplantation, and One World: The Health & Survival of the Human Species in the 21st Century (as editor, with forewords by C. Everett Koop and former President Jimmy Carter). He is a former Fulbright Scholar, and studied as a student in the laboratory of Richard Hynes (MIT), Jonas Salk (The Salk Institute), and Nobel laureates Gerald Edelman (Rockefeller University) and Rodney Porter (Oxford University). He also worked closely (and coauthored a series of papers) with the late Harvard psychologist B.F. Skinner and heart transplant pioneer Christiaan Barnard. Dr. Lanza received his B.A. and M.D. Degrees from the University of Pennsylvania, where he was both a University Scholar and Benjamin Franklin Scholar.

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Edmund Mickunas

Vice President of Regulatory

Mr. Mickunas, a recent addition to the ACT team, is the Company’s Vice President of Regulatory. Mr. Mickunas is in charge of spearheading the company’s effort to translate its cutting edge research into FDA approved therapies ready for clinical trials. Mr. Mickunas is working with Dr. Robert Lanza and ACT’s Development Team to finalize and submit the IND for the RPE program to the FDA. Mr. Mickunas brings 28 years of experience from a number of disciplines including biotechnology, medical device and pharmaceuticals. He has worked in preclinical program development, clinical affairs, regulatory affairs/compliance and quality assurance, and has worked closely with all disciplines involved in product development. Prior to joining Advanced Cell, Mr. Mickunas was Executive Director, Regulatory Affairs and Quality Assurance for Applied Genetic Technologies Corporation, a privately held gene therapy and genomics-focused biotech company. Mr. Mickunas was previously Senior Director of Regulatory Affairs and Compliance for Control Delivery Systems, Inc., where he managed the submissions of IND filings, among other responsibilities. He also held senior regulatory positions at Bioheart, Inc., Cytomed and Del Laboratories. He received his B.S. and pursued graduate studies in human biochemistry at Fairleigh Dickinson University, as well as a Masters Degree from Fairfield University.

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Roger Gay, Ph.D

Senior Director of Manufacturing

Dr. Gay serves as Advanced Cell’s Senior Director of Manufacturing. Dr. Gay is responsible for Process Development and Clinical Manufacturing at Advanced Cell. For the past 28 years, he has been involved in clinical manufacturing and product development at a number of biotechnology companies specializing in cell-based products and services including Organogenesis, Diacrin, Genvec and Mytogen. He has extensive experience directing and leading product development and clinical trial manufacturing for cellular products having planned and executed R&D programs leading to market introduction of first-ever products for two biotechnology companies prior to joining Advanced Cell. He received a Ph.D. in biochemistry from the University of Rochester in 1980 and was a post-doctoral fellow at Harvard Medical School.

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Rita Parker

Director of Operations

With Advanced Cell since 2005, Ms. Parker brings a 20 year career in management to her role as the Company’s Director of Operations. A native of Massachusetts, she has held senior positions in marketing and operational management, focusing on paving the way for local businesses to expand their geographical footprint and increasing their technological and productive capabilities by introducing new and efficient information technology products and systems; a few of these companies include Digital Equipment Corporation, Computer Devices, and Banyan Systems, Inc.

External News Affecting Advanced Cell

Judge Throws Out Stem Cell Lawsuit

by Jocelyn Kaiser

A federal judge has rejected a lawsuit challenging the Obama Administration’s policy lifting restrictions on using federal funds to study human embryonic stem cells. Christian groups had sued the National Institutes of Health in August, arguing on behalf of themselves and embryos that NIH’s stem cell guidelines violate a ban on using federal funds to create or destroy human embryos. According to Bloomberg,  U.S. District Court Judge Royce Lamberth ruled yesterday in Washington, D.C., that the groups had no standing because the U.S. Supreme Court has found that embryos are not persons under the law, and the unborn have no constitutional right to life. The AP’s story says the judge also rejected the argument that the guidelines would reduce the number of embryos available for adoption. http://blogs.sciencemag.org/scienceinsider/2009/10/judge-throws-ou.html

Recent Company News

Advanced Cell Technology, Inc.’s Shares To Trade On Over-the-Counter Bulletin Board
Tuesday, 6 Oct 2009 07:40am EDT

Advanced Cell Technology, Inc. announced that effective immediately the Company’s shares will be traded on the Over-the-Counter Bulletin Board under its previous ticker symbol ACTC. The Company is now fully reporting and up-to-date with all of its filing requirements. The Company`s stock had previously traded on the Pink Sheets.

Advanced Cell Technology, Inc. Completing Pre-Clinical Activities In Preparation For IND Filing
Tuesday, 22 Sep 2009 11:28am EDT

Advanced Cell Technology, Inc. announced an update on pre-clinical activities in preparation of its first IND filing with the Food and Drug Administration for its retinal pigment epithelium (RPE) cell program for the treatment of various eye diseases. In the next few weeks, the Company will be completing the preclinical work necessary for filing the IND. To date, no adverse events have occurred in testing. The results will be part of the submission which Advanced Cell expects to submit to the FDA prior to the end of the year.

Advanced Cell Technology, Inc. and Collaborators At The Casey Eye Institute Present Promising Data Supporting Safety and Efficacy of Stem Cell Therapy to Combat Retinal Disease
Friday, 12 Jun 2009 09:39am EDT

Advanced Cell Technology, Inc. and its collaborators at OHSU reported the long-term safety and efficacy of human embryonic stem cell (hESC)-derived retinal pigment epithelium (RPE) produced under manufacturing conditions suitable for human clinical trials. Two important early potential hESC applications are the use of RPE for the treatment of age-related macular degeneration and Stargardt disease, an untreatable form of eye disease that leads to early-onset blindness. The research, which appears online ahead of print in the journal Stem Cells, shows long-term functional rescue using hESC-derived cells in both the RCS rat and Elov14 mouse, animal models of retinal degeneration and Stargardt, respectively. The cells survived transplantation for prolonged periods (>220 days) and sustained visual function without tumor formation or untoward pathological reactions. Near-normal functional rescue was also achieved in the `Stargardt` mouse. To further address safety concerns, a study was carried out in the NIH III immune deficient mouse model. Long-term data (spanning the life of the animals) revealed no evidence of tumor formation after transplantation.

Advanced Cell Technology, Inc. Prepares IND Filing with the Capability to Produce Stem Cell Lines without the Destruction of the Embryo
Thursday, 12 Mar 2009 08:00am EDT

Advanced Cell Technology, Inc. announced that it is finalizing preparations to file an IND in the second half of this year with the Food and Drug Administration for the Company’s retinal pigment epithelium (RPE) cell program for the treatment of diseases of the eye. It has available the only technology that can today produce stem cell lines without the destruction of the embryo. While President Obama recently issued an Executive Order that authorizes expanded federal funding for research using stem cells produced by destroying human embryos, the decision remains controversial as some believe that the Government should not fund the ongoing destruction of human embryos. In the coming months Congress will be debating altering or eliminating the Dickey Wicker Amendment which is at the core of this controversy. Advanced Cell Technology`s stem cell platform offers a compromise on this issue, as described in peer review scientific journals published over the past several years. Over 3000 healthy children have undergone the medical procedure, PGD, which is at the core of ACTC`s technology.

Overall Sentiment & Technical Analysis ( Click chart to enlarge )

For the past six months, ACTC has moved within a very dependable price channel shown in Blue lines on the chart.  The channel was defined by a 193% gain in price back in May to June of this year.  Since then, the price has been waiting for the bottom trend-line of the price channel to catch up (consolidation). It appears this has finally happened. The stock has found the bottom trend-line of the channel where the big move back in May started.  That move started with a run in price that quickly made it to the middle trend-line (dashed Blue line) around .18 cents. The conditions are classically bullish as the daily 100 SMA (Orange line) is above the 200 SMA (Yellow line).  As the buyers assume control of this stock, the price should easily find the 100 SMA around .15 cents.  With growing volume (gray bars), the stock could quickly move back to the middle trend-line and likely back up into the upper half of the price channel.  Of course, news can trump everything and any FDA action would probably send this stock well above the top trend-line. It’s good to keep in the back of your mind that the price has already tested the top trend-line twice this year and we have seen numerous times that the third time is the charm to finally break out.

Disclosure: Long ACTC

By reading MiV Investments Inc. company profiles you agree to the disclaimer, and thereby will not hold Michael Vlaicu accountable for any transactions or decisions you make. It is up to you to do your own due diligence.

MiV Investments Inc. is not paid, compensated or in any way incentivized to report news and developments about publicly traded companies, unless otherwise stated.

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