Awaiting IND Targetting a Twenty-Eight Billion Dollar Market (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 ( greater than 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 regenerate 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.
The full special report on the company appears today at http://www.stockshaven.com/awaiting-ind-targetting-a-twenty-eight-billion-dollar-market-otcactc-ob/
Disclosure: Long ACTC
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