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Online PR News – 25-July-2011 – – written by Devon Blake, Ph.D.
Some Americans, anxious and afraid after watching their hard-earned portfolios shrinking at the end of September 2008, turned to financial websites and stock message boards in hope of finding advice or that one stock…the one in a thousand that could save them from financial ruin or at least mitigate losses caused by the credit crisis. Out of the plethora of worthy contenders screaming to be heard, one stood alone, proudly and unabashed, yet barely whispering not to be overlooked just because it had a share price of…THREE CENTS in 2008?
Some investors turned to Advanced Cell Technology (OTCBB:ACTC), a Massachusetts-based biotech firm, which appeared to have great promise in the tenuous and controversial world of stem cell research. But equally as many wondered if ACT was just another “too good to be true penny stock,” promising life-changing financial gains for investors and a paradigm shift in health care through stem cell technology. Since 1998 ACT has stood amid tumultuous global outcries causing escalating ideological, philosophical, religious, and legal debates surrounding embryonic stem cell research. From Pope John Paul II’s famous 1995 encyclical to the Dickey-Wicker Amendment, Advocate General Yves Bot opinion to Court of Justice in Brüstle vs. Greenpeace (Europe) and most recently Sherley vs. Sebelius which challenged President Obama March 2009 executive order allowing Federal funds for human embryonic stem cell research. Regenerative medicine has faced uphill battles that could rival those of the classically-beleaguered Sisyphus.
In late 2010 Advanced Cell Technology joined an exclusive club with Geron Corporation (NASDAQ-GERN), in being the only organizations approved by the FDA to conduct human trials using human embryonic stem cells (hESC). Of the three approved trials, ACT is conducting two of the trials. Both Phase 1/2 clinical trials for Stargardt's macular dystrophy and dry age-related macular degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells. On July 12, 2011 ACT announced that patients were treated by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute. Robert Lanza, M.D., chief scientific officer of ACT, attended the procedures. Both patients successfully underwent the outpatient transplantation surgeries and are recovering uneventfully. One advantage of working with cells from the eye, Lanza says, is that they can be effortlessly viewed with high-powered imaging tools. “We can see if there’s engraftment of the cells in the eye and we can see if anything is amiss.” Lanza also went on to say, “Although it’s too early to make any assumptions about the first two patients, the procedures, couldn’t have gone more smoothly.” ACT’s CEO Gary Rabin, indicated at the June 2011 shareholder meeting that the open label three month report will be made available in October 2011.
According to Raymond Lund, Ph.D., a scientific collaborator with ACT, and considered one of the world's foremost experts in retinal cell physiology and vision restoration, commented, “The study results of ACT's RPE cells implanted in the various animal models of macular degeneration was phenomenal. If ACT observes even a fraction of that benefit in humans, it will be nothing short of a home run.”
ACT’s strategic global partnership with leading Korean-based biotechnology company CHA Biotech Co, Ltd. (CHA) which trades on the KOSDAQ is expected to begin its Stargardt's macular dystrophy trials before the end of August. Early this month, InvestorStemCell.com was granted an exclusive interview with Dr. Kwang Yul Cha, President and Chairman of CHA Biotech. Dr. Cha confirmed that CHA Stem Cell Institute will soon inject their first patients with ACT’s hRPE stem cells and, as in the ACT trials, expects initial results in six weeks or less. Earlier this year ACT received China’s State Intellectual Property Office (SIPO) offering broad intellectual property protection for the manufacturing and pharmaceutical preparations of retinal pigment epithelial (RPE) cells from human embryonic stem cells (hESCs). Just last month the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) officially granted ACT's human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells designation as an orphan medicinal product for the treatment of Stargardt's Macular Dystrophy (SMD).
Sai Rosen Director of Clients Services for Stem Cell Media, LLC., remarked, “ACT is looking to corner the world’s market for treating macular degeneration. AMD affects over 100 million people world-wide and is the #1 unmet medical condition. If a company can market a treatment for AMD it would be worth billions in revenue per year. ACT is trading at $0.19 and a market cap under $300 million. Those investing in ACT and other RegMed companies have drawn similar parallels to those that invested in Microsoft, Yahoo and other tech companies at the end of the last century. Getting in early has a level of high risk, however the reward in doing so is attractive for them. According to SEC documents, ACT has still to draw on $21million line and has $13million in cash. Quarterly cash burn of $2.4million ” He went on to say, “ ACT is protecting its IP and adding continuous value to shareholders in doing so. We are watching ACT and 50 plus other companies in the regenerative sector closely. We are hopeful that reducing the cost of healthcare through RegMed will be a reality in this decade”
Stem Cell Media, LLC nor any of its companies has been compensated for this article. Always consult an investment professional before investing.