InvestorStemCell.com interviews Dr. Kwang Yul Cha, President and Chairman of CHA Biotech. Investor Stem Cell is dedicated to bringing investors and stakeholders together in thoughtful discussion to educate and publicize the incredible advancements in the regenerative medicine sector.
Online PR News – 18-July-2011 – – Written By
Devon Chandler Blake, Ph.D.
Don W Kukkido
Advanced Cell Technology (OTC:ACTC), a Massachusetts-based biotechnology leader in the field of regenerative medicine, has crossed the frontier by initiating the first human stem cell trials last week for Stargardt’s Macular Dystrophy (SMD). And across the world, the CHA Stem Cell Institute in Seoul, Korea, through a licensing agreement with ACT, will begin its own human trials within the week using ACT’s hRPE (human retinal pigment epithelial cells) for SMD and the more widely-spread adult type of age related macular degeneration (AMD).
Central to any human drug trial is the hope of biotech companies to acquire Orphan Drug status (granted for drugs which treat rare diseases) and future compassionate use designation (off-label use for severely vulnerable individuals), both of which ACT and CHA have acquired or will shortly. Orphan Drug designation speeds the trial phases while offering the further protection of exclusivity and the opportunity to add many off-label uses of the drugs, ensuring a broader and more significant market.
With these issues in mind and in large part through his association with the www.investorstemcell.com group, a nonpartisan organization which disseminates information about stem cell research and developments on their popular website, InvestorStemCell.com, free-lance writer Don W. Kukkido requested and was granted a rare personal interview with Dr. Kwang Yul Cha, President and Chairman of CHA Biotech. Anticipating groundbreaking progress from the human trials being conducted by ACT and soon by CHA, Kukkido met with Dr. Cha on July 12th in Gangnam-gu, South Korea.
During the interview 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. Cha added that "safety and efficacy standards at his company are equal to and in line with the standards of the US-based, Advanced Cell Technology." Since the United States FDA has already approved the IND (investigational new drug) for cells used in the trials for Stargardt's (MA09-hRPE) and thus their safety for humans, the Safety Phase of the trials will be limited and thus should that of the larger trial in Korea for age related macular degeneration (AMD) using the same hRPE cells.
While Cha will use ACT data, he will also employ his own and offer the findings for required KFDA review. With successful trial results expected, Cha commented, "he would terminate Phase I/II and move faster into Phase III in combination with commercialization." He anticipates that after administering the first immunosuppressant’s and injecting hRPE cells two weeks later he can then reevaluate the strengths and dosages within two months and determine the precise amount of stem cells needed to achieve optimal results for future procedures. Presently applying for Orphan Drug status and further designation for compassionate use, Cha feels KFDA decision could come within a week. However, his main thrust concerns trial completion and moving forward into marketing the myriad off-label uses for over 200 retinal diseases.
More than diseases of the eye, however, are central to the research and development efforts at the CHA Stem Cell Institute. Owing to another licensing agreement with Massachesetts-based Advanced Cell Techology, CHA is building a manufacturing plant to create blood, platelets, and bone marrow under the ACT Hemangioblast Program. Dr. Robert Lanza, head medical researcher at ACT, discovered that hemangioblasts, which are multipotent cells, can be differentiated into the full spectrum of blood cells and can be manufactured in the lab setting, thus obviating the problems with rejection or type matching.
The market for this technology is limitless, and Dr. Cha intends to move forward with KFDA approval by 2013 but stated " it’s still too early to decide whether to use the Red Cross for distribution and marketing." He added that he will build manufacturing plants wherever he sees the need, from the United States, South America, Europe, to Asia—and that he has twenty teams of researchers ready to begin work on whatever is developed first. To supplement these already herculean efforts, Cha has additional teams working on Alzheimer’s Disease and Parkinson’s and will start trials with three patients over an 18-month period, again stating that if these trials also proceed well, he can move ahead to Phase III with minimal effort.
Kukkido asked Dr. Cha, who further plans human cardiovascular trials in 2013 and 2014, if he will use the Single Blastomere technology developed and patented by ACT for harvesting stem cells without damaging embryos. He confirmed this and added that their own Dr. Chung Hyung-Min was one of the developers of the technology.
Finally, Dr. Cha requested that Wortman thank InvestorStemCell.com for helping to set the record straight about his company and for serving as the premier source for disseminating information about advancements in stem cells through its website, InvestorStemCell.com. Sai Rosen Director of Client Services for InvestorStemCell.com commented "ACT and CHA alone offer proof that the exponentially growing field of stem cell research and development is not the stuff of science fiction set in the future but a current reality with limitless potential."
Disclosure: Stem Cell Media, LLC. nor any of its Companies has been compensated for this article.