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ION CHANNEL INNOVATIONS RECEIVES FDA APPROVAL TO BEGIN PHASE 1 TESTS ON HMAXI-K FOR THE TREATMENT OF ERECTILE DYSFUNCTION 8/1/2003 (New York) Today, a primary goal of Ion Channel Innovations, LLC was achieved when the FDA gave permission to begin Phase I human trials for hMaxi-K to treat erectile dysfunction, making it one of only a few companies approved for gene therapy trials. Ion Channel Therapy (ICT) has the potential to be the first breakthrough use of genetic therapy in humans, and the company plans to become the world’s leader in developing and commercializing ICT. The development of Ion Channel Therapy for peripheral organ dysfunction, such as erectile dysfunction and urinary incontinence, is a new approach that has experienced a greater degree of technical success than that observed with developing gene therapy for certain cancers or congenital disorders. Co-inventor, company co founder and directing member Dr. Arnold Melman, MD said, “In contrast to conventional gene therapy, which is typically given systemically, ICT is administered directly to the target organ to maximize gene incorporation into the target tissue and to minimize systemic exposure. In addition, because the gene is administered directly to the target organ, lower doses of the gene are sufficient, compared to systemic administration. We believe this is a much more effective approach and we look forward to the clinical trials. The company also plans to proceed with preclinical testing for applications of hMaxi-K to urinary incontinence and possibly other smooth muscle disorders. Co-inventor, company co founder and directing member Dr. George Christ, PhD said, “Industry organizations have estimated that there are 30 million men in the US with erectile dysfunction and 19 million men and women with urinary incontinence problems. Currently, these are the two largest growing U.S. markets in the field of urology at approximately $2 billion and $857 million in annual sales, respectively. About Ion Channel Innovations LLC: Ion Channel Innovations is a development stage biotechnology company formed to develop Ion Channel Therapy, an innovative gene therapy solution expected to be safe and long-term effective for erectile dysfunction, urinary incontinence, and potentially other smooth muscle diseases. Ion Channel Therapy (ICT) has the potential to be the first breakthrough use of genetic therapy in humans, and the company plans to become the world’s leader in developing and commercializing ICT.
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