What is Ion Channel Innovations?
Ion Channel Innovations is a development stage biotechnology company formed to develop Ion Channel Therapy (ICT), an innovative gene transfer solution (see technology description for more details) expected to be safe and effective for the long-term treatment of erectile dysfunction (ED), urinary incontinence (UI, urinary urgency, frequency and incontinence related to overactive bladder (OAB), and potentially other smooth muscle diseases.
Drs. Melman and Christ invented ICT at the Albert Einstein College of Medicine at Yeshiva University (AECOM). AECOM owns the ICT patents and has granted the company exclusive, worldwide rights in perpetuity to the company and its investors.
First Cohort Completed December 2007
FDA approved Ion Channel Innovation's second IND on December 19, 2006. The trial is for gene transfer of the overactive bladder. The phase I trial entitled, "A Phase 1 Multicenter Study Evaluating the Safety and Potential Activity Of Three Escalating Doses of hMaxi-K Gene Transfer In Female Participants With Overactive Bladder Syndrome and Detrusor Overactivity: Double Blind, Imbalanced Placebo Controlled Design Within 3 Sequential Active Treatment Groups," is managed by the CRO, CE3, of Branford, CT. The first cohort of 13 women participants has now been completed.
Dr. Melman presented an official webcast point-counterpoint debate at the American Urological Association meeting entitled "Gene vs Surgical Therapy for Erectile Dysfunction" before 5000 AUA members. The debate can be viewed online at:
December 21, 2006
Ion Channel's report of the phase I trials results for gene transfer for the indication of erectile dysfunction was print published in Human Gene Therapy. The article was accepted in November and rapidly published the next month and is the first paper in the issue (that has figure 7) of the paper on the front cover of the journal. The paper is preceded by two editorials each highly complementary of the paper (see news section for the entire editorial).
Dr. Arthur Caplan, Chair of the Department of Medical ethics of the University of Pennsylvania School of Medicine note, “As Melman and his co-authors note there are sound physiological reasons to think that gene transfer into smooth muscle in the penis might provide a safer and more useful model for understanding gene therapy then is afforded by targeting other tissues and organs. The generation of key safety data from subjects suffering from a serious and sometimes devastating medical condition is an ethical course for gene therapy researchers to follow as long as their science is sound, their consent of subjects thorough and their reports of results modest, balanced and fair.”