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. The disruptive technology currently in development offers the next logical step in the age of molecular and personalized medicine. ICT can be used for the treatment of a variety of common and pervasive age-related diseases and disorders that compromise smooth muscle cell regulation and function; thus severely compromising the affected individual's quality of life. The potential pool of men and women who could utilize ICT is estimated to be well over 100 million people in the US alone. The company is pursuing approval by the USA FDA for the treatment of both the ED and UI indications, and has now completed the critical phase 1 trial for ED and is seeking funding for completion of the Phase I trial for UI. The data collected to date provide evidence for long- term safety of ICT in both men and women.

OWNERSHIP

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.

2009 Ion Channel has now completed its phase 1 trial for ED and closed the phase 1 OAB trial.

To date, in each of the phase 1 safety trials no transfer-related serious adverse were identified. Moreover, with respect to the ED and the OAB study, no clinically related changes in EKG, clinical chemistry, hematology, or semen were found. Taken together, the results confirm that the technology works (ED trial) and that ICT appears safe for use in humans (ED and UI trials).

The long-term lack of adverse events related to the transfer of hMaxi-K and evidence of efficacy permit Ion Channel Innovations to proceed to phase 2 trials for ICT At the 2009 AUA meeting, Dr. Melman presented an update of the UI trial entitled: "Short and long-term safety of six escalating doses of hMaxi-K as potential therapy for moderate to severe erectile dysfunction of diverse etiology."

Dr. Christ presented a lecture entitled "Clinical Trial of Maxi-K Gene therapy for erectile dysfunction," Urologic Complications of Obesity and Diabetes, March 10-11, 2009, Baltimore, MD. This meeting was sponsored by the National Institutes of Health (National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK)).

2008

A recently completed preclinical study sponsored by ICI showed that in nonhuman primates, ICT enhances both erectile capacity as well as other important measures of sexual behavior (Christ et al., Eur. Urol., 2008; see publications for details). The data imply that increased erectile function per se may lead to increased sexual function. This work won a Best Poster prize and was selected as one of 35 newsworthy abstracts for the American Urological Association (AUA) Meeting in Orlando, Florida, May, 2008, and was presented at a press conference during the AUA meeting. At this same meeting, an update on the status of the phase I trial for ED was also presented as the press conference (Melman et al., Long-Term Safety Follow up of a Phase I Trial for Gene Transfer Therapy of ED with hMaxi-K. J. Urology 179: 426, 2008.

A recently completed preclinical study sponsored by Pfizer illustrated that combination therapy with low-dose gene transfer (i.e., ICT) and orally active agents (i.e., sildenafil) may increase the efficacy, and thereby, logically reduce any potential side effects of the latter. Such an interaction would be an important step forward and would increase the number of patients who are candidates for gene transfer therapy. This work won a Best Poster Prize Award at the European Association of Urologists meeting in Milan, Italy in March of 2008.

May 2007

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: http://webcasts.prous.com/aua2007/article.asp?AID=94&CID=YY&CLID=2

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 and also had a figure displayed on the front cover of the journal. The paper is preceded by two editorials (see news section for the entire editorial). More specifically, Dr. Arthur Caplan, Chair of the Department of Medical ethics of the University of Pennsylvania School of Medicine states, "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."