Results of the completed phase I trial show:

1. The technology works!

2. We have proven that a recombinant gene in a safe vector can be directly instilled into a local, targeted organ of a human to create a tissue specific, physiological, long-lasting effect without significant transfer –related side effects.

There is a significant difference between conventional viral based gene therapy and the Ion Channel Innovations technique. First, because we are targeting organ-specific problems, not cancer or inherited problems, every cell of the target organ or tissue does not have to be altered. Thus, we can use the safest known vector to effect the gene transfer. hMaxi-K uses a “naked,” non-viral human cDNA.

As shown to the left, with naked DNA, there is lack of integration into the chromosome of the cell. The hMaxi-k does its job in the nucleoplasm of the cell and very unlikely to become a permanent component of the cell’s DNA.

Naked DNA is not allergenic. Many of the problems associated with viral vectors are related to the allergic reaction created by the virus as the body fights to rid itself of the foreign body. That does not happen with naked DNA.

The naked DNA is not permanent and the transfer needs to be repeated. In our pre-clinical trials the interal is about 6months.
The rationale for using ICT for ED and UI is that the Maxi-K channel plays a critical role in modulating smooth muscle tone for both penile and bladder smooth muscle cells.
Furthermore, a single administration of the gene product to the bladder has been shown to restore normal bladder function in rats with documented hyperactivity. If these results are reproduced in humans in the upcoming clinical trials, this will represent a major breakthrough in the treatment of ED and UI.

Ion Channel Therapy is a novel approach to relieve conditions resulting from smooth muscle spasm by enhancing the natural molecular mechanism that elicits smooth muscle cell relaxation. Smooth muscle cells are linked via pore connections called gap junctions. These junctions provide a channel that permits the intercellular exchange of ions, such as potassium and calcium, which regulate the functional relaxation and contraction of smooth muscle cells.

A. Shows a cell with hMaxi-K producing extra potassium channels that when open make the cell membrane more negative and close the influx of calcium ion into the cell. B. Shows a contracted smooth muscle cell that becomes relaxed when the influx of calcium is blocked by the effect of the open potassium channel.

ICT causes these cells to make more potassium channels and consequently enhances the relaxation of smooth muscle cells. When the DNA comprising the gene that encodes for the synthesis of a key channel protein is introduced into the affected muscle cell, an increased synthesis of relaxation-inducing smooth muscle cell potassium channels occurs (A.). The DNA for this channel is the therapeutic element in ICT and cause the smooth muscle cell to relax (B).