Scarring
Product Candidate Description
The scar product, SLO, is a single molecule which is a non-toxic form of a common bacterial toxin. It has been shown to be efficacious in the treatment of both internal (adhesions, movement restrictive, Schatzkis ring, cirrhosis) and external (burns, acne, surgical, trauma-induced) scars. It has also demonstrated utility in lessening or preventing scars if used prior to surgery, and has been associated with no adverse effects.
Laboratory Status
Cell culture work indicates that SLO has several mechanisms of action, including:
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mobilization of hyaluronic acid in the immediate area of injury;
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stimulation of CD44 receptors, leading to controlled fiber alignment;
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increases collagenase activity in the area of old scars to break down scar tissue prior to replacement with more vital tissue.
We have also completed gene array assays that indicate mechanism of action of the scar product as evidenced by the up- and down-regulation of various genes associated with the extracellular matrix as well as with inflammation and immunity.
Studies have been conducted with ex-vivo human skin samples that show tissue treated with this formulation heals from both inside-out and outside-in. A paper on this work was published in the peer-reviewed journal, Wound Repair and Regeneration, and another paper is in preparation.
Clinical Status
Anecdotal experience in dogs, cats, horses, and humans has demonstrated efficacy without adverse effects. Consistently positive results have been recorded in conditions ranging from decreased facial scarring (human), improved fertility (human, equine), improved range of motion of joints (all species), and several other indications. Complex disorders such as polycystic kidney disease, claudication, and cardiomyopathy appear to respond this therapy.
Path Forward
A complete toxicology program will have to be completed for this molecule because of its origin. Although it is a well-studied entity, it has never before been used clinically. An IND application will be filed upon completion of the toxicity study, and more complete mechanism-of-action experiments will be initiated.