Right now there is hypochlorous acid, or HOCl, on the immunological front lines in the bodies of people fighting infections, doing its job as an inorganic bactericidal compound of the innate immune system to destroy a wide spectrum of pathogens. Although still not used as a pharmaceutical drug, the important role of hypochlorous acid in biology is only recently emerging, in addition to its well-documented germicidal properties. For example, research by Serhan Sakarya, MD, et al. shows that HOCl in stable form is an ideal wound care solution with a powerful and rapid killing effect on different types of microorganisms, biofilms and microbicidal effect within the biofilm.
This and other research squares with what distinguished dermatology experts recently had to say about the Microcyn-based products of Oculus Innovative Sciences (NASDAQ: OCLS). The Microcyn-based franchise includes products generated through a patented electrochemical treatment of dilute saltwater, which creates a pH neutral solution of hypochlorous acid that is similar in nature to the potent natural HOCl in the human body. These products, branded as Alevicyn and Celacyn, have FDA clearance for use as treatments for wound healing, scar management and more.
Speaking at a virtual round table hosted by Maxim Group discussing breakthroughs in dermatology, Dr. Adam Friedman explained that hypochlorous acid has historically been acknowledged for its antiseptic properties, “But the truth is, it’s much more than that” and it “can have a very important role in modulating and regulating the immune system.” Dr. Friedman is an Associate Professor of Dermatology at the George Washington School of Medicine and author of more than 140 published papers and two textbooks with an emphasis on emerging medical technologies.
He detailed the ability of hypochlorous acid to directly interact with proteins to minimize inflammation and itch, including activating alpha-2-macroglobulin from an inactive state to “a sponge gobbling up numerous inflammatory mediators as well as pro-itch mediators.” Published in the peer-reviewed journal The Journal of Clinical Investigation, Thomas Leung, et al. discovered that hypochlorite, the sodium salt of HOCl, reversibly inhibited the expression of CCL2 and SOD2, two Nuclear factor-?B (NF-?B)-dependent genes, a culprit in inflammatory diseases. In conditions such as atopic dermatitis (eczema), controlling inflammation and itch is critical. In some eczema cases, the itch can be so intense that the sufferer can’t sleep, while skin lesions caused by scratching can lead to infection.
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A natural pathogen destroyer, hypochlorous acid has been an unsung hero for its multiple roles in treating dermatological conditions. Even though not designated as an antibiotic, the unique mechanism of action of hypochlorous acid to swiftly and thoroughly destroy bacteria makes it virtually impossible for resistance to develop, according to Dr. Friedman. Drug resistance has become a hot button topic with governments and global agencies, including President Barack Obama and the World Health Organization, calling for immediate action to combat antibiotic resistance before the world returns to the antibiotic dark ages.
“[It’s] not just about killing bacteria, but it’s actually modulating the dysregulation of these various pro-itch, pro-inflammatory mediators,” explains Dr. Friedman.
Dr. Neal Bhatia, Associate Clinical Professor and Interim Program Director in the Department of Dermatology at Harbor-UCLA Medical Center in Los Angeles, says both dermatologists and non-derms often have a knee-jerk reaction to use topical steroids as adjunctive treatments for itch and symptomatic relief of conditions such as actinic keratosis. These practices “unfortunately, will undo the inflammatory benefits that we’re trying to accomplish,” according to Dr. Bhatia. Dr. Bhatia is a prescriber of Alevicyn and has been published on the product and its efficacy.
Dr. Bhatia sees many tie-ins as to the benefits of Microcyn products by addressing basic symptoms while tackling issues with drug resistance and the lack of good topical antibiotics in the derm space to provide “a long-term benefit without any sort of consequence.”
Derm doctors may have been realizing the benefits of hypochlorous acid without actually recognizing it, as natural hypochlorous acid is, in a rudimentary sense, similar to diluted bleach, though diluted bleach is unstable and more reactive in nature. “Bleach baths,” soaking in a tub with diluted common bleach, are frequently used to treat moderate to severe eczema, but are inefficient and carry risk because if not mixed properly, the bath can further irritate already sensitive skin. To get the greatest benefit and capitalize on hypochlorous acid, the right set up and delivery system of a stable molecule is necessary, such as that with Microcyn-based products.
Dr. Firas George Hougeir, a board certified Dermatologist as well as Fellow of the American Society for Mohs Surgery, elucidated on additional benefits of Oculus products in his areas of expertise in both surgical and non-surgical applications.
Adoption of new products in wound healing and scar management is of particular importance today considering the American Academy of Dermatology is calling for patients to avoid antibiotics following biopsies, Mohs surgery and even standard excisions. Dr. Hougeir, who already avoids antibiotics as much as possible, shares this sentiment, stating, “there’s absolutely no proof that using an antibiotic decreases the rate of infection any more than using, for example, Vaseline.”
In Mohs micrographic surgery, layers of skin are removed one by one to eradicate cancerous tissue, leaving only healthy cells intact. Mohs is the most effective technique for removing Basal Cell Carcinoma and Squamous Cell Carcinoma and its use is widening into other types of skin cancer. The surgery is often done on the face and the wounds are left open, so decreasing the odds of infection developing and promoting optimal healing is paramount. Dr. Hougeir, who commented that he doesn’t believe hypochlorous acid is bleach in any way, thinks that once dermatologists and surgeons start to understand the multiple facets to hypochlorous acid (antipruritic, anti-inflammatory, debridement, increased oxygenation, safety, etc.) that it will be used “very, very much more commonly.”
Part of broader acceptance could be driven by the Microcyn-based products serving as a viable option to steroids or, at the very least, an adjunct therapy to reduce steroid use. On the wound sealing front, results from Celacyn, a hypochlorous acid combination with a modified silicone dimethicone, are shown to be comparable to more expensive full silicones with added benefits that full silicones lack.
As early adopters, Dr. Friedman believes that once dermatologists and surgeons are educated on the underlying mechanisms of hypochlorous acid that they will “connect the dots very quickly.” Dermatologist are faced with endless substitutions for things that don’t work and more “me too” drugs than novel technology at a ratio that can’t even be described, according to Dr. Friedman. Oculus’s products are an answer to these challenges, and at a reasonable price.
Potential uses go well outside the parameters of dermatology and surgical centers, expanding into wound healing centers and for itch related to indications such as renal failure, liver disease, hematologic problems and malignancy. Many people discount pruritus (severe itch of the skin) and the reality that it is an actual disease as defined by the American Academy of Dermatology and associated with primary skin disease, underlying medical problems and side effect of medications. Yet, there are very few effective options for patients. Dr. Friedman says he uses Alevicyn for many different types of itch and sees that it works “across the board” because of its mechanism of action to attack the problem from every angle.
Dr. Friedman’s passion shone in his concluding statement, “If you could stop the patient’s pruritus, you stop their itch, which is driving them crazy, to changing their day-to-day; change their ability to interact with people, work, sleep just that one person, you’ve made a huge difference and that’s why we need products like this and it’s great that we have it available to us.”
Investors in companies that have been pursuing approvals in the dermatology space, such as Vitae Pharmaceuticals (NASDAQ: VTAE), Vanda Pharmaceuticals (NASDAQ: VNDA) and Aquinox Pharmaceuticals (NASDAQ: AQXP) may want to perform some due diligence here. Oculus Innovative Sciences has developed a platform technology with applications across indications, and dermatology experts have been seeing very positive results with their patients.