“We have created chemistries that are hundreds to thousands of times stronger than other (antimicrobial) product currently on the market, are compatible with human and animal tissue, and have been found to be safe.” explains Hoji Alimini, Co-founder/CEO, Spectrum Antimicrobials.
As part of our ongoing Vascular Innovation Series in conjunction with The Way to My Heart, Emmy Award-winning Journalist Kym McNicholas interviews Spectrum Antimicrobials Founder/CEO Hoji Alimi.
The leading cause of amputation in the US is diabetes-related wounds that don’t heal due to infection. Antibiotic resistant bacteria are often to blame. Resistance occurs when bacteria change in response to the use of certain medicines and, over time, the medicines can’t tackle new mutations. Once antibiotic resistant bacteria set in, treatment options for a patient are limited. Spectrum Antiomicrobials is trying to change that.
Spectrum Antimicrobials has developed a solution that mimics the body’s own immune system by producing hypochlorous acid (HOCl), a natural occurring chemical produced by white blood cells to fight infection caused by invading pathogens. It is also free from alcohol, steroids, antibiotics and has been clinically proven to be non-toxic. They’re first product Vetricept, is already cleared for use on animal wounds, and will be submitted to the FDA for approval imminently for use in wounds and dermatology. Other future applications also include a solution for CPAP machines and hand sanitizer to control infections with an initial focus on COVID-19.
Hoji Alimi, founder and CEO of Spectrum Antimicrobials explains how he developed the product, the impact on patients, and the countless use-cases for a solution that isn’t susceptible to becoming antibiotic-resistant.
What is the story behind the technology? Where did it originate?
Hoji Alimini: In the late 1990’s, while I was still working at my previous start-up, I was invited to evaluate a technology containing hypochlorous acid (HOCl) as its primary main active. After extensive testing, the HOCl solution, which worked by mirroring the body’s immune system, had proven to be a highly potent antimicrobial solution, and yet safe to skin and human tissues. The solution, however, was only stable for hours to days.
Frustrated, I decided to in-license the technology and began a multi-year endeavor to improve the chemistry and stability of HOCl. This dream was finally realized in early 2002, when I was able to produce the first shelf stable HOCl solution with 2-year stability. This invention led to a worldwide commercialization effort resulting in the treatment of more than 20 million patients globally and completion of more than 30 clinical trials around the world including a controlled randomized trial in the U.S. sponsored by my former company.
In 2007, the U.S. clinical trial was designed to evaluate the use of a topical stable HOCl solution against Levofloxacin – an antibiotic that had sold more than $2.4 billion dollars annually at that time. In this clinical trial, the topical HOCl solution showed 93% efficacy in treatment of mildly infected diabetic ulcers as compared to 56% efficacy with the use of levofloxicin alone. Stable topical HOCl had one remaining Achilles heel – it would become deactivated in presence of highly infected wounds with exudate and body fluids and blood serum. Therefore, larger volumes and higher concentrations of stable HOCl would be often required to treat an infection. The vulnerability of HOCl to becoming inactivated by blood serum and body fluids was a significant challenge to pass FDA’s standards as a potential drug candidate.
In 2015, I embarked on a new journey to develop the first chemistry of HOCl that would not become deactivated in presence of body fluids and serum and capable of consistently delivering more than 6-log reduction against super bugs and other pathogens. Today, Spectrum Antimicrobials has filed formulation patents on four distinct chemistries containing HOCl. These new formulations withstand the presence of serum and no longer become inactivated.
What need does it address?
Spectrum Antimicrobials is harnessing the power of human’s immune system and its chemistries to better control, prevent and treat topical and invasive infections. Spectrum Antimicrobials is now capable of developing specific chemistries of HOCl for use in a vast number of medical applications to control, prevent and treat infections including viral, bacterial and fungal infections. Some of these include pulmonary, ophthalmology, surgical, wound and skin care applications.
What is the potential for patient impact?
We believe our patent-pending platforms resolve the most important scientific barrier that faces topical anti-infectives as our products can be designed to not deactivate in the presence of blood serum or other organic loads. We have created chemistries that are hundreds to thousands of times stronger than other product currently on the market, are compatible with human and animal tissue, and have been found to be safe.
Furthermore, our product chemistries do not promote bacterial resistance as they are not antibiotics, instead they work as highly reactive ionic agents. We have five formulation platforms each with its own unique chemistry. We have received three issued patents, have four patent applications pending, and have more than 40 PCT applications filed worldwide to date. One of our product chemistries is currently under review by a potential partner for use as a potential pulmonary drug to treat viral and bacterial infections. SPC-069 is being developed to target pulmonary infections caused by coronavirus including pneumonia, bronchitis, flu and cold. We believe, SPC-069 may ultimately improve patient outcomes by reducing hospitalization rates, shorten treatment times, and reduce the potential for the emergence of new resistant strains of viruses and bacteria against the SPC-069 drug candidates.
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Our predecessor chemistries were approved worldwide and used in accordance with regional regulations. This included the use of HOCl solution in certain countries to effectively treat flesh eating bacteria post-debridement, treatment of children suffering from 2nd and 3rd degree burns while minimizing scaring and shortening hospitalization days.
Our new formulations are designed to replace the previous HOCl formulations in the market while opening new medical markets which current pure and stable HOCl product could not technically serve due to their immediate inactivation in presence of blood serum and short shelf life. Spectrum antimicrobials also recently launched VetriceptTM, a commercial product for the animal health space. In September 2020, we donated more than 1,000 units of Vetricept to U.C. Davis Veterinarian School of Medicine for use in the treatment of wildlife and domesticated animals that were injured due to the Northern California wildfires.
Where is the technology in development and what is next for the company?
The company has both commercial product as well as additional chemistries in its R&D pipeline.
The company plans to launch a non-alcohol-based hand sanitizer and disinfectant in in Q4 2020. In collaboration with SpectrumX, we are launching our differentiated Hand Sanitizer Product in the United Kingdom. Parties are in the process of finalizing packaging, labeling, and final pricing. We have provided over 9,000 gallons of bulk hydrogel hand sanitizer to SpectrumX to be bottled and distributed throughout England in the consumer market. The commercial efforts may launch as early as Q4 of this year. Under the terms of our agreement with SpectrumX, they have invested $2,500,000 in our company.
In addition to the Vetricept product launch we are launching a Pathogenic Resistant WaterTM for use in Continuous Positive Airway Pressure devices (CPAP) in The U.S. This product is formulated to prevent the growth of pathogen in medical devices which require water as a humidifier or cooling solution.
Next, we are working tirelessly to advance our pulmonary drug candidate SPC-069 in clinical trials in Europe and in The U.S. We anticipate the trials to evaluate the safety and efficacy of SPC-069 in patients infected with coronavirus-related respiratory infections.
How can patients, advocates, physicians, or investors get involved?
The company is seeking investors, medical advisors and partners. You may visit the company’s website spectrumantimicrobials.com and contact the company to receive additional information. Please send inquiries to firstname.lastname@example.org.