The Suit Magazine

That’s where Dr. Najafi’s company, NovaBay Pharmaceuticals, has entered the picture.
Founded in 2002, NovaBay is developing a proprietary class of compounds called “Aganocides.”  According to Najafi, chairman and CEO of NovaBay, “Aganocide compounds work by mimicking our own natural defense against infection. Since our immune system works without ever creating resistance, we have taken the effective and rapidly acting molecules that function within our own bodies and created stable analogs of these molecules.” 
How did Najafi wind up taking such an innovative approach in this key medical battle? “I grew up in Iran in a pharmaceutical family,” Najafi said. “My dad had a growing pharmaceutical company in the 1960s and ‘70s, and I worked for him as a sales rep.”

At 17, Najafi came to the United States to pursue his education. His plan was to return to Iran in order to run the family business, but historical events in Iran changed the course of Najafi’s career and life. “The revolution in 1979 [when the Shah of Iran was overthrown], forced me to stay in the US,” he said.

After finishing his first year as a pre-pharmacy major at the University of Pittsburgh, Najafi headed west, working towards a BS and MS in chemistry at the University of San Francisco, working for Professor Soderquist. Finally, he earned a Ph.D. in organic chemistry from the University of California, Davis. There, he worked with Professor George Zweifel, who had made a significant contribution in Organoboron chemistry, which led Professor H.C. Brown to win the Nobel Prize in Chemistry at Purdue University. “It was a very exciting field to be in the 1980s, so I stayed with that,” he said.
Najafi then went to work for Aldrich Chemical Company, where he continued to work with Professor Brown, a consultant to Aldrich. All in all, Najafi is very grateful to those mentors.  “Many people have inspired me along the way, people who took an acorn and grew it into a big oak tree,” he said, “and that has resulted in what we are trying to do at NovaBay.”

The class of Aganocide compounds being developed at NovaBay, is, according to the company website, “fast-acting, broad in spectrum of activity, effective against multi-drug resistant bacteria, effective against biofilm, and has a good safety profile.
“Our Aganocide compounds have killed, in-vitro, all bacteria, viruses, yeasts and fungi against which they have been tested.” 
Dr. Najafi adds, “They act rapidly and effectively to defeat multi-drug resistant pathogens without causing resistance. Our technology can kill all forms of MRSA. In one study, we have been to able treat 129 patients with active skin infections, and we were able to cure 92% of the patients at the highest dose,” an important step for modern medicine.

The NovaBay website further notes that, “The increase in antibiotic resistance since 1990 has been substantial and is especially prevalent in hospital environments. According to [one] State of Pennsylvania 2005 Report, 14% of hospital ICU infections were fatal, and those infections accounted for $2.9 billion in increased costs.” 
Najafi offers that, by replacing antibiotics in many applications, Aganocide compounds will have another benefit – reducing the bacteria’s ability to mutate and adapt, thereby prolonging the life of other antibiotics;  a win-win situation. 

NovaBay has been developing specific Aganocide compounds to target certain indications.  NovaBay’s lead Aganocide compound is currently in Phase 2 clinical testing for treating pink eye, impetigo and catheter-associated urinary tract infections. The company has also retained proprietary early stage programs that address large markets, such as onychomycosis or nail fungus. Najafi told us, “Our strategic goal is to meet or beat antibiotic performance in a number of indications.”

The mechanisms which explain the efficacy of Aganocide compounds are detailed at the website. “The body’s primary defense against infection is the anatomic barrier of the skin and mucous membranes. Once pathogens penetrate the primary defense, the next line of defense is provided by the white blood cells. The most numerous of the white blood cells is the neutrophil. When it encounters a bacterium or other pathogen, the neutrophil engulfs it and generates a series of small molecules with which to destroy it. The process in which these molecules are created is called the ‘oxidative burst.’ These molecules typically have a very short life as they are created ‘on demand’ to accomplish a specific task. We have focused our efforts on understanding these molecules and finding ways, primarily by chemical modification, to impart qualities to them to allow them to be developed as therapeutic products.”  
Of course, Najafi would not have enjoyed his success-to-date without being a pragmatist and businessman, as well as a scientist. “The best and brightest ideas without capital [don’t] go anywhere,” he said. “Good ideas should be financed properly, and we have been able to do that with NovaBay.”

The company has significant corporate partnerships with Alcon, the world’s leading ophthalmology company, and Galderma S.A., a global pharmaceutical firm dedicated to dermatology.  Dr. Najafi proudly reported that currently NovaBay has cash reserves of 11.5 million dollars. Because of its strong financial position, NovaBay has been able to weather the recent economic storm, even benefiting from one of its repercussions.

“On the positive side of things, we have been able to hire people who were laid off by big pharma,” he said. He’s been able to bring that positive attitude into current environmental concerns. By reducing the need for antibiotics, Aganocide compounds can help lead to a cleaner environment, offered Dr. Najafi. “Often, when using over-the-counter antibiotics, these antibiotics get washed off and end up in oceans and bays,” he said. “Bacteria end up mutating and essentially developing superbugs. Test the water from San Francisco Bay or the Hudson River, and you will find lots of low levels of antibiotics and sub-lethal results in terms of bacterial growth.”         

Thanks to the work of Ron Najafi and the rest of his staff at NovaBay, we are on the cusp of introducing a new type of drug which has immense potential benefit. Curing infections without antibiotics, thus reducing the likelihood and prevalence of superbugs – an outcome that can have profound implications on our future health as well as that of our planet. The results thus far achieved at NovaBay are laudable and, with Najafi at the helm, the future looks bright. 

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