A Rome native and member of the Rome Science Hall of Fame is being lauded for his development of antimicrobial compounds, now in clinical trials, to help fight cystic fibrosis and could potentially be used on COVID-19 patients.
Dr. Philip Domenico, retired research director of Infectious Diseases at a teaching hospital in Long Island, now New York University Langone Health, said three major milestones of his career were achieved last month.
“For one, we settled a decade-long lawsuit with the company developing my invention, which puts my name on all their patents as co-inventor,” said Domenico. “Secondly, the drug candidate was given orphan drug designation by the FDA (Food and Drug Administration). Thirdly, the company procured a $17.1 million grant from the Cystic Fibrosis Foundation and a Boston investment firm, CARB-X, to continue studies on an aerosol form of the drug designed to eradicate bacteria from the lungs of cystic fibrosis patients and those with other bacterial lung diseases.”
What’s astounding about Domenico’s new drug is that it would include COVID-19 patients, many of which succumb to a secondary bacterial infection in their lungs. The company developing the researcher’s drug is called Microbion Corporation, headquartered in Bozeman, Mont. According to the company website, Microbion is a clinical-stage pharmaceutical company developing a novel class of compounds for the treatment of difficult-to-treat infections, including chronic infections and antibiotic-resistant infections.
One of those compounds is pravibismane, which Domenico helped develop. On May 4, the company announced it agreed to enter into a settlement agreement with NYU Langone Hospitals, resolving litigation between them. The settlement agreement included a licensing agreement with NYU Langone where Microbion is assigned NYU Langone’s rights to certain patents related to the bismuth-thiol (BTs) technology jointly developed by Dr. Brett Baker of Microbion and Dr. Domenico of NYU Langone and is licensed certain other NYU Langone rights related to BTs. Microbion and NYU Langone agreed that Drs. Baker and Domenico are joint inventors of three patents granted to Microbion by the federal Patent and Trademark Office, according to the company’s statement.
“We are grateful to Dr. Domenico for his initial foundational research on bismuth thiols. Microbion has since improved upon them to create pravibismane,” said Dr. Brett Baker, Microbion’s president and Chief Scientific Officer. “Pravibismane is Microbion’s lead therapeutic candidate and the first compound in a new class of microbial bioenergetic inhibitor agents.”
On May 28, Microbion announced that the FDA granted orphan drug designation for inhalation delivery of pravibismane (BisEDT antimicrobial suspension) for treatment (management) of pulmonary infections in patients with cystic fibrosis.
“We are pleased to have been granted orphan drug designation for our pravibismane inhalation program,” said Mr. Karim Lalji, chairman and CEO of Microbion Pharma Corp. “This designation is consistent with our steadfast commitment to develop innovative solutions to manage chronic pulmonary infections in patients with CF. We will work closely with the FDA and key stakeholders to advance inhaled pravibismane toward regulatory approval for the benefit of patients with cystic fibrosis.”
Pravibismane (inhaled suspension formulation) has also been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA, for the management of cystic fibrosis (CF)-related pulmonary infections.
Pravibismane is the first in a new class of anti-infective drugs structurally unrelated to other clinically utilized antibiotics with a mechanism of action that functions as a microbial bioenergetic inhibitor. Pravibismane exhibits broad-spectrum antimicrobial
activity against CF-relevant pathogens including carbapenem — and multidrug-resistant Pseudomonas aeruginosa — as well as other multidrug-resistant pathogens that are recognized as serious threats to CF patients. Pravibismane also demonstrates potent activity against the microbial biofilms formed by these bacterial pathogens, Microbion officials said.
And then on May 28, Microbion was awarded up to $17.1 million from CARB-X and the Cystic Fibrosis Foundation to advance the development of antimicrobial drug pravibismane for the treatment of cystic fibrosis (CF)-related pulmonary infections.
The $11.5 million in funding from CARB-X and the up to $5.6 million in funding from the CF Foundation will enable Microbion to complete preclinical and Phase 1 studies. The CARB-X funding will also support manufacturing pravibismane drug product for clinical studies.
CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership dedicated to supporting early development antibacterial R&D to address the rising threat of drug-resistant bacteria.
A substantial number of COVID-19 patients get a secondary bacterial infection in their lungs that carries a bad prognosis, and is usually the reason for death, Domenico explained. Microbion may now do some direct testing in these terminally-ill patients in a compassionate care setting using pravibismane.
“They did the same for diabetic wound patients and saved over 500 limbs from amputation,” said Domenico. “Right now it’s all about getting the funding and getting through clinical trials. But it’s also about identifying unmet needs in medicine, so we don’t upset the status quo. There are many obstacles Big Pharma puts in place to stymy competition and control wealth. Microbion has had to keep from being shelved by the powers that be, long enough to make themselves too good to be written off.”
The researcher said another issue has been the lack of understanding in the medical community about the importance of biofilms.
“Most physicians look at you cross-eyed when you talk about it. And biofilms are involved in nearly 80 percent of all bacterial infections,” he said. “But it is getting better.”
A 1970 graduate of Rome Free Academy, Domenico received his associate’s degree in science from Mohawk Valley Community College in Utica, and then went on to earn two bachelor’s degrees in biology and psychology in 1975 from the State University at Albany.
Domenico would then serve three years in the U.S. Army as a medical technician at a reference laboratory in Germany, which sparked his career in infectious diseases. His graduate training was in microbiology and biochemistry at the University of Texas Health Science Center at San Antonio and Texas Tech University Health Sciences Center in Lubbock, where he attained his doctorate in microbiology in 1983.
Post-doctoral training was completed at Rockefeller University in New York, and the LSU Medical Center in New Orleans. In 1987, Domenico became director of the Infectious Disease Research Laboratory at Winthrop-University Hospital, and attained associate professor status at Stony Brook University School of Medicine. In this capacity, Dr. Domenico created his novel class of antimicrobial compounds, the bismuth thiols (BTs).
They are the first anti-biofilm, or anti-slime, agents to be considered for FDA approval, and are now in Phase 2 of clinical trials as a topical cream for wound infections. Biofilm is a cluster of microorganisms that grows on surfaces, like plaque on teeth, which microbes use to cause infection.
The aerosol form of BTs is approaching Phase 1 trials for lung infections.
With the recent breakthroughs, Domenico can’t quite enter into retirement mode.
He and wife Gloria, “are basically downsizing in just about every way right now. We just bought a small home in the Berkshires, but will keep our Pied e terre in Manhattan a while longer. We’ve been volunteering as gardeners for the Central Park Conservancy these last dozen years. Now we’re looking for volunteer opportunities in western Massachusetts,” Dr. Domenico reflected. “We try to support all of our causes with money and time. I’m trying to get my father’s art seen, along with my brother Orin’s poetry. (Orin runs the Cafe Domenico in Utica). There’s more genius with those two than with anything I did. Indeed, I like being part of a trio of greatness. And, of course, Gloria and I want to travel the world.”
“Success with the BTs would change everything, of course,” he continued. “I have a vested interest and stock options in Microbion, so I’m rooting for them. If the money comes in, millions of it will be directed toward research at NYU-Langone, the company that bought Winthrop-University Hospital, and I will be overseeing those research funds. They’ll likely reinstate me at the university in some capacity.”
In 2005, Domenico switched careers to nutrition after “passing the BT baton to Microbion Corporation,” he said. Dr. Domenico was part of technical services for several food and supplement companies, and has his own blog on nutrition — https://thescienceofnutrition.me, and website, https://www.naturalnews.com/Author264.html.
“I was a technical services guy at several nutrition companies, where I supported the science and formulated new products,” Domenico explained. “The merchants of the world think I’m a fool for not being rich many times over at this juncture. Plus, I won’t see much of the proceeds from my invention, because I’m not part of the business end of things. I had those opportunities, but shunned them. I was put on this earth to be curious, creative, playful and helpful in my field of focus. It’s never been about money, except as far as it comforts us in old age. I am concerned mostly about my legacy and making the world a better place.”
Domenico is also the primary author of hundreds of articles and abstracts, and inventor of several patents regarding biofilms and nutrition. He was inducted into the Rome Science Hall of Fame in 2015. He and wife Gloria reside in Manhattan.
But when Domenico isn’t working on his latest inventions to fight bacteria and disease, he also dabbles in the arts, and has even written his own science fiction novel.
“I’m self publishing my sci-fi novel on my blog site: https://thescienceofnutrition.me. It’s a story about a slime pathogen, inadvertently created in a lab, that almost wipes out the world’s food crop. An anti-slime agent is developed in the lab that created the monster and comes to the rescue,” said the author. “Basically, it’s my life story with poetic license. It’s a treatise not only on biological slime, but also on the slime that infects politics, business and love. The story is about integrity, because it’s the lack of integrity that breeds slime, even among frank pathogens.”
He said, “Over 9 out of 10 serious illnesses from COVID-19 are in people who are already ill, mostly from poor lifestyles. Germs take down living things that are out of integrity. Our goal should not be about attacking germs, but rather about promoting health and immunity. This puts me at odds with drug companies, and with my own invention. There are obvious needs for drugs, but we can reduce that need ten-fold by changing our lifestyles and making nutrition part of national health care.”
Domenico also has a couple self-illustrated children’s books he plans to get published. They can be seen in part on his Facebook page: https://www.facebook.com/pdomenico33.