Dana Ferraris has devoted years to medicinal chemistry and drug discovery, and he developed a cancer drug called cedazuridine over a decade ago. Now, it’s been approved.
Last month, the Federal Drug Administration approved cedazuridine, which is intended for adult patients with myelodysplastic syndromes, or MDS, a group of cancers in which immature blood cells in the bone marrow do not mature and cannot form healthy blood cells. This approval was based on clinical trial results that showed similar drug concentrations between intravenous decitabine and Inqovi, the trade name of the combination of cedazuridine and decitabine in pill form, according to an FDA news release.
About half of the patients who were formerly dependent on transfusions were able to no longer require transfusions during an eight-week period. The decitabine is designed to destroy the cancer cell, and the cedazuridine gives decitabine a chance to work.
“You know, this was like the perfect storm being able to have this happen,” Ferraris said. “It still feels kind of surreal, but it’s a neat story. You get congratulatory emails from people, and you don’t really know the impact you’re going to have, right?
“You think, wow, that’s pretty special. It’s a little bit surreal.”
Ferraris, an associate professor of chemistry and department chair at McDaniel College, received his doctorate in chemistry from Johns Hopkins University in 1999 and an MBA from the university’s Carey Business School in 2009. He jumped into the pharmaceutical industry after graduate school; career paths in medicinal chemistry and drug discovery are typical for organic chemists, he said. He worked at a biotech company called Guilford Pharmaceuticals in Baltimore for about six years before it was bought out by a mid-sized pharma company.
Ferraris felt lucky to be retained after the buyout, he said, but the company turned its focus to anti-cancer projects instead of central nervous system projects. That’s where his journey to reaching his drug discovery milestone began.
The company was bought out again a few years later by a major pharmaceutical company, and the site was shut down within a year. Ferraris and other members of his research group shifted to Johns Hopkins Medicine and essentially started a drug discovery group in an academic setting.
“One thing I was able to do when I was there was mentor students,” he said. “We typically got undergraduate students over the summer, and I really enjoyed that part of my job. I ended up parlaying that into a visiting teaching position at Stevenson University for one year. I got some experience there and ended up at McDaniel the next year.”
Across the industry, the average drug costs about $2.5 billion to go from initial development to approval, Ferraris said, and clinical trials with humans can take anywhere from 10 to 15 years. He was fairly new to medicinal chemistry when the cedazuridine project began in 2009, and the third and final clinical trial was completed in 2019.
Ferraris said there are two phases to drug discovery: the discovery phase and the clinical development phase. If the compound is safe and can be taken in pill form, it moves into clinical trials with humans. Phase 1 tests the drug for safety and tolerability in healthy humans, Phase 2 involves a small group of patients with the disease in a double-blind study and Phase 3 involves thousands of patients with the disease in a trial lasting several years.
The discovery phase for cedazuridine took about a year, Ferraris said, with a little bit of pushing to get the compound recognized for research.
Ferraris said he heard the news of the FDA approval from a colleague he worked with to discover cedazuridine and get it developed. He notified McDaniel’s public relations team and celebrated the achievement with his wife and a bottle of Dom Pérignon champagne.
“I was thinking to myself, this is my last shot on goal, I’m not going to be developing drugs in academia probably, so if it gets through, then this will kind of be a notch in my cap,” Ferraris said. “It’d be kind of neat, and, sure enough, the FDA approved this a year later.”