People living with pancreatic cancer find themselves facing devastating odds – the five-year survival rate is in the single digits, according to the American Cancer Rate.
Pursuing treatment often means dealing with the side effects of systemic chemotherapy, including hair loss, fatigue and neuropathy. Shaun Bagai and his team at RenovoRx think that their catheter could help usher in a targeted treatment option for these patients.
The company’s RenovoCath dual-balloon infusion catheter is designed to localize the delivery of chemotherapy to a pancreatic tumor, eliminating the need for systemic chemotherapy and its associated side effects. In a 20-person first-in-human study, RenovoRx’s technology extended one patient’s survival to 31 months past their diagnosis, Bagai touted.
The FDA has granted RenovoCath orphan drug status and even approved an investigational new drug application to proceed directly to a Phase III pivotal trial, the chief executive added. In a 300-person Phase III trial, the company’s technology is going head-to-head with systemic chemotherapy, with a primary endpoint of overall survival.
Bagai is no stranger to the medical device world – he ran TransVascular’s clinical research program until the company was acquired by Medtronic (NYSE:MDT) in 2004, at which point he stayed on at the medtech titan in a clinical marketing manager role.
“I know what resources to tap into in a larger company for the things that we can’t do. But I also know that we, as a small company without all the red tape and bureaucracy, can quickly move things along the pathway,” Bagai said. “We were able to file an IND with the FDA and receive IND approval to move forward with our Phase III trial within four months of meeting the FDA for the first time to discuss the project.”
The company’s technology has already made significant progress on the device side of the FDA – it won 510(k) clearance for the delivery of therapeutics, including chemotherapy, to segments of the peripheral vasculature system. But upon review with the U.S. regulatory agency, Bagai and his team decided it would be best to follow the regulatory pathway designed for drugs.
The regulatory track for combination products can be murky – it’s not always clear which regulatory route a company should pursue. But Bagai said that any concerns he held about following the FDA’s pharmaceutical path were set aside at a pre-IND meeting with the agency.
“They were extremely collaborative and gave us a roadmap to what we needed to do to be successful, which was an amazing experience,” he said. “I’ve worked with the FDA my whole career, I’ve never seen this level of collaboration before.”
In late May, the 12-person company closed a $7 million tranche in a $10 million round, led by Boston Scientific (NYSE:BSX), to fund the development of RenovoCath. Bagai explained that as CEO, part of his job is keeping strategics interested in what his team is building.
“Boston Scientific became an obvious partner as they grew their oncology division and as they saw our data,” he said. “We’ve really focused on building something that may be a nice fit in with one of those companies down the road.”
The year ahead is all about executing on their clinical development program, he added.
“I think the most successful med-therapy companies that you see really focus on the data and on getting the right care to patients. Where we see technologies falter is when they go to market and they hire a sales force and the data is not strong,” Bagai said. “And the fun part about being this small and nimble is that we may be able to quickly go from initial approvals, to patients, and hopefully into the market in the not-too-distant future.”