(EDITOR’S NOTE: This is the final article in a multi-part series exploring the evolution of Provectus Biopharmaceuticals Inc., a Knoxville-based company that traces its roots to research undertaken at Oak Ridge National Laboratory. Since its founding in 2002, the company has experienced a rollercoaster history even for a biotech company. Today, the leadership team that resurrected the company several years ago has it on what they believe is a well-defined path to successful commercialization of drug products in the next few years.)
“We believed in what we had with Provectus and PV-10 when we took it (the company) over,” Ed Pershing says. “We now know it to be true.”
To underscore that point, Dominic Rodrigues, Vice Chair of the Provectus Biopharmaceuticals Board of Directors, adds, “Data we’ve seen thus far represent the floor (of the impact of the drug on cancer treatment); we don’t know what the ceiling is.”
The two friends and business collaborators who have been jointly focused on the company and PV-10 since 2010 still have miles to go in their journey, particularly because of some high bars they have established. They include: (1) taking it as far as they can rather than being acquired; and (2) ensuring that its drugs are accessible to as many people as possible, including those in poverty-ridden areas of the U.S. and the world, by making it affordable, unlike the horror stories about drugs today.
To do so, Pershing, Rodrigues and the rest of the Provectus team are singularly focused on validating both the safety and the efficacy of the drug through on-going clinical trials. They see it as a platform technology that can be used to address a variety of cancers as well as many other applications like in dermatology.
What causes these two leaders of Provectus to be so optimistic after the rollercoaster they have ridden for nearly a decade?
“We are confident about its mechanism of action,” Pershing says in terms of how PV-10 works. Using an analogy that we and hopefully our readers understand, he asked us to imagine a bowl that contained fruit of some type and marbles. The fruit represents a cell with cancer while the marbles represents healthy cells. If PV-10 was added to the bowl, the fruit would absorb it, but the marbles would not.
“Suddenly, I see people understanding,” Pershing says in terms of the mechanism of action. PV-10 accumulates in the lysosome of the cancer cell and is able to differentiate between healthy and diseased cells.
“That’s why it is agnostic to types of cancer,” he adds. That’s because of the way in which an individual’s immune system reacts to the death of the diseased cell.
“This isn’t us saying anything new,” Rodrigues says, citing the work of Christian de Duve who won the Noble Prize in Physiology or Medicine in 1974 for his work that characterized how cells die. “We are standing on the shoulders of a giant.”
Using another analogy – “we’re just pouring the footers for this enterprise,” Pershing says, “We’ve taken it to some of the leading institutions to explore not just its (PV-10’s) treatment benefits but also its healing properties. There are many more applications beyond cancer to be evaluated.”
That said, Rodrigues also notes that “we have to take it farther if we want to impact affordability.”
So, the Provectus team has refined its drug development plan to focus on certain diseases, developed a Scientific Advisory Board, and continued to raise funding.
“We have to think about the finish line . . . what will it look like,” Rodrigues says, citing two pathways – metastatic endocrine cancers and metastatic uveal melanoma. Regarding the first one, he says that “PV-10 alone is capable of showing systemic benefits.” For metastatic uveal melanoma, he sees the pathway as combining PV-1o with two immunotherapies.
Provectus has trials underway in both areas.
“We’re trying to make everything better,” Pershing says.
NEXT: Look for more updates throughout 2020 on the progress of the Provectus team.