Celularity receives FDA approval for early trials of a new cell therapy for COVID-19

Celularity CEO Robert Hariri joins Yahoo Finance’s Alexis Christoforous and Brian Sozzi to discuss potential therapy treatments for coronavirus.

Video Transcript

- I do want to bring in Dr. Robert Hariri. He is the CEO of Celularity. Doctor, good to see you this morning. You guys are doing some very important work in the fight against coronavirus, but using stem cells. Take us through that approach.

ROBERT HARIRI: Well, good morning. Actually, we're using both stem cells and immune cells, which are derived from those stem cells, in order to provide a boost to the immune system of these patients who are fighting this virus. So it's actually a great opportunity, and it comes on the heels of breakthroughs that occurred in immunotherapy for cancer. So this is an established methodology. We're just applying it to viral illnesses.

- So Doctor, have you been given FDA approval for this treatment, and have clinical trials begun? How quickly can that start?

ROBERT HARIRI: Yeah. So we received clearance from the FDA, who accepted our IND, our Investigational New Drug application. And we are now, as we speak, treating patients, first to demonstrate the safety of this approach, and then immediately thereafter, we're going to be looking at demonstrating that this is having an impact on reducing the viral load. A very important strategy here to treat these patients is prevent the virus from overwhelming the immune system.

ALEXIS CHRISTOPHOROUS: So would this be given, if and when it hits market, Doctor, to those who already are showing symptoms? Would it be a certain class of people? Would it be older folks who would be getting this treatment?

ROBERT HARIRI: Great question. So what we know is that there is a difference between people who get infected and develop serious disease and those of us who can get by this with minimal symptoms. In fact, many people don't even know they have this. It's all based upon the integrity of our own immune system.

And so what we are proposing is that this product is used in patients who are documented to have the virus, but are early enough in the development of symptoms that we can have an impact on keeping that viral load from ever spiking. If you can do that, we believe we can control the serious adverse effects, such as these serious pneumonias that are killing people.

- Doctor, where do you stand on hyrdroxychlorquine? Do you think that should be used to help fight coronavirus?

ROBERT HARIRI: So here's the bottom line. I know that there's controversy because some people believe in the absence of a double-blinded, placebo-controlled, randomized study, there's no justification for using it. In my mind, that's the difference between academic medicine and battlefield medicine.

Right now, we have a product that's inexpensive, that has been around for 60 years. Perhaps 10 million or more patients have been exposed to this product with a very good safety record. The doctors who prescribe it think that this is as safe as any other product. And in the face of doctors on the front lines reporting that they believe this is valuable, we should be using it. And you know, I've got to tell you, I think that news will be out shortly that's going to validate that this is an important part of the management of this disease.

ALEXIS CHRISTOPHOROUS: And Doctor, talk to us about a possible timeline for your cell therapy treatment. I mean, realistically, how long must we wait for something like this to be used by a large number of people?

ROBERT HARIRI: Listen, Celularity, my company, like others, we're working around the clock to accelerate the development and creation of the dataset necessary to get our approach approved and used by patients. I believe that in 30 to 60 days after initiating the treatment of these patients, we're going to see data that can support what we're doing.

The beauty of what we do is that it's highly scalable. We can produce these products to the scale necessary or forecasted for this pandemic. It comes from a very, very renewable, reliable source, the postpartum placenta. And we're hopeful that in a very short period of time, the data will be so compelling that we'll get an accelerated review by the FDA, who's done a heroic job in working with groups like ours. And we are hopeful that we'll be able to start treating for more patients in the matter of a few months.

- All right. Dr. Robert Hariri, the CEO of Celularity, keep on the fight. You guys are doing some real important work. Thanks for taking some time.

ROBERT HARIRI: Thank you.