As doctors and researchers around the world work to identify treatments and vaccines for the novel coronavirus, a team from New York’s Capital Region has been testing a cancer drug on COVID-19 patients.
WAMC's Jim spoke with Dr. Stephen Wrzesinksi of New York Oncology Hematology about the research just published in the journal Science Immunology.
Wrzesinksi: This study was published as a case series and what it looked at, or 19 patients 11 patients that required high levels of oxygen in the hospital, and eight patients that had to be intubated and ventilatory support, all with severe COVID-19 disease. And what we look at is whether or not off label treatment with a lymphoma drug called Acalabrutinib would help these patients. And the reason why we looked at this drug is this drug targets a specific enzyme called BTK or Bruton’s tyrosine kinase and B cell lymphomas. That's what it's used to treat. But it can also target this enzyme and other immune cells are thought to be responsible for this hyper inflammatory state in the lungs that can develop and patients with severe COVID-19 illness. And by targeting this enzyme in those cells, predominantly macrophages, it can reduce that inflammatory response or at least that was the hypothesis reduce the inflammatory response and help these patients recover from the illness quicker. What we found were in the 11 patients that did not require intubation, but received the drug, nine of those patients did extremely well. They did not require oxygen. After several days of receiving the drug, and were subsequently able to go home. At the time of the data cutoff, one patient was still requiring supplemental oxygen and was hospitalized and one did pass from the illness. And then in the intubated patient, four of the patients were successfully debated from ventilatory support. Three of those patients were able to go home off of oxygen and one patient is currently at a rehab facility on we had something called a tracheostomy because he had been intubated for a while, sometimes they have to put this tube called a trick tube to help them breeze. The other four patients unfortunately, passed. And so what we think at least from this preliminary data, and again, this is only a case series, it really does need to be validated with a prospective clinical trial is that this drug can potentially help patients that are requiring supplemental oxygen following infection of the disease and maybe prevent them from having to be intubated. That's, you know, that's where we think this drug may be useful for I think the intubated patients, we did see some improvement and half those patients Again, it's a small number and it'll have to be studied in a prospective clinical trial.
Levulis: We've heard that preventing a patient from being intubated is key, as far as the anecdotal evidence does suggest right now, to potentially a positive recovery. Is that is that fair to say at this point?
Wrzesinksi: I think so it's fair to say that if we can prevent the intubation, those patients, at least from the, what I am aware of those patients tend to potentially do better. And we were treating patients when they were intubated very early on. In the course of the intubation we offered it within 24 hours of intubation, because we know that patients with prolonged intubation can develop other problems, including multi organ failure. And we weren't sure that that would be able to help those patients. So he's certainly trying to provide. The intubation could be very helpful for these patients. And that would be something that we would look at in a prospective clinical trial fashion.
Levulis: So can you kind of take us through the next steps for this study?
Wrzesinksi: Absolutely. So the next steps is to open up a phase two clinical trial. And we are in the process of trying to open this up at St. Peter's Hospital, where we did the initial off label evaluation. And that phase two clinical trial is going to look at patients receiving hospital care, kind of the standard of care supportive care with the Acalabrutinib versus a group of patients receiving hospital supportive care, which can also include antiviral care with remdesivir, and that will help us determine what kind of impact adding this drug to the current standard of care for these patients will.
Levulis: And how did this study start? So why NYOH and why St. Peter's?
Wrzesinksi: Absolutely. So the story that started all of this, we are part of a larger network across the country called us oncology research. And one of my colleagues in Oregon, Dr. Jeff Sherman was very involved in developing this class of drugs called BTK inhibitors for lymphoid malignancies. And he has been working with the company that has developed this drug, as well as our colleagues at the NIH to determine whether or not this may be a valid approach to try to help patients with a severe respiratory illness. And there have been some pretty significant preclinical studies looking at this drug in animal models where they have inflammation in their lungs and the drug this class of drugs when given to these animals reduce the inflammation in the lungs following a viral infection in the lungs. So between all of that information and the NIH, Walter Reed Hospital, evaluated this drug initially in two patients and saw an incredible response in those two initial patients treated, we were invited as part of the network to participate in this evaluation of this drug in an off label fashion. And our site was chosen because of our involvement in clinical research, in all bidding, as well as the fact that we had a large number of patients in New York state affected by this pandemic.