This brief interview with Dr. Nasha Winters, ND, FABNO, and Dr. Channing Judith Paller, MD, from the Johns Hopkins University School of Medicine, gives an update on the clinical trial of intravenous (IV) mistletoe extract in patients with cancer. The interview was part of the celebrations at the Believe Big Fundraising Dinner 2018.
Host: Hey, it’s quite an honor for me to share the stage with you two. And I don’t refer to you as Dr. Paller and Dr. Winters, although that is what we should call you. But it is Channing and Nasha. And it is an incredible honor for me to share the stage with you because you are two of my heroes. And you have been part of this journey from the very beginning.
You believed that this was going to be something special from the very beginning. And to look now and to see what’s happened and all of the support and new leadership and new vision is pretty exciting. So, this trial that we’re in, Channing, I’m going to ask you to kick us off a little bit. Can you explain the trial design quickly and where we are today?
Dr. Channing Paller: So, we are doing a standard phase 1 trial: 3 plus 3 design. So, for those of you not familiar, it is where you put 3 patients on the trial at increasing dose levels until they develop a dose-limiting toxicity from the drug. And then we add 3 more patients until we reach the maximum tolerated dose. We have 8 dose levels planned, and I personally consented 12 patients since I last stood on the stage last year. Yes, that is huge. And we have about 18 to 24 more planned, depending how it goes.
Host: And can patients still—so obviously it is still opened, and we’ve got time to do that. What’s the time frame on that? How long will the trial remain open?
Dr. Channing Paller: Right. So, I am thrilled to say we’re going to probably take another 18 to 24 months to finish those because of some requirements that we have from the FDA. So, the FDA requires that I personally follow a patient for 28 days to make sure they’re safe before we give the next patient the drug. Because of that, it will take some time to complete this. So, 18 to 24 months.
Host: Fantastic, fantastic. So, Nasha. You were instrumental because of the work that you’ve done with mistletoe in helping us to advance from the initial design, which was going to be subcutaneous injection of mistletoe. And because of what you’ve done, it allowed us to jump right to the intravenous variety. So, tell us a little bit about, I know that Dr. Paller’s not able to share the specifics of the trial, unfortunately, so you need to let us in behind the scenes about the success that you’ve had with using mistletoe, and in particular the IV mistletoe.
Dr. Nasha Winters: Well, I had great experience for many years with the subcutaneous until about 2014, when I attended a conference where Dr. Paller was also involved and decided to branch out into the intravenous. And the experiences I had with that took my practice and my experience to the next level of people’s response.
Some basic things that I saw happen clinically was people immediately having a sense of well-being in the midst of their IV. People who were on, in some situations, death’s door that were really failing, really sick, really weak, to watch their vitality, their color, everything change as they were having the IV drip. We also saw massive tumor lysis, meaning really quick push back of the actual tumors. Sometimes that can be a little bit scary initially because the labs can look a little bit frightening. But what we find is that that’s a very good and robust response.
And some of the things that Elise talked about earlier about pushing back angiogenesis, anti-inflammatory patterns happening with that, very exciting to see people have extreme resolution of their pain in the midst of these IVs as well. So many places that it seems to have just given a new leg of life to a lot of our patients that were otherwise failing.
Host: That’s amazing. It is great to hear of the success and all of those really complicated words that you just shared with us that I’m having trouble getting my head around. But in other words, the translation is “it’s working.” Okay. So tell us from your perspective, Channing you can go first, and then Nasha you can finish up. Why is this trial important, from your perspective?
Dr. Channing Paller: So, from my perspective, this Believe Big is amazing and provides amazing care for many patients.
But I am looking forward to the day that we can show if mistletoe really does improve overall survival and improves quality of life. Both of those things matter for my patients. And if we can show that in an FDA-approved trial, then we get to look towards the day where other oncologists can prescribe mistletoe and insurance companies can pay for it. And that will really transform care.
Dr. Nasha Winters: And I would absolutely say “ditto,” to that. But also, as a clinician who has used this in my practice since 2003 and IV since 2014, I already have gotten to witness thousands of people have a very positive experience with it already. And my colleague and I have trained over 250 physicians around the country in the use of this. So, we’d like to see these numbers continue to grow and these experiences to continue to grow as well.
Dr. Channing Paller: I need to add one thing. One, Nasha has been an incredible resource for me as I get more experience with the drug. And it has been a real joy to do this trial because most of the trials I do are investigational drugs that are toxic. And so this may be toxic, but they all feel better. And it’s just fun to treat them.
Host: Fantastic. Hey, join me in giving another round of applause for Dr. Paller and Dr. Winters. Thank you.