When you talk about respiratory papillomas is that a form of HPV?
Dr. Steinberg: Yes, it is a disease that is caused by HPV. When you have an HPV infection in your skin, you get skin warts. When you have an HPV infection in the genital tract, you can get genital warts, cervical dysplasia or even cervical cancer. When you have it in the airway, you can get respiratory papillomas.
And what are respiratory papillomas?
Dr. Steinberg: They are benign tumors that grow on the vocal cords and also in the trachea and can even grow down into the lungs, that are caused by the Human Papilloma Virus.
In previous years, did doctors usually cut them off?
Dr. Steinberg: The only approved treatment that we have had up until now is to remove them surgically. You could do that surgical removal with a scalpel and cut it off which is the old fashioned way to do it. You could do it with a laser which burns them and removes them like a cautery or you could do it with newer devices that actually shave it off, but no matter what you do, all it does is it removes that tumor. It does not remove the infection.
How does it spread?
Dr. Steinberg: We do not believe removing the papillomas spreads the virus. We know that patients have the virus all throughout their airway tissue in a silent or latent form, and something (maybe an irritation) stimulates the virus to become active and form papillomas. At any rate, for many patients, they keep coming back.
What is Celebrex?
Dr. Steinberg: What we discovered is that patients with respiratory papillomas express a protein in the papilloma called COX-2. COX-2 is an enzyme and when we inhibited COX-2 in papilloma cells in tissue culture they stopped growing. COX-2 is the target for the drug Celebrex which most people think of for arthritis and inflammation, but COX-2 is also expressed in many tumors.
Does it kill it?
Dr. Steinberg: The cells stopped growing and started to die. We decided on that basis to treat a small number of patients with Celebrex to see it would have any effect on their disease. The first 3 patients that we studied all responded. Two of the patient’s disease went away and it basically has not come back. The third patient, his disease went away, but when he stopped taking the Celebrex it did come back. It is not a magic bullet for everybody, but for many of the patients it looks like it causes a permanent cure.
What do you find exciting about this?
Dr. Steinberg: What I find exciting is that I have been studying this disease in the lab for over 30 years and we have gone from trying to just understand what the virus is about and how it makes the cells grow, to discovering this COX-2 component and then getting a treatment that looks like it works. It is really an exciting journey.
Are there any downsides to Celebrex?
Dr. Steinberg: There are side effects with Celebrex like there are with all drugs. It can elevate your blood pressure. It can upset your stomach in some patients just like aspirin does. For a very small number of people with a risk factor for cardiovascular disease, there are suggestions that at high doses for a long time it can actually possibly trigger a heart attack. We did not enroll anyone in our study that had a history of heart disease and we have had no patients with trouble.
Would this be a possible cure for HPV?
Dr. Steinberg: We are hoping so. We did the small study to start with 3 patients. We not only reported that they responded, but we reported that they have been free of disease, like in Ben’s case, almost 5 years now.
How long did Ben have to take the drug?
Dr. Steinberg: He took it for 1 year. Now, I cannot tell you that he needed to take it for 1 year because that was the study design. The patients were randomized to either start on a placebo or the Celebrex and nobody knew which one they were on but the pharmacist. Ben was actually started on the drug. The study design was they took either the placebo or the Celebrex for 1 year. Then they crossed over for the second year while we monitored them every 3 months to see what happened and then the study was finished.
What is next for this?
Dr. Steinberg: We are now doing a very large study because this was 3 people. Now, we have enrolled more than 45 people into the bigger study. Our goal is to enroll 60 patients.
Could it be a cure for HPV?
Dr. Steinberg: Yes. If this works, there is no reason to think it would not work for HPV infections in other tissues as well. However, those studies will have to be done to be sure.
Could HPV be genetic?
Dr. Steinberg: What we think is happening from this new discovery is that this protein that is expressed is not just in the papillomas, but in the normal tissue. We think that expression is genetic and what we think happens is that lots of people are exposed to this virus. The disease is rare and we think that it is people who express COX-2 that are susceptible to the virus. It’s basically setting you up to have a problem when you get the infection. Otherwise, the virus infects and then your immune system handles it and you never know you had the problem.
Is this a game changer?
Dr. Steinberg: It could be really huge and the most important thing is that patients with this disease have a terrible disease. Those patients that have the worst disease, because it varies from one patient to another, might need surgery every 3 weeks just so they do not suffocate to death. If we have a pill that they can take instead of surgery every 3 weeks, that is just going to be wonderful.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
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