HPV Pill: Medicine's Next Big Thing? - NewsChannel5.com | Nashville News, Weather & Sports

HPV Pill: Medicine's Next Big Thing?

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MANHASSET, NY ( Ivanhoe Newswire) – HPV is the most common sexually-transmitted virus in the U.S., but what many don't know is HPV can also cause a serious respiratory disease. Now, curing this lung problem could be the first step to curing HPV.

About 20-million Americans are living with it; half of sexually active people will develop it; and most don't even know they have it. It's HPV, a sexually transmitted disease that's best known for its link to cervical cancer. But did you know HPV can also affect your throat and lungs? That's what happened to Ben Zehavi.

"I could feel that there is some irritation in my vocal cords and I wanted to cough," Ben Zehavi told Ivanhoe.

Ben had a disease called RRP. Benign tumors form on the vocal cords, trachea and lungs. It's caused by the HPV virus. Until now, the only treatment was surgery to cut out the tumors.

"Those with the worst cases, because it varies, might need surgery every three weeks just so they don't suffocate to death," Bettie M. Steinberg, Ph.D., chief scientific officer at the Feinstein Institute for Medical Research, said.

Doctor Bettie Steinberg is studying what could be an easy fix. Patients with RRP express a protein called Cox-2. The arthritis drug, Celebrex, targets it. In the lab, Celebrex stopped the cells from growing and even killed some. In a small study three RRP patients responded well, and two are still disease-free. Celebrex can cause some side effects but the doctor says if her new, larger study shows the same results as the previous one, she's hopeful.

"There's no reason to think it won't work for HPV infections in other tissues as well," Dr. Steinberg said.

Ben was one of the three study participants. His vocal cords are clear and he's been in remission for five years.

"I know I'm good now, I feel it," Ben said.

RRP affects about 10,000 people in the U.S. It can be transmitted from a mother with HPV to her baby at birth or can be sexually transmitted. It's unknown why some people with HPV develop RRP and others don't. Doctor Steinberg is currently in the process of conducting a large, multi-center study of Celebrex for RRP.

RESEARCH SUMMARY

BACKGROUND: Genital human papillomavirus (also called HPV) is the most common sexually transmitted infection (STI). HPV is so common that at least 50% of sexually active men and women get it at some point in their lives. There are more than 40 HPV types that can infect the genital areas of males and females. These HPV types can also infect the mouth and throat area. Most people who become infected with HPV do not even know they have it and it is possible to pass the virus to others years later.  (Source: www.cdc.gov)

WHAT YOU DIDN'T KNOW: Most cervical cancers and about 25% of head and neck cancers are caused by HPV. It is thought that in both cases, the infection appears to follow sexual contact with an infected partner. RRP (Recurrent Respiratory Papillomatosis) is a disease of the respiratory tract caused by the Human Papilloma Virus (HPV). It causes tumor-like lesions to grow on the larynx and, in some cases, in the trachea and lungs. They invariably cause voice difficulties, including hoarseness and vocal fatigue. They can occasionally convert into cancer. Left untreated, the lesions may grow, causing suffocation and death. Few people have ever heard of RRP. Although the HPV virus that causes Recurrent Respiratory Papillomatosis is widespread (the CDC has estimated that tens of millions of people in the United States are infected with HPV), the prevalence of RRP is very low. It has been estimated that there are 10-25,000 people in the United States with this disease. RRP cannot be called an STD, however, anymore than cervical cancer can. Any speculation that RRP might be an STD, when viewed in this light, is inappropriate.  ( Source: rrpwebsite.org)

NEW TREATMENT: Surgical removal is the current management for RRP, but it is a very traumatic procedure, and often leads to permanent voice dysfunction. The pill Celebrex is FDA approved to treat the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA), and for the management of acute pain in adults and is being studied to stop HPV too.

"What we discovered is that patients with respiratory papillomas express a protein in the papilloma called COX-2," Dr. Bettie Steinberg, Chief Scientific Officer at The Feinstein Institute for Medical Research, explained.  "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 it is also expressed in many tumors."

This treatment has also showed positive results in those suffering from throat warts caused by HPV.

"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," Dr. Steinberg said.
Side effects of Celebrex include elevated blood pressure, upset stomach, and the trigger of heart attacks in those who have a history of heart disease.(Source: www.ncbi.nlm.nih.gov, www.webmd.com, Interview with Ivanhoe Broadcast News).

INTERVIEW

Dr. Bettie Steinberg, Chief Scientific Officer at The Feinstein Institute for Medical Research, talks about a little pill that could knock out a virus that affects half the population.

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.

FOR MORE INFORMATION, PLEASE CONTACT:

Dr. Bettie M. Steinberg
The Feinstein Institute for Medical Research
bsteinbe@lij.edu
(516) 562-1159

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