Most treatment options for cervical intraepithelial neoplasia 2/3 (CIN2/3) are either excisional or ablative, and require sequential visits to health care providers. Connie Trimble, M.D. discusses recent advancements in studies performed to assess the safety and efficacy of self-administered artesunate vaginal inserts in biopsy-confirmed cervical intraepithelial neoplasia patients.
I'm Connie trimble today, I'm going to tell you some good stories about cancer interception which is preventing cancer by identifying and treating the precursor lesion in this case HPV cancers caused by HPV many of you. Um HPV remains very, very common despite the availability of preventive vaccines. Um And one of the avenues which my team works on is treatment vaccines vaccines to treat existing high grade inter epithelial lesions. Um And that's going very well. We've made disease disappear in about two thirds of our patients. So stay tuned. Um But the thing that it spent most of my time today talking about is something new. Um and it's non surgical. Yeah me nonsurgical. Um We have repurposed with France viral therapeutics, a chinese herbal medicine derived from the bark of the warm wood tree, it's called artesunate. Now the chinese have been using this compound for centuries to treat acute malaria. Um And The person who figured out what the active compound was was actually given the Nobel Prize in 2015. Um And many, many millions of people are alive today because of her work. Um our test in eight and related compounds are part of uh W. H. O. Recommended World Health Organization treatment frontline treatment for acute malaria. People who are very very sick. We've given it orally as an I. M. Injection. We've given it intravenously and in little kids who are too sick to keep food down. We give it to them in suppositories up their little bums, all of which is to say that we know a great deal about the pharmacogenetics and the toxicity and safety profile of this compound when given to very very sick people. Now then it turns out that these pre invasive high grade dysplasia is don't care for it either. The first clinical trial we did has been published it was we targeted women who had C. I. N. 23 high grade cervical dysplasia. And we tested one two or three treatment cycles of suppositories that were administered inter vaginally by the patient herself. Each treatment cycle was five consecutive nights of um self administered vaginal suppositories. The most common side effect was itching. Um And the short version is we cured 2/3 of the patients. Um And you know part of the way through the trial it was so clear that it was working. We um also made a formulation based in an ointment and are using that to treat vulvar intra epithelial nia play asia which many of you will know is a very very stubborn beast. The current treatment is surgical mainly. And you know as well as I do that even if you get clean margins and stuff comes back. Uh huh. And we're also using it to treat peri anal disease ai enabled intrepid field Indonesia Malaysia. We're using the um suppository to treat rectal inter episode little disease. Now then if you can imagine having a non surgical treatment for for disease there. That's mind blowing to me in any event. The trails are are having very very promising clinical results. The uh Phase two B for the cervical diseases open not at Hopkins but at MD Anderson and also at the Cleveland clinic. And those trials are open to a cruel here at Hopkins. We have um to current Protocols for the art assassinate one is um we have you know I opened a trial for a compassionate use protocol and it's for women women who have either recurrent high grades. You and I have those patients people even who have completely intact immune systems and they have a C. I. N. 23. You take it out and then it Rikers and you take it out and it Rikers again and eventually you do a hysterectomy because what do you do? And some of my patients have been dealing with recurrent high grade dysplasia for two or three decades. Um It's also open um for people whose immune systems are compromised in other ways including solid solid organ transplant recipients or people who have autoimmune disorders or people living with HIV. And those clinical results are also very very promising enough. So I can tell you what they are but enough. So that um will be filing an amendment to the I. N. D. In order to to expand that protocol. Um Another trial that is currently open at Hopkins is artesunate appointment to treat valve. Are inter epithelial hyperplasia. Um And the results there are very very promising as well. This trial is also open at the Cleveland clinic for a different site. Mm We'd be happy to take questions or referrals or speak to you about any of this work. The best way to contact us is by email at cervix dr dot j H M I dot e d u. And to see a more complete um explanation of the therapeutic HPV vaccine work. You can go to Youtube and google. I mean, look up kicking cancer's butt, which is a ted X talk I did a few years ago in which I spent quite a while explaining the differences between preventive and treatment vaccines and it's working. Um So thank you. Thanks for your attention and I look forward forward to hearing from you.
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