Influence of Pharmacologic Options on Clinical Practices

Pharmaceutical Executive: How does the availability of pharmacologic options influence clinical practice?

Helen Sabzevari: So actually, there has been no standard of care for RRP. Unfortunately, as I mentioned, in the past 100 years, many things has been tried over the years, but none of them have been successful or approved by FDA. And as we mentioned, the surgery, it's very clearly, it's just basically to relieve the symptoms, but not to treat or cure this disease. And this is one of the reason that the surgeons, and ENT surgeons, and also the physicians, they really do not like to do this for a simple reason, because they know that this is not curative. This is not treatment for this surgery. Is not the treatment for these patients. Now, with papzimeos approval, as I mentioned, by FDA for full approval for as a first and only drug for RRP. Now, there is astandard of care. And the standard of care is really papzimeos for all adult, RRP patients, in this regard of their stage or severity, so they can all start receiving this. And I think, according to our investigators, KOLs, talking to physicians and patients. This is something that is paradigm shifting for the field, for the patients and for the physicians, because now they actually have a drug that address the underlying cause of this disease, which is the infection by HPV six and 11. And I think the other important factor here is we do not want to leave any patient behind. And actually, FDA has been very interested and excited about not from the perspective of this Safety as well as the efficacy that to address the pediatric population, because, as you know, this is again another group of patients that they can become infected as early as age of one. And for this patient population and pediatric patients. There is also no other treatment except this continuous surgeries. And so we are very excited to in upcoming year to address also the pediatric population and also having the ability to redose of the patients that are partial responders and the other side, and also that they can be now repeated dose, because, as I mentioned with AdenoVerse platform, this is one of the differentiation and benefit of this platform that you can give number of the injections and courses of this drug with a very that would not raise the neutralizing antibody, and this would be another set of trials that we will be addressing to expand the indication and address the redosing in our partial responders versus our complete responders.