Key Factors in Papzimeos' FDA Approval in Adults Patients with Recurrent Respiratory Papillomatosis

Pharmaceutical Executive: What key factors contributed to Papzimeos becoming the first FDA-approved therapy for adult patients with recurrent respiratory papillomatosis?
Helen Sabzevari: And so in this RRP patients, what we have done is developed an immunotherapy, basically treatment toxin means which uses our innovative technology of adenoverse platform, which is well differentiated than all the other technologies, in a sense that you can give this in a repeated fashion and keep enhancing your own immune system and generate a specific CDA which for the lack of better words, probably is the army of your body that recognize the infected cells now from within, and then they can destroy it. So this way, you basically are addressing the root cause of this disease, which is the infection of HPV six and 11 of these cells. And what we have done is, in our clinical trials, in our pivotal trials, we have shown a very first of all by giving a course of pap smears, which is simply for sub q injection, to the patients that have been suffering from the RRP for years or throughout their whole lifetime, and some of them that after receiving these four injections subcutaneously, we follow these patients for years and the end point of the trial was obviously the safety, but as well as the efficacy, and what we have seen is not only that we have a very favorable safety profile, only grade one and grade two. So for those grade one and twos are simply when you receive, like a flu shot, sometimes you get a rash in the arm, or you get a headache. This is the extent, and then it resolves itself within hours or a day. And as far as efficacy has been concerned, we have shown in two pivotal phase one phase two trial, that 51% of the patients with RRP did not require any surgery for a minimum of one year, and we have been now following these patients well over two years, and some of them into their third years, and they have stayed in response and have not required any surgery. So, this is a paradigm shifting treatment for these patients, with some of our patients having had 10 surgeries per year just in order to be able to speak or have their airways open so they can breathe, if you can imagine that. And now going from that to not requiring any surgeries for more than three years, for instance, this is amazing outcome for the field, for the treatment and pap smears, based on the safety, the efficacy that I mentioned, and the durability of a response, which is now years post treatment, it got approval of the FDA in actually two weeks in advance of the PDUFA date. And what has been very, very exciting for the patients, for us, is now the patients have access to a paradigm shifting treatment which really addresses the core of this disease, and now for the first time, they can go back to a normal life, which is, it's really exciting for everyone, and this has been our goal from the beginning to bring an innovative platform that we have with adenoviruses to indications for the unmet need of the patients, and then pairing it with our regulatory strategy to get it in rapidly to the hands of the patient. So this is in a short journey of pap smears to a start and to get this to the patient.