Noxopharm Limited (ASX:NOX) Chief Medical Officer Dr Gisela Mautner provides an update on the company's lead drug candidate Veyonda in its DARRT program and discusses a new trial program for COVID-19.
Rachael Jones: Hello. I'm Rachael Jones for the Finance News Network. Joining me from Noxopharm (ASX:NOX) is Chief Medical Officer Dr Gisela Mautner. Gisela, welcome back to FNN.
Dr Gisela Mautner: Hello, Rachael. It's good to be here, though only virtually.
Rachael Jones: Yes. And you've told us previously about Veyonda as your lead drug candidate. How have your studies progressed since then?
Dr Gisela Mautner: Yes, since we last talked, we actually have received some exciting results about Veyonda's mechanism of action. Preclinical studies that were performed in labs in Germany as well as in Hong Kong have confirmed that Veyonda has the ability to transform so-called cold tumors into hot tumors. This is truly significant as most tumors are actually cold, which means that they can shield themselves from the immune system whereas hot tumors are visible to the immune system and therefore the immune cells can attack and kill the tumor cells. So Veyonda being able to turn cold into hot tumors has obviously major implications for improving the treatment results of cancer therapies.
Rachael Jones: That's excellent news. And you've progressed Veyonda in late stage prostate cancer in your DARRT program. What's next for that program?
Dr Gisela Mautner: Yes, Noxopharm's DARRT program is testing Veyonda plus radiotherapy as a treatment in late-stage prostate cancer. Now that we have finished the DARRT-1 study very successfully, we are building on it and we are now well into planning the DARRT-2 study. One major step we recently took was to select the clinical research organization or CRO for our DARRT-2 study. Now partnering with the right CRO is absolutely crucial as they are helping us to implement all aspects of the study from compiling and filing the regulatory paperwork to finding the right study sites and ensuring that patient enrollment happens in a timely manner. We selected a CRO as our partner, which is called Parexel. They are a very well known CRO with their headquarters in the United States but they have a very strong Australian team and also deep expertise in prostate cancer studies. So our next trial, the DARRT-2 trial, is going to be a very comprehensive trial that will involve approximately 150 to 200 patients. It will be multinational and it will provide us with the kind of data that prospective commercial partners will be looking for. We expect the DARRT-2 study to commence early next year.
Rachael Jones: Great news. And Noxopharm recently announced that it got approval to go ahead with its COVID study, which is going to study Veyonda in patients with the COVID-19 infection. Can you tell us more about this?
Dr Gisela Mautner: Yes, gladly. This study is called the NOXCOVID study and it is a phase I study to investigate the anti-inflammatory properties of Veyonda, which as you know is Noxopharm's lead drug candidate. This anti-inflammatory mode of action was actually discovered by the Hudson Institute of Medical Research in Melbourne last year.
Dr Gisela Mautner It turns out that the immune system of some COVID-19 patients goes into complete overdrive and they develop what is called a cytokine storm. Now their preclinical studies at the Hudson Institute of Medical Research discovered that Veyonda can block the cytokine storm to a certain extent. So although Veyonda is first and foremost an anti-cancer treatment, we are basically repurposing Veyonda now for the NOXCOVID trial, which is actually not unusual at all. Many other companies are also repurposing their drugs for COVID-19 trials. You go where the science takes you and we are doing it on the basis of sound scientific evidence from the Hudson Institute. I have to say it is our sincere hope that patients treated with Veyonda will not progress into severe COVID-19 disease and deleterious respiratory insufficiency, and therefore we hope to prevent ICU admissions and prevent the need for mechanical ventilation.
Rachael Jones: So, Gisela, how is that trial progressing?
Dr Gisela Mautner: Well. I'm happy to report that we designed the trial very quickly and we received the required approvals in record time. In fact, last Friday we announced that we have started treating our very first COVID-19 patient. Now our NOXCOVID trial is a small pilot study, so we are looking at enrolling about 40 patients. We are planning to finish enrollment in about three to four months. After a short follow-up period, we will have the data readout, starting in quarter one in 2021. So next time we speak about this trial, we will hopefully have some exciting results to share with you.
Rachael Jones: Let's hope so. Noxopharm is certainly showing sustained and positive progress. What do these recent developments mean for Noxopharm shareholders and what news can they expect over the next three to six months?
Dr Gisela Mautner: Well, obviously the oncology program still remains our core focus. There will be progress announcements as the DARRT-2 trial moves towards its launch, which will be in early '21. In addition, we are planning another cancer study as part of our IONIC program, which we will be able to announce hopefully soon.
Now regarding the NOXCOVID trial, we are very grateful that we can contribute to the global COVID-19 efforts and, as I mentioned earlier, we will have the first set of data coming in pretty soon. So clearly all these activities are contributing to develop Veyonda as a drug which has in our eyes blockbuster potential primarily as an anti-cancer drug but perhaps also as an additional treatment for use in the global fight against COVID-19.
Rachael Jones: Dr Gisela Mautner, thanks for the update and some most encouraging progress there.
Dr Gisela Mautner: Thank you, Rachael, for having me.