Noxopharm Limited (ASX:NOX) Managing Director and CEO Dr Graham Kelly discusses the company’s focus on the proposed use of NOX66 as a radio-enhancer in radiotherapy cancer treatment.
Rachael Jones: Hello. I'm Rachael Jones with the Finance News Network. Joining me now from Noxopharm is Managing Director and CEO, Dr. Graham Kelly. Graham, welcome back.
Dr Graham Kelly: Thanks, Rachael. Good to be here.
Rachael Jones: Graham, it's been about two years now since Noxopharm listed on the ASX. What can you tell me about what it has achieved in that time and its aims?
Dr Graham Kelly: Noxopharm is a clinical stage company. We are a drug development company. We work on the oncology space. We currently have just the one drug in the pipeline, and that drug's name is NOX66. This drug is what's known as a radio enhancer, which means it's been designed to boost the ability of radiotherapy to kill cancer cells.
Rachael Jones: Thanks, Graham, and can you tell me a bit more about the Noxopharm story and some of your trials?
Dr Graham Kelly: Well, there are a number of different ways we can use our drug to boost the effect of radiotherapy, but the main focus is something called the DARRT Program. Giving NOX66 and radiotherapy to patients who have what's called metastatic disease, and this is where the cancer has spread beyond its site of origin and led to tumours in many different parts of the body.
It's just not possible to give radiation across the whole body to where all the different tumours are, so you really are restricted to using radiotherapy in one or two sites.
Now, by giving our drug at the same time as the radiotherapy, what we're aiming to do is to get more cancer cells being killed by that dosage of radiation.
Now, we currently are using the DARRT Program in a clinical study in men with late-stage prostate cancer who have multiple tumours. The men received NOX66, and one of their tumours is exposed to radiotherapy. We're then following those men for up to six months to see what happens to both the exposed tumour, that's the direct response, as well as all those other non-exposed tumours, which is the abscopal response.
Rachael Jones: What can you tell me about that study and the implications should it be successful?
Dr Graham Kelly: Well, it's early days at the moment. This study will have finally 24 men in it, and at the moment, we've just done 9 of those 24 men, and these first 9 patients are being exposed to different doses of NOX66. We were obliged to start with a low dose of NOX66, and that was a dose that we didn't really expect to see any significant effect from, and the first patient has just been treated with the top dose, which is what we expect to be a therapeutic dose. Not all of those 9 patients we would expect to see this drug doing a great deal. However, what we have seen is already 2 cases of an abscopal response at 6 and 12 weeks, so this is about 2 out of 4 patients that have been receiving this top dose of drug.
Rachael Jones: What are your plans to commercialise NOX66?
Dr Graham Kelly: Well, the first thing we need to do is to run a phase 3 registration study. A registration study is a study that is designed in conjunction with the regulators like the FDA that's meant to provide the data that the regulators would then consider in terms of approving the drug to marketing.
At the moment, at the very least, the company intends to control the manufacturing process since this is an obvious way of maximising added value for the drug, and I anticipate that sales and marketing eventually will be a mixture of different arrangements that will involve licensing. In other cases, co-marketing right through to us doing our own marketing and all that will depend on the different territories.
Rachael Jones: Last question now, Graham. What can investors look out for in terms of news flow over the next half?
Dr Graham Kelly: Well, the company has a lot going on, Rachael. Also, I expect a fairly strong news flow. There should be at least 2 progressive data readouts on the existent DARRT prostate cancer study. Then, we also have another clinical study underway in prostate cancer patients known as the Lupin study, which I haven't had time to talk about today, but that study is now fully recruited, and we expect to be able to report on that before Christmas.
Beyond these clinical studies, there's a very considerable pre-clinical program going on, and that program has been put in place to support us being able to bring NOX66 to market, and that pre-clinical program will generate I would expect a reasonable source of news flow over the next 6 months.
Rachael Jones: Dr. Graham Kelly, thanks for the update.
Dr Graham Kelly: Rachael, it was a pleasure.