Noxopharm Limited (ASX:NOX) Managing Director & CEO, Dr Graham Kelly, talks about another program using NOX66 and chemotherapy.
Jessica Amir: Hi. Jessica Amir for the Finance News Network. Joining me over the phone from Noxopharm Limited (ASX:NOX) is Managing Director and CEO Dr Graham Kelly.
Hi, Graham. Welcome back.
Dr Graham Kelly: Hello, Jessica. Thank you.
Jessica Amir: Graham, you previously mentioned how your company has been using NOX66 to potentially make radiotherapy work better. Can you explain why you have another program using NOX66 and chemotherapy?
Dr Graham Kelly: It’s a good question. In fact, it's a question I often get asked. If it's the case that you believe that NOX66 and radiotherapy hold so much promise, and particularly with the chance of getting the abscopal response -- we talk about just with two weeks of treatment -- then why would we want to bother with chemotherapy, especially when chemotherapy means a treatment that usually goes on for as much as six months, and usually involves a lot of unpleasant side-effects, and where the best outcome is probably just going to be prolongation of survival and not be curative?
Well, there are two answers.
The first is that not every cancer patient is going to be a suitable candidate for radiotherapy. Most patients will, but some won’t be. For example, some cancers, like the blood cancers, are generally not suitable for radiotherapy.
The second answer is that we are doing it because we can. That's the beauty of NOX66. It appears to work with both radiotherapy and chemotherapy.
And the fact that we can do it because we can gives us the option of running a three-horse race. We've got two different forms of radiotherapy, and now chemotherapy. They are the three horses. I don’t have the luxury of hindsight. Everything we have seen to date suggests that NOX66 in combination with radiotherapy will be our path to market. But until we know that for certain, it's important that we give ourselves the best chance of picking the winner. Hence the three-horse race.
And come the end of this year, we have to be in the position where we can pick the best candidate to take into a registration study in 2019.
Jessica Amir: And tell us what you're hoping to achieve with the chemotherapy program.
Dr Graham Kelly: The aim is quite simple, and that is to make chemotherapy better tolerated. If we can make it work better in terms of an anti-cancer outcome, then that would be very significant. But at the very least we are just trying to protect patients from suffering all those unwanted side-effects of therapy.
Because one of the cruel aspects of chemotherapy is that it doesn’t work in everyone, and in fact the further you get into the disease process, the less it does work, but pretty much everyone gets the unwanted side-effects. If it was possible to identify upfront the patients who would be likely to gain a benefit from chemotherapy, as well as the ones that wouldn't, then it would be possible to avoid exposing a lot of patients to unnecessary harm. But we don’t have that ability. And that is what our chemotherapy program is all about.
Most people are aware of the downside of chemotherapy -- the hair loss, the nausea, the vomiting and diarrhoea. And these gut problems in particular can be really quite unpleasant, but generally they can be helped with medication and they generally reverse or stop once you stop chemotherapy.
What you tend to hear less about are some of the more serious side-effects, particularly those involving nerve damage, including loss of hearing, and this nerve damage affects about one-third of all cancer patients receiving chemotherapy, but about 60% of patients that are treated with some of the more common chemotherapy drugs. Peripheral nerve damage can be particularly debilitating for these patients. In some cases, it is painful, and in others, it means losing function of hands and feet. And there is no medication that helps this problem, and it can go on for months, if not years, after you stop therapy.
So, this is where we believe NOX66 can help. And we believe we can use NOX66 to protect patients from some of the more serious side-effects of chemotherapy, particularly nerve damage. And if we can do that, then that opens up chemotherapy for all those patients who otherwise might not be offered it or who would decline it, and that is now a growing group of cancer patients.
Jessica Amir: Now can you give us some details about the study?
Dr Graham Kelly: Well, the study is called CEP-1, and "CEP" stands for "Chemotherapy Enhancement Program". This is a sighting study, meaning we simply are looking for evidence that NOX66 is working the way we believe it can.
It involves 19 patients, to start with, who have cancer of the breast, prostate, lung or ovary. These patients have what is called end-stage cancer, meaning that their cancers have stopped responding to standard chemotherapy and their disease is progressing.
We are treating them with a fairly powerful and common chemotherapy drug called carboplatin, which most of the patients would have already had prior to them coming onto the study.
And we are using dosages of carboplatin that are below what would normally be used. These are dosages that would not be expected to deliver any meaningful anti-cancer effect, especially with cancers that have already stopped responding to chemotherapy, including drugs such as carboplatin, the one we're using. The patients are getting three months of treatment with half a normal dose of carboplatin, and that's followed by three months with three-quarters of a normal dose. And then patients receive NOX66 for one week around each injection of carboplatin.
The idea is to see if by using a combination of NOX66 and a lower than normal dosage of carboplatin, that we can achieve a meaningful anti-cancer effect, which means slowing down the growth of the cancer, and perhaps even stopping its growth, but more importantly that we do so without causing any serious side-effects.
That’s the summary of the study, but if people want any more details than that, they need to go to our website, which is www.noxopharm.com.
Jessica Amir: And Graham, what are you really expecting from a study?
Dr Graham Kelly: Well, we've already released the data for the first three months of treatment. This interim data involved 15 patients who went on to receive NOX66 plus half the normal dose of the carboplatin.
Now, one of those patients was allergic to carboplatin. They had a bad reaction to the first injection, so that patient was withdrawn. That left 14 patients, who then went on to receive a combination of NOX66 plus carboplatin. Now, we did not see any serious adverse events. That means no serious toxic side-effects in all of those 14 patients. And the important thing is to notice that 12 out of those 14 patients showed a stable disease after three months. In other words, what we'd done was to stop their disease progressing over the three months of treatment.
Those 14 patients then moved on to a higher dose of carboplatin. This next dose of carboplatin is still short of the standard dose -- it's now three-quarters of the standard dose -- but it's dose high enough where we would expect to start to see side-effects, and the whole idea is to see how far we can push up that dose of carboplatin and still get a protective effect from NOX66.
That study is now completed, and the results are being collated and analysed, and the results have been accepted for presentation at ASCO, which is the largest cancer research conference in the world. It's in Chicago in the first week of June.
Jessica Amir: Well done on achieving that acceptance. And lastly, can you summarise where you think the work will really lead to?
Dr Graham Kelly: Well, Jess, as I said at the start, it's actually a cruel irony that about the only guarantee you get with chemotherapy is that it will cause side-effects in most people. And unfortunately it doesn’t come with any guarantee that it will do anything positive over time.
If we could change that equation, then that would be a very major advance for the well-being of all cancer patients undergoing chemotherapy.
But beyond that general effect, there is a subgroup of patients who are either too frail or too old or too damaged from previous chemotherapy to be offered or even to want further chemotherapy. I would like to think that NOX66 means that we're able to offer chemotherapy to this pretty large group of patients with some confidence that it won’t be damaging to them.
And once we have the final report, we will sit down with our advisors and look at the best way to bring NOX66 to market for this opportunity.
But, Jess, based on what we've already seen, the company is hopeful of seeing NOX66 becoming a standard companion drug for both radiotherapy and common chemotherapy. And if we achieve that goal, then NOX66 potentially is in line to become a very widely used anti-cancer drug.
Jessica Amir: And let's hope it does. Dr Graham Kelly, thank you so much for the update.
Dr Graham Kelly: Thank you, Jessica.