Noxopharm Limited (ASX:NOX) MD and CEO Dr Graham Kelly gives an update on the company's research and development program.
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 and welcome back.
Dr Graham Kelly: Thanks Jess.
Jessica Amir: Graham, recently you have spoken about the Company’s NOX66 clinical program. Can you tell us now about what is happening in the background with your Research & Development program?
Dr Graham Kelly: The fact that NOX66 is in clinical trials doesn’t mean that the Research and Development, or “R&D”, as its called, actually stops. In fact, it’s quite the opposite.
That’s when the R&D program really has to be ramped up because there is a lot of behind-the-scenes work that goes into getting a drug onto the market. I’ll give you some examples. Starting with a couple of the practical things.
If we look at the manufacture of NOX66. We want to be producing clinical-grade material on a medium-scale basis by the end of this year, 2018.
Because if the opportunity comes along, we need to be able to provide commercial quantities of the drug at relatively short notice. Manufacturing lead times can be very long, and that means lost opportunity and loss of potential revenue if you are not ready. That means we need to show by the end of this year that we can manufacture NOX66 to a standard which is acceptable by regulators in different parts of the world.
This is all progressing as planned, but it still is a major behind-the-scenes program which is R&D in every sense of the term. On top of this there are the various pre-clinical safety studies that the rules and regulations stipulate must be done. And then all that data then feeds into the monumental amount of paperwork that goes into your application for marketing approval.
Again, all boring behind-the-scenes activity, but certainty vital. On top of this, we also are trying to get a better understanding of how we think NOX66 works to enhance radiotherapy and in particular, how it might induce the abscopal response that Noxopharm talks about. Some of the most commonly used anti-cancer drugs that have been around for 40 years or so, are still being looked at to see how they work. You don’t need to know how it works to be put on the market. The important thing is to be able to show that a new drug works and that it can well be tolerated. But, how it works certainly helps market the drug once it is on the market.
So, for that reason for the fact that radio enhancing is new, there are no radio enhancers on the market. We need to drill down into the actions of NOX66. And, right now, we have pre-clinical collaborations with researchers around the world looking at how NOX66 is interacting with radiotherapy and the bodie’simmune system. This is taking us into the new frontiers of medicine that I have little doubt will ultimatelyrevolutionise the world’s understanding of the body’s response to diseases such as cancer.
Jessica Amir: Graham, most drug development companies have a pipeline of drugs. Is that what your R&D program is doing? Are you looking for new drugs to come up behind NOX66?
Dr Graham Kelly: No, not really. Noxopharm is involved in oncology drug discovery and oncology drug development, so we are open for business and always ready to look for more opportunities, which would create more value for shareholders. But currently we have a full book of work. Some potential opportunities outside of the cancer field fell into our lap a year ago, but we dealt with those by creating our US subsidiary company, Nyrada. Our pipeline lies in the different ways to use NOX66, not in looking for new drugs. For example, our current clinical program, which we discussed in the previous two interviews, is looking at using NOX66 in 3 completely different ways.
First of all, there is NOX66 in combination with 2 different forms of radiotherapy, and then the third way is using in NOX66 in combination with chemotherapy. That is 3 quite separate clinical development strategies. In effect, that’s equivalent to running 3 different drug programs.
Moving that aside, but in terms of pure R&D, we do have 2 other current R & D programs I would like to mention. The first of these is using NOX66 to treat brain cancer.
This is program is on the pre-clinical discovery from animal studies, where we found that we can get NOX66 into the animal brain in very significant quantities. We now are exploiting that discovery to see if we can potentially use NOX66 to make radiotherapy a more effective treatment of human brain cancer.
Chemotherapy is poorly effective in most cases of brain cancer, generally providing only short-term benefits at best. Surgery and radiotherapy remain the best treatment options. In the case of radiotherapy, the brain is very sensitive to radiation and that means that the dose of radiation that you can use, really needs to be quite limited. What we are hoping to do is to work within that dosing limitation, with NOX66 to enhance the cancer-killing effect of the radiotherapy without affecting healthy brain tissue.
We are focusing on brain cancer called, glioblastoma (or GBM) , the main form of primary adult brain cancer, and another one called DIPG, a highly aggressive form of brain cancer in children. This program is currently in the laboratory and it will be at least another year before we are ready to go into the clinic with this approach.
The other pure R&D pipeline program is happening via our Hong Kong-based Noxopharm Asia subsidiary. Like the brain cancer program, this is a pre-clinical program, meaning tha it’s still in the laboratory. It’s focused on using NOX66 with radiotherapy to treat certain cancers common to Asian communities. The 2 we are focusing on are nasopharyngeal cancer and gastric carcinoma. Nasopharyngeal cancer is a rare form of head and neck cancer that is associated with the virus, Epstein Barr virus, which is endemic in East Asia. Gastric carcinoma affects the stomach and is thought to be associated with the bacterial Helicobacter infection that causes gastric ulcers. This was the discovery of a couple of Australian scientists many years ago for which they got the Nobel prize. Both cancers are rare in Australia and other Western countries, but very prominent in East Asia, China in particular. What we are looking to do is to make these cancers, responsd better to therapy and at the moment, they is very very poor responses to radiotherapy and chemotherapy.
We so are looking in the laboratory to see if we can make both cancers respond better to NOX66 and radiotherapy. We currently are working with researchers at hospitals in Hong Kong and China on this program. To put into perspective, three years ago (in 2015) the estimated number of people in China, with these 2 forms of cancer were 60,000 for nasopharyngeal cancer, and 680,000 for gastric carcinoma. So, you can see that this is a huge problem that needs a solution. Those 2 tumours alone tend to dwarf most cancers in other western countries.
Jessica Amir: Thanks Graham. Anything else you would like to add?
Dr Graham Kelly: No, other than to reinforce the fact that Noxopharm is a group of companies that includes its majority-owned US subsidiary, Nyrada, as well as its wholly-owned Hong Kong subsidiary Noxopharm Asia. This group as a whole covers a broad spread of drug development programs across the fields of oncology, neurosciences, inflammatory diseases, and cardiovascular disease. In each case we have programs dealing with major community health issues of high unmet need, where we believe we possibly have first-in-class drugs with something to offer.
Jessica Amir: Dr Graham Kelly thank you so much for the update.
Dr Graham Kelly: Thank you, Jessica.