It’s been 2 months since the listing and IPO.
The first few months in the life of a drug development company is all about laying foundations. Everyone is looking for news flow as evidence of activity, but that requires first building the platforms that will deliver the news flow. As the platforms are progressively built, so the news flow will follow.
The focus has been on bringing NOX66 into the clinic. Conducting a clinical study is an exercise in logistics, and with a target of 3 clinical studies by early next year, those logistics considerable.
Those logistics can be broken into staffing, drug supply, appointment of clinical site, oversight of the study, and obtaining the required approvals.
We are aiming to have a core staff of 5 people experienced in clinical studies in place by early-2017. Dr Marinella Messina (Clinical Affairs Manager) was our first such appointment, which has allowed the clinical program to get underway. Medical Advisor and Chief Scientific Officer positions are the next to be filled, with news on these pending. These 3 then will form the nucleus of the team needed to drive a busy clinical study program.
A batch of NOX66 to meet our immediate Phase 1/Phase 2 clinical study needs has been manufactured and is ready to use. But we also need to look now to the next stage….. the larger-scale supply of drug for anticipated registration studies in 2018 to Good Manufacturing Standards and that will comply with FDA and European regulations. This is something currently being undertaken by an external contractor.
The two sites for the first of the 3 proposed clinical studies are in place. These are in Georgia. I recently conducted an inspection of the two sites and confirmed their ability to meet our objectives. Both sites are experienced in clinical studies of cancer drugs, with a recent FDA audit confirming that exacting FDA standards are being met. Georgia has been selected for the considerable savings it offers in start/completion times and overall costs, all within a high quality healthcare system.
The sites for the 2nd and 3rd proposed clinical studies (Australia and Georgia respectively) also have been identified and will be announced shortly.
Two CROs – Clinical Accelerator in Europe and Datapharm in Australia – have been contracted to oversee the conduct of all three studies.
Approval to conduct a study occurs at 2 levels – by the local institution and at federal level. This 2-step process typically takes 2-3 months and requires the submission of a considerable amount of information. The submission for our first clinical study has been lodged.
The strategy behind conducting three separate studies is to expand our chances of identifying the best and fastest route into a registration study. By using NOX66 in conjunction with chemotherapy (carboplatin) and radiotherapy, and across a number of different cancer types, we are increasing our chances of identifying the optimal clinical indication on which to seek marketing approval.
The summary from the above is that:
- We are on track to have 3 clinical studies up and running in 1Q 2017
- We are on schedule to have the necessary resources and experience (staff, contractors) in place by the end of 2016 to meet a growing clinical program in 2017
- We will be in a position by mid-2017 to meet the need for large-scale manufacture of product to international standards for the next level of clinical trials.
While the main focus has been on the NOX66 clinical program, an emerging R&D program has been quietly going on in the background. This program is being managed currently by our Senior Research Scientist, Dr Kate Porter. It involves 3 programs with Australian universities and hospitals and is directed at providing future candidate drugs to enter our clinical pipeline.
Each of these programs involves the creation of new IP, and details of these programs will be announced progressively as we take the necessary steps to secure that IP. My expectation is that we will be informing the market of these programs over the course of the next 3 months.
That’s what the last 2 months have held, with the next 2 months looking even busier. By Christmas, I hope to have all the key foundation stones in place that will allow 2017 to be a highly productive 12 months.