In terms of priorities:
The DARRT program in prostate cancer is #1. We regard this as our primary path to market approval and a considerable amount of effort is going into seeking to make that happen.
The LuPIN program is #2 in priority.
The DARRT program in cancers other than prostate cancer is #3.
The CEP program is #4 in the queue after the 3 radio-enhancing programs.
This priority ranking has nothing to do with our perceived likelihood of success. It has all to do with what we believe is the quickest, surest and least expensive way to reach the market. It is a well-reasoned commercial strategy with an eventual successful launch of NOX66 onto the market in 2022 in mind.
All 4 programs are continuing, just at different speeds. The strategy is that data from all 4 programs then will feed into the successful launch of NOX66 on the market, helping raise the profile of the drug.
DARRT - 1
August 2018: anticipated release of 6-week data from the first 12 patients and 12-week data from the first 4 patients. Q3 2018: complete recruitment of all 24 patients Q1 2019: completion of full study.
The Company is already preparing for potential success, with a planning meeting in the US in early-August with the medical oncologists and radiation oncologists from a range of leading US hospitals that have indicated an interest in being involved in the drug’s next stage of development. This meeting will review the DARRT-1 data and begin the process of advising on, and planning a multi-national registration study.
LuPIN Study
July 2018: all initial cohort of 6 patients (400 mg NOX66) to have commenced treatment August 2018: first 4 patients complete treatment and cases reviewed August 2018: commencement of second cohort of 10 patients (800 mg NOX66) January 2019: study closes.
The Company will be seeking to release study outcomes following each milestone.
With LuPIN-1 being run at just the 1 site, we now have decided to investigate accelerating the LuPIN program by running a parallel study involving upwards of 100 patients using multiple sites to ensure fast recruitment. That study would include a control arm.
DARRT-2 will be a Phase 2 study across the full spectrum of solid cancers (with the exception of prostate cancer). The study will be multi-national and open to any patient presenting for palliative radiotherapy for metastatic cancer, which means we anticipate the subjects will range from the more common forms of cancer (e.g. lung, breast, large bowel) to the less common (e.g. ovarian, head and neck) to the rare (e.g. various forms of sarcoma).
Protocol planning has commenced and has an objective of the study being opened in Q4 2018. This study will contain a control (no NOX66) arm so that we will have an objective measure of the benefit of DARRT therapy.
CEP-2 shortly is to be the subject of discussion by our medical advisors. The recent CEP-1 data pointed to the potential of using NOX66 to provide safer, and possibly more effective, chemotherapy. The next step is to take advice on what clinical approach oncologists and regulators (FDA, TGA, EMA etc) would see as the most beneficial way to use the CEP concept. I anticipate that the planning process covering protocol design, site selection and an IND application will take all of 6 months, meaning that CEP-2 (a Phase 2 study) will likely commence in Q1 2019.
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