Clinical Strategy

Clinical Development Strategy

The pathway to market for a new pharmaceutical product is a long one, with the time from drawing board tomarket taking on average 10 years … more in many cases. NOX66, however, is a long way down this path, having already passed many of the usual hurdles preventing a drug from reaching the market.

NOX66-Early Phase Clinical Trials

Over the course of 2017-18, NOX66 will be involved in seven early phase clinical trials. Five of these are Company Sponsored trials (i.e. Noxopharm will fund, supervise and manage these trials directly). Two of the 7 are Investigator Initiated Trials where Noxopharm is supplying NOX66 and providing limited funding.

This extensiveearly phase trial program is being undertaken for 2 reasons:

  1. The Company is pursuing a strategy of a condensed 2-step clinical trialling process, rather than the usual 3-step (Phase 1, Phase 2, Phase 3) process, reflecting existing considearble clinical experience with this drug, plus confidence in its safety;
  2. Idronoxil has multiple potential uses as an anti-cancer agent (in combination with chemotherapy, or radiotherapy, or both), creating a need to identify the optimal combination.

The current 7 clinical trial strategy is designed to maximise the likelihood of identifying the 1 or 2 most likely preferred uses of NOX66 to take into the final step of registration studies.

  1. NOX66 plus external radiotherapy:

    Three trials are planned. They are designed to determine the ability of NOX66
    (i) to sensitise tumours directly to irradiation (shrinkage/remission of exposed tumours), and

    (ii) to result in a bystander/abscopal response in non-irradiated tumours.

    Patients will have multiple tumours (minimum 3), with a limited number exposed to radiotherapy. The dose of radiotherapy will be palliative (intended to provide symptomatic relief, not be curative). Treatment (NOX66 + radiotherapy) will be limited to maximum 2 weeks.

    Patients to be scanned at 3 months to determine clinical response in irradiated lesions (direct radio-sensitisation) and non-irradiated lesions (bystander/abscopal effect).

    Clinical trials NOX66-002 (Investigator Initiated) and NOX66-002a (Company Sponsored) both involve patients with late-stage prostate cancer (metastatic, castrate-resistant, post-chemotherapy).

    NOX66-005 involves patients with any form of solid cancer (eg. lung, breast, head & neck etc).
    The relatively short duration of treatment in these three trials is anticipated to provide the first information for the registration clinical trials.

  2. NOX66 plus brachytherapy (localised radiotherapy):

    One trial is planned. It is designed to determine the ability of NOX66 to sensitise cancer cells directly to the killing effects of radioactivity localised within tumours.

    NOX66-003 (an Investigator Initiated Trial) will involve patients with late-stage metastatic prostate cancer receiving experimental treatment with 177Lutetium-PSMA.

  3. NOX66 plus chemotherapy:

    NOX66-001 (a Company Sponsored Trial) is already underway. It is looking at the use of NOX66 in combination with a common chemotherapy treatment – carboplatin – in patients with five common solid tumour types (lung, breast, prostate, ovarian, head and neck). The full course of treatment in this study is 7 months. A key aim is to identify the optimal dosage combination of NOX66 (low/high) + carboplatin (low/high), the optimal duration of treatment, and the most responsive types of cancer.

  4. NOX66 + Chemotherapy + Radiotherapy

    NOX66-004 (a Company Sponsored Trial) is expected to commence 3Q17 and will involve multiple types of solid cancers using different standard chemotherapies + palliative radiotherapy to see if there are cancers best suited to treatment with NOX66 + chemotherapy + radiotherapy.

  5. NOX66 in rare cancers:

    NOX66-006 will involve patients with cancers defined as ‘rare’. There are about 60 different cancers that meet this definition, accounting for 25% of all adult cancers. The very low incidence of these cancers makes it difficult to conduct large and meaningful clinical trials of new treatments for each rare cancer type. As such, many of these cancers have limited options. Noxopharm acknowledges that this is an area of considerable unmet need and as part of its early development program is starting a studyto look at the use of NOX66 in conjunction with standard treatments (chemotherapy or radiotherapy) for these rare cancers. While the data in this study will by its nature be diluted across a range of different cancer types, it is hoped that information gathered will complement the data being generated in the more common cancer types in the eventual registration process.