The NOX66 clinical development program has two broad objectives…to develop NOX66 as:
- An enhancer of radiotherapy (DARRT program)
- An enhancer of cytotoxic chemotherapy (CEP program).
RADIOTHERAPY - DARRT program
The Direct and Abscopal Response to Radio-Therapy (DARRT) program is the Company’s primary clinical program. The aim of this program is to determine the ability and safety of NOX66 in enhancing the effect of radiation across a range of tumour types. Radiation can be delivered externally (“External Beam Radiotherapy”) or internally (brachytherapy). Noxopharm plans to investigate NOX66 with both forms of radiotherapy.
The aim of the DARRT program is to see if NOX66 improves the effect of radiotherapy on tumours directly exposed to radiation and whether the enhancement of effect can stimulate an additional indirect effect, extending to tumours outside of the field of irradiation, providing a bystander or abscopal effect against the cancer.
A. NOX66 plus external radiotherapy:
One Phase 1b study is currently open for recruitment (DARRT-1), aimed to identify the appropriate dose of NOX66 to use in all future trials and to confirm the safety of NOX66 in combination with radiotherapy. This study is recruiting patients with metastatic, castrate resistant prostate cancer.
Following DARRT-1, a series of studies will be undertaken with the objectives of showing the ability of NOX66:
(i) to sensitise tumours directly to irradiation (shrinkage/remission within tumours at sites of irradiation), and
ii) to stimulate a bystander or abscopal response in tumours not directly exposed to or affected by radiation.
Patients will have multiple tumours, and be requiring palliative dose radiotherapy within one or more of these tumours as part of their cancer treatment. Radiotherapy will be administered for up to two weeks with NOX66 provided for up to three weeks. Patients will be actively reviewed for up to 6 months with further follow up depending on the response to treatment.
Studies will include patients with all solid cancer types, with cancers commonly treated with palliative radiotherapy (e.g. prostate and lung) being investigated in randomised trials (where some patients receive NOX66 and some do not) to show the difference in outcomes by using NOX66. Other studies will be conducted to collect information on other common cancers, allowing for future research on these tumours, and in patients with rare cancers – a large unmet medical need.
B. NOX66 plus brachytherapy radiotherapy:
The first NOX66 study with brachytherapy – LUPIN – is underway. Following the completion of this study, and gathering of further data from the DARRT program, Noxopharm plan to explore further modes of brachytherapy to deliver tumour specific radiation in combination with NOX66.
This is an Investigator Initiated Phase 1b study. It involves patients with late-stage metastatic prostate cancer receiving experimental treatment with 177Lutetium-PSMA-617 and NOX66.
CHEMOTHERAPY - CEP program
The objective of the Chemotherapy Enhancement Program (CEP) is to enhance the cancer-killing abilities of standard cytotoxic chemotherapy drugs (such as carboplatin) through NOX66 providing both:
- a direct cytotoxic effect in its own right (additive effect), and
- blockage of the ability of the cancer cell to repair the damage caused by the chemotherapy drug (synergistic effect).
CEP1: This is a Phase 1a/Phase 1b sighting study in 19 patients with late-stage breast, lung, ovarian, prostate, and head and neck cancers. Patients are receiving NOX66 in combination with carboplatin starting with a monthly dose of AUC4 monthly for 3 months and then progressing to AUC6 monthly for 3 months.
Following the completion and reporting of CEP1 further studies are planned in chemotherapy, targeting specific tumour types.