Noxopharm Limited announced that its first NOX66 Phase 1a/1b clinical study involving NOX66 has received approval from the Georgian Ministry of Health to begin recruitment. This first-in-human formal study involves patients with late-stage cancer (breast, ovary, prostate, lung and head and neck) who have failed standard therapies including carboplatin and who have no remaining standard treatment options. NOX66 is being assessed for its ability to overturn the drug- resistance mechanisms developed by cancer cells that enable them to resist all chemotherapy drugs including carboplatin. Apart from seeking to make carboplatin chemotherapy generally more effective, the ultimate objective is to lower chemotherapies such as carboplatin dosages to safer but highly effective levels. The aim is to provide an effective treatment option for patients considered too frail or too elderly to undergo chemotherapy, or for the significant number of cancer patients who currently chose not to undergo further chemotherapy. This study is an amended version of the study originally meant to start in late- 2016. The amendment came about because of data suggesting that it was not necessary to test a third, high-dose of NOX66 as originally proposed. Although causing a 2-month delay to the commencement of the study, the amendment and consequent delay were considered warranted in terms of patient convenience and overall conduct of the study including a potentially earlier completion date. The amendment necessitated re-submission to the Georgian drug regulatory authority, with that approval received today. Recruitment is planned for the last week of February following shipment of drug. The hypotheses being tested are that: NOX66 alone will be well tolerated. NOX66 will not exacerbate carboplatin toxicity. NOX66 will reverse resistance to carboplatin, providing meaningful tumour responses where none would be expected and NOX66 will restore carboplatin effectiveness to the point where its dosage can be reduced to a well-tolerated level. The study also has an adaptive design component that will allow it to be expanded immediately into a Phase 2a study in the event that the above hypotheses are confirmed. The study is being conducted at 2 hospitals in Tbilisi. A total of 16 patients are to be enrolled in the Phase 1a/1b arms using 2 dosages of NOX66 (2 cohorts each of 8 patients), and potentially a further 20 patients in the Phase 2a arm. Enrolment is expected to be complete by Third Quarter 2017. Phase 1 completion milestones to be reported in 2017/2018 are (i) Phase 1 a, (ii) Phase 1b low-dosage carboplatin, and (iii) Phase 1b standard dosage carboplatin. The study is being managed by UK-based CRO, Clinical Accelerator, and Australian-based CRO, Datapharm Australia.