Sydney-based Noxopharm (ASX:NOX) has presented an update on its phase 1b clinical study known as CEP-1 to the 2018 ESMO International Congress on Targeted Anti-cancer Therapies in Paris.
CEP-1 is being conducted at clinics in the US and involves patients with late-stage cancers of the lung, breast, ovary and prostate following disease progression after multiple courses of chemotherapy and who have no remaining standard treatment options. The last patient is due to complete treatment in April 2018.
The company is using the CEP study with the goal of showing it is possible to achieve meaningful clinical benefit in patients with late-stage cancer using a chemotherapy drug regimen that is without significant side-effects.
The drug regimen being initially investigated is NOX66 in combination with low-dose carboplatin (AUC4 intravenously every 4 weeks).
According to the company, this regimen on its own would not be expected to produce any notable anti-cancer effect in patients whose cancers have progressed in the face of previous chemotherapy.
"The data from this study provides proof-of-concept evidence for the beneficial use and tolerability of NOX66 in combination with a low dose of carboplatin, and supports the Company’s underlying belief that it is possible to deliver meaningful clinical benefit without compromising patient safety," it said.
Noxopharm reported that, of the 15 patients in the study, one experienced toxicity serious enough to warrant withdrawal due to an allergic reaction to the carboplatin. The remaining 14 patients were evaluated for disease status after 3 months of treatment. One showed a partial response, 11 stable disease, and two disease progression. The 12 cancers in patients who benefited were breast (5/5), ovarian (3/3), lung (2/4) and prostate (2/2). The partial response was an ovarian cancer.
“Any interpretation of this data comes with the usual caveat that this is a Phase 1b study and as such was not designed to give definitive efficacy data. But considering that the patients in this study had advanced disease which had failed standard therapies, being able to halt the disease process in such a high proportion of patients across 4 common cancers for at least 3 months is a notable outcome,” said CEO Graham Kelly.
“To put this into perspective, a study using a recently approved immuno-oncology drug for late-stage lung cancer showed that just one in five patients responded to treatment and, on average, patients were alive for just 2.8 months longer than on standard therapy.”
“The CEP-1 trial outcome leaves us sufficiently convinced that we are well on the way to achieving that goal, with a Phase 2 study currently being planned and due to start before the end of 2018. Our objective now is to see how long this clinical benefit will last once we continue treatment beyond 3 months,” added Mr Kelly.