Noxopharm (ASX: NOX) has announced the final results from its Phase 1b CEP-1 trial evaluating its lead immuno-oncology/radio-enhancer drug candidate, Veyonda, in combination with low-dose carboplatin in late-stage metastatic solid cancers.
The CEP-1 trial was a first-in-human study for Veyonda and was designed to confirm its safety as a monotherapy and in combination with chemotherapy, as well as patient and doctor acceptance of the treatment regimen.
The company said the study was managed by a UK-based clinical research organisation and conducted in the European country of Georgia at sites subject to FDA audit.
Top line data was presented earlier at the Clinical Oncology Society of Australia (COSA) Annual Meeting on 13 November 2018.
According to the company, the combination of Veyonda and low-dose carboplatin provided a suspension of tumour growth, or better, for at least six months in solid tumours (breast, ovarian, lung, prostate) in nearly 50 per cent of patients considered unlikely to respond to further chemotherapy.
The company said it believes the response rate and ongoing survival of patients post-study, suggests that a meaningful increase in survival is achievable and therefore worthy of consideration of an eventual marketing approval process.
“Chemotherapy induced toxicity remains a significant challenge for patients and oncologists that can lead to longlasting and debilitating side effects, such as peripheral nerve damage and hearing loss. We are hopeful that combining Veyonda with a lower than normal dosage of chemotherapy will provide a more tolerable treatment option for patients who have chemotherapy-resistant disease or who are only able to tolerate lower doses of chemotherapy.” said CEO Dr Graham Kelly.
“We believe that this result goes a considerable way to confirming the good tolerability and efficacy of Veyonda. A high incidence of an anti-cancer effect in such a highly treatment-resistant patient population is very pleasing. The context here is that these patients had progressive disease, had exhausted standard treatment options, and were facing a limited lifespan.
"To be able to stop tumour growth or to even shrink the tumours in many of these patients over the 7 months of this study, and to do so without significant side-effects, substantiates the faith we have in this drug becoming an important addition to standard anti-cancer therapy.”
“Noxopharm is committed to bringing Veyonda to market as a radio-enhancer with a strategy that we believe will see it on-market by 2022, but the CEP-1 outcome adds another dimension to our overall clinical and marketing strategies,” added Dr Kelly.