Noxopharm Ltd (ASX:NOX) has confirmed the tolerability of its immuno-oncology and radio-enhancer drug candidate Veyonda in final results from its phase 1b CEP-1 trial.
Notably a combination of Veyonda and low-dose carboplatin provided suspension of tumour growth, or better, for at least 6 months in solid tumours in nearly 50% of patients considered unlikely to respond to further chemotherapy.
Veyonda was trialled in combination with low-dose carboplatin in late-stage metastatic solid cancers and was a first-in-human study for the drug candidate, designed to confirm its safety both as a monotherapy and in combination with chemotherapy.
The study, which ran between January 2017 and July 2018, was managing by a UK-based clinical research organisation and conducted in the country of Georgia.
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Noxopharm chief medical officer Greg van Wyk said the study data was highly encouraging, suggesting that Veyonda appears to have broader utility as an enhancer of chemotherapy along with serving as a potential enhancer of radiotherapy.
He said: “Chemotherapy-induced toxicity remains a significant challenge for patients and oncologists that can lead to long-lasting 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.”
Increase in survival achievable
Topline outcomes of the study are:
Veyonda was well-tolerated as a monotherapy with just one case of anaemia attributed;
400 and 800 milligram dosages of Veyonda did not exacerbate carboplatin toxicity;
Halt of progression of cancer growth in 50% of patients;
Response and ongoing survival rates of patients post-study suggest an increase in survival is achievable and the company believes it worth of an eventual marketing approval process; and
The combination of Veyonda and low-dose carboplatin can offer potential treatment options for cancer patients considered too unwell to undergo chemotherapy or are unlikely to respond to it.
“On-market by 2022”
Noxopharm chief executive officer Graham Kelly said the company believed the results went a considerable way in confirming the tolerability and efficacy of Veyonda.
He said: “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.”
Three drug candidates in development
Veyonda, previously known as NOX66, is a dosage formulation of the experimental anti-cancer drug idronoxil and was developed specifically to preserve the anti-cancer activity of idonoxil in the body and to enhance its drug-like behaviour.
Idronoxil is a kinase inhibitor that works by inhibiting a range of enzymes, notably the sphingosine kinase which is a key regulator of cell pro-survival mechanisms.
Noxopharm is a clinical-stage company with a primary focus on developing drugs based on an isoflavonoid chemical structure.
Veyonda is Noxopharm’s first pipeline product and three other drug candidates for non-oncology indicates are under development in a subsidiary company.