Biotech drug developer Noxopharm (ASX: NOX) has presented its most-recent clinical data from its groundbreaking CEP-1 clinical study, at the ESMO International Congress on Targeted Anticancer Therapies in Paris, France.
The drug developer said that it wants to “challenge the generally accepted notion that chemotherapy must be toxic to be effective” and says that “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.”
To prove its claims and hypothesis, Noxopharm is progressing NOX66, an innovative dosage formulation of the experimental anti-cancer drug, idronoxil.
NOX66 represents Noxopharm’s first pipeline product, with later generation drug candidates expected to be developed over time.
Noxopharm is currently working on its Phase 1b clinical study at clinics in Georgia, USA.
Its study involves patients with late-stage cancers of the lung, breast, ovary and prostate following disease progression after multiple courses of chemotherapy and with all treatment options exhausted.
From the data made available so far, 15 patients with evaluable disease underwent combination therapy, 1 patient experienced toxicity serious enough to warrant withdrawal from the study due to an allergic reaction to the carboplatin while the remaining 14 patients were evaluated after 3 months of monthly intravenous injections.
Clinical study details
Patients started with a 2-week run-in of NOX66 alone to establish the tolerance of this drug.
This was followed immediately by 3 months of combination therapy of NOX66 with low-dose carboplatin (AUC4 intravenously every 4 weeks), followed by 3 months of combination therapy with a standard dose of carboplatin (AUC6 intravenously every 4 weeks) providing there was no evidence of disease progression. Patients were scanned prior to the study and then after every 3 months of combination therapy.
The main aim of the CEP project is to develop a well-tolerated treatment regimen that could provide meaningful clinical benefit in cancer patients unable to tolerate standard chemotherapy or who are not responding to new treatments.
Noxopharm reported that 1 patient showed a partial response, 11 showed stable disease and 2 patients experienced worsening symptoms.
Efficacy and efficiency
Noxopharm says the main objective was not to substantiate efficacy rates at this early stage, but rather, to prove the low toxicity of its NO66 and carboplatin combined treatment and set the stage for a more thorough clinical trial to be conducted in the foreseeable future, that focuses on demonstrating efficacy rates.
“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 Graham Kelly, CEO of Noxopharm.
“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.”
Mr Kelly also said that “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.”
Noxopharm has confirmed that its current study is now fully recruited with the last patient due to complete treatment in April 2018.