Starpharma has reported positive interim data from the prostate cancer arm of the Phase II trial of its clinical-stage asset, DEP cabazitaxel.
The company found that all the evaluable subjects with Stage IV metastatic prostate cancer demonstrated efficacy responses, using one or more standard measures of ailment.
A nanoparticle form of the traditional cancer drug Jevtana, DEP cabazitaxel is free of detergent-like polysorbate-80.
Being carried out at various study centres in the UK and Australia, the ongoing trial enrolled 51 subjects across all cancer types.
Findings showed that 64% of subjects with assessable tumour lesions had an extended stable disease and substantial decline in tumour size for up to 36 weeks on receiving DEP cabazitaxel treatment.
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Furthermore, 90% of subjects with detectable prostate-specific antigen (PSA) tumour biomarker levels had a decline in PSA on receiving treatment with the drug, while over half of these subjects attained a PSA decline of a minimum of 50%.
In 83% of subjects with secondary bone disease, their lesions either did not advance or improve.
Responses to all three measures were reported in 56% of the participants who were evaluable for these.
Subjects who received the DEP cabazitaxel treatment had substantially reduced severe bone marrow toxicity, severe neutropenia without any cases of neutropenic sepsis, which are linked to traditional cabazitaxel.
Starpharma CEO Dr Jackie Fairley said: “These positive results for DEP cabazitaxel in Stage IV prostate cancer patients are really exciting news for Starpharma and our DEP platform.
“They include high rates of efficacy across three measures of disease – tumour size, PSA, and bone metastases, and compare favourably with published data for conventional cabazitaxel, e.g., Jevtana, particularly given the heavily pre-treated status of the patients in this trial and their older average age.”
The FDA granted qualified infectious disease product and fast track designation for Starpharma’s VivaGel treatment in January 2017.