Noxopharm Limited (ASX: NOX) recently announced the enrolment of 12th patient into the dose-expansion arm of DARRT-1 study, which is the company’s first clinical study of external beam radio-enhancement program (DARRT).
The announcement read that the DARRT-1 study has been completely enrolled. Enrolment of the dose expansion phase closed with the 12th patient, meeting the target number of patients in this phase, who will receive 1200 mg Veyonda® dose.
Direct and Abscopal Response to Radiotherapy, DARRT-1 is a Phase 1b multi-centre study, investigating Veyonda® in combination with low dose external beam radiotherapy in 24 men with late-stage, metastatic, castration-resistant prostate cancer (mCRPC). The study is reportedly being conducted in two stages that include dose escalation stage (12 subjects) and dose expansion stage (12 subjects) across Georgia and Australia.
Direct Response expected from DARRT study (Source: Company’s Presentation)
Dose-escalation arm of the DARRT-1 included 3 cohorts of 4 men receiving 400mg, 800mg and 1200 mg Veyonda® respectively, daily for 15 days in combination with the low-dose radiotherapy to a single lesion. Following the completion of this phase, Noxopharm reported encouraging evidence of durable clinical responses on the basis of 3-month and 6-month post-treatment assessments of subjects with late-stage prostate cancer that is progressive, metastatic and without any remaining standard treatment options. The 1200 mg Veyonda® dose was selected for the dose expansion arm.
The company positions its DARRT treatment regimen as a novel approach to the treatment of mCRPC, which the company believes, if successful, will be a transformative treatment option for this cancer where none currently exists.
In this treatment regimen, the company focuses on triggering an immune response in the irradiated lesion within a short duration and well-tolerated manner, where the best expected outcome (Abscopal Response) is likely to have an improved DIRECT response, along with shrinkage of non-irradiated lesions. For this purpose, it combines a short course (15 days) of Veyonda® (which enables the active ingredient to be supplied to all tumours with adequate blood supply) with a palliative (low) dose of radiation to a single lesion.
Abscopal Response expected from DARRT study (Source: Company’s Announcement)
Noxopharm has selected 1200 mg Veyonda® dose for its dose expansion phase under which it aims to assess the dose response in patients at regular intervals based on two main measures: (i) pain levels, where reduction of ≥ 30% compared to baseline is considered to represent significant pain relief, and (ii) PSA (prostate-specific antigen) levels, where falls in PSA levels of ≥ 50% compared to baseline are considered to be a clinical response.
Clinical-stage drug development company, Noxopharm intends to perform a preliminary analysis of safety and efficacy once the last patient, i.e., 12th patient, in stage 2 has reached the 3-month mark in the study. The data on this 3-month assessment is expected to be released in August 2019, following which the study is expected to reach the 6-month mark in November 2019. Noxopharm further aims to present the topline data in Q4 2019 and full data at an international scientific congress in H1 2020.
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