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-center 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 a 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 tumors 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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