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Veru Announces Positive Phase 1b/2 Clinical Study Update for Sabizabulin (VERU-111) in Men with Metastatic Castration Resistant Prostate Cancer Presented at the 2021 ASCO Annual Meeting
-- Sabizabulin, an oral selective cytoskeleton disruptor, demonstrated good safety, significant evidence of antitumor efficacy, and that chronic
About this update from Veru Inc.
[{"type":"text","content":"-- Sabizabulin, an oral selective cytoskeleton disruptor, demonstrated good safety, significant evidence of antitumor efficacy, and that chronic administration is feasible in ongoing Phase 1b/2 study of 80 men -- -- Phase 3 VERACITY study to evaluate sabizabulin treatment in men who have metastatic castration prostate cancer and have also progressed following at least one androgen receptor targeting agent planned to start this month -- MIAMI, June 07, 2021 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer, today announced the presentation of the Phase 1b/2 clinical trial update of sabizabulin (VERU-111), an oral cytoskeleton disruptor which in prostate cancer also disrupts androgen receptor transport, to treat men with metastatic castration resistant prostate cancer who failed at least one androgen receptor targeting agent, at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting being held June 4-8, 2021. The Phase 1b/2 clinical study was designed as a dynamic study with an initial 3+3 standard safety study component followed by an expanded study with increases in dose and schedule. The Phase 1b/2 clinical trial enrolled 80 men and is ongoing with patients in both the Phase 1b and 2 components still on study. Highlights of the study presentation are as follows: Sabizabulin oral daily dosing was well tolerated, and the most common adverse events, being mostly Grade 1 and 2, were diarrhea, fatigue, nausea, and decrease in appetite. There was no evidence of clinically relevant neutropenia or neurotoxicity. Safety profile was similar to that reported in package inserts for androgen receptor targeting agents, abiraterone and enzalutamide.Clinically meaningful and durable evidence of objective tumor responses were observed in patients on 63mg oral daily dosing schedule: In the ITT population with measurable disease (n=29), the ORR (5 partial responses + 1 complete response) was 20.7%.In the Phase 1b study, ITT population of men that received at least 1 dose of 63mg daily dosing schedule (n=14), the median progression free survival was 10.8 months (2.3-26+ months). Two of these patients on continuous daily dosing of sabizabulin have now reached 27 months and 23 months of treatment without prostat...