VERU-111 sounds promising, and may be... - Advanced Prostate...

Advanced Prostate Cancer

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VERU-111 sounds promising, and may be a Godsend for those with very low blood counts who can't get other treatments

JLS1 profile image
JLS1
2 Replies

Low blood counts weren't a disqualification 2 years ago when I was trying to get my husband into the trial - hopefully this is still the case.

verupharma.com/news/veru-an...

Veru Announces Presentation of Final Positive Phase 1b/2 Clinical Trial Results for Sabizabulin in Metastatic Castration Resistant Prostate Cancer at the 2022 American Society of Clinical Oncology Annual Meeting

MIAMI, June 06, 2022 (GLOBE NEWSWIRE) — Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced that the final results from the Phase 1b/2 clinical study of sabizabulin, a novel oral cytoskeleton disruptor, in 80 men with metastatic castration resistant prostate cancer (mCRPC) that progressed after receiving at least one androgen receptor targeting agent was presented at a poster session during the 2022 American Society of Clinical Oncology Annual Meeting which is being held June 3-7, 2022.

Highlights of final results from the Phase 1b/2 clinical study are as follows:

Safety- Sabizabulin 63mg oral daily dosing was well tolerated with no clinically significant reports of neurotoxicity or neutropenia.

Efficacy- Sabizabulin administration resulted in both cytotoxic and cytostatic anticancer activity with PSA declines and objective and durable tumor responses. For patients with measurable disease, the objective response rate was 20.7%, and for all patients who received at least the 63mg dose, the median radiographic progression free survival was 11.4 months.

Furthermore, the full study has been published online ahead of print: Mark Markowski et al. A Phase Ib/II study of sabizabulin, a novel oral cytoskeleton disruptor, in men with metastatic castration resistant prostate cancer with progression on an androgen receptor targeting agent. Clinical Cancer Research 2022 (doi:10.1158/1078-0432.CCR-22-0162).

The Phase 3 VERACITY clinical study of men with metastatic castration resistant prostate cancer that has progressed on at least one androgen receptor targeting agent compared with the active control is enrolling with the anticipated completion of enrollment at the end of calendar 2022.

“The Phase 1b/2 study of sabizabulin showed a significant 11.4 month median radiographic progression free survival in patients with metastatic castration resistant prostate cancer that has progressed while receiving an androgen receptor targeting agent”, said Dr. Mark Markowski, Assistant Professor, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine, the presenter of the study. “As a benchmark, other drugs that have been used in these patients, like docetaxel chemotherapy or additional androgen targeting agents, typically achieve a median progression free survival between 3 and 4 months. Therefore, these early results demonstrate that sabizabulin appears to be very active in these patients and that chronic oral administration is feasible with an acceptable safety profile.”

Additional information on the meeting can be found on the ASCO website conferences.asco.org/

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JLS1
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Scout4answers profile image
Scout4answers

I want to see one that has 120 month survival

OhioGuy2 profile image
OhioGuy2

Thanks for the post. I spoke with my onco at Cleveland Clinic today along with their research team and I am going to submit to be in the trial.

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