Just got back from my monthly doctor visit. My research doc was at the American Urologic Association conference. Here is one of the thing he seemed excited about:
Veru Advances Novel, First-in-Class Oral Tubulin Inhibitor for Refractory Metastatic Prostate Cancer
GlobeNewswire•November 13, 2018
-- Submits Investigational New Drug Application to FDA --
-- Open Label Phase 1b/2 Clinical Trial Expected to Begin before end of 2018 --
MIAMI, Nov. 13, 2018 (GLOBE NEWSWIRE) -- Veru Inc. (VERU), an oncology and urology biopharmaceutical company, today announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for VERU-111 (bisindole), a first-in-class, next generation, proprietary, oral tubulin inhibitor for the treatment of refractory metastatic prostate cancer. The Company plans to conduct an open label Phase 1b/2 clinical trial in men with metastatic castration resistant prostate cancer that have also become resistant to, or who have failed to respond to, abiraterone or enzalutamide.
“Submission of this IND is an important milestone in advancing into humans VERU-111 -- a first-in-class, next generation, proprietary, oral tubulin inhibitor. VERU-111 is being developed for men who have metastatic castration resistant prostate cancer that have also become refractory to, or who have failed to respond to, abiraterone or enzalutamide. This group of men may be the largest growing segment of advanced prostate cancer unmet need. These men with refractory prostate cancer are now being offered intravenous administration of anti-tubulin taxanes that can have significant safety limitations like hypersensitivity, myelosuppression (neutropenia) and neurotoxicity,” commented Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru.
“Based on our extensive preclinical experience, we believe VERU-111 should demonstrate significant antitumor activity against metastatic castration and novel androgen blocking agent (enzalutamide or abiraterone) resistant prostate cancers with oral dosing and a favorable safety profile. We expect to begin an open label Phase 1b/2 clinical trial before the end of 2018. The open label design of the trial means that we will have safety and efficacy data as early as the first half of calendar year 2019.”
About VERU-111
VERU-111 is a novel, next generation oral anti-tubulin therapy that targets alpha and beta tubulin subunits. In animal models, VERU-111 delivered by oral administration demonstrated significant anti-tumor activity in models of metastatic, castration and novel androgen blocking agent (abiraterone or enzalutamide) resistant prostate cancer. In the preclinical toxicology studies, VERU-111, at oral doses that had significant antitumor effects, did not result in neutropenia or myelosuppression, common dose limiting side effects of other antitubulins including intravenous taxanes or intravenous vinca alkaloids. Also, VERU-111 had antitumor effects in other cancer types including preclinical human models for triple negative breast cancer, ovarian cancer and pancreatic cancer.
About Veru Inc.
Veru Inc. is an oncology and urology biopharmaceutical company developing novel medicines for prostate cancer and prostate cancer supportive care as well as near term specialty pharmaceuticals to address significant unmet needs in urology.
The Veru prostate cancer pipeline includes zuclomiphene citrate (also known as VERU-944, cis-clomiphene) and VERU-111 (bisindole). Zuclomiphene citrate is an estrogen receptor agonist being evaluated in a Phase 2 trial to treat hot flashes, a common side effect caused by hormone treatment for men with advanced prostate cancer. VERU-111 is an oral, next-generation, first-in-class, agent that targets alpha and beta subunits caused by cells to form cellular microtubules to treat castration and novel androgen blocking agent (abiraterone or enzalutamide) resistant metastatic prostate cancer that Veru expects to enter Phase 1b/2 development in late 2018.
Veru is also advancing four new drug formulations in its specialty pharmaceutical pipeline addressing unmet medical needs in urology. Tamsulosin DRS granules and Tamsulosin XR capsules are formulations of tamsulosin, a super selective alpha-1 adrenergic receptor antagonist for the treatment of benign prostatic hyperplasia (BPH), that avoid the “food effect” in currently marketed formulations of the drug, allowing for potentially safer administration and improved patient compliance (NDA submission expected in 2019). Veru is also developing Tadalafil/Finasteride combination tablets for inhibition of both phosphodiesterase type 5 (PDE5) and 5-alpha-reductase to shrink an enlarged prostate, treat symptoms of BPH and to treat erectile dysfunction (NDA submission expected in 2019). Finally, Veru is developing Solifenacin DRG granules, a formulation of a selective M3 muscarinic receptor antagonist for the treatment of overactive bladder in patients who have difficulty with swallowing tablets (NDA submission expected in 2019).
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