-- Submits Investigational New Drug Application to
-- Open Label Phase 1b/2 Clinical Trial Expected to Begin before end of 2018 --
“Submission of this IND is an important milestone in advancing into humans
“Based on our extensive preclinical experience, we believe
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’s currently marketed products are the PREBOOST® medicated individual wipe for the prevention of premature ejaculation and the FC2 Female Condom®. The Female Health Company Division markets the FC2 Female Condom® in the global public health sector to improve the lives, health and well-being of women around the world. To learn more please visit www.verupharma.com.
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Press Release Kari Sharp