In our prostate cancer program, we are enrolling our Phase 3 VERACITY clinical study of sabizabulin for metastatic castration and androgen receptor targeting agent resistant prostate cancer, but prior to IV chemotherapy. We are also enrolling our Phase 2 dose-finding clinical study of VERU-100, a novel long-acting GnRH antagonist 3-month depot injection formulation for androgen deprivation therapy for hormone sensitive advanced prostate cancer. Once completed, we will start the Phase 3 registration study.
Finally, our Sexual Health division, led by robust FC2 sales, and if approved this month, the addition of ENTADFI sales expected in the first half of calendar year 2022, we will continue to have substantial resources to invest in our premium oncology drug pipeline line which is dedicated to addressing significant unmet medical needs for two of the most prevalent cancers, prostate and breast cancer. I am pleased and excited with Veru’s transformation into a premium oncology biopharmaceutical company seeking large market opportunities. The Company remains duty-bound during this persistent global pandemic to pursue this COVID-19 indication even though it is not the primary focus of the Company.”
Pharmaceutical Pipeline Highlights:
Breast Cancer Program
Enobosarm, a Novel Oral Selective Androgen Receptor Targeted Agonist, for the 3rd Line Treatment of Androgen Receptor Positive (AR+), Estrogen Receptor Positive (ER+) and Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer with AR ³ 40% - Phase 3 ARTEST Clinical Study- Enrolling.
Enobosarm is the first new class of targeted endocrine therapy in advanced breast cancer in decades. Enobosarm is an oral, new chemical entity, selective androgen receptor agonist that targets the androgen receptor, a tumor suppressor, in AR+ER+HER2- metastatic breast cancer without the unwanted masculinizing side effects. Enobosarm has extensive nonclinical and clinical experience having been evaluated in 25 separate clinical studies in over 2,000 patients including three Phase 2 clinical studies in advanced breast cancer involving more than 250 patients. In the two Phase 2 clinical studies conducted in women with AR+ER+HER2- metastatic breast cancer, enobosarm demonstrated significant antitumor efficacy in heavily pretreated cohorts that failed estrogen receptor targeting agents, chemotherapy, and/or CDK 4/6 inhibitors and was well tolerated with a favorable safety profile. We are enrolling the Phase 3 multicenter, international, open label, and randomized (1:1) ARTEST registration clinical trial design to evaluate the efficacy and safety of enobosarm monotherapy versus physician’s choice of either exemestane ± everolimus or a SERM as the active comparator for the treatment of AR+ ER+ HER2- metastatic breast cancer in approximately 210 patients with AR nuclei staining ³40% in their breast cancer tissue who had tumor progression on a nonsteroidal aromatase inhibitor, fulvestrant, and a CDK4/6 inhibitor.
Sabizabulin, Novel Oral Cytoskeleton Disruptor Agent, Monotherapy for the 3rd Line Treatment of AR+ER+HER2- Metastatic Breast Cancer with AR< 40% - Phase 2b Clinical Study.
We intend to conduct a Phase 2b clinical study of sabizabulin for the treatment of AR+ ER+ HER2- metastatic breast cancer in patients with an AR nuclei staining <40%. The Phase 2b clinical study will be an open label, multicenter, and randomized (1:1) study evaluating the efficacy and safety of sabizabulin 32mg monotherapy versus active comparator (exemestane ± everolimus or a SERM, physician’s choice) for the treatment of ER+ HER2- metastatic breast cancer in approximately 200 patients with AR nuclei staining <40% in their breast cancer tissue who had tumor progression on a nonsteroidal aromatase inhibitor, fulvestrant, and a CDK4/6 inhibitor. The Phase 2b study is expected to commence in calendar Q1 2022.
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