–Open-Label Phase 1b/2 Clinical Trial Results Expected by Year-End–
— Drug Addresses Significant Unmet Medical Need —
MIAMI, FL, USA I January 22, 2019 I Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company, today announced that it has initiated and enrolled the first patient in a clinical trial of its proprietary, next generation prostate cancer drug, VERU-111. The open-label Phase 1b/2 clinical trial for VERU-111, a novel oral drug, will be evaluated in men with metastatic refractory prostate cancer that would be given prior to intravenous chemotherapy.
“Upon successful completion of this important clinical trial, we will move forward with additional clinical studies including a pivotal Phase 3 trial,” commented Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. “Based on earlier preclinical studies, VERU-111 should be effective against refractory prostate cancer and have a more favorable safety profile compared to intravenous taxanes. Drugs for advanced prostate cancer currently have over $3 billion in U.S. annual sales. Our preclinical studies also suggest that VERU-111 may be effective as a treatment for breast, ovarian, pancreatic and other prevalent cancers.”
“The study will be conducted in approximately five centers in the United States, with results expected by the year-end of calendar 2019. In Phase 1b, the dose escalation portion of the study, patients will receive VERU-111 to determine the optimal dose for testing in Phase 2. In Phase 2, VERU-111 will be assessed for the drug’s effectiveness in lowering prostate-specific antigen blood levels, the primary endpoint.”
Dr. Mark Markowski, MD, PhD, Assistant Professor of Oncology, The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, stated: “VERU-111 addresses a large and growing medical need. New therapies are needed for men with metastatic castration resistant prostate cancer who have also become resistant to androgen blocking agents. Having a drug like VERU-111, a novel, oral selective alpha and beta tubulin inhibitor, would be a valuable option for these men that otherwise have to be treated by intravenous taxane chemotherapy.”
Dr. Mario Eisenberger, MD, Dale Hughes Professor of Oncology, The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center and a member of Veru’s Board of Directors, stated: “While major therapeutic advances have been accomplished with androgen receptor (AR) targeting drugs, it is clear that further improvements in the outcomes of prostate cancer patients rely on drugs and modalities that exert their anti-tumor effects through different mechanisms. VERU-111 has shown significant biological activity against a variety of in vitro and in vivo prostate cancer tumor cells resistant to AR targeting drugs at a level much superior to current FDA approved taxanes. Preclinical toxicology studies suggest that the tolerability of orally administered VERU-111 is superior to the widely used taxanes, docetaxel and cabazitaxel, especially in terms of hematological toxicities.”
About VERU-111
VERU-111 is a novel, proprietary, next generation, first-in-class oral selective antitubulin agent that targets and disrupts alpha and beta tubulin subunits of microtubules. In cancer cells, microtubules are critical for transport of growth factor receptors, cellular proliferation, and metastases. In preclinical effectiveness and toxicity studies, orally administered VERU-111 demonstrated significant antitumor activity against castration and novel androgen blocking agent (abiraterone or enzalutamide) resistant human prostate cancers. Furthermore, VERU-111 had significant antitumor effects against cancers that overexpress multidrug resistant proteins, like P-glycoprotein, a common mechanism by which cancer cells become resistant to cancer drugs. At oral doses that had significant antitumor effects, VERU-111 had a favorable safety profile as it did not cause neutropenia or myelosuppression, common dose limiting side effects of other classes of commercially available antitubulins such as intravenous taxanes or intravenous vinca alkaloids.
Veru is conducting an open label Phase1b/2 clinical trial evaluating the safety and effectiveness of VERU-111 in men who have metastatic castration resistant prostate cancer who have also become resistant to novel androgen blocking agents like abiraterone or enzalutamide. In addition to prostate cancer, VERU-111 had antitumor effects in other cancer types including preclinical human models for triple negative breast cancer, ovarian cancer and pancreatic cancer. VERU-111 has the potential to be the first FDA approved selective antitubulin agent that targets and disrupts alpha and beta tubulin subunits of microtubules to treat cancer.
About Veru Inc.
Veru Inc. is an oncology and urology biopharmaceutical company developing novel specialty pharmaceuticals and medicines for the prostate cancer continuum of care. 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 selective small molecule that targets and disrupts alpha and beta subunits of microtubules in cells to treat metastatic prostate cancer patients whose disease is resistant to both castration and novel androgen blocking agent (abiraterone or enzalutamide) therapies.
Veru is also advancing new drug formulations in its specialty pharmaceutical pipeline addressing unmet medical needs in urology. The clinical trial of the Company’s proprietary Tadalafil and Finasteride Combination tablet (Tad-Fin Combination Tablet) met FDA requirements for bioavailability and bioequivalence for the co-administration of tadalafil 5mg and finasteride 5mg dosed daily for benign prostatic hyperplasia (BPH). Tadalafil (CIALIS®) is currently approved for treatment of BPH and erectile dysfunction and finasteride (PROSCAR® and PROPECIA®) is currently approved for treatment BPH and male pattern hair loss. The co-administration of tadalafil and finasteride has been shown to be more effective for the treatment of BPH than either drug alone. The Company anticipates submitting an NDA for its Tad-Fin Combination Tablet under the 505(b)(2) regulatory pathway in the second half of calendar year 2019. Veru is also developing Tamsulosin DRS granules and Tamsulosin XR capsules which are formulations of tamsulosin, the active ingredient in FLOMAX®, which Veru has designed to avoid the “food effect” inherent in currently marketed formulations of the drug, allowing for potentially safer administration and improved patient compliance (NDA submission expected in 2019).
Veru’s Female Health Company Division markets the FC2 Female Condom / FC2 Internal Condom®, an FDA-approved product for the dual prevention of unwanted pregnancy and sexually transmitted infections, and the PREBOOST® medicated individual wipe for the prevention of premature ejaculation. The FC2 Female Condom / FC2 Internal Condom is marketed commercially and in the public health sector both in the U.S. and globally. FC2 is available by prescription in the U.S. including through the virtual doctor smartphone app “HeyDoctor” at www.fc2.us.com. FC2 improves the lives, health and well-being of women around the world. For PREBOOST® Veru has a co-promotion and distribution agreement with Timm Medical Technologies, Inc., a specialty urology sales organization, and the Company also recently entered into a US distributor agreement with a premier and fast-growing men’s health and telemedicine company that discreetly sells men’s health products via the internet. To learn more about these products please visit www.verupharma.com.
SOURCE: Veru
