MIAMI, May 03, 2018 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), a urology and oncology biopharmaceutical company, today announced that data from a pre-clinical study of VERU-111, a novel oral alpha and beta tubulin inhibitor showing potent activity against paclitaxel sensitive and resistant prostate cancer models, will be presented in a moderated poster session on Sunday, May 20, 2018 at the American Urological Association’s (AUA) 2018 Annual Meeting in San Francisco.
Chemotherapy prolongs survival and improves quality of life of patients with metastatic hormone sensitive and castration resistant prostate cancer. Despite this, many men are not responsive or quickly become resistant to these drugs and these drugs must be given through intravenous (IV) infusion with significant side effects. The Veru study being presented evaluated oral administration of VERU-111 compared with IV docetaxel in a paclitaxel resistant prostate cancer model. IV docetaxel had no impact on tumor growth whereas oral VERU-111 resulted in almost complete inhibition of tumor growth at 10 mg/kg (3 days/ week) as well as 20 mg/kg (1 day/week). In early toxicity studies, VERU-111 was well tolerated and the animals gained weight during treatment.
“This exciting data and the unique properties of VERU-111 provide further support for the utility of this drug to fill the important clinical unmet need in prostate cancer of having oral administration, as well as lack of drug resistance, myelosuppression and hypersensitivity reactions. Further, this drug has been shown to have preclinical activity in other cancer types and should have clinical activity in these other cancers as well,” said James Dalton, Ph.D., Dean of the College of Pharmacy and Professor of Pharmaceutical Sciences at the University of Michigan who will present the study.
“We believe that VERU-111 has the potential to become an important therapeutic option not only for prostate cancer patients, but for other cancer patients with many of the common cancer types. We are currently performing the required toxicity studies and are planning our IND submission and first clinical studies for later this year,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru.
Details on the moderated poster presentation are as follows:
Title: Efficacy of VERU-111, an oral alpha and beta tubulin inhibitor, in taxol responsive and resistant prostate cancer models
Presenter: James Dalton, Ph.D., Dean of the College of Pharmacy and Professor of Pharmaceutical Sciences at the University of Michigan
Session: Prostate Cancer Advanced MP52
Session Date and Time: Sunday, May 20, 2018, 7:00 am – 9:30 am Pacific Time
Location: Room 3020, West Building, the Moscone Center
Drugs like VERU-111 that target tubulin, the subunits of microtubules, have been shown to be the most effective targeted cytotoxic chemotherapy for the treatment of metastatic prostate cancer. Microtubules are critical for cancer cell replication to stimulate genes for cancer cell proliferation. Docetaxel and cabazitaxel are examples of FDA-approved chemotherapy drugs that are given intravenously (IV) that target tubulin to treat metastatic prostate cancer. Although effective, the challenges for this class of chemotherapy drugs, also known as taxanes, include that they must be given intravenously (IV) and that the cancer cells develop resistance to taxanes. There are also serious safety concerns with IV taxanes which include serious hypersensitivity reactions, myelosuppression and neurotoxicity such as peripheral neuropathy and muscle weakness.
Unlike taxanes which bind to just the beta subunit of tubulin, VERU-111 binds strongly to both the alpha and beta subunits of tubulin. VERU-111 has: high oral bioavailability; less resistance as it does not interact with multiple drug resistance proteins so it cannot be pumped out of the cancer cell; minimal drug to drug interactions and high activity against many tumor types including: prostate cancer resistant to drugs like enzalutamide, AR-V7 positive and taxanes, as well as triple negative breast cancer, ovarian cancer, pancreatic cancer, lung cancer, and melanoma. In preclinical studies, VERU-111 appears to have less toxicity and less suppression of white blood cells compared to taxanes and other chemotherapy agents.
Production of the VERU-111 active pharmaceutical ingredient and preclinical safety toxicology studies required for an IND are expected to be completed in 2018. We anticipate filing an IND in 2018 and Phase 1/2 studies are planned for late 2018. Phase 1 studies of VERU-111 are planned in men who have metastatic prostate cancer that has progressed while taking androgen deprivation therapy and abiraterone or enzalutamide as well as in patients with metastatic breast, endometrial, and ovarian cancers. In the U.S., there is a $5 billion annual market for 2nd line hormone therapies for prostate cancer and a $4.8 billion annual market for IV-given taxanes and vinca alkaloids chemotherapies (docetaxel $1 billion and cabazitaxel $500 million in prostate cancer) per Decision Resources Group and Allied Market Research. Second line hormonal therapies like enzalutamide and abiraterone/prednisone have almost complete cross-resistance and should not be used in sequence for the treatment of metastatic prostate cancer. VERU-111 could be substituted for IV given docetaxel and cabazitaxel antitubulin chemotherapies. VERU-111 could also be developed as an oral dosing alternative to chemotherapies for the treatment of metastatic breast, endometrial and ovarian cancers as these tumors that responded to IV taxane chemotherapies.
About Veru Inc.
To help support these clinical development programs, the company markets and sells the PREBOOST® medicated individual wipe, which is a male genital desensitizing drug product for the prevention of premature ejaculation which is being co-promoted with Timm Medical Technologies, Inc. and the FC2 Female Condom® (now available by prescription in the US including through the virtual doctor smartphone app “HeyDoctor” at www.fc2.us.com) in the United States and through The Female Health Company Division in the Global Public Health Sector. The Female Health Company Division markets to entities, including ministries of health, government health agencies, U.N. agencies, nonprofit organizations and commercial partners, that work to support and improve the lives, health and well-being of women around the world. More information about Veru and its products can be found at www.verupharma.com, www.PREBOOST.com, www.fc2.us.com and www.fc2femalecondom.com. For corporate and investor-related information about the Company, please visit https://verupharma.com/investors.
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Press Release Kari Sharp