MIAMI, May 17, 2018 (GLOBE NEWSWIRE) -- Veru Inc. (VERU), a urology and oncology biopharmaceutical company, today announced the publication of data from preclinical studies of VERU-111, a novel oral alpha and beta tubulin inhibitor, that showed efficacy in chemotherapy resistant tumor types. Specifically, VERU-111 reduced tumor growth in a paclitaxel sensitive and resistant triple negative breast cancer (TNBC) model, as well as ovarian cancer and pancreatic cancer models. Three abstracts, which include data related to each of the three cancers, were published as part of the upcoming 2018 American Society of Clinical Oncology Annual Meeting in Chicago.

Triple negative breast cancer is highly aggressive and has poor prognosis due to the frequent development of drug resistance. The study being published evaluated oral administration of VERU-111 compared with IV docetaxel in a paclitaxel resistant TNBC model. IV docetaxel had little impact on tumor growth whereas oral VERU-111 resulted in almost complete inhibition of TNBC tumor growth at 12.5 mg/kg, as well as significantly reduced tumor metastasis.

Metastatic ovarian cancer is a highly lethal gynecological malignancy. Although many patients with ovarian cancer initially respond to treatment with taxane therapies, resistance is common. The study being published evaluated oral administration of VERU-111 in an orthotopic ovarian cancer model. Orally administered VERU-111 had a significant (86%) reduction in ovarian tumor growth and the animals receiving oral VERU-111 had no identifiable liver or spleen metastases.

Likewise, the prognosis for pancreatic cancer is poor since pancreatic cancer usually does not cause recognizable symptoms in its early stages and the disease is typically not diagnosed until it has spread beyond the pancreas itself. The study being published evaluated oral administration of VERU-111 compared with paclitaxel, vinorelbine and colchicine in a pancreatic cancer model. Orally administered VERU-111 had significant impact on pancreatic tumor growth and mechanistically arrested the cell cycle and induced apoptotic pathways in this model.

“We believe that VERU-111 has the potential to become an important therapeutic option for ovarian, pancreatic and breast cancer patients, as well as with many other 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.

About VERU-111
VERU-111 is a novel oral therapy targeting alpha and beta tubulin for the treatment of metastatic prostate, breast, endometrial, ovarian, and other cancers. In 2017, there were approximately 161,000 new cases of prostate cancer in the U.S. and about 25% of these men will die from the disease. In the U.S., 5% of men with prostate cancer will have metastatic cancer and up to 30% of men with high-risk, localized prostate cancer will develop metastatic cancer following initial therapy. The median survival of patients with metastatic prostate cancer ranges from 3.2 to 4.5 years. For these men, the 1st line therapy is androgen deprivation therapy, or medical castration. Although most will initially respond, nearly all these patients will progress to metastatic castration resistant prostate and have a poor prognosis with an average survival of 1.5 years. New 2nd line hormonal agents, like XTANDI® (enzalutamide) and ZYTIGA® (abiraterone/prednisone) have resulted in an additional four to five months of average survival, but nearly all men on these agents will develop progressive metastatic prostate cancer.

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.