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Veru to Start Phase 2 Trial to Evaluate Cis-Clomiphene Citrate to Treat Hot Flashes Caused by Advanced Prostate Cancer Therapy

-- Intellectual Property Position Strengthened; U.S. Patent Issued for VERU-944, Expiring 2035 --

-- VERU-944 Potentially First FDA-Approved Drug for this Indication --

/EIN News/ -- MIAMI, June 12, 2018 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), a urology and oncology biopharmaceutical company, today announced the submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for VERU-944 (cis-clomiphene citrate).  Based on previous input by the FDA, filing the IND will allow the company to advance its proprietary drug candidate, VERU-944, directly to a Phase 2 clinical study. The Phase 2 clinical study will evaluate the efficacy and safety of VERU-944 for the treatment of hot flashes caused by androgen deprivation hormone therapy (ADT) in men with advanced prostate cancer. 

“Hot flashes are the most common and debilitating side effect of ADT for men with advanced prostate cancer,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru.  “According to the scientific literature, up to 80% of men treated with ADT experience hot flashes.  VERU-944 has an estimated U.S. addressable market size of approximately $600 million for hot flashes alone.” 

Dr. Steiner added, “We expect this summer to commence enrolling approximately 120 patients into a Phase 2 multi-center, double-blind, placebo-controlled dose-finding clinical study.  The primary endpoint for the VERU-944 trial will be the change in frequency of ADT-induced moderate and severe hot flashes.  We are able to proceed directly to a Phase 2 clinical trial on an expedited basis because of the significant amount of existing preclinical and clinical information on clomiphene citrate.”

The company also announced today that the U.S. Patent and Trademark Office has issued Patent No. 9,913,815.  The patent, which expires in 2035, provides intellectual property protection for the use of VERU-944 in men with prostate cancer as a method of treating and preventing side effects caused by ADT including hot flashes, bone loss and bone fractures. 

“The issuance of this patent reinforces and strengthens our intellectual property position for VERU-944,” said Dr. Steiner.  “The expansion of our IP portfolio is an integral aspect of our clinical development and commercialization strategy, which is aimed at positioning VERU-944 as a first-in-class therapy.”

About Hot Flashes and Bone Loss in Men with Prostate Cancer Undergoing Hormonal Therapy
ADT is widely used to treat men with advanced prostate cancer. Approximately 600,000 men in the US are currently on ADT, which includes Lupron®, Eligard® and Firmagon®. The symptom of hot flashes is the most common side effect of ADT. These hot flashes can range from bothersome to debilitating.  Associated symptoms may include anxiety and palpitations. Hot flashes usually last from a few seconds to several minutes but can persist for up to 20 minutes. Unlike postmenopausal hot flashes, ADT induced hot flashes do not get better or resolve over time.  Up to 40% of men continue to suffer from moderate to severe hot flashes by 8 years of ADT.

It is widely accepted by the scientific/medical community that an important side effect in men suffering from prostate cancer undergoing ADT is the development of bone loss leading to osteoporosis and bone fractures.  Men on ADT are four times more likely to develop a significant bone deficiency (Shahinian VB et al., NEJM 2005) and a loss of BMD occurs in the majority of patients being treated by ADT by six months.  Men on ADT have an approximately 20% risk for developing a bone fracture which is significantly higher than men not receiving ADT (Bienz and Saad, BoneKEy Reports 2015).

About Veru Inc.
Veru Inc. (Veru) is a urology and oncology biopharmaceutical company. The company is currently developing drug product candidates: Tamsulosin DRS, slow release granules, and Tamsulosin XR capsules for lower urinary tract symptoms of benign prostatic hyperplasia (BPH) (NDA planned 2018), Solifenacin DRG, slow release granules, for overactive bladder (urge incontinence, urgency and frequency of urination) (NDA planned 2019), Tadalafil/finasteride combination capsule for restricted urination because of an enlarged prostate (NDA planned 2019), VERU-944 (cis-clomiphene citrate) for hot flashes in men associated with prostate cancer hormone treatment (planned Phase 2 in 2018), and VERU-111 a novel oral anti-tubulin cancer therapy targeting alpha & beta tubulin for a variety of malignancies, including metastatic prostate, breast, endometrial and ovarian cancers (planned Phase 1/2 in 2018).

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.

"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:
The statements in this release that are not historical fact are "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include statements relating to the regulatory pathway to secure FDA approval of the Company's drug candidates and the anticipated timeframe for clinical studies and FDA submissions.  Any forward-looking statements in this release are based upon the Company's current plans and strategies and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this release. The Company assumes no obligation to update any forward-looking statements contained in this release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, the following: risks related to the development of the Company's product portfolio, including clinical trials, regulatory approvals and time and cost to bring to market; potential delays in the timing of and results from clinical trials and studies and the risk that such results will not support marketing approval and commercialization; potential delays in the timing of any submission to the FDA and regulatory approval of products under development; risks relating to the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; product demand and market acceptance; competition in the Company's markets and the risk of new or existing competitors with greater resources and capabilities and new competitive product introductions; price erosion, both from competing products and increased government pricing pressures; manufacturing and quality control problems; compliance and regulatory matters, including costs and delays resulting from the extensive governmental regulation, and effects of healthcare insurance and regulation, including reductions in reimbursement and coverage or reclassification of the products; some of the Company's products are in development and the Company may fail to successfully commercialize such products; risks related to intellectual property, including the uncertainty of obtaining patents, the effectiveness of the patents or other intellectual property protections and ability to enforce them against third parties, the uncertainty regarding patent coverages, the possibility of infringing a third party’s patents or other intellectual property rights, and licensing risks; government contracting risks, including the appropriations process and funding priorities, potential bureaucratic delays in awarding contracts, process errors, politics or other pressures, and the risk that government tenders and contracts may be subject to cancellation, delay, restructuring or substantial delayed payments; a governmental tender award indicates acceptance of the bidder's price rather than an order or guarantee of the purchase of any minimum number of units, and as a result government ministries or other public sector customers may order and purchase fewer units than the full maximum tender amount; penalties and/or debarment for failure to satisfy tender awards; the Company's reliance on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector; risks related to concentration of accounts receivable with our largest customers and the collection of those receivables; the economic and business environment and the impact of government pressures; risks involved in doing business on an international level, including currency risks, regulatory requirements, political risks, export restrictions and other trade barriers; the Company's production capacity, efficiency and supply constraints and interruptions, including due to labor unrest or strikes; risks related to the costs and other effects of litigation, including product liability claims; the Company's ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company's ability to successfully integrate acquired businesses, technologies or products; and other risks detailed in the Company's press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2017. These documents are available on the "SEC Filings" section of our website at www.verupharma.com/investors.

Contact:
Kevin Gilbert     786-322-2213

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