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SAN DIEGO, June 1, 2015 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that it has begun enrolling patients in a Phase 2b clinical trial to evaluate Apricus' novel product candidate, fispemifene, a selective estrogen receptor modulator ("SERM"), for the treatment of men with symptomatic secondary hypogonadism also known as low testosterone.
The Phase 2 proof-of-concept clinical trial is a randomized, double-blind, placebo-controlled, parallel arm, multi-center study in approximately 160 hypogonadal men aged 18 to 64 who present with sexual dysfunction related to secondary hypogonadism, or low levels of testosterone. The study will evaluate the safety and tolerability of oral fispemifene, and will assess the effects of treatment on the sexual symptoms using Patient Reported Outcome (PRO) endpoints. The study will also assess relevant pharmacodynamic and pharmacokinetic parameters to evaluate the ability of fispemifene to endogenously increase the serum testosterone level. The study will enroll at approximately 15 sites in the United States and the Company expects it to run through the end of the year with topline data expected in the first quarter of 2016.
"I am enthusiastic about the potential of fispemifene, a new SERM, as a treatment option for men with sexual symptoms associated with secondary hypogonadism, and am excited to be an investigator in this important study," said Dr. Jed Kaminetsky, MD, Clinical Assistant Professor at New York University School of Medicine, Medical Director at Manhattan Medical Research, and a Principal Investigator for the Phase 2b study.
"Apricus' development goals for fispemifene are broader than simply demonstrating an increase in serum levels of testosterone in men with secondary hypogonadism," said Barbara Troupin, MD, Chief Medical Officer of Apricus Biosciences. "Our overarching objective is to demonstrate additional clinical benefits in symptomatic hypogonadal men, using fispemifene's novel mechanisms of action, to support approval in the US market. The multi-indication development program is designed to explore additional clinical benefits of fispemifene in other urological conditions where there is currently an unmet need."
Dr. Troupin continued, "Since inappropriate use of testosterone replacement products is of concern to the FDA, we believe our development strategy, which characterizes an appropriate patient population and a treatment approach based on alleviating prevalent symptoms in men with androgen deficiency, positions fispemifene favorably from both a clinical and a regulatory perspective. If successful, the ability to demonstrate meaningful clinical benefits, in a well-tolerated oral formulation, would represent a significant treatment benefit and an attractive alternative to existing treatments."
About Male Hypogonadism
Male hypogonadism or low testosterone is identified as total testosterone less than 280-300 ng/dL in healthy men. Based on the Hypogonadism in Males (HIM) study, hypogonadism is estimated to affect up to 39% of men over the age of 45 in the United States of which 66% present with one or more symptoms, including erectile dysfunction, decreased libido, weakness, decreased bone density, fatigue and decreased lean body mass. Currently approved treatment options include topical and injectable testosterone replacement therapies.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus' lead product, Vitaros®, for the treatment of erectile dysfunction, is approved in Europe and Canada and is being commercialized in several countries in Europe. Apricus' marketing partners for Vitaros include Mylan NV, Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati Ireland Ltd. (Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle. Apricus' second-generation room temperature Vitaros is under development. Apricus commenced a Phase 2a trial for RayVa™, its product candidate for the treatment of the circulatory disorder Raynaud's phenomenon. Additionally, Apricus has initiated a Phase 2 trial for fispemifene, a selective estrogen receptor modulator for the treatment of symptomatic male secondary hypogonadism, and plans to conduct additional studies in other urological conditions.
For further information on Apricus, visit http://www.apricusbio.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, as amended. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things: references to our development strategy for fispemifene; the timing and success of current and planned clinical trials of fispemifene and RayVa™; the size of the commercial opportunity for fispemifene and the potential for it to achieve commercial success; and the potential for fispemifene to be used in a variety of urological indications. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside the control of Apricus, including, but not limited to: its ability to further develop its product fispemifene for the treatment of symptomatic secondary hypogonadism and other urinary conditions in men, as well as the timing of such events; Apricus' ability to carry out clinical studies for fispemifene, as well as the timing and success of the results of such studies; competition in the erectile dysfunction market and other markets in which Apricus and its partners operate; Apricus' ability to obtain and maintain intellectual property protection for fispemifene; Apricus' ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; Apricus' ability to obtain the requisite governmental approval for fispemifene; and market conditions. These forward-looking statements are made as of the date of this press release, and Apricus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Readers are urged to read the risk factors set forth in Apricus' most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q, and other filings made with the SEC. Copies of these reports are available from the SEC's website at www.sec.gov or without charge from Apricus.
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