ENGLEWOOD, Colo., Feb. 1, 2017 /PRNewswire/ -- Aytu BioScience, Inc. (OTCQX: AYTU), a specialty pharmaceutical company focused on global commercialization of novel products in the field of urology, today announced that two posters demonstrating clinical data for Natesto® (testosterone) Nasal Gel were accepted for presentation at the Endocrine Society 2017 Annual Meeting (ENDO) to be held on April 1-4, 2017 in Orlando, FL. Natesto is the first and only nasal formulation of testosterone approved by the U.S. Food and Drug Administration (FDA) as a replacement therapy for men diagnosed with hypogonadism (low testosterone, or "Low T"). Both abstracts will also be published in a future issue of Endocrine Reviews.
"Clinical interest in the benefits of Natesto continues to build, evidenced by the acceptance of these two poster presentations at the Endocrine Society Annual Meeting, which follows the acceptance of two other posters for presentation at the American Urological Association Annual Meeting that we announced earlier this month," said Josh Disbrow, Chief Executive Officer of Aytu.
The two abstracts accepted for presentation at the Endocrine Society 2017 Annual Meeting are as follows:
Title: Seasonal Allergies Do Not Significantly Impact the Absorption of Natesto® (Testosterone) Nasal Gel in Hypogonadal Men
Presenter: Alan Rogol, MD, PhD, Professor, University of Virginia, Charlottesville, VA
Conclusions: The pharmacokinetics, safety, and efficacy of Natesto for restoring normal testosterone levels in men with Low T is not adversely affected by seasonal allergies.
Title: One-Year Hematologic Safety of Natesto® (Testosterone) Nasal Gel in Men with Hypogonadism
Presenter: Margaux Guidry, Ph.D. and Gerwin Westfield, Ph.D., both Aytu Bioscience, Englewood, CO
Conclusions: Treatment with Natesto helped hypogonadal men achieve normal testosterone levels, while on average keeping hematologic levels, particularly hematocrit, well within the normal range.
"Aytu remains committed to expanding the body of scientific evidence on the benefits of Natesto by supporting the research of urology experts. As these benefits are more widely documented, we believe that Natesto will continue to gain broad acceptance as an important new treatment option for the approximately 13 million men in the U.S. who have Low T," concluded Mr. Disbrow.
About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on global commercialization of novel products in the field of urology. The company currently markets three products: Natesto®, the first and only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), ProstaScint® (capromab pendetide), the only FDA-approved imaging agent specific to prostate specific membrane antigen (PSMA) for prostate cancer detection and staging, and Primsol® (trimethoprim hydrochloride), the only FDA-approved trimethoprim-only oral solution for urinary tract infections. Additionally, Aytu is developing MiOXSYS®, a novel, rapid semen analysis system with the potential to become a standard of care for the diagnosis and management of male infertility caused by oxidative stress. MiOXSYS is commercialized outside the U.S. where it is a CE Marked, Health Canada cleared product, and Aytu is conducting U.S.-based clinical trials in pursuit of 510k medical device clearance by the FDA. Aytu's strategy is to continue building its portfolio of revenue-generating urology products, leveraging its focused commercial team and expertise to build leading brands within well-established markets. For more information visit aytubio.com.
Forward Looking Statement
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, including statements regarding our anticipated future clinical and regulatory events, future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. Forward looking statements are generally written in the future tense and/or are preceded by words such as "may," "will," "should," "forecast," "could," "expect," "suggest," "believe," "estimate," "continue," "anticipate," "intend," "plan," or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: risks relating to gaining market acceptance of our products, obtaining reimbursement by third-party payors, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaborations. We also refer you to the risks described in "Risk Factors" in Part I, Item 1A of Aytu BioScience, Inc.'s Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.
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SOURCE Aytu BioScience, Inc.