ENGLEWOOD, Colo., April 4, 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 it presented two posters demonstrating the safety advantages of Natesto® testosterone nasal gel, including the one-year hematologic safety and tolerability among men with seasonal allergies, in men with hypogonadism.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, "Clinical and scientific data presentations continue to demonstrate Natesto's unique attributes including the safety profile of Natesto as indicated by the product's nominal impact on hematocrit levels after long-term use as well as the lack of allergy symptoms observed in men with seasonal allergies who were taking Natesto for a sustained period. Natesto's unique dosing and administration, as the only FDA-approved nasally-administered testosterone replacement therapy, result in a distinct efficacy and safety profile. As such we look forward to sharing additional clinical data as we, along with our clinical collaborators, continue to explore various aspects of Natesto's safety and efficacy."
The posters presented at ENDO 2017 were as follows:
Title: One-Year Hematologic Safety of Natesto (testosterone) Nasal Gel in Men with Hypogonadism
Poster Number: SAT-126
Presenter: Margaux Guidry, PhD, Medical Affairs, Aytu BioScience
Conclusion: Natesto allows men to achieve serum total T levels in the normal range while not increasing hematologic values above the normal range. A potential inference for the distinctive efficacy and safety profile of Natesto is the unique dosing and administration.
Title: Seasonal allergies do not significantly impact the absorption of Natesto ® (testosterone) nasal gel, in hypogonadal men
Poster Number: SAT-126
Presenter: Alan Rogol, MD, PhD, University of Virginia, Charlottesville, VA
Conclusion: Efficacy was similar for allergic rhinitis patients and non- allergic rhinitis patients. Most surprising was the very low incidence of seasonal allergy symptoms reported by susceptible patients while on treatment for ≥6 months. Only 3/52 (5.8%) of these patients with ≥6 months exposure reported seasonal allergy flare-up.
Selection of the abstracts for publication in the press programme does not imply endorsement of the Natesto® by ENDO®.
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 two products in the U.S.: Natesto®, the first and only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T") and ProstaScint® (capromab pendetide), the only FDA-approved imaging agent specific to prostate specific membrane antigen (PSMA) for prostate cancer detection and staging. 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.