ENGLEWOOD, Colo., Oct. 22, 2015 /PRNewswire/ -- Aytu BioScience, Inc. (OTCQB: AYTU), a commercial-stage specialty healthcare company focused on urological and related conditions, presented encouraging clinical data from two prospective clinical studies of its MiOXSYS® System that demonstrated its clinical utility as a tool for measuring oxidation-reduction potential (ORP) to assess the degree of oxidative stress levels in human semen, which is broadly implicated as a major cause of male infertility. The results were presented at the 2015 American Society for Reproductive Medicine (ASRM) annual meeting, in Baltimore, MD.

The studies' principle investigator, Ashok Agarwal, Ph.D., Director of the Glickman Urological & Kidney Institute's Andrology Center at Cleveland Clinic and Director of the American Center for Reproductive Medicine, presented two posters titled "Establishing the Oxidation-Reduction Potential in Semen and Seminal Plasma" and "Effect of Time on Oxidation-Reduction Potential in Semen and Seminal Plasma."

The first study concluded that MiOXSYS can measure ORP accurately in both the semen and seminal plasma, as ORP levels were highly consistent from both sample preparations (P<0.001).  Furthermore, there was a significant inverse correlation between ORP levels and sperm motility in both semen (p=0.004) and seminal plasma (p=0.002), indicating that low sperm motility was related to higher ORP values.  An ORP cutoff of 4.65mV/106 sperm was highly predictive of abnormal sperm motility with 100% sensitivity in both semen (specificity=89.5%) and seminal plasma (specificity=93.8%). These findings suggest that ORP, as measured by MiOXSYS, can be used effectively in the screening of infertile men with oxidative stress. The results are currently being validated in a larger cohort of infertile men.

The second study further evaluated MiOXSYS in assessing oxidative stress levels in semen and seminal plasma samples over time.  Traditional methods of measuring seminal oxidative stress, such as a chemiluminescence assay, are time sensitive and time consuming making them difficult to use for diagnostic purposes. A system that can assess oxidative stress independent of semen age and provide results in real time would be highly advantageous.  The results of this study demonstrated that ORP, as measured by MiOXSYS, did not change significantly over a two hour period in either semen or seminal plasma (P<0.05), indicating that ORP levels are not affected by semen age.  Taken with the MiOXSYS System's ability to produce real-time results, it is easier to employ for diagnostic use.

Josh Disbrow, Chief Executive Officer of Aytu, stated, "We are very encouraged by these early clinical results, which help to position our MiOXSYS System as a validated and useful diagnostic tool for helping to guide the treatment of  male infertility caused by oxidative stress, as well as further position Aytu as an emerging leader in urology. We look forward to continuing this work with our collaborators and expect to initiate the FDA process for MiOXSYS and begin formal clinical studies in the near future."

About Aytu BioScience, Inc.
Aytu BioScience, Inc. is a commercial-stage specialty healthcare company focused on urological and related conditions. The Company's products includes FDA-approved ProstaScint® (capromab pendetide), a radio-labeled monoclonal antibody that targets Prostate Specific Membrane Antigen (PSMA), a protein highly expressed by prostate cancer; as well as Primsol® (trimethoprim oral solution), the only FDA-approved oral solution of trimethoprim, the standard therapy for urinary tract infections.  Aytu's strategy is to continue building its portfolio of revenue-generating urology products and late-stage development assets, leveraging its commercial team and expertise to further build those brands within well-established markets.

For Investors & Media:
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D.: jdrumm@tiberend.com; (212) 375-2664
Janine McCargo: jmccargo@tiberend.com; (646) 604-5150

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. Such forward-looking statements include, without limitation, statements regarding 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. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including without limitation to the risks described in "Risk Factors" in Part I, Item 1A of Aytu BioScience, Inc. 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. These risks are not exhaustive. Other sections of Aytu BioScience, Inc. Annual Report on Form 10-K and such other filed reports and documents include additional factors that could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. We assume no obligation to update or supplement forward-looking statements.

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/aytu-bioscience-demonstrates-clinical-utility-of-mioxsys-for-measuring-oxidative-stress-levels-in-semen-as-a-marker-for-male-infertility-300164489.html

SOURCE Aytu BioScience, Inc.