— Clinical Results Presented at 2015 ASRM Annual Meeting —
Englewood, CO – October 22, 2015 – 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.
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