Aytu BioScience Announces First Clinical Results Demonstrating Clinical Utility of MiOXSYS Male Infertility Test When Used Prior to In Vitro Fertilization (IVF) Procedures

First Clinical Data Demonstrating Predictive Power of Seminal Oxidation-Reduction Potential (ORP) as a Predictor of Fertilization When Used Prior to IVF

ENGLEWOOD, CO / ACCESSWIRE / June 25, 2019 / Aytu BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced the presentation of novel clinical data demonstrating the predictive power of the company’s MiOXSYS® male infertility diagnostic system in assessing fertilization outcomes following In Vitro Fertilization (IVF).

These clinical studies are the first to demonstrate the predictive power of oxidation-reduction potential (ORP), the diagnostic output of the MiOXSYS System, in determining fertilization outcomes following artificial insemination procedures. When measured in semen samples prior to the introduction of sperm via both IVF and Intracytoplasmic Sperm Injection (ISCI) procedures, both studies reported that oxidation-reduction potential was highly predictive of fertilization.

Two MiOXSYS clinical studies were presented on June 24, 2019 at the 35th Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) in Vienna, Austria.

The studies are detailed below.

Study #1

“Prediction of Successful ICSI Cycles by Oxidation-Reduction Potential (ORP) and Sperm DNA Fragmentation (SDF) Analysis”

Principal Investigator:

Ralf Henkel, PhD, Professor
Department of Medical Biosciences
University of Western Cape, Bellville, South Africa

Study Summary:

The study utilized 51 ejaculated semen samples and conducted sperm preparation for ICSI and oxidative stress measurement via ORP measurement with the MiOXSYS System. Sperm DNA fragmentation analysis was conducted via TUNEL assay.

Key Result:

• When using an ORP cutoff value of 1.36 mV/106 sperm/mL, the predictive power of ORP for fertilization was 81.3% following ICSI (p=.0002).

Conclusions:

• This study demonstrated strong predictive capabilities of ORP (oxidation-reduction potential, as measured by the MiOXSYS System) measurement in the clinical setting.
• ORP is clinically useful in providing the clinician with a valuable diagnostic tool for prediction of fertilization in ICSI cycles.
• When used in conjunction with semen analysis, ORP can be used to predict and improve the likelihood of fertilization outcomes.

Dr. Ralf Henkel, the study’s principal investigator and Professor at the University of Western Cape, commented, “Having done functional andrological diagnostics for more than 20 years, I have seen the progress andrological diagnostics have made. Now, for the first time, an easy, standardized and therefore properly quantifiable parameter is available, which correlates very well with semen quality and fertilization after assisted reproductive techniques. This is a major step forward in the right direction.”

Study #2

“Relationship Between Oxidative Stress in Semen and the Fertilizing Capacity of the Sperm – Evidence from the Conventional IVF Model in Couples with Unexplained Infertility”

Principal Investigator:

Hassan Sallam MD, PhD, Professor of Obstetrics and Gynecology
Head, Alexandria Fertility and IVF Center
University of Alexandria, Alexandria, Egypt

Study Summary:

This prospective study was conducted between September 2017 and December 2018, and 25 couples with unexplained infertility were included in the cohort. Couples were treated for one cycle of combined IVF/ICSI if 12 oocytes or more were retrieved. Oxidation-reduction potential (ORP) was determined in native semen samples by measuring ORP using the MiOXSYS System to assess correlation of ORP with fertilization rates.

Key Results:

• Seminal ORP as measured by the MiOXSYS System, using a cutoff value of 1.5692 mV/106 sperm/mL, demonstrated a positive likelihood ratio (+LR) of 80.0% among IVF/ICSI couples who had greater than or equal to 50% fertilization of oocytes.
• The mean ORP in the native semen in couples with =>50% IVF fertilization was 1.02 ± 0.1 mV/106 sperm/mL which is significantly lower than in couples with
• Seminal ORP as measured by the MiOXSYS System, effectively distinguished between those couples above and below 50% fertilization rates.

Conclusion:

• Measuring ORP in native semen can/should be used in couples with unexplained or male factor infertility to help determine the best management option: antioxidant therapy, intrauterine insemination (IUI), in-vitro fertilization (IVF), and intra-cytoplasmic sperm injection (ICSI).

Dr. Hassan Sallam, MD, PhD, the study’s principal investigator and Professor of Obstetrics & Gynecology at Alexandria University, concluded, “This study offers conclusive evidence that ORP (as measured via the MiOXSYS System) is negatively and significantly related to the fertilizing capacity of the spermatozoa.”

The MiOXSYS System is currently in use in over thirty countries around the world, and is CE Marked and cleared by Health Canada, the Australian Therapeutic Goods Administration (TGA), and Mexico’s COFEPRAS.

Selection of the abstracts for publication or presentation in this press release does not imply endorsement of the MiOXSYS System by ESHRE.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or “Low T”). Aytu also has exclusive U.S. and Canadian rights to ZolpiMist™, an FDA-approved, commercial-stage prescription sleep aid indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Aytu recently acquired exclusive U.S. commercial rights to Tuzistra® XR, the only FDA-approved 12-hour codeine-based antitussive syrup. Tuzistra XR is a prescription antitussive consisting of codeine polistirex and chlorpheniramine polistirex in an extended-release oral suspension. 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 of the U.S. where it is a CE Marked, Health Canada cleared, Australian TGA approved, Mexican COFEPRAS approved product, and Aytu is planning U.S.-based clinical trials in pursuit of 510k de novo medical device clearance by the FDA. Aytu’s strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com.

Forward-Looking Statements

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 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 revenue growth, our anticipated future cash position and future events under our current and potential future collaboration. 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.

Contact for Investors:

James Carbonara
Hayden IR
(646)-755-7412

SOURCE: Aytu BioScience, Inc.

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