Demonstrates Statistical Clinical Improvement of Integrity of Human Sperm DNA in Infertile Grade I Varicocele Patients
SAN DIEGO, CA - (NewMediaWire) - November 04, 2015 - Innovus Pharmaceuticals, Inc. ("Innovus Pharma") (OTCQB: INNV), an emerging commercial stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men and women's health and respiratory diseases, has announced today the results from the fifth clinical trial of its licensed product Androferti® were published in the Journal of Human Fertility (Human Fertility, 2015; Early Online: 1-5).
Dr. Bassam Damaj, Ph.D., Chief Executive Officer, said, "We are extremely pleased that clinical trials with Androferti® keeps yielding statistically significant clinical improvement in infertile men. We believe that Androferti® is the only product in this field showing clinical benefit as a whole product in five published clinical trials."
The clinical trial was run at two of the world's top infertility centers at the Universitat Autònoma de Barcelona, Bellaterra, Spain and 6 Centro de Infertilidad Masculina y An á lisis de Barcelona (CIMAB) by Drs. Agustín García-Peiró, Juan Prats and Josep Gual-Frau. Twenty infertile patients with grade I varicocele were given Androferti® daily for three months. Semen parameters including total sperm count, concentration, progressive motility, vitality, and morphology were determined before and after treatment. In addition, sperm DNA fragmentation and the amount of highly degraded sperm cells were analyzed by Sperm Chromatin Dispersion.
After treatment, patients in the clinical trial showed:
1. An average relative reduction of 22.1% in sperm DNA fragmentation;
2. 31.3% fewer highly degraded sperm cells; and
3. Total numbers of sperm cells were increased.
Androferti®, has been shown in multiple published clinical trials to statistically increase seminal quality (concentration, motility, morphology and vitality) and enhances spermatozoa quality (decreases of vacuoles in the sperm nucleus, decreases DNA fragmentation, decreases the dynamics of sperm DNA fragmentation, and improvement on the inventory of mobile sperms (REM).
The Company believes that Androferti® is the only product clinically proven to increase the Sperm Quality and enhance Spermatozoa Quality as compared to other products where the claims are based on an ingredient used in the products.
Innovus Pharma obtained the exclusive rights to commercialize the product in the U.S. and Canada from Q Pharma, Spain in January 2015.
About Innovus Pharmaceuticals, Inc.
Headquartered in San Diego, Innovus Pharma is an emerging leader in OTC and consumer products for men's and women's health and vitality. The Company generates revenues from its lead products Zestra® for female arousal and EjectDelay® for premature ejaculation and has a total of five marketed products in this space, including Sensum+® for the indication of reduced penile sensitivity, (for sales outside the U.S. only), Zestra Glide®, Vesele® for promoting sexual and cognitive health, Androferti® (in the US and Canada) to support overall male reproductive health and sperm quality and eventually FlutiCare™ OTC for Allergic Rhinitis, if its ANDA is approved by the U.S. FDA.
For more information, go to www.innovuspharma.com; www.zestra.com; www.ejectdelay.com; www.myvesele.com; www.sensumplus.com;www.myandroferti.com
Innovus Pharma's Forward-Looking Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the company, including, but not limited to, receiving patent protection for any of its products, receiving approval or to be compliant with the requirements of any relevant regulatory authority relating to Androferti®, to successfully commercialize such products and to achieve its other development, commercialization, financial and staffing objectives. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
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