Positive Data From Endometrial Cups Study with Settle® Presented at International Symposium

The study was conducted by researchers at the Gluck Equine Research Center at the University of Kentucky in collaboration with Rood & Riddle Equine Hospital, and was presented by Dr. Carleigh Fedorka, PhD.
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NovaVive Inc., an animal health immunobiology company, announces that data from a U.S. study with its immunotherapy for equine endometritis, Settle®, to treat endometrial cups was presented today at the International Symposium on Equine Reproduction (ISER) in Foz do Iguaçu, Brazil. The study was conducted by researchers at the Gluck Equine Research Center at the University of Kentucky in collaboration with Rood & Riddle Equine Hospital, and was presented by Dr. Carleigh Fedorka, PhD (UKY).

Endometrial cups are specialized placental tissues that invade the uterine lining and secrete the hormone equine chorionic gonadotropin (eCG). This hormone results in the prolonged suppression of estrus and false pregnancy in the mare. Pregnancy loss after the development of endometrial cups often leads to the inability to breed mares back for the remainder of the breeding season.The study mares received either treatment (6 ml of Settle diluted with 14 ml of LRS; n=10) or placebo (LRS; n=6), with mares randomly assigned into groups. Treatment involved intra-endometrial injection (1ml/endometrial cup, with any excess volume being injected peripherally into the endometrial stroma surrounding the cups). This treatment was repeated one week later. Blood was obtained prior to hysteroscopy, in addition to weekly post-treatment to measure eCG as a marker of endometrial cup viability, and this continued for eight weeks.

Repeated hysteroscopic-guided injections of Settle led to a dramatic reduction of eCG concentration in comparison to placebo-treated mares. This reduction in eCG concentration was most pronounced at seven days following treatment, with a diminished response noted throughout the remainder of the study. Researchers also saw increased IFN-g in Settle-treated mares. This cytokine is believed to be involved in natural endometrial cup degradation.

“To our knowledge, this is the first report of a successful treatment for degradation of endometrial cups following abortion, by hastening the natural immune response to these structures,” the researchers noted. “This caused mares to return to cyclicity within a month following treatment onset, allowing for repeat attempts at a successful pregnancy within the confines of the breeding season.” In the Settle-treated mares, a pre-ovulatory follicle was noted, on average, 23.4 days following treatment.

This Settle treatment regimen is now being used in U.S. equine clinics, with 17 successful procedures to date (leading to pregnancy) in Lexington, KY-based clinics alone.

About Settle®

Settle is manufactured using the NovaVive Mycobacterium cell wall fraction (MCWF) technology. It is approved in the USA, Australia, New Zealand and UAE as an aid in the treatment of equine endometritis caused by Streptococcus zooepidemicus, the hardest to treat cause of the disease. When administered by IV injection or intrauterine (IU) infusion, Settle stimulates the mare’s immune system to fight the infection.

About NovaVive Inc.

NovaVive is a private company founded in July, 2014. The Company has an advanced veterinary immunotherapeutic platform based on mycobacterium cell wall fraction (MCWF) technology with 5 regulator-approved products in the USA. One formulation has been developed as an anticancer therapy in dogs and horses. Other formulations have demonstrated the capability of reducing the reliance on antibiotics in the treatment of bacterial diseases of horses and cattle or effectively treating viral equine respiratory disease. For more information about the Company, please visit www.NovaVive.ca.

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