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Klox Technologies announces positive top-line results from a pivotal study of Phovia™ for the management of Canine Deep Pyoderma
DUBLIN, Ireland, July 02, 2018 (GLOBE NEWSWIRE) -- Klox Technologies Limited, a subsidiary of Klox Technologies Inc. (‘KTI’) has announced they have completed a pivotal study of Phovia for the management of Canine Deep Pyoderma. The 80-patient study met all endpoints and demonstrated that Phovia significantly reduces time to clinical resolution while reducing the duration of antibiotic use.
Phovia is a first-in-class, topical fluorescence biomodulating product, using proprietary technology, to engage inherent biological systems.
This prospective, randomized, controlled, blinded study compared the current standard of care (systemic antibiotic therapy) versus the standard of care plus Phovia twice weekly, until clinical resolution was achieved.
Phovia demonstrated efficacy for the primary endpoint, with the proportion of patients reaching clinical resolution at six (6) weeks being 26.5% for the control group and 84.6% for the Phovia treated group (p<0.001). The statistically significant differences between the two (2) groups were obtained as soon as week three (3). For the secondary endpoints, the Phovia treated group showed a statistically significant reduction of clinical scores, and an improvement in neutrophil engulfing bacteria scores. An exploratory endpoint demonstrated that the median time to clinical resolution for the control group was 12.7 weeks while the Phovia treated group was 4.0 weeks; a significant reduction in treatment times. No product related adverse events were recorded.
Prof. Andrea Spaterna from the University of Camerino, Italy, and principal investigator of the Phovia study, stated that, “Reducing the treatment time of deep pyodermas to this extent is tremendous news for veterinarians, patients and owners alike. A critical part of the results includes reducing the duration of systemic antibiotic use, as it is becoming abundantly clear in the international community that long-term antibiotic use has a high risk factor for the development of antibiotic resistant bacteria.”
Investigators strongly believe that a product like Phovia is ready for the veterinary market, as veterinarians and pet owners are more reluctant to treat patients with long-term antibiotics. “I am finding most pet owners are really open to innovative therapies like Phovia, and having the patients come into the clinic for treatment allows for better monitoring of deep pyodermas”, concluded Prof. Spaterna.
Klox is advancing discussions with potential partners to bring Phovia, and its pipeline products to market. Partnerships are expected to be announced later this year, and Phovia is anticipated to be commercially available in Europe during H1 2019.
Phovia is a first-in-class, topical fluorescence biomodulating product, using proprietary technology, to engage inherent biological systems. It is based on Klox's patented Fluorescence Biomodulation technology platform, which is a non-invasive, non-thermal technology targeted to improve the management of serious skin/soft tissue disorders for companion animals and horses. It is intended to create an environment that promotes accelerated healing of pyoderma lesions in dogs and promotes wound healing in dogs, cats and horses.
About Canine Deep Pyoderma
Canine deep pyoderma (CDP) is a difficult to treat skin disease in small animals1 characterized by dissemination of bacteria into the deep dermis and/or bacterial infection of the panniculus. The causative organism is Staphylococcus pseudintermedius (formerly S. intermedius) in the vast majority of cases. Bacteria in lesions of deep pyoderma are often located in the center of fibrotic or inflammatory foci, associated with chronic diseases and scarring. Recurrence of the disease is frequent, which requires long-term systemic antibiotic use, and an additional one to two (2) weeks of extended antibiotic use post clinical resolution to ensure complete microbiological remission2,3.
About Klox Technologies
Klox Technologies Inc. is a private biomedical technology innovator, advancing the development and commercialization of its flagship fluorescence generating technology for specific skin/soft tissue conditions and diseases. With franchises in wound care, dermatology, veterinary and oral health, Klox is well positioned to capitalize on significant market opportunities. For more information please visit www.kloxtechnologies.com
Klox Technologies Limited
Dr. Ricardo Garvao, Head of Animal Health
+353 (0) 1 7006216
- Lund EM, Armstrong PJ, Kirk CA et al. Health status and population characteristics of dogs and cats examined at private veterinary practices in the United States. Journal of the American Animal Hospital Association 1999; 214: 1336–41.
- Scott DW, Miller WH Jr, Griffin CE. Muller and Kirk’s Small Animal Dermatology, 6th edn, ed. Philadelphia: W.B. Saunders, 2001; 453–7.
- Spaterna A. Dermatosi a carattere pustoloso e/o foruncoloso. In: Spaterna A. Dermatologia del cane, dal segno clinico alla diagnosi e terapia, Point Vet. Italie Ed., Milano, 2008; 139-170.