Liposomal Superoxide Dismutase
Polymun has encapsulated recombinant human Cu/Zn superoxide dismutase (SOD) in liposomes using its proprietary technology. The liposomal formulation enables topical application of SOD as well as application by inhalation. As a scavenger of free oxygen radicals, SOD has high potential for the treatment of pathologic conditions connected with oxidative stress free of any adverse effects.
Polymun has evaluated the transdermal application of Lipoxysan™ in patients suffering from Induratio Penis Plastica (IPP, also Peyronie′s disease) in phase II and III clinical trials. The studies were conducted at three centres in Austria under the leadership of Claus Riedl, M.D. (firstname.lastname@example.org) and resulted in significant and rapid decrease of pain and amelioration of the other symptoms of IPP. Lipoxysan™ treatment was efficacious, free of side effects and convenient thus leading to high patient satisfaction. Details to the studies can be found in our publications "Pilot Study on Liposomal Recombinant Human Superoxide Dismutase for the Treatment of Peyronie′s Disease" and "Liposomal Recombinant Human Superoxide Dismutase for the Treatment of Peyronie′s Disease: A Randomized Placebo-Controlled Double-Blind Prospective Clinical Study".
Lipoxysan™ is also tested for the treatment of inflammatory skin disorders and chronic skin ulcers. Beneficial effects of Lipoxysan™ therapy in wound healing were obtained in animal models of thermal lesions (Vorauer-Uhl et al. 2002).
Lipoxysan™ is believed to have high therapeutic potential in dermatological conditions since increased production of reactive oxygen species (ROS) was connected with various inflammatory skin disorders.
As oxidative stress induced by UV-light, cigarette smoke, air pollution, ozone, and chemicals is believed to trigger premature skin aging, there is a strong rationale to use liposomal SOD in cosmetic anti-aging products. All ingredients of the liposomal SOD are on the inventory of ingredients used in cosmetic products (Section I of the Annex to Commission Decision 96/335/EC).
In May 2015, Polymun entered into a license an development agreement with SCARLETRED Holding GmbH for development and marketing of SOD for several indications.
SOD - the Smart Antioxidant
Cu/Zn-Superoxide dismutase selectively degrades superoxide anions, the by-products of oxygen metabolism. Thereby, SOD prevents the chain reaction these superoxide anions trigger. Unlike conventionally used antioxidants as vitamin A, C or E, SOD is not depleted in the reaction due to its enzymatic nature but detoxifies superoxide anions constantly. Hence, even low doses of SOD have great effect. SOD is present in all aerobic living organisms and protects cells by preventing damage from free radicals. Due to the human sequence it is tolerated by the immune system causing no side effects. Recombinant human SOD (rhSOD) is produced in E. coli.
Application of superoxide dismutase in liposomes
granted by: AU 690377; CA 2,204,493; EP 0 789 584; MX 206295; NZ 296098; US 5,942,245; US 6,312,720
Schaller G, Dittrich P, Felizeter M, Gouya G, Leuchten N, Kapiotis S, Vcelar B, Vorauer-Uhl K, Wolzt M (2012) Human pharmacokinetics of intravenous recombinant human Cu/Zn superoxide dismutase. Int J Clin Pharmacol Ther 50(6):413-7
Kaipel M, Wagner A, Wassermann E, Vorauer-Uhl K, Kellner R, Redl H, Katinger H, Ullrich R (2008) Increased biological half-life of aerosolized liposomal recombinant human Cu/Zn superoxide dismutase in pigs. J Aerosol Med Pulm Drug Deliv 21(3):281-90
Wild T, Budzanowski A, Vcelar B, Wagner A, Vorauer-Uhl K, Katinger H (2006) Successful treatment of a leg ulcer occurring in a rheumatoid arthritis patient under methotrexate therapy by reduction of oxidative stress and nutritional supplementation. Journal of Wound Healing 5/06:258-61
Wagner A, Vorauer-Uhl K, Katinger H (2006) Nebulization of liposomal rh-Cu/Zn-SOD with a novel vibrating membrane nebulizer. J Liposome Res 16(2):113-25
Braun E, Wagner A, Fürnschlief E, Katinger H, Vorauer-Uhl K (2005) Experimental design for in vitro skin penetration study of liposomal superoxide dismutase. J Pharm Biomed Anal 40(5):1187-97
Riedl CR, Sternig P, Galle G, Langmann F, Vcelar B, Vorauer K, Wagner A, Katinger H, Pflüger H (2005) Liposomal recombinant human superoxide dismutase for the treatment of Peyronie′s disease: A randomized placebo-controlled double-blind prospective clinical study. Eur Urol 48(4):656-61
Fürnschlief E, Vorauer-Uhl K, Wagner A, Ferko B, Katinger H (2002) Sofortbehandlung von Verbrühungswunden mit liposomal inkorporierter Superoxid-dismutase in der frühen Nachbrennphase. Published in: Kosmetische Medizin, June edition
Vorauer-Uhl K, Wagner A, Borth N, Katinger H (2002) Long term stability of rh-Cu/Zn-SOD-liposomes prepared by the crossflow injection technique following ICH-guidelines. European Journal of Pharmaceutics and Biopharmaceutics 54:77-81
Vorauer-Uhl K, Fürnschlief E, Wagner A, Ferko B, Katinger H (2002) Reepithelization of experimental scalds effected by topically applied superoxide dismutase: controlled animal studies. Wound Repair and Regeneration 10(6):366-71
Riedl CR, Plas E, Vorauer K, Vcelar B, Wagner A, Pflüger H (2001) Pilot study on liposomal recombinant superoxide dismutase for the treatment of Peyronie's disease. Eur Urol 40(3):343-8
Vorauer-Uhl K, Fürnschlief E, Wagner A, Ferko B, Katinger H (2001) Topically applied liposome encapsulated superoxide dismutase reduces postburn wound size and edema formation. European Journal of Pharmaceutical Sciences 14(1):63-7