S.I.S has conducted a large variety of pre-clinical studies in accordance with the requirements of the health regulatory authorities and in order to support the development processes of Zep-3 and Zep-4 cream as a product and to establish its safety and efficacy. S.I.S has completed all essential toxicology and safety studies required for the submission of a file for Phase I Clinical Study. Zep-3:, Zep -3 is in Phase I clinical study (at the Dep. of Dermatology, Shiba Hospital, Israel). After concluding the study (Q2, 2013) we will initiate a Phase II study for HSV1 Cold Sores indication and a Phase II study for the Genital Herpes indication. In relation to HSV1 infection, Zep -3 is a fast acting drug, which causes an immediate relief from pain and itching within less than 5 minutes and prevents lesion formation within 36 hours. Furthermore, it seems to have no adverse side-effects.read more.
The total skin disorders market is estimated to be $28 Billion annually (for 2011), about 1/3 of which is due to viral infections, most of these being the Herpes virus (HSV1, HSV2 and Herpes Zoster) By the age of 40, nearly 90% of adults, have been exposed to HSV1, 15% of those exposed to HSV1 may develop symptoms (blisters, cold sores) every year. In the Western World (U.S., Europe and Japan) the potential market is over 100 Million patients, these patients develop clinical symptoms every year.read more.
S.I.S has conducted a large variety of pre-clinical studies in accordance with the requirements of the health regulatory authorities and in order to support the development processes of Zep-3 and Zep-4 creams as products and to establish their safety and efficacy. The drug permeation study revealed that during the 24 hrs experiment, ZEP-3 API and Zep-4 peptides have a very low absorption profile across the skin (less than 1%) while a significant amount of drug is accumulated in the skin. In order to cover the regulatory basic genotoxicology battery, Zep-3 and Zep-4 peptides were tested under GLP conditions for mutagenicity, clastogenicity and aneugenic activity potential. Zep-3 and Zep-4 peptides were assayed for mutagenicity by the Bacterial Reverse Mutation Test (Ames test)read more.