Out-licensing

New Indication for Griseofulvin as a Local Treatment for Fungal External Otitis: Shraga Undergoing Clinical Development

Introduction/Background

Griseofulvin is an antifungal agent first isolated from a Penicillium spp. in 1939. It is used to treat dermatophyte infections eg, skin infections such as jock itch, athlete's foot, and ringworm; and fungal infections of the scalp, fingernails, and toenails. Otomycosis, an external ear canal infection, is caused by dermatophytes particularly aspergillus niger and candida albicans. Griseofulvin is effective after oral ingestion and reaches the skin and hair. Griseofulvin inhibits fungal mitosis by disrupting the mitotic spindle through interaction with polymerised microtubules. The compound is insoluble in water.

Aims/Hypothesis

Griseofulvin, which had been used orally as a treatment for fungal skin diseases, can be used topically with a high degree of effectiveness to treat fungal skin diseases and fungal external otitis. The aim is to develop a methodology for the topical use of this drug by the preparation of Griseofulvin in water.

Research

Griseofulvin is a drug that is poorly soluble in water. During the course of our laboratory studies, we found that the solubility of Griseofulvin in water can be increased by mixing it with a high molecular weight carrier, such as a certain herbal agent. This preparation does not contain any polysaccharide, nor does the preparation contain ethanol since there is a considerable interaction between Griseofulvin and ethanol, which may cause severe side effects. The results of preliminary studies performed by the inventor of Shraga®, in patients with otomycosis, have been very encouraging. Following a short course of treatment (less than 7 days), a complete clinical and mycological cure was achieved. Fifteen patients with fungal disease of their external ear canal, who were diagnosed clinically and mycologically, were treated with Shraga® and clinical and mycological cures were achieved in 12 patients whose ages ranged between 18-60, within 7 days of twice daily applications of the topical treatment.

In this project, we have found that the solubility of griseofulvin was higher in mixtures with high molecular weight carriers such as herbal agents, but not saccharides and not alcohol. The product has already finished the stage of clinical trials for the first group of 50 patients. The Helsinki committee of the Hadassah Medical Center and the Ministry of Health has approved the preparation and the clinical studies. These studies performed by Department of Ear, Nose, and Throat, Head & Neck Surgery of the Hadassah University Hospital in Jerusalem, Israel, in patients infected with Otomycosis have proved very successful. Following a short course of treatment (less than 10 days), clinical and mycological cure was established in all 15 patients.

Conclusion

Shraga®, is a new drug for the treatment of fungal infections of the external ear canal. The new drug is an innovative, and safe topical treatment for otomycosis.

Relevance/Opportunity

Shraga® is intended for treatment of fungal external otitis caused by both Aspergillus niger and Candida albicans. A worldwide PCT patent application for the new formulation and its uses was already filed, further to successful clinical results obtained in the course of the ongoing clinical trial. The product is already, ready for marketing shortly after the completion of the financial procedure. Currently, we are seeking licensing partnerships to further drive our novel agent through the marketing; please enquire below if you are interested in this opportunity.

Phase I