Generex Biotechnology Corporation, engaged in the research, development, and commercialisation of drug delivery systems and technologies, has begun research and development work on buccal Leuprolide.

The company previously announced a memorandum of understanding with NHTherapeutics, Inc. pursuant to which the companies will co-develop a formulation for the delivery of Leuprolide into the human body via the buccal mucosa using the Generex proprietary RapidMist buccal drug delivery platform technologies.

Generex has received from NHTherapeutics the first tranche of funding under the MoU as well as the initial shipment of Leuprolide. The Generex RapidMist R&D protocols have been initiated, the goal of which is to achieve a formulation for the safe, simple, rapid, dose-specific, and effective administration of the active pharmaceutical ingredient into the human body via the buccal mucosa, after which local irritation and stability testing will be undertaken.

The companies' intention is that, upon successful completion of the R&D work, Generex will grant to NHTherapeutics a license for the global commercial exploitation of the product in the field of endocrine disorders in exchange for royalties.

Leuprolide belongs to a class of medications called gonadotropin-releasing hormone (GnRH) agonists. Traditionally, GnRH agonists are used at a high dose to chronically decrease hormonal release. Leuprolide is given by injection and is marketed to treat the symptoms associated with advanced prostate cancer, central precocious puberty (CPP), endometriosis, and anemia. NHTherapeutics intends to administer low dose Leuprolide and other GnRH agonists through an easy to use buccal spray to chronically increase hormonal levels.