Generex Biotechnology Corporation and NHTherapeutics, Inc. have signed a Memorandum of Understanding establishing the co-development of a delivery system for the medication Leuprolide to treat endometriosis through the buccal mucosa into the human body. The formulation will be based on Generex’s proprietary buccal drug delivery system, RapidMist.
The drug delivery platform technology RapidMist was developed by Generx to improve active pharmaceutical administration through the use of an aerosolized metered dose spray. By using it in the mouth, the buccal mucosa absorption is faster and more efficient. In addition, NHT has intellectual property for the dosing regimen and administration route of the medication.
“NHT recognizes that the Generex RapidMist drug delivery platform and attendant product development experience, together with NHT’s expertise in the field of endocrine disorders, creates a unique opportunity to formulate Leuprolide for rapid and effective administration through the buccal mucosa,” stated David Brusegard, PhD, the chief operating officer of Generex. “Generex is pleased with this new opportunity to expand our RapidMist platform technology.”
According to the fee-for-service agreement, Generex will develop a Leuprolide formulation consistent with the use of the RapidMist with safe, practical, fast and effective capabilities of offering dose-specific administration. Generex will also examine the product for local irritation and stability and, depending on the results of the RapidMist Leuprolide formulation data, the company may provide NHT a license with the rights for global commercialization of the technology, according to the arrangement.
Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist, which typically needs to be administered in high doses to chronically decrease hormonal release. Delivered by injection, it is prescribed mainly to treat symptoms associated with endometriosis, advanced prostate cancer, central precocious puberty (CPP), or anemia.
The purpose of the novel system is to find an easier way to deliver low doses of Leuprolide and other GnRH agonists to chronically increase hormonal levels, which has already been proven possible in proof of concept studies. “There is a real market need for a compound that can chronically increase hormonal levels, that is safe, can be easily administered, and that does not affect fertility,” stated the president and CEO of NHT, Aldemar Degroot, MS, PhD.
“Unlike existing products that increase hormonal release, NHT’s lead product (NH901) is non-scheduled and will not induce supratherapeutic hormonal levels, which can result in severe adverse effects. We look forward to working with Generex to make this product a reality. Its extensive experience with the buccal delivery of peptide drugs along with its RapidMist technology combined with our own experience in endocrine disorders and our intellectual property are bound to lead to success,” he added.
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