Generex Biotechnology has entered into a binding Letter of Intent (LoI) to purchase a 51% stake in regenerative medicine firm Regentys to expand its medical device and wound care portfolio.
Regentys is engaged in the development of treatments for patients with gastrointestinal (GI) disorders.
Generex has paid an initial amount of $400,000 to secure the deal, and is currently involved in the process to complete the legal documents for closing the transaction in the coming weeks.
The extra-cellular matrix hydrogel (RECMH) is Regentys’ non-pharmacologic and non-surgical treatment option for patients with ulcerative colitis (UC).
Regentys CEO Rick Bulman said: “Generex provides our company with an exceptional opportunity for the continued development of a remarkable clinical asset that has the potential to improve patient outcomes, reduce medical costs and better the quality of life of many UC patients.”
Regentys has obtained guidance from the US Food and Drug Administration (FDA) to get approval for the treatment via FDA office of device evaluation as a 510(k) de novo application.
The firm intends to begin the clinical studies required to secure approval for the treatment by the end of fourth quarter of 2019.
Regentys RECMH is a patented UC treatment designed to protect damaged tissue from waste flow and boosts tissue regeneration and healing instead of suppressing the immune system compared to other treatments.
Through using polymeric characteristics, the company has developed the product, which converts ECMH from a liquid to gel form upon adherence to the mucosal lining of the diseased colon, serving as bio-scaffold bandage to the affected area.
The RECMH bio-scaffold will cover the ulcer to minimize the inflammatory response, enabling to facilitate healing and functional repair of the colon lining. Later, the bio-scaffold provides a framework to activate endogenous (the body’s own) stem cells.
UC is a chronic and inflammatory disease that affects around 750,000 patients in the US and 1.9 million patients across the world. It forms sores or ulcers in the lining of the large intestine or the colon.
At present, four biologics have been approved by the FDA to treat UC, including Humira (adalimumab), Simponi (golimumab), Remicade (infliximab) and Entyvio (vedolizumab).
Generex CEO Joe Moscato said: “Our acquisition of and investment in Regentys will provide Generex with significant upside potential. We have worked closely with CEO Rick Bulman and his team to define the clinical and commercialization strategy, and we look forward to executing on our plan.”