MIRAMAR, Fla.—Generex Biotechnology Corporation announced today that Regentys Corporation (formerly Asana Medical), a clinical stage regenerative medicine company contracted to become a subsidiary of Generex, was granted European Patent No. 2983616 entitled “Method And Composition For Treating Inflammatory Bowel Disease Without Colectomy.”
The company’s patent secures market exclusivity for its key product. Regentys ECMH is a novel application of extracellular matrix technology using a hydrogel bio-scaffold to enable the body to protect damaged tissue as it undertakes its natural healing process. Regentys ECMH is a first-in-class therapy for patients suffering from ulcerative colitis (UC), an inflammatory bowel disease that affects an estimated 2 million people in Europe and 1 million in the United States.
This specific patent provides exclusive market protection in the European Union for the company’s ECMH technology that is being developed for global markets; patents are pending in the United States and China. In addition to the UC treatment indication, Regentys is developing ECMH to treat other inflammatory bowel diseases, including Crohn’s Disease, which affects an additional 2 million people in the EU and U.S.
“As we advance our platform approach for the treatment of ulcerative colitis, and other inflammatory bowel diseases (IBD), we are mindful of the value of building an intellectual property portfolio that supports our proprietary formulations, applications and therapies,” said Rick Bulman, Chief Executive Officer of Regentys Corporation. “We are pleased to have been granted the ‘616 patent as a recognition of our efforts. UC really impacts the quality of life of patients and we look forward to advancing our translational research program into the clinic, where we expect to initiate first-in-human studies of Regentys ECMH in Q3 2019.”
In late November, Generex Corporation entered into a binding letter of intent to purchase 51% of Regentys. Regentys received a $400,000 upfront payment on the $15M purchase price, the bulk of which will support the clinical trials required by regulatory authorities for the commercialization of ECMH.
“Upon closing the pending deal with Generex, which is almost complete, we look forward to operating as a subsidiary of NuGenerex Therapeutics (a wholly-owned subsidiary of Generex), and advancing ECMH through the clinical and regulatory process,” Bulman continued. “We look forward to positive clinical results and believe our collaboration with the Generex team will help us realize substantial benefits through a more efficient regulatory approach and reduced time to approval and market commercialization in the EU and US. The closing documents are in final stages and we expect corporate approvals in the coming weeks.”
“We view the opportunity to help Regentys commercialize its technology as a unique opportunity to address an unmet need in a $6 billion global market for inflammatory bowel diseases. Their novel approach to the treatment of ulcerative colitis provides UC patients with a targeted non-surgical solution to help the body heal rather than using immunosuppressant therapies, expensive antibody therapies, or surgically removing diseased sections of the patient’s colon,” added Joseph Moscato, CEO of Generex.
“With 20-30% of UC patients requiring surgery to help combat this disease, any relief the Regentys ECMH hydrogel can provide to minimize the effects of UC or disrupt the progression of the disease would be extremely beneficial to the millions that now suffer from this debilitating disease who can’t get true relief. We welcome Regentys to the family of NuGenerex Therapeutics companies.”