NX Development Corp. is Granted Orphan-Drug Designation Status by US FDA for Gleolan® in Ovarian and Related Cancers

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LEXINGTON, Ky., March 5, 2024 (Newswire.com) - NX Development Corp. (NXDC) has achieved another milestone as we proudly announce the recent granting of orphan-drug status by the U.S. Food and Drug Administration (FDA) for Gleolan (aminolevulinic acid HCl). This designation was provided for the “real-time detection and visualization of epithelial ovarian tumors during debulking surgery.”

Dr. Salvatore DeSena, CEO of NX Development Corp., shared this excitement, stating, “On behalf of our entire team, I am proud to announce that NX Development Corp. secured orphan-drug status for Gleolan in ovarian, fallopian tube, and primary peritoneal cancer. This achievement demonstrates NXDC's commitment to exploring new and innovative uses for Gleolan to help patients and surgeons in their fight against these cancers.” 

“This important milestone underlines the capabilities of aminolevulinic acid HCl in fluorescence-guided surgery. As a group, we aim to expand this further, also to other countries as well, providing support to patients and healthcare professionals combating cancer globally,” said Dr. Ulrich Kosciessa, Chairman of the Board of NXDC and CEO of photonamic GmbH & Co KG. (Pinneberg, Germany), parent company to NXDC. 

Gleolan is an optical imaging agent indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery. Gleolan has gained clinical recognition for its use in visualizing malignant glioma tissue during surgery. 

About NX Development Corp.: NX Development Corp., a wholly-owned subsidiary of photonamic GmbH & Co. KG., a member of the SBI Holdings Inc. Group (Tokyo, Japan), is dedicated to revolutionizing cancer care through innovative solutions and groundbreaking developments in fluorescence-guided surgery.

About Gleolan