{"id":383343,"date":"2020-11-17T14:14:52","date_gmt":"2020-11-17T19:14:52","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=383343"},"modified":"2020-11-17T14:14:52","modified_gmt":"2020-11-17T19:14:52","slug":"nx-development-corp-nxdc-launches-gleolan-aminolevulinic-acid-hcl-meningioma-phase-iii-clinical-trial-nxdc-men-301","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/nx-development-corp-nxdc-launches-gleolan-aminolevulinic-acid-hcl-meningioma-phase-iii-clinical-trial-nxdc-men-301\/","title":{"rendered":"NX Development Corp. (NXDC) Launches Gleolan (aminolevulinic acid HCl) Meningioma Phase III Clinical Trial (NXDC-MEN-301)"},"content":{"rendered":"
\n

Lexington, KY, Nov. 17, 2020 (GLOBE NEWSWIRE) — NX Development Corp (NXDC)<\/a>, a life sciences company wholly owned by photonamic GmbH & Co. KG., today announced the enrollment of the first patient in a Phase III multicenter study of Gleolan to enhance visualization of brain tumors in patients with newly diagnosed or recurrent meningiomas.\u00a0 This international study will enroll 100 patients and is expected to be completed in approximately 15 months. The first patient was enrolled at the University Hospital M\u00fcnster in Germany by Prof. Dr. Walter Stummer, who is the co-Global Principal Investigator in the NXDC-MEN-301 study. (https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04305470<\/a>).<\/p>\n

\u201cWe are pleased to initiate this landmark study evaluating the utility of fluorescence-guided surgery (FGS) in the meningioma\u00a0patient population. \u00a0We are excited about the execution of this important study as we continue to expand the use of Gleolan in cancer surgeries around the world,\u201d said Alan M. Ezrin, Ph.D., co-founder and CEO of NXDC.\u00a0<\/p>\n

The study is designed to show the potential benefit of real-time visualization of Gleolan-induced fluorescence under blue light, helping surgeons more accurately distinguish tumor from adjacent non-tumor or scar tissues more reliably than conventional white light intraoperative assessment.\u00a0 The use of Gleolan-induced fluorescence in patients with meningioma may enable the surgeon to more clearly see meningioma tumor in real-time and to make better informed decisions to determine if the tissue should be removed.<\/p>\n

Gleolan may be an important visual aid not only for intraoperative real-time visualization of the primary tumor, but also of tumor remnants, satellite lesions, and infiltrating tissue in the meninges, bone flap, sinuses and brain parenchyma.\u00a0 The use of Gleolan may allow the surgeon to have greater confidence that the target tumor has been effectively removed.<\/p>\n

NXDC obtained FDA approval in 2017 for the use of Gleolan as an intraoperative imaging agent. Gleolan is currently indicated in the United States for patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery.<\/p>\n

For more information on Gleolan, please visit www.gleolan.com<\/a> or email customersupport@nxdevcorp.com<\/a>.<\/p>\n

Please refer to Full Prescribing Information here<\/a>.\u00a0<\/p>\n

###<\/p>\n

\n About NX Development Corp. (NXDC) <\/b>\n <\/p>\n

NXDC is a privately held life science company dedicated to the commercialization of Gleolan in the U.S. The company was acquired in 2018 by photonamic (PHN)\u00a0 GmbH & Co. KG. (Pinneberg, Germany)<\/p>\n

\u00a0<\/p>\n

\n About Gleolan<\/b>\n <\/p>\n

\n US INDICATION AND IMPORTANT SAFETY INFORMATION<\/b>\n <\/p>\n

Gleolan\u00a0is an FDA-approved optical imaging agent indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery. Gleolan helps neurosurgeons see malignant tissue in real time during surgery and is provided orally 20mg\/kg,\u00a0 2-4 hours prior to glioma surgery. During operation, the surgeon utilizes a modified surgical microscope with a specific blue light filter for the visualization of red-violet fluorescence. To-date Gleolan has been used in more than 80,000 cases of high grade gliomas worldwide.<\/p>\n

\n Important Safety Information<\/u><\/p>\n

Contraindications:<\/u>
\n
Do not use Gleolan in patients with:<\/p>\n