{"id":413274,"date":"2021-01-12T10:13:07","date_gmt":"2021-01-12T15:13:07","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=413274"},"modified":"2021-01-12T10:13:07","modified_gmt":"2021-01-12T15:13:07","slug":"nx-development-corp-nxdc-receives-fda-orphan-drug-designation-for-gleolan-aminolevulinic-acid-hcl-in-meningioma","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/nx-development-corp-nxdc-receives-fda-orphan-drug-designation-for-gleolan-aminolevulinic-acid-hcl-in-meningioma\/","title":{"rendered":"NX Development Corp. (NXDC) Receives FDA Orphan-Drug Designation for Gleolan\u00ae (aminolevulinic acid HCl) in Meningioma"},"content":{"rendered":"
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Lexington, KY, Jan. 12, 2021 (GLOBE NEWSWIRE) — NX Development Corp. (NXDC)<\/a>, a life sciences company wholly owned by photonamic GmbH & Co. KG., today announced FDA orphan-drug designation for Gleolan, an optical imaging agent for the visualization of tumor tissue in patients undergoing surgical resection for meningioma. \u00a0Gleolan 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. Orphan-drug designation is provided to drugs intended for the treatment, prevention or diagnosis of a rare disease or condition. \u00a0<\/p>\n

Meningiomas are tumors that affect the membranes that surround the brain and spinal cord and account for about 36% of all primary brain tumors.1<\/sup>\u00a0 The surgical debulking of the tumor mass is an important tool in the management of this rare disease.<\/p>\n

\u201cWe were thrilled to receive orphan-drug designation to support our efforts in evaluating the potential utility of fluorescence-guided surgery (FGS) in the meningioma\u00a0patient population.\u201d said Alan M. Ezrin, Ph.D., co-founder and CEO of NXDC.\u00a0 \u201cTo date, the use of Gleolan in patients with suspected high grade gliomas has been performed in excess of 80,000 patients worldwide and the expansion into meningioma is a key initiative of our company\u2019s worldwide strategy as we strive to develop surgical application in a variety of tumor types.\u201d<\/p>\n

Last month, NXDC announced enrollment of the first patient in the Phase III multicenter study of Gleolan to enhance visualization of brain tumor in patients with newly diagnosed or recurrent meningiomas (NXDC-MEN-301).\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 joined by surgeons at 9 other key brain tumor centers in the US, Germany and Austria\u00a0\u00a0\u00a0 (https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04305470<\/a>). <\/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>.<\/p>\n

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\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).\u00a0 PHN is wholly owned by SBI ALApharma\u00a0(Hong Kong) a subsidiary of SBI Holdings, Inc. (Tokyo , Japan)<\/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.<\/p>\n

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

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