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NovAccess Global Announces Filing of Orphan Drug Application for TLR-AD1
NovAccess Global Announces Filing of Orphan Drug Application for TLR-AD1.
About this update from Novaccess Global Inc.
[{"type":"text","content":"Accelerating on the Path Toward Immunotherapy for Glioblastoma (Brain Cancer)CLEVELAND, OH / ACCESSWIRE / July 19, 2022 / NovAccess Global Inc. (OTC PINK:XSNX), a biomedical company developing novel immunotherapies for brain tumor patients, today announced the filing of an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for TLR-AD1, a vaccine immunotherapy for the treatment of aggressive brain cancers, including glioblastoma multiforme (GBM) and other high grade gliomas.GBM is a form of aggressive brain cancer that annually impacts approximately 250,000 people globally and is on the rise in many countries, according to NovAccess scientists and published reports. The market data is more alarming, with GBM accounting for approximately 50% of all malignant brain cancers diagnosed in the United States each year, and more than 10,000 Americans dying from this tumor type annually. Less than 5% of people with this cancer live longer than 5-years after their diagnosis. The global GBM treatment market was estimated to be valued in excess of $2 billion in 2020, with projections for a compounded annual growth rate of more than 8% throughout the remainder of the decade."We are very excited to announce the filing of an Orphan Drug application for TLR-AD1 as it may lead to the granting of special status and enable the acceleration of the development of our therapies to treat multiple forms of glioblastomas," said Dr. Dwain Irvin, Chief Executive Officer of NovAccess Global. "The ODD process supports the development and evaluation of new treatments for rare diseases which is a key priority for both the FDA and for NovAccess Global. Receiving this important designation would represent a milestone in the development of TLR-AD1 and would highlight the need for potential new treatment options for patients with aggressive brain cancers which today have no immunotherapy treatment leaving only the option of highly invasive and complicated surgery."Dr. Irvin continued, "Upon receiving ODD, the product will significantly bolster NovAccess Global's intellectual property portfolio, which presently includes the rights to U.S. patent #US9764014B2 granted under the "Cancer Antigens" category related to the "treatment of cancer using vaccination therapy." We ar...