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CORRECTION: NovAccess Global Announces Filing of Orphan Drug Application for TLR-AD1
CORRECTION: NovAccess Global Announces Filing of Orphan Drug Application for TLR-AD1.
About this update from Novaccess Global Inc.
[{"type":"text","content":"This corrects the release that ran earlier today, replacing the name of the executive quoted in the press release and other minor edits.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 and other high grade gliomas.Glioblastoma 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 glioblastoma 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 glioblastoma 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. If we obtain FDA approval it would grant us special status and enable the acceleration of the development of our therapies to treat glioblastoma patients," Dr. Christopher Wheeler, President of StemVax Therapeutics. "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. Wheeler continued, "Upon receiving ODD, the product will significantly bolster NovAccess Global's intellectual property portfolio, which presently includes the rights to U.S. patent #US97...