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Ewing sarcoma is a primitive cell in the bone marrow, first reported by American pathologist James Ewing in 1921.
Food and Drug Administration (FDA) has awarded TK216 the "rare pediatric disease title" for the treatment of Ewing sarcoma, the company's biopharmaceutical company, Oncternal Therapeutics, announced today.
TK216 is a small molecular inhibitor that targets the E26 conversion-specific (ETS) cancer protein family.
"rare pediatric disease" is defined as a serious or life-threatening pediatric disease that affects fewer than 200,000 people in the United States.
if the FDA approves TK216 for the treatment of Ewing sarcoma, Oncternal may be eligible for a priority review certificate.
if this voucher is issued, it can be redeemed for priority review of subsequent marketing applications or sold or transferred to other sponsors.
. James Breitmeyer, President and CEO of Oncternal, said, "Ewing sarcoma is a devastating cancer with a high demand for medical care.
are currently recruiting patients with relapsed/resusctic Ewing sarcoma to participate in clinical trials of TK216, and we hope to provide data on ongoing Phase I clinical trials in the fourth quarter of 2020."
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