RALEIGH, N.C., March 1, 2016 /PRNewswire/ -- FLAG Therapeutics Inc. announced today that the U.S. Food and Drug Administration's Office of Orphan Products Development and the European Medicines Agency (EMA) have both granted Orphan Drug Designation to FLAG-003 for the treatment of glioma. Gliomas (including Glioblastoma) are the most aggressive forms of brain cancer and carries a very poor prognosis for survival and is one of the deadliest forms of cancer. Two and 5-year survival rates are 27% and 10%, with the median progression-free survival (PFS) being only 6.9 months.
Orphan status is granted by the FDA to promote the development of products that demonstrate promise for the treatment of rare diseases – those which affect fewer than 200,000 Americans annually. Orphan drug designation entitles FLAG Therapeutics to 7 years marketing exclusivity following product launch in the United States (10 years marketing exclusivity in the EU) and enables the company to apply for research funding, tax credits, a waiver from FDA (PDUFA) user fees, FDA assistance in clinical trial design, and access to the central authorization procedure within the European Union.
FLAG-003 for the treatment of Glioma
FLAG-003 is a small molecule which exerts both cytotoxic and cytostatic activity due to two distinct and well characterized mechanisms of action. It possesses cytotoxic anti-tubulin activity by binding to the colchicine site of tubulin causing microtubule depolymerization. It also possesses anti-angiogenic activity through binding and inhibition of RTK receptor tyrosine kinase (RTKs) activity. The anti-tubulin and anti-angiogenic activities of FLAG-003 have translated into potent antitumor and anti-vascular effects in vivo with significantly better inhibitory activity on GBM tumor growth and vascularization than the currently approved chemotherapy, temozolomide (TMZ).
About FLAG Therapeutics
FLAG Therapeutics is a North Carolina based company founded on breakthrough research that has yielded two novel classes of small-molecule, water-soluble oncology drugs. Their compounds have well elucidated mechanisms of action against clinically validated targets. In preclinical models, FLAG's lead compounds have demonstrated statistically significant superiority in the appropriate disease models vs. approved comparator drugs. Each program has a late-stage preclinical lead within one year from IND filing. To learn more about FLAG Therapeutics, please visit www.flagtherapeutics.com.
Frank L. Sorgi, PhD, President and CEO, FLAG Therapeutics, Inc.
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SOURCE FLAG Therapeutics