Trovagene (NASDAQ: TROV) this morning said that on September 28 the U.S. Food and Drug Administration (FDA) granted an orphan drug designation to PCM-075 for the treatment of patients with acute myeloid leukemia (AML). The company is initiating a phase 1b/2 open-label trial to evaluate the safety and anti-leukemic activity of PCM-075 in combination with standard-of-care in patients with AML. The study will take place at 10 research sites across the U.S. “We see the FDA’s granting of orphan drug designation for PCM-075 as underscoring the medical need for new therapies for patients with AML and an important step forward in our clinical development program,” Trovagene chief executive officer Bill Welch stated in the news release.
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About Trovagene, Inc.
Trovagene is a precision medicine biotechnology company developing oncology therapeutics for improved cancer care by leveraging its proprietary Precision Cancer Monitoring® (PCM) technology in tumor genomics. Trovagene has broad intellectual property and proprietary technology to measure circulating tumor DNA (ctDNA) in urine and blood to identify and quantify clinically actionable markers for predicting response to cancer therapies. Trovagene offers its PCM technology at its CLIA/CAP – accredited laboratory and plans to continue to vertically integrate its PCM technology with precision cancer therapeutics. For more information, please visit www.trovagene.com
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