Bio-Path Holdings (NASDAQ: BPTH) shares are rallying premarket on Tuesday after the company announced that the US Food and Drug Administration (FDA) has reviewed and cleared the Investigational New Drug (IND) application for BP1002.
BP1002 is the company's second drug candidate. The clearance allows for an initial Phase 1/1b clinical trial that will evaluate BP1002 in treating refractory/relapsed acute myeloid leukemia (AML) patients.
The trial is expected to occur at several leading cancer centers in the United States, including the Weill Medical College of Cornell University, The University of Texas MD Anderson Cancer Center, and the Georgia Cancer Center.
The trial will initially evaluate 6 patients.
“AML patients that fail frontline venetoclax-based therapy have very poor prognosis with a median overall survival of less than three months and a novel treatment modality is urgently needed for such patients,” said Peter Nielsen, President and CEO of Bio-Path.
The company's shares are up 30.58% premarket at $7.43.
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