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Bio-Path Stock Jumps as Leukemia Treatment Candidate Moves to Testing

The FDA approves the company's new investigational drug application, allowing it to move to Phase 1/1b clinical stage.

Shares of Bio-Path Holdings  (BPTH) - Get Bio-Path Holdings, Inc. Report jumped Tuesday afternoon after the company announced that the U.S. Food and Drug Administration has reviewed and cleared its investigational leukemia treatment. 

The company's second drug candidate BP1002 has been cleared for an initial Phase 1/1b clinical trial that will evaluate its ability to treat refractory/relapsed acute myeloid leukemia patients. 

"Preclinical studies indicate that the BP1002 and decitabine combination is effective against venetoclax-resistant cell lines, suggesting that the BP1002 and decitabine combination therapy may provide benefits to patients who have relapsed from venetoclax-based treatment," said CEO Peter Nielsen. 

The company says that by targeting its treatment at the DNA level rather than the protein, BP1002 might "overcome and prevent some of the mechanisms of resistance that affect venetoclax."

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Phase 1/1b clinical trials feature humans and provide the first introduction of a pharmaceutical product into patients having the disease of interest. The primary endpoint of the trial is determining safety, metabolism and pharmacokinetic properties of the product. 

The investigational new drug review process was performed by the FDA's Office of Oncologic Disease Division of Hematologic Malignancies and involved the agency conducting a comprehensive review of data submitted by the company. 

“We are excited to move into these advanced clinical studies and look forward to generating data that not only support the DNAbilize platform but bring us one step closer to bringing these potentially lifesaving drugs to patients,” said Jorge Cortes, chairman of Bio-Path's scientific advisory board. 

Bio-Path shares rose 16% to $6.63 a share Tuesday at last check.