By Robb M. Stewart


Bio-Path Holdings Inc.'s shares advanced early Wednesday after the biotechnology company received U.S. regulatory clearance for its investigational new drug application to begin an early-stage trial of a treatment for patients with solid tumors.

In premarket trading, the shares were 10% higher after ending Tuesday at $4.95, up just over 40% since the end of last year.

Bio-Path said the Food and Drug Administration reviewed and cleared its application to initiate a Phase 1/1b clinical trial of prexigebersen-A in patients with solid tumors, including ovarian, endometrial, pancreatic and triple negative breast cancer.

Jorge Cortes, chairman of the Bio-Path scientific advisory board, said that given encouraging pre-clinical results generated to date, the company is optimistic prexigebersen-A may offer much needed respite to patients suffering with solid tumors who face limited treatment options.

In April 2018, data were presented demonstrating the treatment of solid tumors in gynecologic malignancies with prexigebersen-A at the American Association for Cancer Research annual meeting showing an 86% decrease in tumor burden and multinodular burden in the combination prexigebersen-A/paclitaxel group compared with control, Bio-Path said. In addition, there was no apparent toxicity with mice on combination therapy losing less weight than the control group, it said.

A Phase 1/1b clinical trial is expected to be conducted at several U.S. cancer centers, and initially six evaluable patients are scheduled to be treated with prexigebersen-A monotherapy, it said.


Write to Robb M. Stewart at


(END) Dow Jones Newswires

October 27, 2021 08:15 ET (12:15 GMT)

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