Bio-Path Shares Up Premarket After FDA Trial Clearance
October 27 2021 - 8:30AM
Dow Jones News
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 robb.stewart@wsj.com
(END) Dow Jones Newswires
October 27, 2021 08:15 ET (12:15 GMT)
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