By Chris Wack
Processa Pharmaceuticals shares were up 60% to 32 cents in premarket trading after the company said it plans to expand the development of Next Generation Capecitabine, or NGC-Cap, into a treatment of advanced or metastatic breast cancer beginning with its next Phase 2 trial.
The move follows Processa's meeting with the U.S. Food and Drug Administration, with Processa deciding the next NGC-Cap trial would be a Phase 2 trial in breast cancer.
This decision was supported through discussions with the FDA where Processa agreed with the FDA that pursuing breast cancer will lead to a more efficient development program while providing a greater likelihood of FDA approval.
The FDA stated that the previously generated data in past and existing studies could be used to directly support the Phase 2 trial in breast cancer.
The company plans to begin its Phase 2 study in the third quarter of 2024.
Processa said the NGC-Cap potential market for breast, colorectal and other cancers is greater than 250,000 patients per year.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
01-19-24 0824ET