Processa completes Phase 1b of NGC-Cap; recommends two Phase 2 doses for advanced breast cancer

Processa Pharmaceuticals, Inc.

Phase 1b trial in 18 advanced GI cancer patients achieved 2-10x greater 5-FU exposure than FDA-approved capecitabine.
Hand-foot-syndrome incidence only 6% (1 of 16) vs >50% for capecitabine; severe HFS 0% vs >10%.
Myelosuppression at lower 150 mg BID dose: 33% overall, 0% severe vs 80% and 3% for capecitabine.
Of 5 evaluable patients at highest doses, 80% had positive response (1 partial response, 3 stable disease).
Phase 2 will target advanced/metastatic breast cancer using two selected dosing regimens.

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