secwatch.observer — SEC 8-K summary
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Issuer:     Processa Pharmaceuticals, Inc. (PCSA)
CIK:        0001533743
Form:       8-K
Filed at:   2024-01-25T23:59:59+00:00
Accession:  0001493152-24-003705
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1533743/000149315224003705/0001493152-24-003705-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1533743/000149315224003705/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-003705

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer