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CAL-101 MECHANISM OF ACTION
The PI3K pathway is a central signaling pathway in cells responsible for cellular proliferation, survival, and immune cell trafficking. In B cell leukemias and lymphomas, the PI3K Delta isoform is overexpressed and plays a key role in cancer cell surivival.
CAL-101 selectively inhibits PI3K Delta selectively resulting in cancer cell death demonstrated in preclinical models. This PI3K Delta selectivity provides a more targeted therapy approach than PI3K inhibitors that hit all isoforms which may result in unwanted toxicities. In preclinical models, this cell death has been demonstrated in cell lines, primary patient cells. In a Phase 1 clinical trial, single agent oral therapy has resulted in clinical responses in patients with CLL, indolent NHL, and mantle cell lymphoma. CAL-101 was generally well tolerated with the most common adverse event being an elevation of transaminases that was both monitorable and reversible in all patients.
CAL-101 is currently being investigated in clinical trials and has not received U.S. F.D.A. approval. Calistoga Pharmaceuticals does not claim that this technology or any of its product candidates are safe or will be effective in preventing, treating or curing any disease or condition.
