Calistoga Pharmaceuticals Initiates First Oncology Clinical Trial Of Novel PI3K Delta Inhibitor, CAL-101

Main Category: Cancer / Oncology
Also Included In: Blood / Hematology;  Clinical Trials / Drug Trials
Article Date: 14 Jul 2008 - 4:00 PST

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Calistoga Pharmaceuticals, Inc., a company dedicated to developing innovative medicines for the treatment of cancer and inflammatory diseases, announced the initiation of a Phase 1 clinical trial of its lead compound, CAL-101, a small molecule phosphoinositide-3 kinase (PI3K) delta inhibitor, in patients with hematologic cancer.

"We at Calistoga are very pleased to be entering our first oncology trial. PI3K delta is a novel target in cancer, and we look forward to evaluating CAL-101 as a potential treatment to improve outcomes in patients with certain types of leukemias and lymphomas," said Albert Yu, M.D., Vice President, Clinical Affairs and Chief Medical Officer.

"There is a strong scientific basis for a critical role of PI3K delta in hematologic malignancies, and our preclinical data have demonstrated cell killing by CAL-101 in primary cancer cells from acute myeloid leukemia and chronic lymphocytic leukemia patients," said Neill Giese, Ph.D., Chief Scientific Officer. "Additionally, based on results from our first Phase I trial in normal healthy volunteers, we expect that even the earliest cohorts of patients in this trial will achieve plasma concentrations that provide PI3K delta inhibition."

This open label trial will explore the safety and clinical activity of CAL-101 in patients with chronic lymphocytic leukemia, selected B-cell non-Hodgkin lymphoma and acute myeloid leukemia. The trial has been registered on the clinicaltrials.gov website.

"Initiating our first oncology trial is an important milestone for Calistoga as we begin to evaluate one of many important indications for PI3K delta inhibition, which includes rheumatoid arthritis, pulmonary and autoimmune diseases as well as hematologic malignancies," said Daryl Winter, Ph.D., J.D., Chief Operating Officer. "In addition to this oncology trial, we plan to start an asthma trial later in the year."

About PI3K Inhibition

Phosphoinositide-3 kinase (PI3K) mediates critical intracellular signaling pathways that promote cell proliferation, growth, motility, metabolism and survival. While these processes are important for the health of normal cells, inappropriate activation contributes to the development and progression of cancer and immune disorders. Calistoga has established a differentiating position by focusing on particular isoforms of the PI3K family of proteins, especially PI3K-delta. Unlike other isoforms of PI3K, the delta isoform is expressed primarily in blood-cell lineages, including cells that cause or mediate hematologic malignancies, inflammation, autoimmune diseases and allergies. A specific inhibitor of the PI3K-delta is expected to have therapeutic effects in these diseases without broadly inhibiting PI3K signaling that is critical to the normal function of healthy cells.

About Calistoga Pharmaceuticals

Calistoga Pharmaceuticals is developing multiple compounds selectively targeting the PI3K pathway that is known to be involved in certain cancers and inflammatory diseases. Calistoga is a privately held organization headquartered in Seattle, Washington.

Calistoga Pharmaceuticals