SOURCE: Calistoga Pharmaceuticals, Inc.

March 11, 2008 07:30 ET

Calistoga Pharmaceuticals Initiates Its First Clinical Study of Novel Oral PI3K Delta Compound, CAL-101

SEATTLE, WA--(Marketwire - March 11, 2008) - Calistoga Pharmaceuticals, Inc., an early stage clinical company dedicated to developing innovative medicines for the treatment of cancer and inflammatory diseases, today announced that it has initiated a Phase I clinical trial of CAL-101, a novel orally-available small molecule inhibitor of an important intracellular signaling component known as phosphoinositide-3 kinase (PI3K) delta.

"We are very excited to enter human trials with our first delta isoform selective PI3K compound," said Daryl B. Winter, Ph.D., J.D., Chief Operating Officer. "Extensive data from preclinical studies support the rationale for our target and that CAL-101 has desirable pharmaceutical properties."

"Entering the clinic is an important first step for us and for patients with unmet medical needs who we are trying to serve, particularly those with hematologic malignancies," said Albert S. Yu, M.D., Vice President, Clinical Affairs and Chief Medical Officer. "This trial in healthy volunteers is designed to help define dosing regimens to assess in patients with inflammatory diseases and cancer."

"This first study is being conducted in Europe and to our knowledge it will be the first oral delta isoform selective PI3K inhibitor in the Clinic," Dr. Winter added. "We believe this study will provide us the information needed to move our 2008/2009 clinical programs forward and begin multiple trials using compounds with different PI3K isoform selectivity profiles; each of which should a have unique profile tailored to specific diseases."

About PI3K Inhibition

Calistoga Pharmaceuticals' current research efforts are focused on developing small molecule inhibitors of a critical intracellular signaling component known as phosphoinositide-3 kinase (PI3K). The PI3K pathway stimulates numerous processes 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 Pharmaceuticals has established a differentiating position in the field by focusing on particular isoforms of the PI3K family of proteins, especially PI3K-delta. Unlike other forms of PI3K, the delta form 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 inhibiting PI3K signaling that is critical to the normal function of healthy cells. A variety of studies have shown that inhibition of some of the other PI3K forms can cause significant toxicities, particularly with respect to insulin action, which is essential for regulation of blood glucose levels.

About Calistoga Pharmaceuticals

Calistoga Pharmaceuticals is an early stage clinical company developing multiple compounds selectively targeting the PI3K pathway, a pathway known to be involved in certain cancers and inflammatory diseases. Calistoga Pharmaceuticals was formed through a spin out of the PI3K inhibitor drug development program from the ICOS Corporation. The Company has raised more than $26 million from high-quality venture investors in life sciences including Frazier Healthcare Ventures, Alta Partners, Three Arch Partners and Amgen Ventures. Lilly Ventures also has an equity position in the Company. Calistoga Pharmaceuticals is a privately held organization headquartered in Seattle, Washington. For more information about Calistoga Pharmaceuticals, visit the Company's website at:

Contact Information

  • Media and Investor Contacts:
    Daryl Winter
    Chief Operating Officer
    Calistoga Pharmaceuticals, Inc.
    Phone: 206.728.4700
    Email: Email Contact

    Stacie D. Byars
    SDByars Communications, LLC
    Phone: 206.660.2588
    Email Contact