On July 15, 2021 Curtana Pharmaceuticals, a privately-held, preclinical stage biopharmaceutical company, reported that it has signed an agreement with Catalent to support tablet formulation and manufacturing of Curtana’s CT-179, a drug therapy for the treatment of glioblastoma (GBM), medulloblastoma (MB), and other brain cancers (Press release, Curtana Pharmaceuticals, JUL 15, 2021, View Source [SID1234587031]).
CT-179 is a highly potent and selective small molecule inhibitor of OLIG2, a transcription factor that is essential to normal early brain development but is not actively expressed in most normal adult brain cells or in normal tissues outside the brain. However, it is expressed in all diffuse gliomas and it has been shown that OLIG2 drives tumor initiation, tumor growth, invasion into healthy brain tissue, and resistance to chemotherapy and radiation therapy. Studies to-date have demonstrated the viability of CT-179 to markedly prolong survival in numerous, relevant animal models of GBM, MB and other brain cancers. The drug is orally bioavailable, readily crosses the blood-brain barrier, and achieves high concentrations in the brain.
"This is a significant milestone for the company as we move into clinical trials, which are anticipated to commence in the first half of 2022," said Gregory Stein, M.D., M.B.A. and Chief Executive Officer, Curtana Pharmaceuticals. "GBM is a devastating disease with a poor prognosis and a variety of therapeutic challenges. We are excited to bring this easy-to-use oral therapy with the potential to improve quality of life and prolong survival of patients with GBM and other devastating brain cancers."
Formulation development and CGMP manufacturing of the clinical trial product will take place at Catalent’s 98,000 square-foot facility in San Diego, CA. This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, CGMP manufacturing, clinical packaging, labeling, and worldwide distribution.
"Catalent is proud to partner with Curtana in the pursuit of a treatment for brain cancer," said Bryan Knox, General Manager of Catalent San Diego. "The Catalent team in San Diego is focused on early-stage development of small molecule and peptide drug candidates, from the bench to the clinic, and our expertise in oral delivery makes us an ideal partner for Curtana on the further development of CT-179."
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