
Kazia Gains Orphan Designation for Investigational Glioblastoma Treatment
Kazia Therapeutics Limited, an oncology-focused biotechnology company, announced on Friday that it has received the FDA’s Orphan Drug Designation for its investigational drug, GDC-0084, for the treatment of glioblastoma multiforme, the most aggressive form of primary brain cancer.
Sydney, Australia—based Kazia Therapeutics Limited, an oncology-focused biotechnology company, announced on Friday that it has received the FDA’s Orphan Drug Designation (ODD) for its investigational drug, GDC-0084, for the treatment of glioblastoma multiforme, the most aggressive form of primary brain cancer. The
Kazia’s CEO, James Garner, MA, MBA, MBBS,
Kazia says that it expects to undertake the phase 2 clinical trial beginning in March or April of 2018. Initial data are expected in early 2019.
Glioblastoma multiforme, which is
GDC-0084, which Kazia licensed from Genentech in 2016, is an inhibitor of the phosphoinositide-3-kinase pathway, which Kazia
In addition to GDC-0084, Kazia is also in development with TRX-E-002-1, a third-generation benzopyran molecule with activity against cancer stem cells. This drug is being developed to treat ovarian cancer and is in a phase 1 clinical trial in Australia and the United States.
Reference
1. Wen PY, Cloughesy TF, Olivero A, et al. A first-in-human phase 1 study to evaluate the brain-penetrant PI3K/mTOR inhibitor GDC-0084 in patients with progressive or recurrent high-grade glioma. Presented the 2016 ASCO Annual Meeting, June 4, 2016; Alexandria, Virginia. https://meetinglibrary.asco.org/record/125239/abstract.
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