Kinex Pharmaceuticals is set to begin clinical trials of its dual src / pretubulin inhibitor, KX02, as a treatment for glioblastoma, following the FDA’s approval of its investigational new drug (IND) application.
The FDA is currently in the process of finalising the Phase I clinical protocols for the lipophilic dual src/pretubulin inhibitor, which is the company’s second internally-developed compound to enter clinical studies.
Kinex chief scientific officer Dr David Hangauer said; "In stereotactic mouse models, KX02 cleared brain tumors in about 50% of the animals and engaged a durable immune response to the tumor cells that allowed these mice to live to their full life expectancy without tumor recurrence or further drug treatment."
The company believes KX02 has the potential to inhibit a panel of brain tumour cell lines, including those resistant to commonly-used Temodar chemotherapy for the treatment of malignant glioma.
Studies involving brain tumour animal models demonstrated KX02’s ability to consistently clear brain tumours after a four-week therapy in 30% – 60% of treated animals.
The investigational compound was absorbed orally with 76% penetration into brain tissue from plasma in pharmacokinetic studies, and in mouse tumour model studies it induced necrosis of the glioma while engaging a durable immune response to the glioblastoma tumour cells.
XiangXue Pharmaceuticals is the strategic partner of Kinex for the development of KX02 in China.
XiangXue chairman and CEO YongHui Wang said; "XiangXue is developing our IND application for the Chinese State FDA and we hope to initiate KX02 trials for Chinese brain tumor patients in 2014."
Image: Coronal MRI with contrast of a glioblastoma WHO grade IV in a 15-year-old male. Photo: Courtesy of Christaras A.