US-based Kinex Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for its dual src/pre-tubulin inhibitor ‘KX02’ to treat gliomas, which are the most common and aggressive form of brain cancer.
KX02 is a small molecule drug that has shown potent inhibitory activity against a broad panel of brain tumour cell lines such as those that are resistant to temozolomide (T98G), the most widely used chemotherapy for the treatment of deadly glioma.
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The orphan drug status will help the company in furthering the development of KX02 as a potentially new and effective treatment for patients with gliomas.
The orphan designation provides Kinex with seven years of marketing exclusivity for KX02 in the treatment of glioblastoma patients if KX02 is approved for this indication.
According to the company, the standard treatment for glioblastoma consists of surgical removal of the tumour bulk, followed by radiation and chemotherapy with temozolomide.
KX02 has showed the ability to clear gliomas after four weeks of therapy in a well-established brain tumour animal model and also prevent tumour recurrence in these animals.
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By GlobalDataThe trials demonstrated that KX02 induced more necrosis compared with Temodar, in addition to creating an immune response to the glioblastoma tumour cells.
Pharmacokinetic trials demonstrated that KX02 is absorbed orally and has 76% penetration into brain tissue from plasma.
Kinex chief scientific officer David Hangauer said receiving orphan drug status for KX02 speaks to the need for new treatment options for patients with gliomas.
"KX02 is a novel compound with good potential for these patients in terms of generating a durable immune response to tumour cells in mice that allow the animals to live to their full life expectancy without tumour recurrence or further drug treatment," Hangauer added.
Kinex senior vice-president of operations Lyn Dyster said: "We have worked diligently with clinical sites to establish the trial protocols and expect to initiate a Phase I trial imminently."
XiangXue Pharmaceuticals is Kinex’s joint development partner for KX02 in China and has an exclusive license from Kinex for the territory. XiangXue is currently developing the IND application for the Chinese State FDA and is planning to start KX02 trials for Chinese patients with brain tumour in 2014.
Image: Two MRI images of human brain (rear view on left, top view on right) showing a low grade, encapsulated cyst-like glioma (or multiple gliomas). Photo: courtesy of Magnus Manske.
