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news.PLX3397, an oral investigational drug for treating multiple diseases, including metastatic cancer and rheumatoid arthritis
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Plexxikon has initiated dosing of cancer patients with PLX3397 in its phase 1 clinical trial. PLX3397 is a novel, oral investigational drug for treating multiple diseases, including metastatic cancer and rheumatoid arthritis.
PLX3397 is a highly selective kinase inhibitor that down-modulates macrophages, osteoclasts and mast cells, derived from the immune system as well as certain tumor cells that promote tumor growth and metastases to the bone.
Reportedly, by targeting these cells and consequently, certain cytokines, PLX3397 has been shown to be effective in reducing circulating tumor burden, bone erosion and pain associated with such erosion, in preclinical cancer models.
Similarly, PLX3397 has demonstrated reduced inflammation and joint disease in several models of inflammation and autoimmune disease. Plexxikon expects to advance a second drug candidate from this portfolio to the clinic in 2010 to more specifically address other disease indications.
The company informed that the phase 1 study is a dose escalation trial, which will enroll up to 50 patients with certain cancers, including metastatic disease. Patients with solid tumors will receive PLX3397 orally in cycles of 28 days.
The primary objective of this trial is to assess the safety, tolerability and pharmacokinetic profile of PLX3397. An additional follow-on phase 1b study is planned in patients with rheumatoid arthritis. Pending completion of the phase 1 studies, Plexxikon plans to explore further clinical development potentially both in cancer and rheumatoid arthritis patients.
Peter Hirth, CEO of Plexxikon, said: “PLX3397 is the sixth IND candidate to be generated by Plexxikon, further validating our platform as a discovery engine. It represents the first molecule among a portfolio of compounds with distinct and rational profiles selective for these target. In addition, the brain penetrability of PLX3397 potentially makes this an attractive drug for brain cancer and neuro-inflammatory diseases, such as Alzheimer’s Disease and multiple sclerosis.”