California, USA-based TorreyPines Therapeutics said that data from its multiple-dose clinical trial of tezampanel, an antagonist of the AMPA and kainate subgroup of glutamate receptors, show that the product candidate is safe and well-tolerated in normal male and female subjects.
These Phase I results support the company's continued development of tezampanel as a novel therapeutic for chronic pain and expand its potential therapeutic applications across a variety of persistent conditions in which activation of glutamate receptors initiates or sustains pathophysiological processes, the firm added. These conditions include cancer pain and neuropathic pain, as well as non-pain conditions such as epilepsy, muscle spasticity and rigidity and Parkinson's disease.
A recently-completed Phase IIb clinical trial of tezampanel in 306 patients with migraine met its primary endpoint for pain relief at two hours using a single 40mg subcutaneous dose. In five previously-conducted placebo-controlled, Phase II studies, an intravenous formulation of tezampanel demonstrated analgesic effect across all five studies using a variety of chronic pain models.
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