This excerpt taken from the TPTX 10-K filed Mar 29, 2007.
Preclinical and clinical data suggest that tezampanel has the potential to be effective across a wide range of therapeutic applications both within and extending beyond the area of chronic pain. Tezampanel was shown to be efficacious in validated preclinical models of epilepsy, cerebral neuroprotection, generalized anxiety disorder, and muscle spasticity and rigidity secondary to spinal cord injury as well as persistent pain.
In three separate double-blind, placebo-controlled, Phase IIa clinical trials, tezampanel was statistically superior to placebo in relieving lower back pain, pain from spinal cord trauma and post-operative pain. In another Phase IIa clinical trial, using a capsaician-induced pain model, tezampanel was shown to relieve the pain and hypersensitivity associated with central sensitization. The capsaicin model is a validated approach in humans to create a controlled, central sensitization effect by injecting capsaicin, an irritating substance, under the skin. In central sensitization, the body develops a memory for pain that abnormally alters subsequent responses to both painful and normally non-painful stimuli. Central sensitization is commonly seen in a number of chronic pain conditions. Collectively, these four Phase IIa clinical trials support the experimental premise that tezampanel relieves pain from a variety of sources. In the second half of 2007, we anticipate initiating a multiple dose clinical trial of tezampanel, given by subcutaneous administration.