This excerpt taken from the TPTX 8-K filed Feb 14, 2008.
Maximize Value of Versatile Lead Compounds
AMPA/kainate receptor antagonists
· Conduct a Clinical Guidance meeting with the U.S. Food and Drug Administration (FDA) in the first half of the year to discuss the efficacy results from the recently completed Phase II clinical trial of tezampanel in acute migraine headache. As reported last October, tezampanel met its primary endpoint of headache pain relief in a double-blind, placebo-controlled, Phase IIb trial in 306 patients with acute migraine. Depending on the outcome of the meeting, the company intends to conduct an end-of-Phase II meeting with the FDA in the second half of 2008.
· Initiate a Phase II trial of tezampanel in muscle spasticity and rigidity secondary to spinal cord trauma in the second half of the year. This trial will be the companys first for tezampanel in a non-pain indication and is intended to demonstrate the potential utility of tezampanel for indications beyond migraine and chronic pain.
· Complete the ongoing Phase I maximum tolerated dose trial of NGX426, the oral prodrug of tezampanel, in the first half of the year.
· Initiate a Phase I single-dose trial of NGX426 in a capsaicin model for neuropathic pain in the first half of the year. The purpose of this trial is to show that tezampanel may be an effective analgesic when administered orally as NGX426. Tezampanel has been shown in six Phase II trials to be an effective analgesic when administered parentally.
· Initiate a Phase I multiple dose trial of NGX426 in the second half of the year.
· Initiate a Phase II trial of NGX267 in xerostomia, or dry mouth, secondary to Sjogrens syndrome in the first half of the year. The company has demonstrated the safety of single and multiple doses of NGX267 in three Phase I trials involving healthy volunteers. In two of these studies, statistically significant increases in salivary flow were demonstrated.