This excerpt taken from the TPTX 8-K filed May 13, 2008.
First Quarter 2008 and Recent Accomplishments:
· Held a clinical guidance teleconference with the U.S. Food and Drug Administration (FDA) and confirmed that it has no objection to TorreyPines moving forward into Phase III clinical trials for the treatment of acute migraine with the 40 mg dose of tezampanel. Prior to initiating any Phase III clinical trials TorreyPines intends to hold an end-of-Phase II meeting with the FDA, currently planned for the second half of 2008, to discuss the overall Phase III program.
· Completed a Phase I multiple dose clinical trial of tezampanel that demonstrated the compound to be safe and well-tolerated, supporting the development of tezampanel in pain and non-pain indications that require chronic dosing.
· Completed dosing of up to 210 mg of NGX426 in a Phase I maximum tolerated dose trial evaluating the oral prodrug of tezampanel. Following completion of this trial TorreyPines intends to initiate a multiple dose clinical trial of NGX426 to support the chronic dosing of NGX426.
· Pharmacokinetic data from the ongoing Phase I maximum tolerated dose trial of NGX426 suggest that 90 mg of NGX426 results in blood levels of tezampanel that the company believes will prove to be analgesic. TorreyPines intends to initiate a study in a model of capsaicin-induced pain to confirm the analgesic activity of NGX426 administered orally, with data from this study expected by the end of year.
· Initiated a Phase II study of NGX267 for the treatment of xerostomia, or dry mouth, secondary to Sjögrens syndrome. Data from this study are expected by the end of year.
· Presented animal data on TorreyPines proprietary gamma secretase modulator (GSM) compounds at the Keystone Symposium on Alzheimers disease. The data demonstrated that TorreyPines GSM compounds provide a more selective mechanism than gamma secretase inhibitors. TorreyPines is developing its GSM compounds as a potential treatment for Alzheimers disease.
· Acquired from Johns Hopkins University the rights to intellectual property related to the novel use of glutamate receptor antagonists, including TorreyPines compounds tezampanel and NGX426, for the prevention and treatment of stroke, heart attack and other conditions associated with increased platelet aggregation.
· Received notification that an abstract describing the results from the completed Phase IIb clinical trial of tezampanel for the treatment of acute migraine was accepted for presentation at the 50th Annual Scientific Meeting of the American Headache Society to be held in Boston June 26-29, 2008.