Alzheimer's would be the obvious target indication for CX701... it is more potent with once-a-day dosing characteristics. CX717 is synergistic in action with Aricept... my bet is this would be a class effect. The question is how you do it? How you establish value in a reasonable amount of time.... phase Ia, Ib, IIa. Here is how one company EPIX did it, leading to a nice partnership. I don't expect this magnitude of deal, but it could be nice. Note that EPIX used an endpoint of cerebral activity with EEG's for a lot of their work. Cortex once had a nice slide of synergism with Aricept with an EEG. Note, they did a phase Ia and Ib which used some innovative trial design as was their brief-pass phase IIa program... I think it was 14 days or so....
"Dec. 5, 2006--EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX) announced today the initiation of a Phase 2a clinical trial to further evaluate PRX-03140 as monotherapy and in combination with donepezil for the treatment of Alzheimer's disease. This Phase 2a trial is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRX-03140 administered orally once-daily for 14 days in patients with mild Alzheimer's disease who are on a stable dose of donepezil (10 mg). Data from this trial are expected in the second half of 2007.
"This Phase 2a trial is designed to build on the promising results observed in our Phase 1b trial, in which treatment with PRX-03140 resulted in the desired changes in brain wave activity in patients suffering from Alzheimer's disease," said Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX Pharmaceuticals. "To date, our data indicate that PRX-03140 stimulates acetylcholine production in the brain without the peripheral side effects commonly seen with currently approved drugs. There remains a significant unmet need for Alzheimer's disease drug therapies that will improve symptoms with minimal side effects. Because of its complementary mechanism of action with cholinesterase inhibitors, we believe that PRX-03140 may produce a synergistic effect when administered in combination with donepezil."
The primary endpoints of this randomized, double-blind, multiple ascending dose Phase 2a trial are to assess the safety and tolerability of PRX-03140 administered alone and in combination with donepezil, and to measure the effect of PRX-03140 on quantitative electroencephalograms (qEEGs), including the alpha/theta ratio (a biomarker which indicates an effect on the cholinergic system in the brain). Secondary endpoints of the trial include assessing the effects of repeat doses of PRX-03140 on a battery of standardized cognitive function tests, as well as evaluating the pharmacokinetic effect of PRX-03140 on donepezil concentrations in patients with mild Alzheimer's disease.
PRX-03140 was well tolerated in a Phase 1b trial in patients with Alzheimer's disease and in two additional Phase 1 clinical trials in healthy adult and elderly volunteers. In the 14-day Phase 1b clinical trial, treatment with PRX-03140 resulted in changes in brain wave activity in Alzheimer's patients that are consistent with those seen in clinical trials with currently approved drugs for Alzheimer's disease. The Phase 1b trial assessed the effects of PRX-03140 on quantitative electroencephalograms (qEEGs) and treatment with PRX-03140 resulted in a statistically significant improvement in the quantitative EEG slow wave pattern when compared with placebo. This trial demonstrated that PRX-03140 is active in the central nervous system."
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