>>The 14-day multi-dose trial involved 40 patients in 6 dose cohorts from
100mg (50mg, BID) to 800mg (400mg, BID) daily. The results indicate that
ACP-104 is generally safe and well-tolerated up to the MTD of 600mg per day.
At 800mg 3 patients were withdrawn from the study including 2 SAE's. The
first was a seizure unrelated to the drug and the second fever on day 13,
followed by mild leukopenia that was likely due to viral infection but could
not be ruled completely unrelated to drug. Although not necessarily related
to agranulocytosis as seen with Clozapine, this is something to keep an eye
on in the future. Other AE's included tachycardia and hypertension related
to ACP-104.<<
Compare to this from rxlist.com:
>>Sixteen percent of 1,080 patients who received CLOZARIL® (clozapine) in pre-marketing clinical trials discontinued treatment due to an adverse event, including both those that could be reasonably attributed to CLOZARIL treatment and those that might more appropriately be considered intercurrent illness. The more common events considered to be causes of discontinuation included: CNS, primarily drowsiness/sedation, seizures, dizziness/syncope; cardiovascular, primarily tachycardia, hypotension and ECG changes; gastrointestinal, primarily nausea/vomiting; hematologic, primarily leukopenia/granulocytopenia/ agranulocytosis; and fever. None of the events enumerated accounts for more than 1.7% of all discontinuations attributed to adverse clinical events. <<
For ACP-104 the drop-out rate is comparable, & the SE profile better, though not perfect. So why has the stock been taken out and whipped this badly:
stockcharts.com
Somebody enlighten me before I step in front of a train, cuz I'm very tempted at these prices. Is 600mg going to be the dose, and will it not show efficacy or what?
Cheers, Tuck |
