Werde ich ebenso auf meine Watch-List setzen wie auch die weiter unten erwähnte Vanda Pharmaceuticals Co. ( A0JJT3 ), Kurse von Titan & Vanda gingen nach Bekanntgabe dieser Meldung durch die Decke, bröckeln z.Z. wieder etwas ab, heute - 5%.
Gruß + Stöffen
Titan Reports Positive Results in Iloperidone Phase III Clinical Trial
Titan Pharmaceuticals, Inc. (AMEX:TTP) today announced positive results from a Phase III clinical trial evaluating iloperidone, an atypical antipsychotic, in patients with schizophrenia. In this important study, iloperidone demonstrated statistically significant improvement compared to placebo on the Positive and Negative Symptom Scale (PANSS), the trial's primary endpoint. Iloperidone also achieved significant efficacy on the positive and negative symptom subscales of PANSS. The safety profile was consistent with what has been observed in previous iloperidone Phase III trials.
Iloperidone's efficacy and safety was also evaluated in this study in patients with specific genetic profiles using pharmacogenetics (PG), in order to potentially give physicians and patients information to help individualize their antipsychotic therapy. It had been previously identified that a certain polymorphism in a gene, occurring in approximately 70% of patients, may be associated with the pathogenesis of schizophrenia and appeared to correlate with iloperidone response. Iloperidone achieved statistical significance vs. placebo on the PANSS scale in these patients, with a magnitude of response greater than that seen in the overall iloperidone population.
The Phase III trial was a randomized, double-blind, placebo-controlled, multi-center, 4 week study that enrolled 604 patients with schizophrenia. The trial evaluated 12 mg of iloperidone dosed twice-daily, or 24 mg per day. The primary endpoint was efficacy vs. placebo in PANSS (total) using the Mixed Method Repeated Measures (MMRM) methodology. The secondary endpoint was efficacy in the previous described genetic subpopulation.
The efficacy results vs. placebo include:
* Efficacy (intent to treat population):
* PANSS (total): p=0.006
* PANSS (positive symptoms only): p=0.0009
* PANSS (negative symptoms only): p=0.027
* Brief Psychiatric Rating Scale (BPRS): p=0.0128
* Efficacy (genetic subpopulation):
* PANSS (total): p=0.002
Using Last Observation Carried Forward (LOCF) methodology, iloperidone achieved statistical significance in both the primary and secondary endpoints. Iloperidone efficacy was also equal to the active control arm.
The study also evaluated the effect of iloperidone on the QT interval, a well understood atypical antipsychotic class side effect. The mean QT prolongation was consistent with previous experience. No patients experienced QT intervals in excess of 500 milliseconds, a threshold of concern to the FDA. The study also confirmed, with an additional genetic marker, that the QT prolongation was shorter in the majority of patients who are good iloperidone metabolizers.
The specific results include:
* QTc change from baseline:
* All patients: 11.4 milliseconds (msec)
* Good metabolizers: 10.4 msec
* Poor metabolizers: 15.0 msec (p=0.008, good vs. poor)
"We are very pleased with these results for iloperidone in this Phase III study", stated Louis R. Bucalo, Chairman, President and CEO of Titan Pharmaceuticals. "These results strongly support our position in the advancement of iloperidone".
The Phase III study was performed by Vanda Pharmaceuticals Inc. (Nasdaq:VNDA). Vanda acquired the rights to iloperidone from Titan's sublicensee, Novartis. Vanda plans to file an NDA for iloperidone by the end of 2007. Titan's agreements provide that Titan will receive a royalty of between 8-10% on worldwide sales of iloperidone.
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