SuperGen Commences Phase Ib Trial for Tyrosine Kinase Inhibitor
Posted on: Wednesday, 19 December 2007, 06:00 CST
SuperGen has announced that investigators have dosed the first patient in a multi-arm Phase Ib clinical trial of MP470, an oral, multi-targeted tyrosine kinase inhibitor.
The trial will evaluate MP470 in combination with several standard of care chemotherapy regimens, including carboplatin/paclitaxel, carboplatin/etoposide, docetaxel, topotecan and erlotinib.
The trial is expected to enroll up to 105 patients at five study centers. The Phase Ib trial is an open-label, dose-escalation study designed to assess the safety and tolerability of MP470 in combination with chemotherapy regimens, and to define the dose of MP470 to advance into Phase II combination studies. Additionally, the company will assess pharmacokinetic and biomarker data from the study. The trial is open to chemotherapy-naive or treatment-experienced patients with a variety of solid tumors irrespective of previous lines of therapy.
Gregory Berk, chief medical officer of SuperGen, said: "MP470 shows significant preclinical synergy with all of these well-established chemotherapy agents. Its preclinical toxicology profile, as well as preliminary safety data from our ongoing Phase I trial, suggests it will be safe to combine it with these regimens. In preclinical models, MP470 also suppresses Rad51, a protein that plays a key role in the mechanism of resistance to these treatments. We believe this offers the potential for MP470 to improve on the efficacy of these therapies."
Source: Datamonitor
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