Date: 2013-08-07
Type of information:
phase: 1
Announcement: initiation of the trial
Company: Wilex (Germany)
Product: WX-037
Action
mechanism: WX-037 is a PI3K inhibitor. This candidate was acquired from UCB for further development in 2009 under the terms of a strategic alliance. Since then several preclinical trials concerning toxicology, pharmacology and pharmacokinetics have been conducted and the process for producing WX-037 in capsule form has been developed.With the WX-037 project, Wilex is participating in the m4 Personalised Medicine and Targeted Therapies initiative of the Munich-based m4 Biotech Cluster, prize winners of the “Leading-Edge Cluster” competition run by the Federal Ministry of Education and Research (BMBF). Wilex receives total funding of up to € 2.6 million from the BMBF for the preclinical and clinical development of the PI3Kinhibitor.
Disease: solid tumours
Therapeutic area: Cancer - Oncology
Country: UK
Trial
details: This phase I study will test the safety of escalating doses of the novel PI3K inhibitor WX-037 and explore its effectiveness in combination with WX-554 which targets mitogen activated protein kinase (MEK1 and MEK2). Preclinical evidence indicates that these two novel compounds could provide targeted inhibition of both pathways to block tumour growth. (NCT01859351)
Latest
news: * On August 7, 2013, Wilex has announced that the first patients were enrolled and dosed in a clinical phase I trial with the PI3K inhibitor WX-037. The open-label, dose-escalation study is being conducted in patients with solid tumours in three study centres in UK.The purpose of the trial is to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of the PI3K inhibitor as monotherapy as well as in combination with the MEK inhibitor WX-554. In the first part patients with advanced solid tumours, for whom there is no effective standard therapy available, will be given WX-037. In the second part of the trial, patients with a deregulatedPI3K pathway will be treated with WX-037 in combination with WX-554. According to the study design treatment cycles of three weeks until toxicity or tumour progression are planned.
