Endocyte, Inc. (ECYT - Analyst Report) announced that it dosed its first patient in its phase I study evaluating candidate EC1456, for the treatment of advanced solid tumors.
We note that EC1456 is a folate receptor (FR)-targeting folate-tubulysin conjugate.
The phase I study is divided into parts. The two-division study is an open-label, multicenter, non-randomized, dose-escalation study which will evaluate EC1456 in advanced solid tumors.
Evaluation of the maximum tolerated dose (MTD) will be carried out in the first part of the study. The first will also evaluate the recommended dose for the phase II study. The second part of the study will evaluate the efficacy of EC1456 in patients with select cancers known to express the folate receptor (FR) with all target lesions positive for FR and treated with MTD.
30 patients will be enrolled in the first part of the study while 10 patients each with advanced solid cancer indication, will be included in the second part of the study.
The first part of the study will enroll patients with metastatic or locally advanced solid tumors who have failed to respond to standard therapy, if available. The second part will enlist patients with the advanced solid cancer indication, who have not received more than two chemotherapies in the past.
The primary endpoint of the study is to evaluate MTD and a recommended dose for phase II of the study. Identification of the safety profile of EC1456, efficacy and pharmacokinetic analysis, as well as the correlation between baseline folate expression measured by etarfolatide scans and antitumor activity of EC1456 constitute the secondary endpoints of the study.
We note that an investigational new drug application for EC1456 was accepted by the U.S. Food and Drug Administration (FDA) in the third quarter of 2013.
Endocyte continues to progress in developing its small molecule drug conjugates portfolio. Endocyte currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Aeterna Zentaris Inc. (AEZS - Snapshot Report), Actelion Ltd. (ALIOF - Snapshot Report) and Jazz Pharmaceuticals plc (JAZZ - Analyst Report). All these stocks carry a Zacks Rank #1 (Strong Buy).