About AEZS-108 and its Phase 2 program
AEZS-108 represents a new targeting concept in oncology using a cytotoxic peptide conjugate which is a hybrid molecule composed of a synthetic peptide carrier and a well-known cytotoxic agent, doxorubicin. The design of this product allows for the specific binding and selective uptake of the cytotoxic conjugate by LHRH-receptor positive tumors. The binding of AEZS-108 to cancerous cells that express these receptors, results in its accumulation and preferential uptake in the malignant tissue.
In a Phase 2 study program entitled, "The antitumoral activity and safety of AEZS-108 (AN-152), a LHRH agonist linked doxorubicin in women with LHRH-receptor positive gynaecological tumors", patients with tumors expressing LHRH receptors are administered an intravenous infusion of 267 mg/m2 of AEZS-108 over a period of 2 hours, every Day 1 of a 21-day (3-week) cycle. The proposed duration of the study treatment is 6, 3-week cycles.
Study AGO-GYN 5 is performed with 14 centers of the German Gynaecological Oncology Working Group (AGO; www.ago-ovar.de), in cooperation with 3 clinical sites in Europe.
The program was planned to include up to 82 evaluable patients, up to 41 with a diagnosis of platinum-resistant and taxane-pretreated ovarian cancer, (for which positive results were disclosed on November 2, 2009) and up to 41 with advanced or recurrent endometrial cancer. For both indications, patient recruitment was planned in 2 stages, with 21 and 20 patients, respectively, and the primary efficacy endpoint at the end of stage 2 was defined as 5 or more patients with
|Copyright©2009 PR Newswire.|
All rights reserved