Date: 2014-06-10
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: AstraZeneca (UK)
Product: AZD5312 (ISIS-ARRx)
Action
mechanism: ISIS-ARRx/AZD5312 is an antisense drug designed to inhibit the production of androgen receptor (AR) for the treatment of patients with prostate cancer.
Disease: prostate cancer
Therapeutic area: Cancer - Oncology
Country: USA, UK
Trial
details: This first time in man (FTIM), Phase I study has been designed to determine the maximum tolerated dose, recommended phase 2 dose, safety, tolerability and pharmacokinetics of AZD5312. Approximately 90 patients are expected to be enrolled in this multicentre study.The study involves two parts, Part A, Dose Escalation and Part B, Dose Expansion. (NCT02144051)
Latest
news: * On June 10, 2014, Isis Pharmaceuticals announced that AstraZeneca has initiated a Phase 1 clinical study of ISIS-ARRx in patients with cancer. Isis earned a $15 million milestone payment associated with the clinical advancement of ISIS-ARRx. AstraZeneca is planning to develop ISIS-ARRx broadly to treat patients under a variety of settings during the course of prostate cancer treatment, including both as a single agent and in combination therapy. The open-label, dose-escalation Phase 1 study will evaluate the safety and efficacy of ISIS-ARRx in patients with advanced solid tumors, such as metastatic castrate resistant prostate, breast, bladder and ovarian cancers, where the androgen receptor pathway is potentially a contributing factor. The endpoints for the study include measurements of anti-tumor activity and AR and AR-variant levels in tumor biopsies. The study will also evaluate safety. Isis and AstraZeneca are collaborating to discover and develop antisense drugs to treat cancer. Last June AstraZeneca has added this development candidate, ISIS-ARRx, to its collaboration with Isis. Isis earned a $10 million milestone payment associated with this decision. With the initiation of the Phase 1 study for ISIS-ARRx, Isis has earned $57 million in upfront and milestone payments from its relationship with AstraZeneca and is eligible to earn additional milestone payments as the drug progresses in development as well as royalties on sales of ISIS-ARRx if it is commercialized.
