CRANBURY, N.J., June 19, 2012 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE MKT: PTN) today announced that a Phase I clinical trial being conducted by AstraZeneca of AZD2820, a subcutaneously-administered peptide melanocortin-4 receptor partial agonist under development for the treatment of obesity, has been halted. AZD2820 is a clinical candidate under development by AstraZeneca from a collaborative research program with Palatin Technologies.
The Phase 1 clinical trial of AZD2820 was halted by the Safety Review Committee established by AstraZeneca after meeting a predefined stopping criterion. The stopping criterion was a serious adverse event. It is suspected that the subject may have had an allergic reaction following his first dose. The subject was treated at the clinical site and has fully recovered. A review and investigation of the incident has commenced.
"We are pleased that the subject has fully recovered from this unfortunate adverse event and we will work closely with our partner AstraZeneca to investigate the cause of this incident and the overall plans for the AZD2820 program," said Dr. Carl Spana, President and Chief Executive Officer of Palatin. "AstraZeneca has confirmed their remaining commitment to the continued advancement of melanocortin agonists for treatment of obesity, including a number of collaboration compounds in various stages of preclinical testing."
The phase I single center study, conducted by AstraZeneca, targeted enrolling 72 obese but otherwise healthy male subjects, with a body mass index between 30 and 35 kg/m 2, in a randomized, single-blind, placebo-controlled, trial. Eleven subjects had completed their dosing regimen prior to the halting of the trial. The primary outcome of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD2820 after administration of multiple ascending doses. Another Phase 1 single ascending dose study of AZD2820 was finalized in 2011 without any reported serious adverse events.Pursuant to the terms of the research collaboration and license agreement with AstraZeneca, Palatin is eligible for milestone payments upon achieving development and regulatory milestones and further payments on achievement of sales targets, in addition to royalties on sales of approved products. AstraZeneca has responsibility for product commercialization, product discovery and development costs.