Inclusion and exclusion criteria

Results on Efficacy of PMZ-1620, an Endothelin-B Agonist, from Ongoing Phase II Trial in Patients with Cerebral Ischemic Stroke Presented at International Stroke Conference 2019

Retrieved on: 
Thursday, February 7, 2019
RTT, Chemistry, Medicine, Health, Stroke, Sitaxentan, Inclusion and exclusion criteria, Saline, Endothelin

A prospective, multi-centric, randomized, double-blind, parallel, saline controlled phase II study is in progress with PMZ-1620 as an endothelin-B receptor agonist for cerebral ischemic stroke (CTRI/2017/11/010654).

Key Points: 
  • A prospective, multi-centric, randomized, double-blind, parallel, saline controlled phase II study is in progress with PMZ-1620 as an endothelin-B receptor agonist for cerebral ischemic stroke (CTRI/2017/11/010654).
  • A total of 516 subjects were screened, of which 40 subjects met inclusion and exclusion criteria and were included in the study.
  • PMZ-1620 administered intravenously was started within 24 hours after the onset of stroke and given till day 6.
  • An improvement in Barthel Index of 50 or more was observed in significantly greater number of patients treated with PMZ-1620 compared to control (standard treatment).

Phase 2 Results on Efficacy of PMZ-2010 (Centhaquin) in Patients with Hypovolemic Shock Presented at AHA Scientific Sessions 2018

Retrieved on: 
Monday, November 12, 2018
Medicine, Medical emergencies, Health, RTT, Intensive care medicine, Shock, Hypovolemia, Acute stress reaction, Inclusion and exclusion criteria

Clinical Phase 2 results demonstrate that PMZ-2010 significantly improved all three surrogate clinical end points of blood pressure, blood lactate and base-deficit in patients with hypovolemic shock compared to standard of care.

Key Points: 
  • Clinical Phase 2 results demonstrate that PMZ-2010 significantly improved all three surrogate clinical end points of blood pressure, blood lactate and base-deficit in patients with hypovolemic shock compared to standard of care.
  • A prospective, multi-centric, randomized, double-blind, parallel, saline controlled phase II study was carried out with PMZ-2010 (centhaquin) as a resuscitative agent for hypovolemic shock (CTRI/2017/03/008184).
  • A total of 137 subjects were screened, of which 50 subjects met inclusion and exclusion criteria and were included in the study.
  • The results indicate that PMZ-2010 (centhaquin) is a highly effective resuscitative agent and is likely to improve the outcome of patients of hypovolemic shock.

CytoSorbents REFRESH 2-AKI Protocol Amendment Approved by FDA

Retrieved on: 
Tuesday, September 4, 2018
Health, Clinical research, Pharmaceutical industry, Food and Drug Administration, Clinical trial, Design of experiments, Drug discovery, Inclusion and exclusion criteria

As previously discussed, based on the recommendations of key clinical advisors, a protocol amendment was submitted to the FDA to improve operational aspects of the patient screening process and expand the inclusion criteria.

Key Points: 
  • As previously discussed, based on the recommendations of key clinical advisors, a protocol amendment was submitted to the FDA to improve operational aspects of the patient screening process and expand the inclusion criteria.
  • The approved amendment has now been distributed to 9 active clinical trial sites, 7 additional sites nearing budget and contract finalization, and 9 additional sites completing start-up activities, awaiting individual ethics committee review.
  • Dr. Eric Mortensen, Chief Medical Officer of CytoSorbents Corporation stated, "We thank the FDA for their rapid review and approval of this protocol amendment.
  • Feedback from the clinical sites on the protocol revisions has been very positive and we expect enrollment to significantly increase."