NAPERVILLE, IL, USA I May 17, 2018 I Pharmazz, Inc. is pleased to announce interim analysis of a prospective, multi-centric, randomized, double-blind, parallel, saline controlled phase II study of PMZ-2010 (centhaquin) as a resuscitative agent for hypovolemic shock due to excessive blood loss (CTRI/2017/03/008184). A total of 23 subjects were screened, of which 19 subjects met inclusion and exclusion criteria and were included in the study. All subjects received standard treatment for shock (the type of treatment and care the enrolling institution would provide). Patients included in the study were randomly assigned to either control cohort (N=7) that received standard treatment along with normal saline or PMZ-2010 cohort (N=12) that received standard treatment along with PMZ-2010. Interim analysis shows comparable demographics of patients in both cohorts. The investigational drug PMZ-2010 met its primary endpoint of safety and no adverse event was reported. Of the total hospital stay, PMZ-2010 treated patients spent only 38.6% time in intensive care unit compared to 57.3% of control. Time spent on ventilator was only 0.85 ± 0.71 days in patients from PMZ-2010 group while it was 5.09 ± 3.14 days in patients from control group. Total fluids needed in the first 48 hours of resuscitation was 19.9% less in PMZ-2010 treated patients; similarly, total blood products administered in the first 48 hours was 23.4% less in PMZ-2010 treated group compared to control. Systolic blood pressure increased by 34.5% from baseline (at the time of inclusion) till 48 hours after resuscitation in the control group while an increase of 45.2% was observed in PMZ-2010 treated group. Similarly, diastolic blood pressure increased by 15.4% in the control group while 34.9% in PMZ-2010 treated group 48 hours after resuscitation. Total amount of vasopressors needed in first 48 hours of resuscitation were 18.4 ± 12.1 mg in the control group, while only 1.3 ± 1.2 mg was needed in PMZ-2010 treated patients. Blood lactate levels decreased by 47% in control and 63% in PMZ-2010 treated patients. Importantly, multiple organ dysfunction score (MODS) on day 3 of resuscitation was significantly lower in PMZ-2010 treated group (0.92 ± 0.23) compared to control group (2.43 ± 0.78). Similarly, ARDS on day 4 was 0.08 ± 0.06 in PMZ-2010 treated group compared to 0.57 ± 0.30 in control group. Interim analysis indicates that PMZ-2010 improved numerous parameters that are indicative of its effectiveness as a resuscitative agent. PMZ-2010 (centhaquin) has a unique property of increasing blood pressure and cardiac output, and decreasing vascular resistance following hemorrhagic shock, if approved it is likely to be a novel first-in-class resuscitative agent for the treatment of patients with hypovolemic shock.
About Pharmazz, Inc.
Pharmazz, Inc. is a privately-held company engaged in the development of novel products in the area of critical care medicine. Additional information may be found on the Company’s website, www.pharmazz.com.
SOURCE: Pharmazz
Post Views: 30
NAPERVILLE, IL, USA I May 17, 2018 I Pharmazz, Inc. is pleased to announce interim analysis of a prospective, multi-centric, randomized, double-blind, parallel, saline controlled phase II study of PMZ-2010 (centhaquin) as a resuscitative agent for hypovolemic shock due to excessive blood loss (CTRI/2017/03/008184). A total of 23 subjects were screened, of which 19 subjects met inclusion and exclusion criteria and were included in the study. All subjects received standard treatment for shock (the type of treatment and care the enrolling institution would provide). Patients included in the study were randomly assigned to either control cohort (N=7) that received standard treatment along with normal saline or PMZ-2010 cohort (N=12) that received standard treatment along with PMZ-2010. Interim analysis shows comparable demographics of patients in both cohorts. The investigational drug PMZ-2010 met its primary endpoint of safety and no adverse event was reported. Of the total hospital stay, PMZ-2010 treated patients spent only 38.6% time in intensive care unit compared to 57.3% of control. Time spent on ventilator was only 0.85 ± 0.71 days in patients from PMZ-2010 group while it was 5.09 ± 3.14 days in patients from control group. Total fluids needed in the first 48 hours of resuscitation was 19.9% less in PMZ-2010 treated patients; similarly, total blood products administered in the first 48 hours was 23.4% less in PMZ-2010 treated group compared to control. Systolic blood pressure increased by 34.5% from baseline (at the time of inclusion) till 48 hours after resuscitation in the control group while an increase of 45.2% was observed in PMZ-2010 treated group. Similarly, diastolic blood pressure increased by 15.4% in the control group while 34.9% in PMZ-2010 treated group 48 hours after resuscitation. Total amount of vasopressors needed in first 48 hours of resuscitation were 18.4 ± 12.1 mg in the control group, while only 1.3 ± 1.2 mg was needed in PMZ-2010 treated patients. Blood lactate levels decreased by 47% in control and 63% in PMZ-2010 treated patients. Importantly, multiple organ dysfunction score (MODS) on day 3 of resuscitation was significantly lower in PMZ-2010 treated group (0.92 ± 0.23) compared to control group (2.43 ± 0.78). Similarly, ARDS on day 4 was 0.08 ± 0.06 in PMZ-2010 treated group compared to 0.57 ± 0.30 in control group. Interim analysis indicates that PMZ-2010 improved numerous parameters that are indicative of its effectiveness as a resuscitative agent. PMZ-2010 (centhaquin) has a unique property of increasing blood pressure and cardiac output, and decreasing vascular resistance following hemorrhagic shock, if approved it is likely to be a novel first-in-class resuscitative agent for the treatment of patients with hypovolemic shock.
About Pharmazz, Inc.
Pharmazz, Inc. is a privately-held company engaged in the development of novel products in the area of critical care medicine. Additional information may be found on the Company’s website, www.pharmazz.com.
SOURCE: Pharmazz
Post Views: 30
