NAPERVILLE, Ill., Nov. 12, 2018 /PRNewswire/ -- Pharmazz, Inc., today announced that data from the Phase 2 clinical study in patients with hypovolemic shock, were presented in the Drug Discovery-Heart Failure Oral Abstracts Session II at the American Heart Association Scientific Sessions in Chicago November 12, 2018.
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. Dr. Anil Gulati, Inventor and Founder of Pharmazz said that "PMZ-2010 is likely to be the first-in-class therapy to treat hypovolemic shock, through a new mechanism of action, of increasing cardiac output and decreasing vascular resistance to augment tissue blood perfusion."
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. All subjects received standard treatment for shock and were randomly assigned to either control cohort (N=26 of which 21 completed the study) that received standard treatment along with normal saline or PMZ-2010 cohort (N=24 of which 23 completed the study) that received standard treatment along with PMZ-2010. Demographics of patients in both cohorts was comparable. Systolic blood pressure in control did not reach statistical significance (Mean diff. -12.95.00% Cl of diff -26.95 to 1.047; p=0.0795) 12 hours after resuscitation compared to baseline (before resuscitation) on the other hand in PMZ-2010 cohort highly significant (Mean diff. -29.39; 95.00% Cl of diff -37.85 to -20.94; p<0.0001) increase in systolic pressure was observed. Similarly, a significant (Mean diff. -17.13; 95.00% Cl of diff -23.45 to -10.81; p<0.0001) increase was observed in diastolic blood pressure in PMZ-2010 cohort and not in control (Mean diff. -5.09; 95.00% Cl of diff -12.26 to -2.07; p=0.248). An improvement in base deficit of hemorrhaged patient was observed (p=0.0374) in control and (p<0.0001) PMZ-2010 cohort. Blood lactate levels decreased but did not reach statistical significance (p=0.2919) in control, however, in PMZ-2010 cohort a highly significant (p=0.0028) decrease in blood lactate levels occurred at day 3 compared to baseline at day 0. A female patient from control group with massive blood loss having blood lactate level of 11.18 mmol/l at the time of inclusion did not survive, while another female patient from PMZ-2010 group with blood lactate level of 17.41 mmol/l at the time of inclusion survived. Two patients died in control and none in PMZ-2010 cohort. 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. Company plans to initiate a multicenter clinical Phase 3 study soon and seek regulatory approval for marketing.
Pharmazz also announced the presentation # Sa4267 "ETB receptor agonist, IRL-1620, decreased cerebral ischemic damage by decreasing fission and increasing fusion of mitochondria in rat" at the American Heart Association Scientific Sessions in Chicago November 12, 2018. A clinical phase 2 study in patients with cerebral ischemic stroke is in progress; the results are encouraging and will be presented at an international meeting on stroke.
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.
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties including the risk that Pharmazz, Inc. cannot execute its business plan for lack of capital or other resources, distribution, partnering or licensing/acquisition opportunities. Actual events or results may differ materially from those projected in any of such statements due to various factors. Any of these risks could cause Pharmazz, Inc. or its industry's, actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by the forward-looking statements in this presentation. Except as required by applicable law Pharmazz, Inc. does not intend to update any of the forward-looking statements to conform these statements to actual results.
SOURCE Pharmazz, Inc.