Centhaquine Improved Shock Index, ARDS, MODS, Reduced Blood Lactate Levels, And 8.8% Absolute Reduction In 28-Day All-Cause Mortality
Publication of phase III results on Lyfaquin®, a resuscitative agent free of arterial constriction
WILLOWBROOK, Ill., June 1, 2021 /PRNewswire/ -- Pharmazz, Inc., a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care. The Company is marketing Centhaquine Citrate, with the brand name, Lyfaquin® to health care professionals in India, and more than 1,000 patients have already been resuscitated with positive results.
Pharmazz is pleased to announce the peer-reviewed publication of the manuscript titled " A Multicentric, Randomized, Controlled Phase III Study of Centhaquine (Lyfaquin®) as a Resuscitative Agent in Hypovolemic Shock Patients." The manuscript is published in Drugs and is available for download at https://link.springer.com/article/10.1007/s40265-021-01547-5.
Severe blood or fluid loss due to trauma, gastrointestinal bleeding, major surgery, postpartum hemorrhage, diarrhea, or vomiting can cause hypovolemic shock. About 1.9 million people worldwide die because of hemorrhagic shock every year, most dying within the first 6 hours.
Centhaquine converts the venous unstressed blood volume to stressed blood volume and improves cardiac output and blood circulation, making it an ideal candidate for the resuscitation of patients. Centhaquine increased cardiac preload and decreased cardiac afterload to augment cardiac output during resuscitation. Patients with uncontrolled bleeding undergo damage-control resuscitation to stop blood loss and initiate resuscitation, keeping in mind permissive hypotension targeting a mean arterial pressure of 65 mmHg. Resuscitation with centhaquine limits the use of blood, blood products, and vasopressors and helps achieve resuscitation free of arterial constriction.
Analysis of randomized controlled trials has demonstrated reduced mortality rates attributed to disease conditions rather than new therapy. To our knowledge, this is the only late-stage clinical study that has demonstrated a significant survival advantage, with an 8.8% absolute reduction in mortality. Centhaquine was safe and well-tolerated, with no drug-related AEs. A meta-analysis of mortality data obtained from phase II and III studies because the inclusion criteria were similar and found that mortality was 10.71% in the control group (N = 56) and 2.20% in the centhaquine group (N = 91) (OR 5.34; 95% CI 1.27–26.50; p = 0.03), which is statistically significant at the 95% CI.
The therapeutic potential of centhaquine in treating other forms of shock associated with hemodynamic instability or refractory hypotension and resulting in multiorgan failure and ultimately death is of interest. Some of these conditions may include distributive shock. Septic shock is a type of distributive shock where a significant shift occurs within the vascular compartment and out of the vascular system, resulting in a state of hypovolemia managed by the administration of fluids and vasopressors. Centhaquine increases cardiac preload and reduces cardiac afterload. An increase in cardiac preload can benefit patients with distributive shock by improving microcirculation. Initiating studies to determine the efficacy of centhaquine in patients with COVID-19 or septic shock are planned.
Lyfaquin® is a frontline therapy used in conjunction with the standard of care and is well-positioned to address critical unmet need for a pharmacologically active resuscitative agent.
About Pharmazz, Inc.
Pharmazz, Inc. is a privately held company engaged in developing novel products in 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. They involve many 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 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. Pharmazz, Inc. does not intend to update any forward-looking statements to conform these statements to actual results except as required by applicable law.
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SOURCE Pharmazz, Inc.