US FDA approved IND submitted by Pharmazz, Inc. to initiate a phase III clinical trial of centhaquine in patients with hypovolemic shock
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WILLOWBROOK, Ill., Sept. 29, 2021 /PRNewswire/ -- Pharmazz, Inc., a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, is pleased to announce that its Phase III clinical study of the drug candidate, centhaquine, has been approved by the US FDA for the treatment of hypovolemic shock. The Phase III clinical study will be a multi-centric, double-blind, placebo-controlled to be conducted on 430 patients randomly assigned equally to both arms with 28-day mortality as the primary endpoint. Pharmazz is expected to begin enrollment towards the end of 2021 or the beginning of 2022.
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.
Centhaquine, a resuscitative agent free of arterial constriction, IND for the Phase III trial approved by the US FDA
The Company is marketing Centhaquine Citrate, with the brand name, Lyfaquin® to health care professionals in India, and more than 2,000 patients have already been resuscitated with positive results. The peer-reviewed publication of the manuscript titled " A Multi-centric, 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. Another peer-reviewed publication titled "Resuscitative Effect of Centhaquine (Lyfaquin®) in Hypovolemic Shock Patients: A Randomized, Multi-centric, Controlled Trial" published in Advances in Therapy is available for download at https://link.springer.com/article/10.1007%2Fs12325-021-01760-4. Analysis of randomized controlled trials carried out by Pharmazz in India has demonstrated an 8.8% absolute reduction in mortality. To our knowledge, this is the only late-stage clinical study that has demonstrated a significant survival advantage with no drug-related adverse events. A meta-analysis of mortality data was 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 5.340; 95% CI 1.27–26.50; p = 0.027). Centhaquine improved Shock Index, ARDS, MODS, reduced base-deficit, and blood lactate levels in patients with hypovolemic shock.
Lyfaquin® is a frontline therapy used in conjunction with the standard of care and is well-positioned to address the critical unmet need for a pharmacologically active resuscitative agent free of arterial constriction.
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.
Forward-Looking StatementsThis 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.
ContactPharmazz, Inc. Shruti Gulati630-780-6087[email protected]
SOURCE Pharmazz, Inc.
http://www.pharmazz.com
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