WILLOWBROOK, IL, USA I October 28, 2019 /PRNewswire/ — Pharmazz, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients in critical care, today announced that it successfully submitted Application for Marketing Authorization of centhaquine to the Central Drugs Standard Control Organization (CDSCO), Director General of Health Services, Ministry of Health and Family Welfare, Government of India for the treatment of patients with hypovolemic shock and excessive blood loss.
The company also submitted a request for pre-IND meeting with US FDA and has been granted a type C face to face meeting for December 3rd, 2019.
centhaquine is an investigational therapy, with a unique method of action of increasing cardiac output and decreasing vascular resistance, that met important goals of resuscitation. This is the result of a total of 180 human subject study involving 21 centers across India. Considering the unmet need for serious and life-threatening condition of hypovolemic shock the company is now seeking marketing authorization to commercialize centhaquine in India.
The safety and tolerability of centhaquine was demonstrated in a human phase I study in 25 subjects (CTRI/2014/06/004647; NCT02408731). Clinical phase II results indicated that, centhaquine is potentially a novel first-in-class highly effective resuscitative agent for hypovolemic shock (CTRI/2017/03/008184; NCT04056065). Safety and highly significant efficacy in improving systolic and diastolic blood pressure, lactate levels and base-deficit in Phase III (CTRI/2019/01/017196; NCT04045327) studies in patients of hypovolemic shock was convincing to submit application of centhaquine for market approval for hypovolemic shock patients in India.
The submission is based on positive results from the pivotal Phase 2 and 3 studies in patients with hypovolemic shock. In a 155-patient study with hypovolemic shock, which included patients with moderate blood loss with trauma, centhaquine reduced the mortality from 9.68% to 2.15% with odds ratio of 4.875 (95% CI 1.162 to 24.18, P=0.0190).
“Our submission of centhaquine for the treatment of hypovolemic shock is a very important milestone for the field of critical care medicine and is the culmination of more than a decade of hard work,” said Anil Gulati, MD, PhD, Chairman and Chief Executive Officer of Pharmazz. “I am grateful to hundreds of patients with hypovolemic shock for participating in our clinical studies, the investigators and study personnel at our study sites all around India, and the entire team of Pharmazz for bringing us to this point. We look forward to continuing to work with the regulatory agency through the review period and believe that, if approved, centhaquine has the potential to become a first-in-class treatment for patients with hypovolemic shock.”
Pharmazz, Inc., sponsored the development and registration of centhaquine as an Innovative Drug. Its subsidiary, Pharmazz India Private Limited conducted the clinical trials in India and submitted the Application for registration of centhaquine to the Indian regulatory authorities. Pharmazz will conduct further clinical studies on a post-marketing basis to further investigate clinical benefits of centhaquine.
About hypovolemic shock
Hypovolemic shock occurs as a result of either blood loss or extracellular fluid loss. Hemorrhagic shock is hypovolemic shock due to blood loss. Traumatic injury is by far the most common cause of hemorrhagic shock. Other causes of hemorrhagic shock include gastrointestinal bleed, bleed from an ectopic pregnancy, bleeding from surgical intervention, vaginal bleeding and other such conditions. Resuscitation with intravenous fluids and blood products has remained the gold standard. Balanced transfusion using 1:1:1 or 1:1:2 of plasma to platelets to packed red blood cells is recommended. Vasopressors are generally used to increase blood pressure and cardiac output, but they do not correct the primary problem and tend to further reduce tissue perfusion and are associated with adverse effects. Considering the unmet need for serious and life-threatening condition of hypovolemic shock we believe that, if approved, centhaquine has the potential to become a first-in-class treatment and significantly reduce mortality in 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: 34
WILLOWBROOK, IL, USA I October 28, 2019 /PRNewswire/ — Pharmazz, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients in critical care, today announced that it successfully submitted Application for Marketing Authorization of centhaquine to the Central Drugs Standard Control Organization (CDSCO), Director General of Health Services, Ministry of Health and Family Welfare, Government of India for the treatment of patients with hypovolemic shock and excessive blood loss.
The company also submitted a request for pre-IND meeting with US FDA and has been granted a type C face to face meeting for December 3rd, 2019.
centhaquine is an investigational therapy, with a unique method of action of increasing cardiac output and decreasing vascular resistance, that met important goals of resuscitation. This is the result of a total of 180 human subject study involving 21 centers across India. Considering the unmet need for serious and life-threatening condition of hypovolemic shock the company is now seeking marketing authorization to commercialize centhaquine in India.
The safety and tolerability of centhaquine was demonstrated in a human phase I study in 25 subjects (CTRI/2014/06/004647; NCT02408731). Clinical phase II results indicated that, centhaquine is potentially a novel first-in-class highly effective resuscitative agent for hypovolemic shock (CTRI/2017/03/008184; NCT04056065). Safety and highly significant efficacy in improving systolic and diastolic blood pressure, lactate levels and base-deficit in Phase III (CTRI/2019/01/017196; NCT04045327) studies in patients of hypovolemic shock was convincing to submit application of centhaquine for market approval for hypovolemic shock patients in India.
The submission is based on positive results from the pivotal Phase 2 and 3 studies in patients with hypovolemic shock. In a 155-patient study with hypovolemic shock, which included patients with moderate blood loss with trauma, centhaquine reduced the mortality from 9.68% to 2.15% with odds ratio of 4.875 (95% CI 1.162 to 24.18, P=0.0190).
“Our submission of centhaquine for the treatment of hypovolemic shock is a very important milestone for the field of critical care medicine and is the culmination of more than a decade of hard work,” said Anil Gulati, MD, PhD, Chairman and Chief Executive Officer of Pharmazz. “I am grateful to hundreds of patients with hypovolemic shock for participating in our clinical studies, the investigators and study personnel at our study sites all around India, and the entire team of Pharmazz for bringing us to this point. We look forward to continuing to work with the regulatory agency through the review period and believe that, if approved, centhaquine has the potential to become a first-in-class treatment for patients with hypovolemic shock.”
Pharmazz, Inc., sponsored the development and registration of centhaquine as an Innovative Drug. Its subsidiary, Pharmazz India Private Limited conducted the clinical trials in India and submitted the Application for registration of centhaquine to the Indian regulatory authorities. Pharmazz will conduct further clinical studies on a post-marketing basis to further investigate clinical benefits of centhaquine.
About hypovolemic shock
Hypovolemic shock occurs as a result of either blood loss or extracellular fluid loss. Hemorrhagic shock is hypovolemic shock due to blood loss. Traumatic injury is by far the most common cause of hemorrhagic shock. Other causes of hemorrhagic shock include gastrointestinal bleed, bleed from an ectopic pregnancy, bleeding from surgical intervention, vaginal bleeding and other such conditions. Resuscitation with intravenous fluids and blood products has remained the gold standard. Balanced transfusion using 1:1:1 or 1:1:2 of plasma to platelets to packed red blood cells is recommended. Vasopressors are generally used to increase blood pressure and cardiac output, but they do not correct the primary problem and tend to further reduce tissue perfusion and are associated with adverse effects. Considering the unmet need for serious and life-threatening condition of hypovolemic shock we believe that, if approved, centhaquine has the potential to become a first-in-class treatment and significantly reduce mortality in 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: 34
