NIHSS

Pharmazz Inc. Presents Positive Results of Phase III Clinical Trial Demonstrating Sovateltide’s Efficacy as a Treatment for Acute Cerebral Ischemic Stroke

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Monday, October 31, 2022
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WILLOWBROOK, Ill., Oct. 31, 2022 (GLOBE NEWSWIRE) -- Pharmazz, Inc. (“Pharmazz”), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, today presented positive results of its Phase III clinical trial evaluating sovateltide as a treatment for acute ischemic stroke. Sovateltide demonstrated statistically significant and clinically meaningful improvements in multiple neurological outcomes in patients with acute cerebral ischemic stroke and was well tolerated. The trial results were presented in an oral session at the 14th World Stroke Congress in Singapore.

Key Points: 
  • WILLOWBROOK, Ill., Oct. 31, 2022 (GLOBE NEWSWIRE) -- Pharmazz, Inc. (Pharmazz), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, today presented positive results of its Phase III clinical trial evaluating sovateltide as a treatment for acute ischemic stroke.
  • Sovateltide demonstrated statistically significant and clinically meaningful improvements in multiple neurological outcomes in patients with acute cerebral ischemic stroke and was well tolerated.
  • The trial results were presented in an oral session at the 14th World Stroke Congress in Singapore.
  • Results of this trial make us highly encouraged regarding the potential of sovateltide to be a clinically meaningful treatment for patients suffering from acute ischemic stroke.

GNT Pharma Provides Update on Two Phase III Studies of Nelonemdaz for Acute Ischemic Stroke Patients Treated with tPA (ENIS-3) or Endovascular Thrombectomy (RODIN)

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Monday, September 19, 2022
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Promising efficacy and safety profiles were observed in prior Phase II studies in acute ischemic stroke patients treated with recanalization therapies.

Key Points: 
  • Promising efficacy and safety profiles were observed in prior Phase II studies in acute ischemic stroke patients treated with recanalization therapies.
  • In the prior phase II trial in China (ENIS, 237 patients), administration of nelonemdaz reduced disability primarily in moderate to severe ischemic stroke patients treated with a thrombolytic drug.
  • The ENIS-3 trial was then designed to examine the efficacy and safety of nelonemdaz in 946 patients with moderate to severe acute ischemic stroke treated with tPA within 8 hours of stroke onset.
  • In China, a phase II study of nelonemdaz (ENIS trial) has been completed in acute ischemic stroke patients receiving a thrombolytic drug within 8 hours of stroke onset (n=237).

Pharmazz Inc. Announces Positive Results of Phase III Clinical Trial Evaluating Sovateltide as a Treatment for Acute Cerebral Ischemic Stroke

Retrieved on: 
Wednesday, May 25, 2022
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The results have prompted Pharmazz to apply for marketing authorization from the Indian Central Drugs Standard Control Organization (CDSCO).

Key Points: 
  • The results have prompted Pharmazz to apply for marketing authorization from the Indian Central Drugs Standard Control Organization (CDSCO).
  • The randomized, double-blind, parallel, placebo-controlled Phase III clinical trial conducted in India enrolled 158 adult acute ischemic stroke patients who were provided the standard of care and treated with either vehicle or sovateltide.
  • Ischemic stroke was radiologically confirmed either by computed tomography (CT) scan or magnetic resonance imaging (MRI) prior to enrollment.
  • Treatment with sovateltide was well tolerated, and results on the other endpoints will be presented at an upcoming medical conference.

Pharmazz Inc. Announces Completion of Enrollment of Phase III Clinical Trial Evaluating Sovateltide as a Treatment for Acute Cerebral Ischemic Stroke

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Thursday, February 17, 2022
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Sovateltides biological properties may have the potential to protect and assist in the neurovascular recovery of at-risk brain tissue following ischemic stroke.

Key Points: 
  • Sovateltides biological properties may have the potential to protect and assist in the neurovascular recovery of at-risk brain tissue following ischemic stroke.
  • The randomized, double-blind, parallel, placebo-controlled Phase III clinical trial conducted in India enrolled 158 adult acute ischemic stroke patients who were provided the standard of care and treated with either vehicle or sovateltide.
  • Ischemic stroke was radiologically confirmed either by computed tomography (CT) scan or magnetic resonance imaging (MRI) prior to enrollment.
  • A prespecified interim analysis during the Phase III trial (more than 30 patients per arm) showed a similar result.

DiaMedica Therapeutics Initiates Pivotal Trial of DM199 for the Treatment of Acute Ischemic Stroke

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Monday, September 13, 2021
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The ReMEDy2 Trial is a randomized, double-blind, placebo-controlled Phase 2/3 adaptive trial designed to enroll 350 patients at 75 sites in the United States.

Key Points: 
  • The ReMEDy2 Trial is a randomized, double-blind, placebo-controlled Phase 2/3 adaptive trial designed to enroll 350 patients at 75 sites in the United States.
  • DM199 is currently being studied in patients with acute ischemic stroke and chronic kidney disease.
  • DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from serious diseases.
  • DiaMedicas lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality for the treatment of acute ischemic stroke and chronic kidney disease.

GNT Pharma Announces Approval of IND Application for the Phase III RODIN Trial of Nelonemdaz for Acute Ischemic Stroke Patients

Retrieved on: 
Wednesday, September 8, 2021

GNT Pharma Inc. today reported that the Korea Ministry of Food and Drug Safety (MFDS) has approved the Investigational New Drug Application (IND) for a phase III study of nelonemdaz for acute ischemic stroke patients (RODIN trial).

Key Points: 
  • GNT Pharma Inc. today reported that the Korea Ministry of Food and Drug Safety (MFDS) has approved the Investigational New Drug Application (IND) for a phase III study of nelonemdaz for acute ischemic stroke patients (RODIN trial).
  • The IND approval for a more extensive phase III trial is based on the encouraging results of GNT Pharmas earlier phase II trials.
  • The outcomes of this phase III study will be instrumental in documenting the therapeutic potential of nelonemdaz as an effective treatment for acute ischemic stroke.
  • Safety of nelonemdaz has been demonstrated in two phase I studies for 165 healthy subjects and two phase II studies for 447 ischemic stroke patients.