Mayo Clinic & University of Pittsburgh have initiated patient dosing in AIR001 studies
SAN DIEGO, CA, USA I February 4, 2015 I Mast Therapeutics, Inc. (NYSE MKT: MSTX) today reported the initiation of patient dosing in two institutional-sponsored Phase 2a studies of AIR001 for the treatment of patients experiencing heart failure with preserved ejection fraction (HFpEF). The Phase 2a studies, currently underway at Mayo Clinic and the University of Pittsburgh, are evaluating the hemodynamic effects of AIR001 in both acute and exercise conditions, as well as change in submaximal oxygen consumption before and after AIR001 versus placebo. A third clinical study designed to compare the hemodynamic benefits versus the formation of methemoglobin comparing intravenous nitrite to AIR001 is expected to begin later this year.
Brian M. Culley, Chief Executive Officer, stated: “We are pleased to report that patient dosing recently began in these Phase 2a studies of AIR001. Last year, we reported positive top-line results from a Phase 2 study of AIR001 which demonstrated improvements in hemodynamic parameters and exercise capacity and showed that AIR001 was well-tolerated, with no treatment-related serious adverse events. That data showed benefits consistent with prior studies of AIR001, supporting our plans for continued development. We believe the hemodynamic benefits of AIR001 are particularly suited to a HFpEF population with elevated pulmonary artery and pulmonary capillary wedge pressures, for which no FDA-approved therapies are currently available. We anticipate reporting preliminary data from these Phase 2a studies beginning the second half of this year.”
About AIR001
AIR001 is a sodium nitrite solution for intermittent inhalation via nebulizer. Nitrite is a physiological signaling molecule with roles in intravascular endocrine nitric oxide (NO) production, hypoxic vasodilation signaling, and cytoprotection after ischemia-reperfusion. Nitrite serves as the largest physiologic reservoir of NO and can be converted to NO independent of nitric oxide synthase (NOS) activity. In experimental models, nitrite use has demonstrated improved remodeling both in the pulmonary vasculature and right ventricle. Hemodynamic effects include venodilation with reductions in right atrial pressures, pulmonary and systemic vasodilation with reductions in pulmonary vascular resistance and left atrial pressures, and improved cardiac relaxation. Mast Therapeutics obtained the AIR001 program through its acquisition of privately-held Aires Pharmaceuticals, Inc. in 2014.
About Mast Therapeutics
Mast Therapeutics, Inc. is a publicly traded biopharmaceutical company headquartered in San Diego, California. The Company is leveraging the MAST (Molecular Adhesion and Sealant Technology) platform, derived from over two decades of clinical, nonclinical and manufacturing experience with purified and non-purified poloxamers, to develop vepoloxamer (MST-188), its lead product candidate, for serious or life-threatening diseases and conditions typically characterized by impaired microvascular blood flow and damaged cell membranes.
The Company is enrolling subjects in EPIC, a pivotal Phase 3 study of vepoloxamer in sickle cell disease, and in a Phase 2 study to evaluate whether vepoloxamer improves the effectiveness of recombinant tissue plasminogen activator therapy in patients with acute limb ischemia. The Company also is planning to initiate a Phase 2 study of vepoloxamer in patients with acute decompensated heart failure in the second quarter of 2015. More information can be found on the Company’s web site at www.masttherapeutics.com. (Twitter: @MastThera)
SOURCE: Mast Therapeutics
Post Views: 107
Mayo Clinic & University of Pittsburgh have initiated patient dosing in AIR001 studies
SAN DIEGO, CA, USA I February 4, 2015 I Mast Therapeutics, Inc. (NYSE MKT: MSTX) today reported the initiation of patient dosing in two institutional-sponsored Phase 2a studies of AIR001 for the treatment of patients experiencing heart failure with preserved ejection fraction (HFpEF). The Phase 2a studies, currently underway at Mayo Clinic and the University of Pittsburgh, are evaluating the hemodynamic effects of AIR001 in both acute and exercise conditions, as well as change in submaximal oxygen consumption before and after AIR001 versus placebo. A third clinical study designed to compare the hemodynamic benefits versus the formation of methemoglobin comparing intravenous nitrite to AIR001 is expected to begin later this year.
Brian M. Culley, Chief Executive Officer, stated: “We are pleased to report that patient dosing recently began in these Phase 2a studies of AIR001. Last year, we reported positive top-line results from a Phase 2 study of AIR001 which demonstrated improvements in hemodynamic parameters and exercise capacity and showed that AIR001 was well-tolerated, with no treatment-related serious adverse events. That data showed benefits consistent with prior studies of AIR001, supporting our plans for continued development. We believe the hemodynamic benefits of AIR001 are particularly suited to a HFpEF population with elevated pulmonary artery and pulmonary capillary wedge pressures, for which no FDA-approved therapies are currently available. We anticipate reporting preliminary data from these Phase 2a studies beginning the second half of this year.”
About AIR001
AIR001 is a sodium nitrite solution for intermittent inhalation via nebulizer. Nitrite is a physiological signaling molecule with roles in intravascular endocrine nitric oxide (NO) production, hypoxic vasodilation signaling, and cytoprotection after ischemia-reperfusion. Nitrite serves as the largest physiologic reservoir of NO and can be converted to NO independent of nitric oxide synthase (NOS) activity. In experimental models, nitrite use has demonstrated improved remodeling both in the pulmonary vasculature and right ventricle. Hemodynamic effects include venodilation with reductions in right atrial pressures, pulmonary and systemic vasodilation with reductions in pulmonary vascular resistance and left atrial pressures, and improved cardiac relaxation. Mast Therapeutics obtained the AIR001 program through its acquisition of privately-held Aires Pharmaceuticals, Inc. in 2014.
About Mast Therapeutics
Mast Therapeutics, Inc. is a publicly traded biopharmaceutical company headquartered in San Diego, California. The Company is leveraging the MAST (Molecular Adhesion and Sealant Technology) platform, derived from over two decades of clinical, nonclinical and manufacturing experience with purified and non-purified poloxamers, to develop vepoloxamer (MST-188), its lead product candidate, for serious or life-threatening diseases and conditions typically characterized by impaired microvascular blood flow and damaged cell membranes.
The Company is enrolling subjects in EPIC, a pivotal Phase 3 study of vepoloxamer in sickle cell disease, and in a Phase 2 study to evaluate whether vepoloxamer improves the effectiveness of recombinant tissue plasminogen activator therapy in patients with acute limb ischemia. The Company also is planning to initiate a Phase 2 study of vepoloxamer in patients with acute decompensated heart failure in the second quarter of 2015. More information can be found on the Company’s web site at www.masttherapeutics.com. (Twitter: @MastThera)
SOURCE: Mast Therapeutics
Post Views: 107
