This page contains Forward Looking Statements made as of October 19, 2016.*
Below is a list of our current clinical studies.
AIR001 – Phase 2, HFpEF (“INDIE”)
AIR001 has been selected by the Heart Failure Clinical Research Network (HFN) for evaluation in a 100-patient, multicenter, randomized, double-blind, placebo-controlled, Phase 2 clinical trial known as the Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF (INDIE-HFpEF) study. The HFN is made up of premier clinical centers located across North America and was established to expedite clinical research on treatments and strategies to improve the management of acute and chronic heart failure. The HFN is providing the platform to conduct the INDIE-HFpEF study. Mast will provide test materials, nebulizers, and regulatory, technical, and additional financial support. For more information, please visit the study detail page at ClinicalTrials.gov.**
AIR001 – Phase 2, HFpEF Cohort of PH
This Phase 2 clinical study is a single-center, open label study to evaluate the effect of AIR001 in a dose escalation manner on the change in pulmonary vascular resistance (PVR) in subjects with pulmonary hypertension undergoing right heart catheterization. Planned for patients (n=50) with a diagnosis of pulmonary hypertension, 20 of which are diagnosed with HFpEF. The primary endpoint of the study is change in pulmonary vascular resistance (from time zero and at 15, 30, and 45 minutes of nebulization). Patient enrollment is ongoing – publication / interim results are expected Q4 2016. For more information, please visit the study detail page at ClinicalTrials.gov.**
AIR001 – Phase 2, HFpEF (“INABLE”)
The Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in HFpEF (“INABLE”) study is an investigator-sponsored, single-center, randomized, interventional study to evaluate whether AIR001 improves clinical responses and tolerability of exercise training (ET) in patients with a diagnosis of HFpEF (n=68). Patients will undergo 12 weeks of cardiac rehabilitation including ET after being randomized to AIR001 or placebo inhalation solution through the training period. The primary endpoint of this study is change in exercise capacity as measured by peak oxygen consumption. Patient recruitment has been initiated. For more information, please visit the study detail page at ClinicalTrials.gov.**
Vepoloxamer - Phase 3, Sickle Cell Disease
In February 2016, we completed patient enrollment in our Phase 3 clinical study of vepoloxamer for the treatment of vaso-occlusive crisis in patients with in sickle cell disease, known as the EPIC study. Top-line data from EPIC has been reported. For more information, please visit theEPICstudy.com or the study detail page at ClinicalTrials.gov.**
Vepoloxamer - Phase 2, Chronic Heart Failure
Our randomized, double-blind, placebo-controlled, multicenter Phase 2 study of vepoloxamer will enroll approximately 150 ambulatory patients with chronic heart failure (LV ejection fraction ≤ 35%). Patients in this study are randomized into one of three approximately 50-patient study arms and receive one of two dose levels of a new formulation of vepoloxamer or placebo control intravenously over three hours in an outpatient setting or short-stay inpatient unit, depending on local practice and resource availability. For more information, please visit the study detail page at ClinicalTrials.gov.**
*Forward-Looking Statements: Any statement contained in this page that is not a statement of historical fact should be considered a forward-looking statement that speaks only as the date of the post in which it is made. Forward-looking statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including risks related to the development and commercialization of pharmaceutical products. Please see the Terms and Conditions of Use page of this website for more information about forward-looking statements.
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