Recardio Completes Interim Analysis of Phase 2 in AMI
Recardio Inc., a clinical-stage life science company, announced that it has completed an interim analysis of its Phase 2 study of dutogliptin in combination with filgrastim in early recovery post-myocardial infarction. Patient recruitment continues at all participating centers.
SAN FRANCISCO, Feb. 17, 2020 /PRNewswire/ -- Intended to evaluate the safety and efficacy of Recardio's lead candidate dutogliptin to restore lost myocardial function in patients who experience a severe heart attack and receive percutaneous coronary intervention with stent placement, the randomized, double-blind, placebo-controlled Phase 2 study will include a total of 120 patients. In agreement with the trial's Data Safety Monitoring Board, an interim analysis was carried out, which confirmed that continuation of the study is fully warranted. Therefore, the participating trial centers carry on their patient recruitment activities.
"The interim analysis was a critical milestone to completion of the study. We are encouraged by the efforts of the clinical investigators and look forward to the conclusion of the trial by this year," remarked Roman Schenk, Recardio's Executive Chairman.
Recardio's regenerative therapeutic approach to minimize and repair the heart muscle injury that follows an infarction consists of mobilizing, recruiting, and homing stem cells in-vivo by using cytokines and inhibitors. Specifically, engraftment and an improvement in cardiac output are possible by mobilizing bone marrow stem cells into circulating blood with G-CSF and then initiating stem cell migration and homing to cardiac sites of ischemia or injury with dutogliptin, a small molecule inhibitor of dipeptidylpeptidase-IV (DPP4), the key enzyme responsible for degradation of stromal derived factor-1α (SDF-1α), which is the major chemokine responsible for mobilization and migration of stem cells to areas of ischemic injury.
More information about the clinical program is available by visiting the "clinicaltrials.gov" website at the following link: https://clinicaltrials.gov/ct2/show/NCT03486080
About Recardio
Recardio Inc. is a clinical-stage life science company focusing on therapies for cardiovascular, oncology and infectious diseases. The company is located in San Francisco, California, and is having its operations in USA and Europe. The company's lead drug candidate, dutogliptin, is a DPP-IV inhibitor that has demonstrated significant effects in activating various chemokines like SDF-1, a protein that is critical for cardiac regeneration. In addition to its current Phase 2 cardiovascular clinical program, Recardio will fully develop the therapeutic platform as a regenerative medication for patients with various cardiovascular diseases including acute myocardial infarction and chronic heart failure, with the potential of improving heart function, quality of life and survival. In addition, other development programs are in the preclinical stage.
For more information, visit: http://www.recardio.eu
Related Files
2020.02.17. RECARDIO News Release Interim Analysis.pdf
SOURCE Recardio
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