Regen BioPharma Inc

Regen, incorporated on April 24, 2012, focuses on developing regenerative medical applications. The company aims to license, internally develop, or acquire these applications up to the successful completion of Phase I and/or Phase II clinical trials. Following these trials, Regen plans to either sell or license the developed applications or advance them to Phase III clinical trials. The decision to proceed to Phase III is primarily based on a greater than anticipated indication of efficacy observed in Phase I trials. Currently, Regen has HemaXellarate in development. HemaXellarate is a cellular composition derived from a patient's own adipose (fat) tissue, containing endothelial progenitor cells and mesenchymal stem cells. The company believes that re-infusing HemaXellarate into a patient will regenerate their bone marrow and restore normal function. On February 5, 2013, Regen filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) to begin a Phase I clinical trial for HemaXellarate. This trial assesses HemaXellarate in patients with drug-refractory aplastic anemia. The Phase I trial's primary goals are to determine the safety and feasibility of intravenously administered autologous SVF cells in patients with severe, immune suppressive refractory aplastic anemia. Secondary goals include evaluating efficacy based on patients achieving a complete response, partial response, or relapse. On December 10, 2015, the FDA informed Regen that all clinical hold issues related to the HemaXellarate IND application were resolved, allowing the company to initiate the Phase I clinical trial.