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A New Trial for Congestive Heart Failure, Bioheart (BHRT)

Bioheart (OTCPK:BHRT) is a biotechnology company focused on the discovery, development and commercialization of autologous cell therapies for the treatment of chronic, acute heart damage, and peripheral vascular disease.  BHRT.OB initiated its REGEN trial, a Ph I clinical trial to test genetically modified MyoCell® in patients suffering from Congestive Heart Failure (CHF). BHRTs  MyoCell® is a regenerative cell therapy that uses myoblasts, or muscle stem cells that are grown from a patient’s own muscle.  MyoCell® has been tested successfully on patients in four clinical trials. The REGEN trial is designed to test the safety and effectiveness of a composition of muscle stem cells that have been gene-modified to induce a greater than usual release of the SDF-1 protein.

The REGEN trial is being funded by 1 of the BHRT.OB’s institutional investors (Ascent Medical Technology Funds).  CRO,  Biomed Product Development Centre will be managing  the study that is being conducted in Jordan.

Bioheart is focused on commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease.

  • MyoCell® is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient’s heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients,
  • Heart failure is a debilitating condition. When heart failure is in an advanced state, the heart is unable to pump enough blood to the body to allow a person to enjoy a normal, productive life,
  • This disease affects over 5 M people in the US. Over 500 K new cases are diagnosed annually in the US, making heart failure the most rapidly growing of all cardiovascular disorders,
  • According to statistics provided by the American Heart Association in the US, approximately $22.5 B are the direct and indirect annual costs of heart failure treatment,
  • Persons over the age of 65 experience heart failure as the number #1 cause of hospitalization and the number one cause of death.

BHRT.OB is currently utilizing the regenerative cells isolated by their TGI 1200 System (which takes advantage of an easily accessible source of regenerative cells from adipose or fat tissue) for a variety of clinical applications including chronic heart ischemia in Venezuela and for critical limb ischemia in the Czech Republic.

  • In collaboration with University Hospital Ostrava in the Czech Republic which has already begun treating patients with critical limb ischemia utilizing ASCs; BHRT hopes to place the TGI systems throughout the Czech Republic for additional indications including acute myocardial infarction and chronic heart ischemia, and is developing treatment plans targeted for patients with these heart issues.

BHRT.OB also, recently announced positive clinical results for MyoCell following the first part of its Phase 2/3, double-blinded, placebo-controlled clinical trial called MARVEL.  Over the 6 month observation period in this trial, the most pronounced changes were seen in the cell-treated groups.  The 6 minute walk distance (6MWD), an established parameter of efficacy utilized in heart failure studies (one of the primary end points in the trial) increased on average by more than 91 meters, or 35%, in cell-treated patients, whereas in the placebo-treated group a decrease of nearly 4 meters was seen.  This suggests that patients with heart failure could return to a more active lifestyle after receiving BHRT’s treatment.  No stem cell related safety issues such as arrhythmias, or irregular heartbeat, were observed.  An arrhythmia event is disturbing but not serious. In the MARVEL trial pre-treatment with amiodarone enabled patients to avoid arrhythmias.