Bioheart, Inc., (OTC Bulletin Board: BHRT) announced today plans for establishing two Centers of Excellence in the Middle East to provide its cell therapy procedures to patients suffering from congestive heart failure (CHF) and peripheral arterial disease (PAD). Dr. Karl E. Groth, Chairman and CEO, and Peggy A. Farley, Chief Operating and Financial Officer, are now in that region holding discussions and performing site inspections.
Dr. Groth commented: "We feel that the Middle East region is a splendid second site for our Centers of Excellence. There is easy access to both of the sites that we are considering, Jordan and Turkey, from other countries in the Middle East as well as from Europe and South Asia." In light of site selection, Dr. Groth said: "Increasing economic wealth in the Middle East and North Africa has been accompanied by urbanization. Cardiovascular disease, a corollary to urban life, has been increasing rapidly and is now the region's leading cause of death, accounting for 25 to 45 percent of total deaths. Over the past few decades, daily per capita fat consumption has increased in most countries in the region, ranging from a 13.6 percent increase in the Sudan to a 143.3 percent increase in Saudi Arabia. Ischemic heart disease is the predominant cause of cardiovascular disease, with about three ischemic heart disease deaths for every stroke death. Also more prevalent in the Middle East than in the rest of the world, rheumatic heart disease remains a major cause of morbidity and mortality, but the number of hospitalizations related to this problem is declining rapidly. Cell technologies have not been used for treatment of rheumatic heart disease, but one can reason that they would be effective."
The company has commenced work in Jordan on its REGEN trial, a Phase I Clinical Trial to test genetically modified MyoCell® in patients suffering from Congestive Heart Failure (CHF). The first patient is expected to receive treatment in July.
Peggy Farley added: "The facilities and physicians in Jordan and Turkey are comparable to the best facilities and physicians in the United States. Once we introduce Bioheart's therapies into the Centers, patients with cardiac issues and limb ischemia will be able to access treatments that we have seen resolve those problems." Mentioning Bioheart's future plans, she went on to say: "Bioheart has plans for establishing a cell manufacturing facility in Jordan as well. Once there are a sufficient number of cases that are treated at our Middle East Centers of Excellence, it makes sense to have a second manufacturing site. Jordan's capabilities in laboratory medicine and its research into gene and cell solutions for medical problems are superb—superior to most in the world."
Bioheart's 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 SDF-1 protein is a molecule in the human body that, after an injury, is naturally released by most tissues to attract stem cells. The stem cells assist with the healing process.
Unlike other tissues, the heart muscle does not release enough SDF-1 to attract the number of stem cells that would result in complete self-healing. As a result, scar tissue forms and impairs normal heart function.
Results from Bioheart's preclinical animal studies have shown that the genetically modified MyoCell® is far more effective than MyoCell® alone in accomplishing repair and tissue regeneration. With SDF-1, there is a release of additional therapeutic proteins to assist in the tissue repair process, resulting in a more expansive and quicker repair. Once that repair or regeneration has occurred, the patient's improved heart function permits the patient to return to a normal life style.
The REGEN trial is being funded by one of the company's institutional investors, the Ascent Medical Technology Funds, and the Philadelphia BioMed Product Development Centre, PSC, a preclinical and clinical research organization located in Amman, is responsible for the study. The trial is being conducted in Jordan because its clinical research capabilities and facilities rival those of the US and Europe. The country's leadership in medicine has made it a destination for patients from the Middle East, Europe, South Asia, and even the United States, for treatments that encompass the full range of complexity, including the most innovative procedures for ameliorating cardiovascular disease and cancers. The Jordanian government and medical community have commenced programs on cell and stem therapies, establishing four research centers to concentrate on these disorders.
Imad Alhaddad, MD, FACC, FACP and Co-Director of the Jordan Cardiovascular Centre, is Principal Investigator, leading the study. He is a pre-eminent interventional cardiologist. Previously, he was Director of Vascular Services at Johns Hopkins Hospital, and the author of many clinical studies, and an extensive number of publications. He is a member of the REGEN trial's Executive Committee also.
The treatment with MyoCell® involves taking a biopsy from the patient's leg muscle, transporting that biopsy to Bioheart's cell manufacturing facility, expanding the number of cells from the biopsy, and inducing the cells to regress to produce precursors to muscle cells called myoblasts. These cells know that they are muscle cells, but do not know which muscle. Once those precursor cells, or myoblasts, are present, they are segregated from the muscle cells and grown until they number over 1 billion cells. The myoblasts are then transported back to the patient's treatment centre. Some are then injected into the patient's heart with a needle tipped injection catheter. The treatment used in the REGEN trial involves genetically modifying myoblasts, utilizing Bioheart's proprietary process. The modified cells are injected in the same manner into the patient's heart. The modified myoblasts are created using an adenovirus vector or a non-viral vector. The myoblasts will release increased levels of the SDF-1 protein, which stimulates angiogenesis and regeneration of tissue.
A heart attack limits adequate blood flow to the heart. In response, the body naturally increases the level of SDF-1 protein in the heart but not enough to heal the damaged tissue. By modifying the myoblasts to express additional SDF-1, the SDF-1 protein levels present in the heart are multiplied exponentially.. The additional quantities of SDF-1 protein stimulate the recruitment of the patient's existing stem cells to the cell transplanted area. The recruited stem cells will assist in the tissue repair and blood vessel formation process. Preclinical animal studies showed a 54 percent improvement of heart function when the myoblasts were modified to increase SDF-1 protein prior to injection of myoblasts as compared to 27 percent for the animals treated using myoblasts without modification. The animals treated with a placebo showed a decline in function of 10 percent.
After completing the REGEN trial, the company plans to transition this second-generation product into its FDA approved Phase II/III MARVEL study. Bioheart plans to further study the modified myoblasts by treating a set of patients who are participating in the study and observing the differences in clinical and heart function among the modified group, those who are treated with MyoCell® alone, and a placebo.