By Matthew Willett
Taking a blood vessel from a patient's leg and moving it to the heart is common.
Taking muscle cells from a patient's thigh, expanding them and moving them to a weakened heart is novel enough to garner a company $11 million in its first round of venture financing. That's just what Bioheart Inc.'s MyoCell platform does, and that's just what the company did.
The Fort Lauderdale, Fla., company raised $11 million in the financing that was led by Exeter, N.H.-based Tyco International Ltd.'s venture capital unit, Tyco Ventures.
Founded in 1999 by a group of biotechnology veterans, Bioheart has brought together leading researchers in heart regeneration technology to complete proof-of-concept testing for its cell therapy platform. The company said it is only weeks away from submitting an investigational new drug application to the FDA to begin clinical development of MyoCell.
CEO and co-founder Howard Leonhardt told BioWorld Today his company plans to develop MyoCell for a variety of cardiac indications.
"We spent most of 1999 trying to select the right cell," Leonhardt said. "We looked at embryonic stem cells, we looked at adult stem cells, we looked at cardiomyocytes, and we finally looked at myoblasts, and after consideration we found that myoblasts were the best candidates to move into clinical trials."
The MyoCell process harvests the myoblasts, a class of stem cells programmed to become muscle, from a patient's thigh. After expansion the cells are implanted around damaged heart muscle via the femoral artery through an endoventricular process.
Leonhardt said myoblasts have several advantages: they're ischemia-resistant, they're effective during contraction - unlike other cells effective only during cardiac muscle relaxation - they're easily obtained and they won't be rejected by the patient, who also is the donor.
"The other driving reason for myoblasts is that, unlike other cell types, they have a natural program to avoid over-proliferation, tumor-like growth," Leonhardt said. "The way they avoid that is that they're programmed to connect to the surrounding tissue or themselves within a certain time period of being released, we think about 48 hours after their release. When they connect there is no further proliferation."
He added that the process holds promise for further therapeutic benefit, partially because of the angiogenic properties of the newly implanted myoblasts.
"We've initiated a study in animals simulating congestive heart failure, and we expect that to be another, and perhaps the most important, expansion," Leonhardt said. "This technology could also potentially benefit patients with angina. Even though the technology is to grow new muscle, myogenesis, it also has the side effect of creating new blood vessels, angiogenesis. The combination of increased muscle growth and new blood vessels could aid in pain from angina. We believe that could be a future market and we think the trials will show benefit for those patients."
Bioheart CFO John Babitt said the financing will fund those clinical trials, and he added the funding should last the company into the fourth quarter of this year.
"The purpose of the financing is to focus on the remainder of the preclinical work and to provide the initial funding for us to enter clinical trials," Babitt said. "Additionally, there is some ground-level research with respect to cell culturing, validation and transport data that we'll also utilize a portion of these funds for."
And with plans to file an IND in April, the first trial on the list is aimed at evaluating the process's safety and efficacy in the regeneration of damaged heart muscle.
"The first study in Phase I testing will focus on safety, and it'll be a very limited trial," Babitt said. "We can say that it is the goal of the company, to be the first in the world to enter endoventricular delivery trials of this technology."