BAR HARBOR — Novo Biosciences Inc., a spinoff of the MDI Biological Laboratory, has received a two-year, $1.5 million Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) for the development of a potential regenerative medicine therapy for the treatment of patients who have suffered an acute heart attack.
The grant will allow Novo Biosciences to move ahead with studies of the effectiveness of MSI-1436 in pigs. The pig heart, which closely resembles that of humans, allows scientists to model a human heart attack. The compound already has been demonstrated to regenerate damaged heart muscle and improve heart function in adult zebrafish and mice. The study in pigs is the critical next step in moving the drug candidate into clinical trials.
“We believe MSI-1436 has enormous potential,” said Kevin Strange, CEO of Novo Biosciences and president of the MDI Biological Laboratory. “No drug now exists to treat heart attack. Heart disease is the world’s leading killer. In order to advance MSI-1436 into clinical trials, we need to first test its effectiveness in a large animal model.”
The studies will be conducted in collaboration with scientists from Louisiana State University in New Orleans. “If MSI-1436 is found to be effective in pigs, Novo Biosciences will seek an FDA IND (Investigational New Drug) authorization to conduct clinical trials in heart attack patients,” said Voot P. Yin, a scientist at the MDI Biological Laboratory.
MSI-1436 is a natural compound that was originally discovered in the dogfish shark at the MDI Biological Laboratory in the 1990s by Michael A. Zasoff. In response to Zasloff’s hunch that the compound might also stimulate regeneration, Yin tested it for its ability to regenerate heart muscle tissue in zebrafish, and then in mice.
The results of those tests were extraordinary. In mice, which are mammals like humans, the compound improved heart function, increased survival, reduced scarring and stimulated the proliferation of heart muscle cells. Strange, Yin and Zasloff, who is scientific director of the MedStar-Georgetown Transplant Institute at Georgetown University Hospital, were subsequently awarded a patent for use of MSI-1436 to treat heart disease.
“The current therapies for heart damage are limited to efforts to prevent secondary heart attacks and to transplantation for heart failure,” said Yin, chief scientific officer of Novo Biosciences and the principal investigator for the SBIR grant. “If MSI-1436 shows results in humans that are anything like what we have demonstrated in mice, it will be a game-changer for patients who have suffered a heart attack.”
“If the pig study is successful, Novo Biosciences will seek investors to move the potential drug through the multi-stage clinical trial process,” Yin said.
MSI-1436 likely would be licensed to a pharmaceutical company with the resources to commercialize the research discovery.
The discoverers of MSI-1436 also are exploring its use as a potential treatment for the regeneration of skeletal muscle tissue and cardiac muscle tissue in patients suffering from Duchenne muscular dystrophy.