NeoStem says publication supports cell therapy product for cardiac treatment
NeoStem (NYSE:NBS) said Wednesday that an article published by the International Scholarly Research Network provides “further evidence” that its lead cell therapy candidate, AMR-001, “appears capable” of preserving heart muscle function.
Shares of NeoStem rose 2.16 per cent on the news, trading at 71 cents as at about 10:15 a.m.
The publication by Dr. Sabha Bhatti and colleagues, including NeoStem’s chief medical officer Dr. Andrew Pecora, examines NeoStem's AMR-001, which showed in a phase 1 trial that it preserved heart muscle function when a therapeutic dose of cells was administered.
Owned through its subsidiary, Amorcyte, AMR-001 is a cell therapy developed to preserve heart muscle and prevent major adverse cardiac events following acute myocardial infarction (AMI), or a heart attack.
The treatment consists of a patient's own bone marrow cells, which are processed to create pharmaceutical-grade cells that are then re-injected through coronary arteries into damaged areas of the heart, six to 11 days after a patient experiences a heart attack.
Because the treatment is autologous, meaning cells are taken from the same individual that they're transplanted into, it has no risk of rejection and can provide support for an extended period of time, the company said.
NeoStem said that no patient experienced deterioration in heart muscle function who received 10 million cells or more, whereas 30 to 40 per cent of patients not receiving a therapeutic dose did.
The new study shows that cardiac muscle function sparing effects are evident even earlier after treatment than previously shown.
Previously, Amorcyte showed that six months after being treated with AMR-001, blood flow to the heart was improved and heart muscle was preserved.
By using specific measuring tools, NeoStem said that the new publication shows that AMR-001's effects are evident by three months after treatment.
The article is published online at http://www.isrn.com/journals/radiology/2013/371028.
Amorcyte is now enrolling patients in a phase 2 trial to investigate AMR-001's efficacy in preserving heart function and preventing adverse clinical events after a large heart attack.
The Amorcyte AMR-001 product development program also extends to congestive heart failure, with the company preparing to launch a phase 1 trial for this indication in early 2013.
NeoStem said it continues to develop and build on its core capabilities in cell therapy, and said it anticipates that cell therapy will have a significant role in the fight against chronic disease “and in lessening the economic burden that these diseases pose to modern society”.
The biopharmaceutical company has adult stem cell operations in the U.S., a network of adult stem cell therapeutic providers in China and a 51-per-cent ownership interest in a Chinese generic pharmaceutical manufacturing company, which in September it was in the process of selling.
The company is focused on accelerating the development of proprietary cellular therapies and becoming a single source for collection, storage, manufacturing, therapeutic development and transportation of cells for cell based medicine and regenerative science globally.
Last month, NeoStem said that Amorcyte announced a “significant expansion” in its claims granted to protect the use of its cell therapy product designed to help repair tissue that sustained an ischemic injury.
The company said that it received notification that claims granted in the United States had been granted by the Japanese patent office and that the grant represents another major market to grant patent protection for Amorcyte's product.