A Medical Device Daily

Amorcyte (Hackensack, New Jersey), a private biotech company developing cell therapy products to treat cardiovascular disease, reported concluding a $4.2 million first round of financing to fund an initial Phase I clinical trial.

Colt Ventures (Dallas), lead investor for the financing, focuses on life sciences, technology and natural resource industries.

“This financing is a strong indication of support for our business plan and is the first step in our strategy to develop cell-based therapies to treat cardiovascular disease that are deliverable on a commercial scale and reimbursed by insurance,” said Dr. Andrew Pecoara, chairman of Amorcyte.

Amorcyte, incorporated in May, is pursuing cell-based therapies for cardiovascular disease. It received FDA approval for its Phase I trial in September 2005. The 40-patient clinical trial is designed to determine safety and measure meaningful biologic activity.

The company said in a statement: “Unique to this trial are the pre-determined measures for assessing the effect of various stem cell dosages.” It said that trial results are expected in 12 to 18 months.

The Phase I trial is now open at Emory University School of Medicine (Atlanta), where patients are being screened for trial eligibility by the principal investigator, Arshed Quyyumi, MD. Amorcyte said it also is in negotiations to open the trial in another cardiology center within 90 days.

It is estimated there are about 1.1 million instances of acute myocardial infarction, 12 million cases of chronic ischemia, and 5 million occurrences of congestive heart failure in the U.S. per year. And the company says that a significant percentage of these patients are in need of additional therapies to ameliorate the symptoms of their disease.