NeoStem (NYSE MKT:NBS) (AMEX:NBS) said Wednesday that its Amorcyte subsidiary received approval last week to continue the PreServe phase 2 clinical trial for its AMR-001 cardiac therapy.
The approval followed the first interim data and safety review by the Data Safety Monitoring Board.
The trial is a phase 2, placebo-controlled study that is expected to include 160 patients at more than 40 clinical sites.
study will test AMR-001, which is designed to preserve heart function
following acute myocardial infarction (AMI), more commonly known as a
Patient enrollment for the trial began in January
and the company anticipates completing enrollment in 2013, with six
months initial data readout near the end of 2013.
pleased that, similar to our Phase 1 trial, the first external review of
our Phase 2 trial data confirms that there are no safety signals that
would preclude the trial from continuing as planned," said chief medical
officer of NeoStem, Andrew L. Pecora, M.D.
PreSERVE AMI study to date indicates that multiple National Study sites
are capable of acquiring the necessary volume of bone marrow to create
the AMR-001 product five to seven days after an AMI in a safe and
practical manner, and once created the product can be delivered and
administered without a safety signal."
The treament 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, 6 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.
Peak annual worldwide sales of AMR-001 for this indication could exceed $1 billion, NeoStem said.
therapy is protected by two issued and multiple pending U.S. patents,
with corresponding patent coverage in selected markets globally.
Amorcyte AMR-001 product development program also extends to congestive
heart failure (CHF), with the company preparing to launch a phase 1
trial for this indication in early 2013.
The worldwide CHF patient population is estimated to be four times larger than that of AMI, NeoStem noted.
reported yesterday that revenue from continuing operations rose nearly
55 per cent in the second quarter as the cell therapy company continues
to complete the divestiture of its Chinese generic pharmaceutical
For the three months that ended June 30, revenues from
continuing operations, which consist of the company's cellular therapy
business in the United States, were $3.4 million, versus $2.2 million a
The growth was driven mainly by clinical service revenues in the
company's Progenitor Cell Therapy (PCT) manufacturing subsidiary,
reflecting increased penetration into the cell therapy marketplace.
Shares of the company were up 2.8 per cent late morning, at 68.4 cents.