Brookhaven Science Associates, the company that operates and manages the U.S.
Department of Energy's Brookhaven National Laboratory (BNL), and Biosurface
Engineering Technologies, Inc. (BioSET), have been issued a U.S. patent on a
synthetic peptide, called B2A.
“About 250,000 Americans undergo lumbar spine fusion surgeries each year
to treat lower back pain,” said Tom Rouche, BioSET President and CEO.
“We have developed a novel combination medical device, called AMPLEX,
that incorporates B2A osteo-inductive growth factor with an ultra-high grade
ceramic bone substitute for use in this type of surgery. Preclinical studies
have found that it is a safe and highly effective.”
B2A enhances the effects of a tissue growth factor known as bone morphogenetic
protein 2, or BMP-2. BMPs are a family of proteins in the human body responsible
for the proliferation, repair and differentiation of cells in many tissues,
Brookhaven Lab scientist Louis Peña developed B2A with BioSET, and he
performed the initial studies at Brookhaven. "I became interested in bone
growth factors after NASA built a radiation research facility at Brookhaven,”
Peña said. “Weightlessness in space causes bone loss, and cosmic
radiation can cause damage to cells, so I thought I might be able to study the
interaction of the two. In setting up for that, I developed B2A and couldn’t
ignore its biomedical applications, so I focused on it instead. The ability
to shift direction and follow promising leads is important in science, and I've
had the freedom to do that at Brookhaven. I am gratified that BioSET has been
able to take the B2A technology to a new level of clinical testing."
In recent preclinical studies, University of Iowa researchers used a rabbit
model to evaluate AMPLEX spine fusion. They found that it enhanced the fusion,
compared to a conventional surgical method that uses the rabbit’s own
pelvic bone to form the bone graft. Also, a team of researchers assembled by
BioSET reported at a 2008 Orthopedic Research Society meeting that AMPLEX enhanced
spine fusion in sheep, a large animal model that more closely resembles the
BioSET has received approval from the U.S. Food and Drug Administration to
initiate a pilot study to evaluate the safety and preliminary efficacy of AMPLEX
in approximately 22 patients. Also, the company received approval from Health
Canada for a similar study with 24 patients in that country. Each controlled
study will compare AMPLEX to an autograft from the patient’s own hip bone
in lumbar fusion procedures to treat degenerative disc disease.
The first patient surgery in the Canadian study was performed by a neurosurgeon
at Foothills Medical Centre in Calgary, Canada. The surgeon reported that AMPLEX
handled as well as other ceramic graft alternatives and the patient was recovering
well after surgery. Data from all patients in the clinical studies will be evaluated
at six-month intervals.
The initial research to develop B2A was funded by the U.S. Department of Energy’s
Office of Science, the National Institutes of Health, and BioSET. The patent
on B2A (Patent # US 7,482,427 B2), titled “Positive Modulator of Bone
Morphogenic Protein-2,” was issued on January 27, 2009.