Brookhaven Lab, BioSET, Patent Synthetic Peptide That Enhances Bone Growth

Brookhaven Science Associates, the company that operates and manages 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," says 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, including bone.

Brookhaven 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 says. "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, according to Brookhaven. 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, the lab says. 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 human spine, the lab adds.

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 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.

BioSET is a private, clinical stage company developing proprietary therapeutic peptides as medical devices to improve bone and soft tissue repair.

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Physicists Receive Patent for Improved Cancer Therapy Device

Four physicists at Brookhaven National Laboratory have been awarded a U.S. patent for the design of a "medical synchrotron" capable of delivering precision doses of proton radiation to cancerous tumors with minimal damage to surrounding healthy tissue. The new device would be more precise and less costly than existing proton-therapy systems, potentially increasing the availability and benefits of this treatment for caner patients worldwide. The Brookhaven scientists are now seeking industrial partners to license and commercialize the technology.

"In the realm of cancer treatment, proton therapy is considered 'surgery without a knife' because proton beams can deliver cell-killing energy with extreme precision, unlike conventional x-ray radiation therapy," says Brookhaven physicist Stephen Peggs, one of the lead scientists on the project. Peggs, while working at the Fermi National Accelerator Laboratory, witnessed the completion of the nation's first hospital-based proton-therapy synchrotron, installed at
California's Loma Linda University Medical Center in 1990.

"Almost as soon as the Loma Linda synchrotron went out the door, we started thinking about ways to build a better machine," Peggs says. The current design -- developed and refined as Peggs and other physicists worked on large-scale accelerators for physics experiments, including the Relativistic Heavy Ion Collider (RHIC) at Brookhaven Lab -- is the culmination of that effort.
"Our new design has improvements in beam-focusing technology to make the smallest possible beam size -- that is, the sharpest possible 'knife,'" says Peggs. Because smaller beams deliver radiation with increased precision, this improvement could have a significant impact by shortening the duration of treatment, increasing its effectiveness, or both. The new design also promises to be less costly and more reliable, which should increase its availability.

How it works

The idea behind radiation therapy is to deliver a lethal dose of radiation to cancerous cells. In conventional x-ray radiation therapy, many healthy surrounding cells are also exposed to the radiation because x-ray beams deposit their energy as they travel through tissue. In fact, most of the dose of x-rays is deposited near the surface of the body. Though cancerous cells tend to be more susceptible to the damaging effects of radiation (or less able to repair it), the collateral damage to healthy tissues limits the dose physicians can use to destroy the tumor.

Proton therapy offers an advance over conventional x-rays because proton beams deposit most of their energy where the beam stops. The original proton therapy synchrotrons were designed to deliver cell-killing doses of radiation to tumors in three dimensions by aiming proton beams from multiple directions to stop at the depth of the tumor tissue. That precision targeting allows doctors to deliver higher doses to the tumor cells while sparing healthy surrounding tissue.

But accelerators are often costly to build and difficult to maintain, explaining why the design principles for hospital-based accelerators must be radically modified, and why relatively few hospitals have them. The new accelerator design developed by the Brookhaven team offers two main advantages: "rapid cycling" and "strong focusing."

Rapid cycling allows proton beams to be injected and extracted from the synchrotron in just one turn around the circular particle accelerator. Unlike the earlier machines, which required multiple turns, this eliminates the need for sensitive feedback systems to control the beam currents, the researchers say.

"This makes the machine more robust and reliable to operate. It's more of a turn-key operation," Peggs says. "Turn it on and it consistently starts up like a transformer, rather than booting up like a PC."

Strong focusing refers to the ability to shape the proton beam and keep it focused to pinpoint dimensions. In contrast to the Loma Linda machine, where beams measure up to a centimeter across, the new design can achieve beams as narrow as one millimeter.

Pinpoint accuracy reduces collateral damage and allows physicians more flexibility in the doses they use. Higher doses could yield more effective therapy, possibly in fewer treatments.

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