BB&T

What if Sen. Edward Kennedy could have taken a simple blood test that would have revealed a growing brain cancer long before the symptomatic seizure occurred? Could an earlier diagnosis improve a prognosis? More than likely, yes, according to Oncolab (Boston).

Surprisingly, a test to do such early stage checking for cancer has been available for three decades. That test, ironically developed in collaboration with the institution that is treating Kennedy, Massachusetts General Hospital (Boston), now is the subject of a reinvented marketing effort by Oncolab.

"It's been a sleeper," Oncolab's founder, Samuel Bogoch, MD, PhD, told Biomedical Business & Technology last month. "It's been available and permitted by the FDA since 1977. But nobody noticed that it was available and we weren't particularly good at marketing. We were basically an R&D group and hadn't marketed at all."

Amas allows early detection of a wide range of human cancers. It detects a circulating, cancer-specific antibody, the anti-malignin antibody, in human serum. Anti-malignin is a normal antibody in humans which has been found to increase with age, as the risk of cancer increases. During the early stages of cancer, the anti-malignin antibody increases markedly in concentration. Determining the concentration of this antibody is the basis for Amas.

"It was originally discovered for glioblastoma [brain cancer] and then we found out it was a general marker for any transformed or malignant cell," Bogoch said. "We figured out that it's measuring rapid replication. When cells replicate more rapidly than usual, they produce a peptide called a replicon and these replicons increase in concentration in cells. So when these increase in concentration, the body makes antibodies against them. Our test measures the antibodies. It's quite unique."

There are other blood tests that help to diagnose cancer, but those tests measure carcinoembryonic antigen (CEA), which measure less well-defined antigens whose serum levels tend to be inconstant but elevated late in the disease.

Alternately, the Amas test measures a well-defined antibody whose serum levels rise early in the course of the disease. In some cases, the Amas test has been positive early, one to 19 months before clinical detection of cancer

But it only works if the cancer is active and rapidly replicating. "A lot of cancers go through periods that are dormant. For example in prostate cancer, 80% to 90% don't do much early on, but 10% replicate," Bogoch said. "The same holds true with breast cancer; it doesn't get very active early.

Because it monitors an aspect of the body's immune response to cancer, rather than cancer antigens or cancer cells in the bloodstream, the Amas test is especially accurate early in the recurrence or first occurrence of cancer, when clinical signs of the disease may not be evident or may just be emerging.

So, is it time to incorporate the Amas test into every person's physical, along with other standard blood work-ups?

"Nobody disagrees that if you are at high risk, you should take the test," Bogoch said. "If you had cancer before or are at high risk, with a heavy genetic load, it should be taken. It's being ordered by doctors every three to six months in high-risk patients.

"Ten years ago," he said, "nobody talked about early detection, and nobody thought antibodies were important to cancer. Only in the last three to four years have antibodies been used in therapy. There's been a marked change in the environment. Early detection is important and better for treatment. And antibodies seem to be more important in cancer."

The $165 test already is approved for reimbursement via Medicare.

Oncolab has launched a new sales and marketing campaign as it tries to get the word out about its previously unknown test.

Medtronic beats Street's expectations with Endeavor sales

Medtronic (Minneapolis) blew analysts' expectations out of the water in the latter part of May, when it reported its fourth-quarter financial results — and it had its Endeavor device, a second-generation drug-eluting stent (DES) to thank for it, at least in part.

The company reported 4Q08 revenue of $3.86 billion, up 18% from the $3.28 billion reported a year ago. Medtronic also reported a strong close to the year, with revenue for the year up 10% to $13.515 billion, compared to $12.299 billion in fiscal 2007.

In addition to launching the Endeavor in the U.S., Medtronic President/CEO Bill Hawkins told inves-tors and reporters during a conference call that the stabilization of the ICD market, and strong performance in "virtually every business and geography provides positive momentum as we begin our new fiscal year."

Rick Wise, med-tech analyst for Bear Stearns (New York), wrote in a research note that Medtronic's 4Q sales "beat our estimate by $125 million." He also said that U.S. Endeavor 4Q08 sales of $81 million came in "nearly double our $45 million estimate."

After becoming the first to win marketing ap-proval in the U.S. for a second-generation DES earlier this year, Medtronic wasted no time making the Endeavor stent available to physicians. Scott Ward, president of Medtronic's CardioVascular business, had told BB&T in early February that the company would begin commercialization immediately, and expected to ship 100,000 units to U.S. hospitals in the first 30 days after FDA approval.

The Endeavor, coated with the drug zotarolimus, received an FDA panel recommendation for approval last October.

According to Wise, the device took about 17% of the U.S. market share in its first quarter of launch, exiting at a greater than 20% share. "This momentum reinforces the positive feedback we gleaned at the EuroPCR meeting and leaves us more optimistic that our 20% peak share estimate within 12 months post-launch is achievable," he said.

Boston Scientific ordered to pay $250 million in patent suit/P>

Medtronic also received some welcome legal news last month, with a U.S. District Court jury in Marshall, Texas, ordering Boston Scientific (Natick, Massachusetts) in late May to pay it $250 million in damages for infringing on three patents owned by Medtronic.

"We are delighted with the results. We believe the jury did an excellent job of interpreting the evidence and the law," Medtronic spokesman Daniel Beach told BB&T. Beach added the $250 million figure is "almost exactly the amount we requested."

Medtronic sued Boston Scientific in 2006, asserting that Boston Sci's Taxus Express2, Express2, Liberte, Maverick, Maverick2 and Quantum Maverick products infringed the Fitzmaurice and Anderson catheter patents owned by Medtronic.

The trial began on May 16 and lasted one and one-half weeks. It was heard by Judge T. John Ward and concluded Tuesday when jurors issued their verdict following five hours of deliberations.

A team of attorneys from the law firm McKool Smith (Dallas) represented Medtronic, including firm principals Sam Baxter, Kevin Burgess, Mark Mathie, Rosemary Snider and Ted Stevenson. "Both our team and our client are extremely pleased with this verdict," said Baxter, lead counsel. "The jury closely considered the facts and delivered what we believe is a just result."

The Fitzmaurice patents cover angioplasty catheters with narrowed distal ends, which improve the deliverability of angioplasty catheters. The Anderson patent covers semi-compliant angioplasty balloons. The Anderson balloons provide sufficient strength to withstand repeated inflations allowing custom vessel sizing.

Boston Scientific, in a statement, said that it had raised a number of defenses which were not considered by this jury, but which will be heard by the U.S. District Court in Marshall on July 31. If those defenses are successful, the jury's verdict will be set aside.

If the verdict stands, Boston Scientific said it will seek its overturn in post-trial motions, and, if necessary, appeal to the U.S. Court of Appeals for the Federal Circuit in Washington. The company said it is "confident" it will prevail on appeal.

PTG is acquired, and it unveils antimicrobial solution

Concerning hospital- and device-acquired infections: Polymer Technology Group (PTG; Berkeley, California), specializing in the development of biomaterials, says it has a much better solution than current coatings and drug-eluting compounds presently on the market. The company touts its Thermoplastic Polycarbonate-Urethane biomaterial application as being a much stronger solution than other applications, during the eighth World Biomaterials Congress in Amsterdam the last week of May.

The report coincided with PTG being acquired, for an unspecified sum, by Royal DSM (Heerlen, the Netherlands), which makes synthetic fibers. The companies said the DSM and PTG organizations will be "closely linked" to best serve the global market. CEO Bob Ward will stay on as president of DSM PTG.

"The device industry has been challenged to produce polymeric biomaterials with built-in antimicrobial surface properties for reducing device-centered infection," said Ward.

"But most approaches to date have used drug-eluting compounds or coatings that are eventually consumed. It is much more desirable to have easily processed biomaterials with good wet-strength and long-term efficacy without leachable additives, drugs or biocides. We believe we have an answer to this problem."

Shanger Wang, PhD, characterized PTG's polymeric biomaterial as a permanently-bonded antimicrobial surface designed to reduce medical device-centered infection.

Wang's report said that polyurethanes with surface-active alkylammonium chloride end-groups were successfully synthesized and their physical properties, surface chemistry and biocidal activities evaluated.

The presence and self-assembly of end-groups in the surface was confirmed by sum frequency generation spectroscopy.

Six Michigan hospitals seek commission's okay for proton-beam center

Six Southeastern Michigan healthcare systems are joining together to develop a $160 million cancer treatment center, a plan that will put them in competition with Beaumont Hospitals (Royal Oak, Michigan), which wants to build its own facility in partnership with a private investor, ProCure Treatment Centers (Bloomington, Indiana).

The six health systems in the joint venture project include Ascension Health (Grand Blanc), the Barbara Ann Karmanos Cancer Center (Detroit), Henry Ford Health System (Detroit), McLaren Health Care (Flint), Trinity Health (Novi) and the University of Michigan (Ann Arbor).

The consortium was made possible through a new rule approved in April by the state's Certificate of Need Commission, which oversees healthcare projects to ensure that expensive facilities aren't needlessly duplicated.

The rule, which still must go before Governor Jennifer Granholm and the state legislature, requires hospitals to collaborate to provide proton beam therapy rather than competing to offer the costly service. If neither Granholm nor the legislature takes action, the rule would go into effect in mid-June.

Proton beam therapy is considered most effective for so-called solid tumors that haven't spread, including cancers of the head, brain, neck, lung and prostate, as well as many pediatric tumors.

The joint-venture participants say their approach will have broader economic benefits to more communities. Beaumont reportedly will share its facility with other hospitals but that, as a leader in radiation therapy, it can create a top center without being slowed down by a consortium approach.

Despite the Certificate of Need Commission having endorsed the consortium's plan, Beaumont said it plans to move forward with its application and hopes to convince state officials of the merits of developing the center on its own.

With state licensing in hand, AMIC is producing medical isotopes

Advanced Medical Isotope (AMIC; Kennewick, Washington) has begun producing Fluorine-18, the first in a series of isotopes that it plans to manufacture at its Kennewick production facility, after receiving its radioactive materials license from the state of Washington in mid-May.

CEO Bill Stokes told BB&T that the company has installed a compact proton linear accelerator at Kennewick and plans to use it to produce radioisotopes for use in PET imaging. But because the company needed permission from the state to make radioactive materials, the license was a "big milestone" for AMIC, he said.

"Our initial product line is diagnostic, enhanced imaging and we understand from our medical colleagues that a good 40% of the procedures are directly affected by what they see on the PET scans ... so the PET imaging is extremely important to the diagnostic process," Stokes said.

AMIC will proceed with start-up operations of its production center, which Stokes said is built around the nation's first compact proton linear accelerator used for isotope production. The permit was issued, he said, after an "in-depth review" by state officials of the company's personnel, operations controls and physical security.

"Our device is relatively unique in that we have basically no shielding in the walls, the shielding is contained on the machine itself," Stokes said. He also noted that the machine is unique because it is considered compact at 16 feet in length.

The company said it began hot functional testing the linear accelerator "immediately" after getting the license, and produced its first batch of radioactive materials just two days later.

The license was issued just a week after the company reported signing a letter of intent to buy all the assets of the Center of Molecular Research (CMR; Moscow), which sells stable and radioactive isotopes to clients worldwide.

The acquisition includes CMR technologies of separation processes, and analytical works from multiple production and scientific partners, as well as several proprietary contracts.