Cattlemen’s Ball shatters fund-raising record for cancer research

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From UNMC public relations

2013 Cattlemen's Ball

2013 Cattlemen’s Ball

OMAHA, Neb. (July 16, 2013)—The 2013 Cattlemen’s Ball raised $2.12 million to support cancer research, shattering the event’s previous record of $1.49 million by some $600,000, event officials announced Monday.

All of the money stays in Nebraska to support cancer research and local health and wellness programs.

Ninety percent of the proceeds — approximately $1.9 million — will go to support cancer research at the Fred & Pamela Buffett Cancer Center in Omaha. Ten percent of the proceeds — around $200,000 — will be distributed as grants to health and wellness organizations in the Paxton-Sutherland area.

Read more at UNMC News.

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Anderson named to U.S. committee on human research protection

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Jim Anderson, Ph.D.

Jim Anderson, Ph.D.

by John Keenan, UNMC Communications

WASHINGTON, D.C. (July 16, 2013)—Jim Anderson, Ph.D., associate dean for research in the College of Public Health, has been named to the Advisory Committee on Human Research Protection through the U.S. Department of Health and Human Services. The committee is directed by HHS Secretary Kathleen Sebelius.

The committee’s role is to advise, consult with and make recommendations to Secretary Sebelius as to the responsible conduct of research involving human subjects.

Read more at UNMC News.

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UNMC team finds early heart disease warning with simple blood test

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CORRECTIVE AMENDED, 7/11/13, 12:58 p.m.

by Charles Litton, UNeMed

OMAHA, Neb. (July 10, 2013)—It’s a virtual certainty that everyone over 50—more than 98 million Americans—has coronary artery disease. So do 70 percent of 40-year-olds. And about half of people in their 20s and 30s probably have it too.

Yet heart disease doesn’t kill everybody.

Understanding the difference between those who die and those who don’t has been a confounding riddle for modern medicine.

An interdisciplinary team of researchers at the University of Nebraska Medical Center in Omaha—Dan Anderson (left), Michael Duryee (right) and Geoff Thiele (not pictured)—believe they found a way to determine who will develop potentially deadly heart disease with a simple blood test.

An interdisciplinary team of researchers at the University of Nebraska Medical Center in Omaha—Dan Anderson (left), Michael Duryee (right) and Geoff Thiele (not pictured)—believe they found a way to determine who will develop potentially deadly heart disease with a simple blood test.

An interdisciplinary team of researchers at the University of Nebraska Medical Center believe they’ve made a potentially ground-breaking discovery. It’s a simple test that effectively determines whether or not a patient is harboring the dangerous type of heart disease that kills one in four Americans every year. Even better, the test could tell an apparently healthy 40-year-old that they are in the earliest stages of the world’s No. 1 killer.

Most people live with it, blissfully unaware. They only develop complications late in life, such as chronic chest pain or angina. But there are others who unexpectedly suffer a debilitating or fatal heart attack. It doesn’t seem to matter if they’re young, fit and trim or a world famous actor vacationing in Europe.

Coronary artery disease is the accumulation of plaque deposits inside the arteries that feed the heart. As plaque builds up, it restricts blood flow. For people who have the unstable and usually lethal form of the disease, a piece of that plaque can break off creating two potential problems.

While that debris is swept away in the blood stream, things like blood platelets and clotting factor start building up at the rupture site, creating a bottleneck that blocks blood flow. And the debris itself can get wedged further down the line where it could also dam off blood flow.

Either way, the result is a sudden heart attack or stroke.

Unfortunately, that heart attack is too often the first indication that a patient has the lethal form of the disease. But UNMC’s new test could change that.

Dr. Geoff Thiele, a professor of internal medicine, and Michael Duryee, a research coordinator for the Division Rheumatology and Immunology at UNMC’s College of Medicine, made the initial discovery. While looking for clues to help understand inflammatory conditions such as arthritis and alcoholic liver disease, they focused on a molecule that is a strong indicator of inflammation. Known as MAA or malondialdehyde–acetaldehyde, the molecule also appeared to indicate the presence of coronary artery disease.

Dr. Geoff Thiele

Dr. Geoff Thiele

“We thought it was cool scientifically, but we’re not clinical guys,” Duryee said. “We don’t see this everyday.”

Thiele and Duryee brought in cardiologist Dan Anderson, an assistant professor in the Division of Cardiology who is a rare blend of researcher and practicing physician.  He has a frontline view of the battle against the world’s most prolific killer, which annually takes more than an estimated 17 million people. Heart disease accounts for 600,000 American deaths every year.

“In the current realm of understanding disease, we know that inflammation is important in cardiovascular disease,” Dr. Anderson said. “But we really don’t understand a lot about why or how.”

By current measures, Anderson said, about 30 percent of people with heart disease slip through the cracks. For those people, the first indication of trouble may be a killer heart attack in what Anderson called “a failure of medicine.”

“We should have seen and recognized this decades prior, and prevented it,” he said. “People tend to feel okay and think they’re okay. But they’re not even seeing the tip of the iceberg.”

But there are others with the disease who suffer few, if any, ill-effects. Predicting which patients will develop the more deadly form of heart disease is little more than a guess.

Then Dr. Thiele and Duryee knocked on the door.

“I said, ‘Oh, my God.’ From a clinical diagnostic perspective, this becomes invaluable to help understand those different groups of patients,” Dr. Anderson said.

Over the course of two pilot studies, the team tested hundreds of volunteer patients’ blood, and found a remarkable correlation.

“Right now, the data really is incredible,” Dr. Thiele said.

It’s no minor feat for pilot studies to generate significant results with such a small group of patients. Most other studies in cardiovascular research don’t show significant results until thousands of patients are included in a study, Dr. Anderson said.

“We’re seeing differences where we haven’t been able to predict those differences before, and I think that’s the value,” he said.

The initial results have gained attention elsewhere.

The research team and UNMC’s technology transfer office, UNeMed Corporation, are currently in preliminary discussions with several companies on how to translate the results into products that can better factor in a patient’s risk of heart attack

Thiele said that any test developed from the discovery would be cheap and easy to implement with any clinical lab facility’s existing equipment. It would be a simple blood test, not unlike tests that measure blood-sugar levels for diabetics.

The next rounds of testing will be critical to understand how accurate the test can be, particularly studies that follow individual patients over the course of five or 10 years, Duryee said.

If successful, researchers hope the test could be used to definitively tell younger patients in their 40s, 30s or even their 20s whether or not they will develop potentially fatal heart disease. Perhaps even patients in their teens could get early warnings, and begin taking preventative measures.

“That’s what we don’t know, but that’s our goal,” Dr. Anderson said.

***

CORRECTION: The sixth paragraph was amended and the seventh paragraph added to more accurately describe the effects of buildup and subsequent rupture of plaque in coronary arteries.

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UNMC nanotechnology protects skin from cancer and early wrinkles

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UNeMed, ProTransit Nanotherapy sign licensing deal on drug delivery technlogy from UNMC

OMAHA, Neb. (July 8, 2013)—Nanotechnology developed at the University of Nebraska Medical Center could strengthen things like sunscreen and anti-aging cosmetics into more potent barriers, protecting the skin from UV radiation that can cause wrinkles and skin cancer.

A new startup company, ProTransit Nanotherapy, L.L.C., was founded on the innovation, and hopes to commercialize the nontoxic, biodegradable system within the next 18 months. If successful, the nanotechnology could serve as a platform that can deliver targeted treatments to a vast range of ailments, including stroke and heart disease.

The root cause of many of those diseases are renegade atoms or molecules known as free radicals that damage neighboring cells. The best-known weapons against free radicals are antioxidants. But effectively delivering those antioxidants has been a challenging riddle for modern science.

Vinod Labhasetwar, Ph.D., former faculty at UNMC’s Department of Pharmaceutical Sciences, appears to have solved that problem.

Dr. Labhasetwar—currently a professor of biomedical engineering at the Lerner Research Institute at Cleveland Clinic in Ohio—developed nanoparticles that can carry a wide range of proteins, enzymes and even genetic materials that can be customized to deliver targeted treatments.

Gary Madsen and Michael Dixon signs licensing agreement at UNeMed.

ProTransit Nanotherapy co-founder Gary Madsen (left) and UNeMed Corp. president Michael Dixon sign the licensing agreement on a technology that could make skin care products more protective against harmful UV radiation from the sun. (Photo by Jack Mayfield/UNeMed)

The first application of the nanotechnology will be to deliver a powerful blend of protective antioxidants in topical formulations to protect skin from the sun’s UV radiation—a major cause of skin cancer and premature skin aging.

ProTransit Nanotherapy was formed in collaboration with Gary Madsen, Ph.D., the entrepreneur in residence at UNeMed Corporation. UNeMed is the technology transfer office at UNMC.

Dr. Madsen will serve as the new company’s president and CEO. Dr. Labhasetwar, a co-founder of the company, will serve as the Chief Scientific Officer.

ProTransit Nanotherapy is also working with UNMC’s Center for Drug Delivery and Nanomedicine to develop facilities for the manufacture of nanoparticles and other nanomedical products.

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Clinical trial set for Parkinson’s treatment

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from a news article written by Rick Ruggles, Omaha World-Herald

OMAHA, Neb. (July 1, 2013)—University of Nebraska Medical Center researcher Howard Gendelman, M.D., will soon start a human trial on a promising new drug treatment for Parkinson’s disease.

Dr. Howard Gendelman

Dr. Gendelman

Dr. Gendelman, chairman of UNMC’s Department of Pharmacology and Experimental Neuroscience, believes he found a way to halt the degenerative disease’s progression. Current treatments for Parkinson’s largely treat symptoms and are only effective for a short time.

Dr. Gendelman will use a two-step approach to implement his innovative treatment. The first step is to stop the disease’s progression, which will be tested in the upcoming trial.

If it works, Dr. Gendelman can move into the second part of his research: Use a vaccine he’s building to sweep out the faulty protein that causes Parkinson’s.

“We hope to cure Parkinson’s disease,” Dr. Gendelman told the Omaha World-Herald. “I know it’s a lofty goal.”

Read the entire article at the Omaha World-Herald website, Omaha.com.

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My first year as entrepreneur in residence

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by Gary L. Madsen, UNeMed | July 2, 2013

It’s been a full year since I began work as the entrepreneur in residence for UNeMed Corporation.   As I look back over the year, I think there are important lessons that others can learn from, especially if you or your organization is about to embark on a similar adventure.

large_gary Madsen_0After spending the last 30 years entirely in the private sector, I was curious: Will my first foray into academia be a success? Can I successfully achieve important goals in this environment?

I hoped that I could fashion the position in a way that would meet the needs of the University and my career desires at the same time. Was this even possible?

The position is structured as a consulting arrangement that pays for about half of my time, which allows me to focus on my other responsibilities such as other consulting opportunities, selling our home in Madison and fixing up a house in Omaha.  UNeMed president Michael Dixon and I agreed upon a set of goals for year one, with a primary focus on identifying a solid technology patented by UNMC that would make a good foundation for a biotech startup company, starting the company and leading the effort to make it a success.  My other goals are centered on helping other UNeMed startup biotech companies, working to improve UNeMed’s licensing processes, and helping EIRs at other facilities around the state.

It is difficult to come into an organization like UNeMed and learn all the procedures and technologies that are important for the organization.  However, I immediately noticed and felt comfortable with their general technology review process and the types of documents they work with.  I have worked in business development like this in several other companies, so I feel that I know the ropes pretty well.  However, the unusual part was all of the medical terms and jargon that are used in this work, so it took a long time to understand some of the technologies.  In addition, every organization has its own set of acronyms and phrases that are foreign to newcomers, so communication in the early days was difficult.  Gradually, I started to learn the ropes and understood better what was going on.   I also met a steady stream of important contacts, supplied by Dr. Dixon who would help me do my job down the road.  I quickly discovered again just how nice and helpful the people of Nebraska are, and how similar the work in academia and industry really is.

As I met more of the faculty, I became involved with several startup efforts that were already underway, being rejuvenated or just beginning.  I love having conversations with budding entrepreneurs who have previously focused only on academic pursuits.  These are world-class researchers who want to learn and understand new areas.  Some of my favorite discussions over the last year were with researchers like Sam Sanderson, Dong Wang, Vinod Labhasetwar, Joe Vetro and Greg Gordon.  I’m amazed by their willingness to take a chance on commercializing their technologies and do everything possible to get viable products to the market.  With serious entrepreneurs like these folks (and many others), I think the future of biotechnology in Nebraska is bright.  To be successful, Nebraska needs to have some major success stories that will attract other entrepreneurs who have a path to follow.

In April of 2013, Vinod Labhasetwar and I founded a nanoparticle drug delivery company, ProTransit Nanotherapy, LLC.  We licensed the technology from UNeMed and will test our prototype product this summer at the Cleveland Clinic under a sponsored research agreement.   I’ve discovered, to my great delight, that there is a flourishing and expanding nanomedicine group at UNMC, so I’m trying to tap into their expertise anywhere that I can

So as it turns out, I successfully reached my primary goals as an EIR.  I’m pleased to report that I recently signed up for another year with UNeMed and continue to be committed to helping anyone I can who is interested in a biotech startup company in Nebraska. Even our grand-parenting goals were met when our grandson, Cole, was born last September right here in Omaha….

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UNMC dedicates new surgical simulation suite

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Facility is the most technologically advanced in the country

by Lisa Spellman, UNMC Communications

OMAHA, Neb. (June 28, 2013)—The University of Nebraska Medical Center today dedicated the Dr. Wayne and Eileen Ryan Surgical Simulation Suite.

Surgical simulation lab

The new surgical simulation lab at the University of Nebraska Medical Center is among the nation’s most technologically advanced.

Modeled after the simulation center at the Mayo Clinic, the surgical suite is the most technologically advanced in the country and will allow UNMC to become a regional training and testing site for medical students. Only one-third of all medical schools in the United States have a simulation center.

The suite was made possible by a $1 million gift from Wayne Ryan, Ph.D. and his late wife Eileen.

Dr. Ryan, the chairman, CEO and founder of Streck Labs is a former biochemistry and research associate professor of obstetrics and gynecology in the UNMC College of Medicine. He’s a longtime benefactor and friend of the UNMC College of Medicine and this project touched on his three passions of education, research and clinical care.

“What we have to stress is that surgery has become so incredibly complicated and so technologically dependent that it’s a little bit like trying to fly a 747,” said Dmitry Oleynikov, M.D., the Joseph and Richard Still Endowed Professor of Surgery at UNMC.

Wayne and Eileen Ryan

Wayne and Eileen Ryan

The new facility, located on the first floor of the Sorrell Center, simulates what happens in a modern operating room, he said.

“Along with the simulated operating room, this suite also features pre and post op care areas,” said Paul Paulman, M.D., assistant dean for clinical skills and quality in the UNMC College of Medicine.

And it is part of the clinical skills center, which is home to a variety of high fidelity task trainers and mannequins that allow learners to practice many invasive procedures prior to performing those procedures on humans, he said.

“We haven’t touched what we can do with it,” said Patti Carstens, program manager in the clinical skills center. “We tried to be as flexible as we can, because we know we’re probably never going to get a donation like this again. We built it for now and the future.”

Multimedia equipment allows for “virtual reality” scenarios in the middle of surgery. Monitors will show anything and everything. Teachers can run the session or interact with students from a control room perched behind one-way glass.

“Sometimes they don’t see the big picture and how it all interrelates until we videotape it and play it back and talk about it,” Carstens said.

Cameras and audio-visual retrieval systems allow students and teachers to go back and review training sessions. There will be mannequins – some costing up to $250,000 – which will “log” every touch and allow for training in endoscopic and laparoscopic surgery.

Through a partnership agreement, the facility also will be used by students and faculty at the Creighton University School of Medicine.

At Thursday’s dedication event UNMC faculty, staff and students demonstrated the suite’s high-tech capabilities, which include sound, video and state-of-the-art surgery-simulation mannequins.

Through world-class research and patient care, UNMC generates breakthroughs that make life better for people throughout Nebraska and beyond. Its education programs train more health professionals than any other institution in the state. Learn more at unmc.edu.

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UNMC, Japanese firm strike research deal

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by Charles Litton, UNeMed

OMAHA, Neb. (June 19, 2013)—Thanks to research at the University of Nebraska Medical Center, the world might finally learn a solution to the alarming rise of antibiotic resistant bacteria.

Dr. Gus Wang

Dr. Gus Wang

The Japan-based Taisho Pharmaceutical Company agreed to sponsor additional research by Dr. Guangshun Wang, a UNMC microbiologist who may hold the answer to a new way to fight infections. UNMC’s Sponsored Programs Administration and the UNMC technology transfer office, UNeMed Corporation, brokered the deal.

“We’re interested in partners that want to advance science and advance health care,” said Michael Dixon, president and CEO at UNeMed. “We’re very interested in developing partnerships on a global scale.”

Dr. Wang, an assistant professor at UNMC, is an expert in the design and evaluation of tiny proteins called peptides. He has developed a process to regularly review all reports and publications to find new sequences of peptides, and catalogs them in a massive database. The database’s importance is underscored by a mention in the May 2013 edition of Nature Biotechnology, a nationally recognized peer-reviewed research journal.

The database can be used to find or even create peptides that have the potential for use as new medications, said Dr. Steve Hinrichs, chairman of the Pathology and Microbiology Department at UNMC.

“Dr. Wang is a very special scientist,” Dr. Hinrichs said. “He has the rare ability to work in multiple areas including proteomics, information technology and microbiology.”

One well-known peptide, insulin, regulates blood sugar, and antimicrobial peptides are the immune system’s first line of defense against invading microorganisms such as viruses, bacteria, or even cancer.

Fighting bacterial infections today presents a growing problem inherent within traditional antibiotic medication: Bacteria eventually develop a resistance to the medicine, resulting in stronger and tougher “superbugs.”

Peptides are a distinct improvement over traditional antibacterial medications in at least one respect—Bacteria are far less likely to develop a resistance.

It’s a novel approach to fighting infections, and one that might answer several alarms raised in recent months.

Dr. Margaret Chan, director general at the World Health Organization, told a conference of infectious disease experts in Copenhagen last May that the rise of antibiotic resistant bacteria could mean “an end to modern medicine as we know it.”

To make matters worse, there are too few new products emerging to stem the tide of so-called “superbugs,” according the Infectious Disease Society of America, or IDSA.

“Simply put, the antibiotic pipeline is on life support and novel solutions are required to resuscitate it — now,” IDSA president Dr. David Relman told Reuters in an April 2013 statement.

Dr. Wang at UNMC may have found that novel solution, and Taisho wants to help reload the pipeline with the next generation of effective antibacterial treatments.

“The key interest, for us, is it’s unlikely to cause a drug resistance,” said Dr. Toru Seo, deputy general manager at Taisho. “I think that’s where we see the leverage point using peptides.”

The concept of using peptides as an antibacterial agent is nothing new. But the technology to make it a practical reality is a much more recent development. The potential for peptides in the battle against infections is a “provocative” idea, said Dr. Seo of Taisho.

“The development of peptide therapeutics is a challenging task,” Dr. Wang said. “But it is on the frontier.”

Using the database, Dr. Wang and his team can now engineer peptides custom-built to defeat specific superbugs such as MRSA or methicillin-resistant Staphylococcus aureus—a dangerous bacterial infection that is resistant to most antibiotics.

Wang and his database can take peptides even further, engineering compounds to fight viral and fungal infections. There are non-medical applications as well, such as an antimicrobial peptide called nisin that has already been used in 50 countries as a food preservative. Antimicrobial peptides could also be used to treat building materials to resist rot and mold.

“He’s done great work, and has good leads,” said Dixon at UNeMed. “But they need to be developed. That’s where the relationship comes in.”

Dr. Wang’s research is still in early stages. It may be years before his work can be developed into an effective drug, but the partnership with Taisho represents a critical new chapter that brings his work one step closer to helping patients.

“This kind of investment is worthwhile because it helps us move the research forward,” Dr. Wang said, “and helps advance our understanding of how peptides work.”

That additional research doesn’t often happen without support and funding from companies like Taisho.

“Anything feasible generated in academia can be handed up to us, and we can develop it into a reality,” said Dr. Seo. “That’s what we’re good at.”

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Glorified chaos amid Supreme Court’s Myriad decision

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by Agnes Lenagh, UNeMed | June 18, 2013

DNAGene patents have been the focus of attention on every media outlet since the Supreme Court unanimously ruled in Association for Molecular Pathology v. Myriad Genetics that genes isolated from DNA are not patentable subject matter.

However, there are other ways to protect discovery without claiming ownership of genes.

While the Supreme Court struck down key parts of Myriad’s patents, their invalidated claims are only a small subset of an extensive patent portfolio they own for the BRCA1/2 genes. Myriad still has patent protection for making and using gene-based inventions.

As a patent holder, Myriad had seemingly exercised its authority to prevent anyone from looking for mutations in the genes through standard clinical testing. The Association for Molecular Pathology—primarily healthcare professionals who regularly perform genetic testing—disagreed. They filed a petition in Sept. 2012 questioning whether human genes may be patented.

The Supreme Court ruled that isolated genes are ineligible for patents and invalidated Myriad’s claims.

Justice Clarence Thomas wrote in the Court’s opinion: “Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”

The ruling is clear: Genes are not eligible for patent protection because they are naturally occurring.

The opinion accepted that the company might be eligible to get a patent on the synthetic form of the genes. Complementary DNA, or cDNA, could be patented because it is a copy of DNA that omits non-coding portions and is artificially created in the lab.

But the opinion did not grant cDNA-specific entitlement to patent protection, which leaves this as a potential question for a future court.

Likewise, the decision does have other limits. There are no method claims and no “new application of knowledge.”

“We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material,” the opinion concluded.

Patents can still protect the key elements of making and using a gene-based invention, even if the genes themselves aren’t patentable.

Myriad’s president, Peter D. Meldrum, confirmed that the company still had “strong intellectual property protection” for gene testing.

On the same day the Supreme Court announced its decision, the U.S. Patent and Trademark Office issued a memorandum providing preliminary guidance on the decision.

Andrew Hirshfeld, the Deputy Commissioner for Patent Examination Policy, advised that: “Claims clearly limited to non-naturally-occurring nucleic acids, such as a cDNA or a nucleic acid in which the order of the naturally-occurring nucleotides has been altered (e.g., a man-made variant sequence), remain eligible.  Other claims, including method claims, that involve naturally occurring nucleic acids may give rise to eligibility issues and should be examined under the existing guidance in MPEP 2106, Patent Subject Matter Eligibility.”

For the patent community, the Supreme Court’s decision might not have affected researchers’ patents.

The decision reassures that patent claims still hold true if gene-based inventions focus on methods and application of knowledge rather than composition of matter.

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UNeMed lands tech deal with Chinese startup

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by Charlie Litton, UNeMed

OMAHA, Neb. (June 17, 2013)—Technology developed at the University of Nebraska Medical Center will provide the groundwork for a new Chinese biotechnology start-up company, Bohe Biotech.

UNeMed, China deal signed

UNeMed president and CEO Michael Dixon (left) and Bohe Biotech founder Wang Jiang sign a technology licensing agreement as UNeMed’s Qian Zhang looks on. (Photo by Matt Miller)

In a deal brokered by UNeMed Corporation, UNMC’s technology transfer office, Bohe Biotech founder Wang Jiang and UNeMed president Michael Dixon signed a licensing agreement recently during a small ceremony in Chengdu, China.

The agreement bridges research at UNMC to biotechnology production in China that could lead to additional research, funding and opportunities here and abroad, Jiang said in a translated email.

“This signing has not only marked a new stage of our collaboration,” Jiang said, “but also laid the foundation for us to build a higher level of innovation and development platform for technologies from UNeMed.”

Bohe Biotech will pursue commercial uses of a novel derivative of menthol, a common ingredient found in oral hygiene products. UNMC researcher Dr. Dong Wang’s new menthol derivative binds to the tooth’s surface, and then slowly releases the menthol flavoring over time.

The result is fresh breath that may last longer than the regular menthol. And a longer feeling of fresh breath could have a secondary impact as well.

“From the consumer prospective, it may help to improve people’s compliance to regular oral hygiene procedures and improve their oral health,” said Dr. Wang, an associate professor in UNMC’s Department of Pharmaceutical Science in the College of Pharmacy.

Dr. Dong Wang

Dr. Dong Wang.

Bohe Biotech will focus on producing the new menthol derivative as an additive that could be used by companies who produce any number of oral hygiene products, such as mouthwash, floss, chewing gum or toothpaste.

If successful in China, Bohe could expand the licensing agreement to North America and Europe and enter international markets.

“Sitting in the middle of the country, we need to reach out and not only sell our beef and beans and corn,” Dr. Wang said, “but also share the intelligence and talent we have. There’s a lot of potential here on UNMC campus.”

The deal could also lead to wider success for Dr. Wang, who filed a number of patent applications he has developed while at UNMC, said Qian Zhang, UNeMed’s international licensing associate who drove the deal.

“That’s that we hope for,” said Zhang. “Dr. Wang has a lot of good ideas.”

Bohe Biotech will first need to perform additional research and testing before gaining regulatory approval in China. The process could take about four or five years before Chinese consumers see a product on store shelves.

“On my deathbed,” Dr. Wang said, “if somebody tells me, ‘You just got something marketed and helped people,’ then I could say, ‘Amen,’ and close my eyes.”

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Nebraska joins Big Ten Cancer Research Consortium

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by Vicky Cerino, UNMC Communications

OMAHA, Neb. (June 14, 2013)—In athletics, the Big Ten universities compete against each other but now many will join together against a common foe — cancer.

Leaders from the universities’ cancer centers, including the University of Nebraska, kicked off the Big Ten Cancer Research Consortium recently in Chicago. They are uniting to transform cancer research through collaborative oncology trials that leverage the scientific and clinical expertise of the Big Ten universities.

“UNMC is proud to be a part of this consortium which is rich in both scientific research expertise and superior clinical care for patients,” said Ken Cowan, M.D., Ph.D., director of the Fred & Pamela Buffett Cancer Center at the University of Nebraska Medical Center in Omaha. “From development of new, improved diagnostic tools to detect cancer earlier, to more effective therapies for treating each patient’s specific tumor, the outcomes of this collaboration will be broad and sustainable, reaching patients not only in these Big Ten Cancer Centers, but nationwide.”

The clinical trials that will be developed will be linked to molecular diagnostics, enabling researchers to understand what drives the cancers to grow and what might be done to stop them from growing.

Also, the consortium forms a powerful collaboration because of the impact each university already has made in cancer research and the solid research infrastructure already in place at each university. The consortium also leverages geographical locations and existing relationships among the cancer centers.

“The consortium will allow our physicians more options for new treatments for all types of cancers available for patients in the region,” said Julie M. Vose, M.D., Neumann M. and Mildred E. Harris Professor and chief of the University of Nebraska Medical Center Division of Hematology/Oncology. “It also means that patients at the other cancer centers can participate in our clinical trials and our patients in other centers’ clinical trials without having to travel for specific types of newer therapies and treatments.”

The Big Ten Cancer Research Consortium creates a unique team-research culture in which cancer leaders will collaborate with and mentor the research leaders of tomorrow with the goal of improving the lives of all cancer patients. The consortium will provide junior faculty and fellows the opportunity to write, conduct and complete trials, which would not normally be done at a single institution or on a national level for young investigators.

The following universities and cancer centers comprise the Big Ten Cancer Research Consortium:

The Indianapolis-based Hoosier Oncology Group will serve as the administrative headquarters for the Big Ten Cancer Research Consortium. Since 1984, Hoosier Oncology Group has initiated more than 150 trials with more than 4,000 patients.

About the Big Ten

The Big Ten Conference is an association of world-class universities whose member institutions share a common mission of research, graduate, professional and undergraduate teaching and public service. Founded in 1896, the Big Ten has sustained a comprehensive set of shared practices and policies that enforce the priority of academics in student-athletes’ lives and emphasize the values of integrity, fairness and competitiveness. The broad-based athletic programs of the 12 Big Ten institutions sponsor more than 300 teams competing for championships in 25 official conference sports, 12 for men and 13 for women. Big Ten universities provide in excess of $136 million in athletic scholarship aid to more than 8,200 men and women student-athletes, the most of any conference. For more information, visit www.bigten.org.

Through world-class research and patient care, UNMC generates breakthroughs that make life better for people throughout Nebraska and beyond. Its education programs train more health professionals than any other institution in the state. Learn more at unmc.edu.

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UNeMed signs Adapt IP Ventures to broker patent deal

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by Charlie Litton, UNeMed Communications

OMAHA, Neb. (June 10, 2013)—UNeMed Corporation will expand its reach in developing and discovering new partners for technologies invented at the University of Nebraska Medical Center (UNMC).

UNeMed, the technology transfer office at UNMC, announced today a new collaboration with patent brokerage firm Adapt IP Ventures.

Adapt IP Ventures will help UNeMed license a patent invented in Nebraska that teaches methods for effectively growing high-yield protein cultures using nanoparticles. Prized in molecular research, high-yield protein cultures are critical for the research, development and manufacture of biological molecules. The technology is especially needed now for the development of next generation biological drugs and new regenerative therapies.

UNMC’s reputation made the patent particularly appealing, Adapt IP Ventures founder and CEO Grant Moss said.

“The university itself has a good reputation as an innovative group,” Moss said. “So there’s a name recognition there that is and was important in my decision to move forward.”

Moss said the technology should be particularly attractive to high-growth companies that perform groundbreaking research and analysis using proteins, such as PerkinElmer and Life Technologies, which is being acquired by Thermo Fisher.

“What we want to see is a company like Life Technologies/Thermo Fisher or PerkinElmer building new products,” Moss said, “and having the university share in the success of a product launch. That’s the goal.”

Moss said another driving force behind the patent’s potential success is that some laboratories might already be using the method or similar methods for high-yield protein cultures. That means companies can adopt the technology at minimum risk and cost, “rather than change or introduce a completely new or different technology,” Moss said.

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UNMC, Omaha VA to conduct 5-year, $2.1 million study to test diabetes treatment

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by Vicky Cerino, UNMC Communications

OMAHA, Neb. (June 6, 2013)—The University of Nebraska Medical Center and the Omaha VA Medical Center and 36 other sites will take part in a nationwide study to compare the long-term benefits and risks of four widely used diabetes drugs in combination with metformin. The project is called the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study.

The five-year, $2.1 million study funded by the National Institutes of Health aims to enroll about 5,000 patients nationwide diagnosed with type 2 diabetes within the last five years currently only taking metformin. During the study, participants will take metformin, along with a second medication randomly assigned from among four classes of medications, all approved for use with metformin by the U.S. Food and Drug Administration.

While short-term studies have shown the effectiveness of different drugs when used with metformin, there have been no long-term studies of which combination works best and has fewer side effects. When metformin is not enough to help manage type 2 diabetes, physicians may add one of several other drugs to lower glucose (blood sugar).

“We know the effectiveness of drugs in lowering the blood glucose levels in the short term, but we don’t know which combinations of medications work the best and how long the combinations work for,” said Cyrus Desouza, M.D., professor and chief of the UNMC Division of Diabetes, Endocrinology & Metabolism. Dr. Desouza also has an appointment at the Omaha VA Medical Center.

“We’ll also evaluate what works better for diverse populations such as in African Americans and Hispanics and how long the drug combinations remain effective in patients,” Dr. Desouza said. “I think the impact is going to be really important because we will be able to individualize therapy for our patients.”

The study will compare the effects of drug combinations on glucose levels, adverse effects, diabetes complications and quality of life over an average of nearly five years.

Three of the classes of medications increase insulin levels. They are: sulfonylurea, which increases insulin levels directly; DPP-4 inhibitor, which indirectly increases insulin levels by increasing the effect of a naturally occurring intestinal hormone; and GLP-1 agonist, which increases the amount of insulin released in response to nutrients. The fourth type of medication is a long-acting insulin.

Study participants will receive diabetes medications for glycemic control including blood glucose, glucose strips and glucose monitor supplies. Participants will make four clinic visits each year, including for laboratory tests for monitoring lipids, A1c and blood pressure. Patients will continue to receive health care through their primary care providers. The providers will receive quarterly reports from UNMC.

Dr. Desouza, who is principal investigator of the study, said he hopes the information will provide new drug treatment guidelines, as the current guidelines are very general. “This also will help primary care providers so that they can apply it in their practices,” he said.

The Centers for Disease Control and Prevention estimates that 7.1 percent of Nebraskans have been diagnosed with diabetes, primarily due to obesity. Implications of not receiving the most optimal drug can result in complications such as kidney failure, lower-limb amputations, and blindness.

Learn more about the study at https://grade.bsc.gwu.edu.

For more information contact Grace Rodriguez at mrodrigu@unmc.edu or 402 559-6244.

GRADE (ClinicalTrials.gov number: NCT01794143) is supported under NIH grant U01DK098246. Additional support in the form of donation of supplies comes from the National Diabetes Education Program, Sanofi-Aventis, Bristol-Myers Squibb, Novo Nordisk, Merck, BD Medical and Roche Diagnostics.
 
Through world-class research and patient care, UNMC generates breakthroughs that make life better for people throughout Nebraska and beyond. Its education programs train more health professionals than any other institution in the state. Learn more at unmc.edu.

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Antibiotic pipeline needs new ideas

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by Charles Litton, UNeMed | June 6, 2013

Scientists, physicians and major media have long been raising alarms about antibiotic-resistant strains of bacteria, but too few have drilled down deep enough.

Resistant bacteria are certainly bad enough, but it’s not our biggest problem.

What should really keep us awake at night is not the bacteria’s ability to adapt to our countermeasures, but our inability to match their pace.

Systemic Antibiotics approved by FDA, 1980-2012

Systemic Antibiotics approved by FDA, 1980-2012
Sources: Infectious Disease Society and Center Watch.

The way things are going, it won’t be long before our marvelous modern medicine may not look or feel so, well, modern.

The antibiotic pipeline is drying up, and there aren’t many pharmaceutical companies working on solutions to so-called “superbugs,” or even average not-so-super bugs for that matter. In the last 10 years, the FDA has approved just eight new antibiotics, or less than half of the 17 that were approved in the previous decade.

At this point it’s tempting to supply some cheeky assurance that it’s not as bad as all that. It would be a great place to work in a reference to “Theodoric of York: Medieval Barber.”

But Brad Spellberg, an infectious disease expert at UCLA, might find the reference more accurate than we’d like.

As he told the New York Times in 2010, “For these infections, we’re back to dancing around a bubbling cauldron while rubbing two chicken bones together.”

TB Ward

Simply put, if research and innovation doesn’t soon start matching pace with bacterial adaptation, then modern hospitals will have to start clearing space for a few retro-styled downgrades: Like a new tuberculosis ward, lined with long rows of beds filled with people waiting to die.

The biggest causes of death back in good old, pre-antibiotic days were infections like pneumonia and tuberculosis. A small cut on the finger while trimming the rose bushes could lead to a funeral. Good times, good times.

Today, we in the developed world worry more about cancer and heart disease partly because antibiotics allow us to live long enough for those diseases to become problems in the first place.  Without antibiotics, aggressive chemotherapy treatments would be nearly impossible. An appendectomy again becomes a procedure with grave risk. And you can forget about organ transplants and joint replacements.

Maybe “rubbing two chicken bones together” is going a bit overboard, but in a world without effective antibiotics, one of the best treatments could be a pungent yet strangely delicious poultice of mashed garlic and fresh honey.

So what’s the problem?

In a 2012 paper, Spellman outlined core causes for the shriveling antibiotic pipeline. Discovering new antibiotics is increasingly more difficult, expensive and time-consuming, which probably shouldn’t be a huge problem.

But antibiotics are different.

They are, in a word, amazing. They actually cure stuff. And by “stuff” we mean scary, kill-you-in-your-sleep stuff.

Take a relatively cheap, $100-bottle of pills for a week or two and a potentially deadly infection goes away.

Many other medications work differently. They manage chronic conditions that can cost tens of thousands, sometimes for the rest of a patient’s life. Think of diabetes or blood pressure medications.

Even when a new antibiotic hits the shelves, physicians are reluctant to use it without first prescribing older medications. New antibiotics become weapons of last resort in a sense, used only when nothing else works. There’s a practicality problem there.

Pharmaceutical firms look at investing more than $1 billion over a dozen years of a difficult and arcane regulatory process, only to watch their product placed in a locked case labeled “break glass in case of emergency.”

You can argue all you want about big pharma profit margins, and what they can or can’t afford to do. I don’t care who you are—$1.5 billion is big boy money, and 12 years is a long swallow on something that isn’t likely to turn a profit.

Volcano LairOne estimate in Forbes, factoring for the price of failure, says the true cost of bringing a new drug to market is more like $4 billion to $11 billion. That’s enough to buy not just an island, but an entire island chain. And there might be enough spare change left over to hollow out a dead volcano for a modest evil lair.

It’s not surprising then that just four of the world’s 12 biggest pharmaceutical companies still research new antibiotics, according to a 2012 story in The Washington Post.

And that might soon drop to three. AstraZeneca, which drops a gob-smacking $11.7 billion for each new drug developed, announced in March that they plan to reduce spending on anti-infectives.

Several ideas exist on how to replenish the pipeline. They range from changing the price structure of antibiotics to amending the regulatory process, which Congress has already addressed in some small measure with the GAIN Act.

It would be nice if those ideas offered some small portion of comfort, but what seems more likely is we need something different—Some new approach, found in some small, underfunded lab.

Not unlike Alexander Fleming and his unkempt London facility in 1928, someone will have to find a whole new way to fight infections.

Hopefully soon.

Fleming’s penicillin needed about 15 years of additional work to arrive at the bedside, and we don’t have the specter of a world war as added motivation.

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New sepsis treatment falls short in trials

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by Lisa Spellman, UNMC Communications

A University of Nebraska Medical Center researcher has determined that the investigational drug Eritoran used in a large clinical trial to treat a severe and often deadly infection known as sepsis did not reduce mortality. As a result of the study Eritoran will not be recommended for wider use and no further clinical trials are planned.

Eritoran would have been the first drug developed specifically to treat sepsis but, as a result of the study, it will not be recommended for use, said Andre Kalil, M.D., an associate professor of medicine at UNMC and principal investigator. The results of the study appeared in the March issue of The Journal of the American Medical Association.

Sepsis, which kills more than one million people a year in the United States, is brought on by any number of infections, such as pneumonia, urinary tract, abdominal or skin infections, and is usually treated by conventional antibiotics.

It is triggered by a component of bacteria called endotoxin that leads to the inflammatory response of the body’s immune system. In a five-year randomized trial at 200 hospitals worldwide, Dr. Kalil found that of the 1,961 patients treated with Eritoran only 72 percent survived.

Dr. Kalil and his collaborators were hoping for better results.

“Even with this powerful inhibitor we did not see improvement in survival,” Dr. Kalil said.

With conventional antibiotics the survival rate is 70 to 75 percent. The hope was that Eritoran would boost those numbers.

Eritoran was administered intravenously and works by grabbing onto the endotoxin that is a potent activator of the acute inflammatory response.

But that is just one pathway that triggers the sepsis, there are several others, Dr. Kalil said, and this might be why the drug was ineffective.

Another reason could be that the drug is not administered soon enough, he said.

“On average, once a patient was found to have developed sepsis, the drug was administered within nine hours of diagnosis, which was faster than previous studies,” he said.

Yet, that doesn’t account for the time lost before the patient presented at the hospital with the symptoms of infection that developed unknowingly throughout the body, Dr. Kalil said. Nor does it account for biological reasons why some people respond better to some drugs and others do not.

The study was conducted between 2006 and 2011 with support from Eisai Inc., the manufacturer of Eritoran. The drug company is not planning to pursue further studies, Dr. Kalil said.

Dr. Kalil is applying similar principles to another study looking at a different method for ridding the body of the bacteria that cause sepsis. Marius Florescu, M.D., an assistant professor in nephrology in the UNMC College of Medicine, is his co-investigator.

Using a device that acts like a filter, Drs. Kalil and Florescu hope to remove the endotoxin from the blood instead of just inhibiting it.

“As a clinician standing at the patient’s bedside, I am always wondering – what more can I do to help? It’s what keeps me going,” Dr. Kalil said.

Through world-class research and patient care, UNMC generates breakthroughs that make life better for people throughout Nebraska and beyond. Its education programs train more health professionals than any other institution in the state. Learn more at unmc.edu.

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Breast cancer patients might avoid chemo with new gene test

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New standard of care set

by Tom O’Connor, UNMC Communications

OMAHA, Neb. (May 30, 2013)—A new gene test for patients with breast cancer – called MammaPrint – could dramatically reduce the number of women who need to undergo chemotherapy to treat the disease.

The test is available at the University of Nebraska Medical Center and its hospital partner, The Nebraska Medical Center. It analyzes 70 key genes and accurately determines which patients are at low risk of breast cancer recurrence and could safely choose not to undergo chemotherapy.

The test has been validated in a peer-reviewed study called MicroarRAy PrognoSTics in Breast CancER (or RASTER), conducted in 16 community-based clinics in the Netherlands. The results were published online earlier this year in The International Journal of Cancer and will later appear in the journal’s print edition.

The five-year study involved 427 breast cancer patients who were given the MammaPrint test. The test determined 219 women to be low risk and 208 to be high risk.

Of the 219 low-risk patients, 85 percent chose not to have chemotherapy. Of those patients, 97 percent were disease-free after five years. Of the 208 high-risk patients, 81 percent chose chemotherapy and 91 percent were disease-free after five years.

Dr. Edney

Dr. Edney

“This is an important breakthrough for breast cancer patients,” said James Edney, M.D., UNMC professor of surgical oncology. “By incorporating MammaPrint results along with the traditional clinical parameters, such as tumor size, grade, patient age and lymph node status, we can significantly reduce the number of women who need chemotherapy. In doing so, they can avoid the side effects and toxicity of chemotherapy treatment, some of which can be permanent and debilitating.”

Long-term side effects of chemotherapy could include damage to the heart, kidneys, lungs, nerves or reproductive organs. There is also the chance of developing a second cancer as a result of chemotherapy, Dr. Edney said.

Dr. Edney has used the test on approximately 160 patients, and it has been met with an extremely positive response, he said.

Unlike other breast cancer genomic tests that are limited to patients with certain disease characteristics, such as certain receptor and lymph node status, Dr. Edney said MammaPrint can be administered to virtually all early-stage breast cancer patients. It requires a breast cancer assay performed on either fresh or fixed tumor tissue.

MammaPrint results benefit the physician, he said, by clearly categorizing all patients as high or low risk and eliminating the uncertainty of indeterminate scores reported by other genomic test methods.

The RASTER study is considered unique, Dr. Edney said, because it is the first and only study to prospectively evaluate the performance of a genomic breast cancer test by using outcome data. In this case, the patient cohort was followed for five years.

The study showed that MammaPrint identified 30 percent more patients as low risk than the traditional clinical parameters often used in the U.S. to determine risk of recurrence. The test has been cleared by the U.S. Food and Drug Administration.

MammaPrint was developed by Agendia, a molecular diagnostic company headquartered in Amsterdam, the Netherlands with a genomics laboratory in Irvine, Calif.

Through world-class research and patient care, UNMC generates breakthroughs that make life better for people throughout Nebraska and beyond. Its education programs train more health professionals than any other institution in the state. Learn more at unmc.edu.

With a reputation for excellence, innovation and extraordinary patient care, The Nebraska Medical Center is ranked by U.S. News and World Report as one of America’s Top Hospitals in cancer, neurology/neurosurgery, orthopaedics, gastroenterology and nephrology. It has earned J.D. Power and Associates’ Hospital of Distinction award for inpatient services for six consecutive years and has also achieved Magnet recognition status for nursing excellence.  As the teaching hospital for the University of Nebraska Medical Center, this 627 licensed bed academic medical center has an international reputation for providing solid organ and bone marrow transplantation and is well known nationally and regionally for its oncology, neurology and cardiology programs.  The Nebraska Medical Center can be found online at www.nebraskamed.com.

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