Archive for October, 2013

UNMC study to test ‘breakthrough’ drug in mantle cell lymphoma patients

by Vicky Cerino 

voseJulie Vose, M.D. 

The University of Nebraska Medical Center is involved in testing a drug the Food and Drug Administration has fast-tracked towards approval because of its dramatic results in patients with mantle cell lymphoma and other cancers.

“This experimental drug, Ibruitinib, is so promising that the FDA gave it fast track designation which rarely happens,” said Julie M. Vose, M.D., chief of the division of hematology and oncology and Neumann M. and Mildred E. Harris Professor at UNMC.

“Patients who’ve been on the treatment have had remarkable results with limited side effects. We are able to offer this to patients through an expanded access program which occurs about six months before the FDA approves it.”

The new study is targeted for patients age 18 and older with mantle cell lymphoma who’ve relapsed – meaning other treatments have failed. The study, which aims to enroll as many patients as possible, is being conducted in about 50 locations across the United States and in Puerto Rico. Those eligible for the study will be provided the drug at no cost.

The FDA designated Ibruitinib as a breakthrough therapy. The designation is intended to expedite the development and review of drugs for serious or life-threatening conditions that demonstrate the drug may have substantial improvement over available therapy. The study will remain open until the medication is FDA approved, which should be by the end of the year, Dr. Vose said.

Dr. Vose, who is principal investigator of the UNMC study, said Ibruitinib works differently than other drugs for this type of cancer. The drug, developed by Pharmacyclics, Inc and Johnson & Johnson’s Janssen Pharmaceutical division, basically poisons one of the pathways that helps the cancer grow.

“It kills the lymphoma,” she said. “It has fairly limited side effects. It’s a pill rather than an intravenous delivery, and it also has potential to be used with other treatments due to the limited side effects.”

Steven “Robert” Whisnant of Morganton, N.C., and his wife, Quteen, came from North Carolina for the trial after his physicians told him there was nothing else they could do. Whisnant has had a dramatic response to the medication as have many other patients, Dr. Vose said.

“I’m thankful that there’s somebody out there trying to find different things to help people because if I hadn’t have gotten the medication, I’d have died,” Whisnant said. “So far it seems to be working. All the tumors in my neck are gone and the ones in my stomach have shrunken. It gives us hope and I’m thankful for that.”

Mantle cell lymphoma is a rare, B-cell non-Hodgkin lymphoma that most often affects men over the age of 60. The disease may be fast or slow growing. It comprises about five percent of all non-Hodgkin lymphomas.

Dr. Vose said results thus far have seen a 75 percent response rate in patients with mantle cell lymphoma whose disease has failed all other treatments.

“We have been involved in several of the first clinical trials with this particular medication,” Dr. Vose said. “We don’t think it’s a cure but it’s been found to be able to keep patients in remission longer to control their symptoms and allow them to have a good quality of life. These patients have very limited other options. This is a breakthrough and works very quickly.”

Clinical trials began on Ibruitinib a few years ago. It also is being tested at other sites for other types of lymphoma, leukemia and multiple myeloma.

Other co-investigators in the study are UNMC physicians Jim Armitage, M.D., Phil Bierman, M.D., and Greg Bociek, M.D.

For more information about the study, contact Maribeth at 402 559-9053 or mahohens@unmc.edu. For a complete list of other study locations go to clinicaltrials.gov and search “NCT01833039.” The study is funded by the drug company.

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.


New laser a cutting edge treatment for retinal diseases

by Bill Citro, UNMC Physicians

eyeQuan Dong Nguyen, M.D., left, and Diana Do, M.D. 

A new laser is helping experts at the Truhlsen Eye Institute provide better treatment for eye diseases. This advanced laser can prevent blindness for some patients with serious conditions.

“This new laser with yellow light is currently the only one of its caliber in the U.S., and there’s only one other being used in the world right now,” said Quan Dong Nguyen, M.D., the McGaw Memorial Endowed Chair in Ophthalmology and the director of the Truhlsen Eye Institute.

On July 22, the first patient received treatment from the laser for proliferative diabetic retinopathy, the most severe stage of eye disease caused by diabetes.
“Overall, it is more effective, efficient and may be safer than traditional lasers.”
Diana Do, M.D.

“This laser is the most cutting-edge laser device available today,” said Diana Do, M.D., associate professor of ophthalmology and director of the Carl Camras Center for Innovative Clinical Research at the Truhlsen Eye Institute.

Dr. Do was the retina specialist who performed the first treatment.

“It allows us to apply a large number of laser spots in a variety of patterns. Overall, it is more effective, efficient and may be safer than traditional lasers,” she said.

Traditional lasers are limited in the number of patterns and pulsing they can accommodate, whereas the new laser allows for more nuanced and problem-specific targeting, Dr. Do said.

The laser provides treatment for various rare eye diseases, including retinal vein occlusion, neovascular glaucoma, and retinal tears. In addition, with micropulse application capability, it also can be combined with other therapies to treat diabetic macular edema, the most common cause of moderate vision loss for diabetes patients.

“With diabetes rates on the rise nationally and in Nebraska, more and more patients will be able to benefit from the superior treatment that new technology like this can bring,” Dr. Do said.

The full name of the laser is the Supra Scan Multi-spot Laser. It is manufactured by Quantel Medical, which is headquartered in Paris, France.

The Truhlsen Eye Institute, which opened in June 2013 at 3902 Leavenworth St., is the newest building on UNMC’s campus, and offers state-of-the-art eye care in many eye subspecialties as well as routine prescription and optical shop services.

To make an appointment at the Truhlsen Eye Institute, please call 402-559-2020.


Trial explores new treatment for ‘silent killer’

by Kalani Simpson, UNMC public relations

Timothy Baxter, M.D.-

When diagnosed with an abdominal aortic aneurysm, all most people can do is worry, watch and wait. Timothy Baxter, M.D., professor of surgery, has compared it to being forced to live with the ticking of a time bomb.

It can take years before an aneurysm is recommended for repair — when it finally grows large enough (about 5.5 cm) that the risk of rupture outweighs the risk of surgery.

“This approach is very unsettling to patients,” Dr. Baxter said.

“Some people, every day they wake up worrying about it,” agreed Jason MacTaggart, M.D., assistant professor, surgery.

Most would rather do something, anything. Now, at least a few of them can.
UNMC is the clinical coordinating center for a $12.2 million multi-center randomized placebo-controlled clinical trial of medical management of aneurysm disease. The management would be via a pill, which some scientists believe will significantly slow aneurysm growth. The study is being conducted under the auspices of a National Institutes of Health grant.

“It’s considered a silent killer because there are no symptoms until it ruptures.”Timothy Baxter, M.D.


The Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (NTA3CT) aims to enroll 250 patients with the collaboration of 15 top academic medical centers across the U.S.

Fifty percent of the trial’s enrollees will receive the antibiotic doxycycline, an inexpensive generic now widely used for acne and other conditions. Dr. Baxter’s preliminary research in animal models shows the drug inhibits the enzymes which weaken aortic walls, thus causing aneurysms.

If successful, it’s an inexpensive, noninvasive, proactive approach.

Dr. MacTaggart said the surgery to repair aneurysms can come with a mortality rate of up to 3 percent — and a cost that can run from $20,000 to $100,000. More than 40,000 such procedures are done each year nationwide.

“Multiply all of that together,” Dr. MacTaggart said. “If you can change a $100,000 operation to $10 a year for some pills, it’s going to save the health care system a ton of money.”

But the study will show more than whether the pill works. It should also garner a host of invaluable information.

Aortic aneurysms affect 3 percent to 5 percent of the population, but are most common in men age 65 and older, often smokers with a family history.

“It’s considered a silent killer,” Dr. Baxter said, “because there are no symptoms until it ruptures. Most aneurysms we find by luck when imaging is done for other medical conditions.”

And then, there is only worrying and waiting as it grows. Nothing you can do.

Until now.


UNMC among world’s top 75 universities in clinical medicine/pharmacy

by Tom O’Connor, UNMC public relations

campus (2)UNMC is ranked among the top 75 universities in the world in clinical medicine and pharmacy according to rankings released this month by a leading Chinese university that has been ranking universities worldwide since 2003.

“The rankings validate that UNMC is well on its way to becoming a world-class institution,” said UNMC Chancellor Harold M. Maurer, M.D. “This has always been our goal, so it is reassuring to know that our presence worldwide is growing.”

The Academic Ranking of World Universities (ARWU) is published by the Center for World-Class Universities, Graduate School of Education of Shanghai Jiao Tong University in China.

“As the teaching hospital for UNMC, we’ve always known what a high-quality institution we’re partnering with,” said Glenn A. Fosdick, president and CEO of The Nebraska Medical Center. “We take pride in that partnership and look forward to continuing our cooperative relationship in the future.”

“To be ranked this highly in clinical medicine and pharmacy is very significant, as these are two of the areas that are most impactful on the health and well-being of the public.”

Courtney Fletcher, Pharm.D.
Dean, UNMC College of Pharmacy

UNMC is ranked with 25 other universities as No. 51-75 by ARWU. Only 31 U.S. universities are rated higher. Some of the other U.S. universities rated at the same No. 51-75 level are the University of Arizona, University of Florida, University of Iowa, University of Illinois at Chicago, University of Rochester, and Washington University in St. Louis.

UNMC’s ranking is higher than several notable universities, including Case Western Reserve University (76-100), University of Cincinnati (76-100), New York University (76-100), University of Miami (76-100), and The Ohio State University (101-150).

“Obviously, we are in very good company,” said Brad Britigan, M.D., dean of the UNMC College of Medicine. “It speaks volumes for the quality work being done by our faculty and staff.”

Courtney Fletcher, Pharm.D., dean of the UNMC College of Pharmacy, said: “To be ranked this highly in clinical medicine and pharmacy is very significant, as these are two of the areas that are most impactful on the health and well-being of the public.”

ARWU uses six objective indicators to rank world universities. These include:

  • the number of alumni and staff winning Nobel Prizes and Fields Medals.
  • the number of highly cited researchers selected by Thomson Scientific.
  • the number of articles published in Nature and Science, two leading scientific journals.
  • the number of articles indexed in Science Citation Index – Expanded and Social Sciences Citation Index.
  • percentage of articles published in the top 20 percent of journals in a specific field.
  • per capita performance with respect to the size of an institution.

UNMC nanotechnology protects skin from cancer, early wrinkles

by Charlie Litton, 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) 

Nanotechnology developed at UNMC could turn things such as sunscreen and anti-aging cosmetics into even more potent barriers protecting the skin from UV radiation that can cause wrinkles and skin cancer.

A new startup company, ProTransit Nanotherapies, 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., a former faculty member 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.

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