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Center Awards Pilot Studies in Clinical, Translational Research

  1. Top of page
  2. Center Awards Pilot Studies in Clinical, Translational Research
  3. European Group Hopes to Move Translational Research from Lab to Clinic
  4. New Drug Offers Hope for Patients with Advanced Melanoma
  5. Interactive Programs Address Barriers to Clinical Trial Enrollment

A half-dozen pilot study award winners in clinical and translational research were recognized at the University of Buffalo's Clinical and Translational Research Center's (CTRC) second annual Clinical and Translational Research Colloquium in Buffalo, New York last April. Among the winning studies was an effort to improve vaccine efficacy in ovarian cancer and research in the use of photodynamic therapy to treat bacterial infections.

“These kinds of pilot studies are becoming increasingly important to make faculty competitive for larger National Institutes of Health and foundation awards because the funding climate is so challenging,” says Timothy Murphy, MD, director of the CTRC. The CTRC through its collaborating members–including the Buffalo Translational Consortium–provided a total of $200,000 in 2012 to fund six one-year awards. “This is a stellar example of collaboration and cooperation among institutions that ends up being an advantage to everyone.”

The 2012 funded studies were:

  • Diagnosing graft skin lesions. Researchers developed a multifunctional optical imaging probe for diagnosing skin lesions that occur in graft versus host disease, a common and potentially serious disorder in patients who have had bone marrow and stem cell transplants. The study was designed to determine if this method works better than a physical exam.
  • Screening biomarkers for autoimmune skin disease. Investigators created a proteomics microarray method to screen and identify the triggers of autoimmune response in people with pemphigus vulgaris, an autoimmune disease of the skin. The next step will to be screen large numbers of people to look for patterns, understand mechanisms, and identify biomarkers for the disease.
  • Identifying breast cancer patients at greater risk for heart damage. In an effort to predict which breast cancer patients are more likely to develop heart problems–a complication from a common chemotherapy known as doxorubicin (Adriamycin)–researchers found that patients with a particular genetic marker (about 40% of the population) are far more susceptible to heart damage than those who lack the marker–specifically, the carbonyl reductase 3 genotype.
  • Using photodynamic therapy to treat bacterial infections. Investigators are exploring the use of this novel antibiotic therapy to treat bacterial infections caused by biofilms, which are bacteria encased in a thick material that resist traditional antibiotics. Photodynamic therapy is also used to treat certain cancers, but in this case, researchers are applying it to ear infections.
  • Enhancing vaccine efficacy in ovarian cancer. Scientists are working to better understand how tumors resist the human immune system by investigating the tumor microenvironment. Their goal is to discover new ways to overcome suppression of the immune system and therefore improve cancer vaccines.
  • Using tissue-engineered blood-vessel grafts. Researchers are using tissue engineering to create vascular grafts that surgeons can use to bypass blocked blood vessels. This approach presents a potential alternative to current methods of harvesting veins from other sites in the body.
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Dr. Timothy Murphy, director of the University of Buffalo's Clinical and Translational Research Center, which awarded $200,000 to pilot study researchers last year.

European Group Hopes to Move Translational Research from Lab to Clinic

  1. Top of page
  2. Center Awards Pilot Studies in Clinical, Translational Research
  3. European Group Hopes to Move Translational Research from Lab to Clinic
  4. New Drug Offers Hope for Patients with Advanced Melanoma
  5. Interactive Programs Address Barriers to Clinical Trial Enrollment

A new consortium, known as the European Advanced Translational Research Infrastructure in Medicine (EATRIS), aims to move biomedical innovations to the clinic more quickly and efficiently.

EATRIS was officially launched last June at the organization's Translational Medicine conference in Amsterdam, where EATRIS is headquartered. The conference will occur annually as “a platform for debate between all stakeholders in drug development,” says Deborah Alfarez, PhD, the consortium's head of communications and funding.

The consortium has enlisted 60 academic institutions and biomedical translational research centers to provide access to their resources in five core areas: biomarkers, small molecules, imaging and tracing, advanced therapy medicinal products and biologics, and vaccines. EATRIS is governed by member states that want to create a sustainable infrastructure for translational research.

“Bridging the translational gaps between basic and clinical research requires greater intensity and coordination of efforts,” notes Dr. Alfarez.

“The European member states feel that a multi-national and multidisciplinary approach is essential and will enable Europe to compete in the knowledge base with the United States, China, and India.”

For a list of EATRIS' current members and partners, see www.eatris.eu/services/sitepages/partnermap.aspx.

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EATRIS scientific director Giovanni Migliaccio oversees the 60-member consortium designed to encourage multinational collaboration on drug development.

New Drug Offers Hope for Patients with Advanced Melanoma

  1. Top of page
  2. Center Awards Pilot Studies in Clinical, Translational Research
  3. European Group Hopes to Move Translational Research from Lab to Clinic
  4. New Drug Offers Hope for Patients with Advanced Melanoma
  5. Interactive Programs Address Barriers to Clinical Trial Enrollment

In preliminary tests, the new drug lambrolizumab (Anti-PD-1), shows promise in treating patients with advanced melanoma, according to a recent study in the New England Journal of Medicine.

“Until two to three years ago, we didn't have any good drugs for patients with melanoma,” says Bartosz Chmielowski, MD, PhD, assistant clinical professor at UCLA's Jonsson Comprehensive Cancer Center in Los Angeles and co-author of the study.

According to Dr. Chmielowski, the types of treatment for melanoma can be divided into three groups: traditional chemotherapy, targeted therapy, and immunotherapy. The first has neither a frequent nor a durable response; the second has a frequent, but not long response; and the third has a less frequent, but longer response rate, he notes. This study of lambrolizumab–a new immunotherapy–indicates that the drug offers both a frequent and durable response.

The results are from the first clinical trial of the drug, which examined 135 advanced melanoma patients with different treatment regimens. Across all dose cohorts, the confirmed response rate was 38%, according to the study. Some 25% of patients on the lowest dose saw improvement, compared with 52% who saw improvement at the highest dose. Researchers reported that 81% of patients who were followed for 11 months had improvement and continued to remain on the drug without signs of disease progression at the time of analysis last March.

Although the study is not a randomized trial, Dr. Chmielowski calls the results “extremely encouraging.” Side effects of the drug included fatigue, rash, loss of skin color, and muscle weakness, though 13% of patients had more severe side effects, such as inflammation of the lung or kidney, or thyroid problems.

Researchers say lambrolizumab shows the highest rate of durable response of any drug tested so far in melanoma. The drug is an antibody that blocks a protein called PD-1, which enables cancer cells to hide from the immune system's T cells and avoid attack. By blocking PD-1, lambrolizumab activates the body's immune system to attack the cancer and then enables it to remember that melanoma is the enemy. Researchers also are testing the drug in patients with other cancers, including lung cancer.

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Preliminary tests of the drug lambrolizumab in patients with advanced melanoma have shown both frequent and durable response rates.

Interactive Programs Address Barriers to Clinical Trial Enrollment

  1. Top of page
  2. Center Awards Pilot Studies in Clinical, Translational Research
  3. European Group Hopes to Move Translational Research from Lab to Clinic
  4. New Drug Offers Hope for Patients with Advanced Melanoma
  5. Interactive Programs Address Barriers to Clinical Trial Enrollment

Researchers have developed two new technologies they hope will help streamline the process of enrolling patients in cancer clinical trials.

“The problem I've been trying to address for more than a decade is that although clinical trials are required for breakthroughs in cancer therapy, very few patients participate in clinical research,” says Neal Meropol, MD, chief of the division of hematology at University Hospitals Case Medical Center of Cleveland who led studies evaluating the technologies.

The first is a tailored, interactive, Web-based intervention program to help patients address and overcome their barriers to clinical trial participation. Known as PRE-ACT–Preparatory Education About Clinical Trials–the intervention surveys patients about their knowledge of clinical trials and asks which issues they are most concerned about, such as whether they might be assigned to a placebo. Based on their answers, patients watch specially tailored videos that address their concerns before meeting with a physician.

After a year in development, researchers conducted a randomized clinical trial of 1,255 patients to determine if PRE-ACT improved their knowledge of clinical trials, reduced attitude barriers to enrollment, and helped them feel more prepared for their appointment. By contrast, patients in a control group received online, text-based information that was not tailored to their individual concerns. Researchers found that patients who underwent PRE-ACT had better awareness and attitudes about barriers and were more satisfied with the information provided to them than the control group, but felt equally prepared to consider enrolling in clinical trials as the controls.

The second intervention, called Trial Prospector, aims to overcome physicians' barriers to clinical trials–namely, time. Instead of manually entering patients' health information into a database to match trials to specific patients, physicians can match patients to trials through this automated system based on data extracted from patients' electronic medical records. If patients are not eligible for a trial, the program notes why and enables physicians to add additional data to narrow their search. In a pilot study, the matching algorithm for Trial Prospector was 100% effective and saved physicians time in identifying potential clinical trials.

“At this point, it's a proof of principal that this can be done,” says Dr. Meropol. “We are trying to add disease sites to it and improve the interface to make it more functional and ready for potential dissemination.”

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New online programs provide answers to patients considering enrollment in cancer clinical trials and help doctors more easily match patients with studies.