News

UofL pulmonologists treat first local patient in COPD clinical trial

Targeted lung denervation may offer new option for COPD patients

Physicians from the University of Louisville are the first in Kentucky to perform an investigational procedure designed to help patients with chronic obstructive pulmonary disease, or COPD. The procedure, known as targeted lung denervation (TLD), may provide an additional treatment option for patients suffering from frequent COPD flare-ups, or lung attacks.

COPD causes restricted airflow from the lungs, resulting in breathing difficulty, cough, mucus production and wheezing. TLD involves the removal of tissue in the lungs that may be making symptoms worse. Performed via bronchoscopy, the procedure is designed to disrupt pulmonary nerve reflexes, which may have the potential to reduce COPD exacerbations.

AIRFLOW-3, a phase 3 clinical trial sponsored by Nuvaira, is enrolling patients with moderate-to-severe COPD, high symptom burden and a history of COPD exacerbations, including increased coughing, wheezing and breathing distress, to evaluate the safety and effectiveness of TLD. 

Umair A. Gauhar, M.D., associate professor at the UofL School of Medicine, led a medical team in the Division of Pulmonology that successfully treated a COPD patient with TLD therapy in one-hour-long outpatient procedure at UofL Health – UofL Hospital. The patient returned home the same day. 

“Many of our COPD patients experience exacerbations which cannot be controlled with their inhaler medications,” Gauhar said.  “As a pulmonary community, we need to embrace the development of interventional therapies which may stabilize COPD patients and help reduce their risk of exacerbation. Based on the existing evidence, we are enthusiastic about the potential of TLD to meet a true unmet medical need and are proud to have treated our first patient in the AIRFLOW-3 clinical trial.”

Debbie Sowers, a 58-year-old resident of Madison, Ind., said she participated in the trial at UofL to help develop better treatments for COPD.

“I participated to help everybody that has COPD and to try to better my breathing,” Sowers said. “There need to be more studies on COPD because it is a really bad disease. It stops your life.”

UofL is the only center in Kentucky enrolling COPD patients for AIRFLOW-3 and is one of up to 25 centers across the United States enrolling patients in the trial.

Nuvaira is headquartered in Minneapolis, Minn. The company’s proprietary Nuvaira® Lung Denervation System addresses airway hyper-responsiveness, a pathophysiologic underpinning of both COPD and asthma, with TLD therapy. The Nuvaira Lung Denervation System is an investigational device in the United States and has CE mark approval in the European Economic Area (EEA). Nuvaira has completed and published four clinical studies, including AIRFLOW-2, a randomized, sham-controlled, double-blind, multicenter clinical trial.

UofL medical students encourage youth affected by violence to become future healers

UofL medical students encourage youth affected by violence to become future healers

Christopher 2X with UofL medical students Jenci Hawthorne, Karen Udoh and Briana Coleman at the presentation of the Kelsie Small Future Healer Award on Feb. 23.

High rates of violence have plagued Louisville in recent years, escalating sharply in 2020. Students in the UofL School of Medicine are working to combat patterns of violence with action.

Students in the UofL Student National Medical Association (SNMA) are working with Christopher 2X Game Changers and UofL faculty in creating the Future Healers Program to help Louisville youth affected by violence in their neighborhoods navigate the trauma of violence and inspire them to build a better future for themselves and their communities.

Karen Udoh, UofL SNMA president and a second-year medical student, spearheaded the White Coats for Black Lives rally on the Health Sciences Center Campus in June 2020. But she and fellow SNMA members wanted to do more than only demonstrate to fight violence in the community.

“It’s not enough for us to be here in our white coats saying that we care and then go back to our offices and not do anything about it,” Udoh said. “That’s how we came to work with the UofL Department of Surgery, the Trauma Institute and the Christopher 2X Game Changers to create the Future Healers Program. We want to show these youth that we care about the environment they are in, we want to invest in them and change these issues.”

Udoh, Briana Coleman, Jenci Hawthorne and Satya Alluri worked with Department of Surgery faculty members Keith Miller, M.D., and Christopher Jones, M.D., to develop educational sessions to teach preschool and middle school students about general anatomy and surgery. The Future Healers Program is aimed to inspire youth in the neighborhoods most affected by violence to pursue lives of healing as health care professionals.

“We felt like this is our realm – medicine – so let’s inspire people. It’s a simple way we can at least show our youth, this is something you can aspire to be. You have a choice, you have options,” Udoh said.

In mid-February, the SNMA team conducted a pilot session of the Future Healers Program with approximately 50 preschool and middle school children at the Chestnut Street YMCA. The students conducted 45-minute interactive, virtual sessions that included pre-recorded videos with the faculty members, a mindfulness activity and hands-on activities for the kids. A “doctor’s bag” with masks, gloves and modelling clay for creating their own anatomy models was provided to each of the children.

“Seeing the children shape clay into stomachs and small intestines was such a joy. Together we crafted a space for intellectual curiosity and trust,” Hawthorne said. “Our goal is to create a trusting relationship with the youth that we hope can become our future healers. We want them to know that we see them and that we are here for them. We want them to see us as allies who love them and who care about them.”

With additional support from medical student, staff or trainee volunteers, sponsors, School of Medicine faculty members and Christopher 2X Game Changers, the UofL students plan to conduct future regularly scheduled sessions with the youth and to expand the program to more young people in the community.

“At the School of Medicine, we have a goal to create and train physicians who are culturally aware, culturally responsive and social-justice minded. We not only want to train the best doctors, but doctors who are willing to roll up their sleeves and get out into the community,” said Dwayne Compton, Ed.D., associate dean for community engagement and diversity in the School of Medicine and a faculty adviser for SNMA. “These students have created a program that will have a profound impact in our community.”

Earlier this week, Udoh and the SNMA joined Christopher 2X, UofL Health and the UofL Hospital Trauma Institute to present the first Kelsie Small Future Healer Award. The award honors the life of Kelsie Small, a nursing student at Northern Kentucky University who was shot and killed in Louisville in May 2020. Christopher 2X Game Changers will present the award annually to honor a skilled, compassionate health care worker. The first Future Healer Award was presented to Small’s mother, Delisa Love.

To support the SNMA Future Healers Program as a volunteer or through sponsorship, contact or faculty liaison .

UofL healers and researchers honored as health care heroes

UofL healers and researchers honored as health care heroes

V. Faye Jones, M.D., Ph.D., M.S.P.H.

Louisville Business First has named six medical professionals affiliated with the University of Louisville as 2021 Health Care Heroes, including a lifetime achievement award for V. Faye Jones, M.D., Ph.D., M.S.P.H.

A UofL School of Medicine alumna, Jones leads UofL’s diversity initiatives as senior associate vice president for diversity and equity. She also is associate vice president for health affairs/diversity initiatives, professor of pediatrics and vice chair, Department of Pediatrics-Inclusive Excellence.

In addition to the lifetime achievement award for Jones, the publication recognized the following faculty members and UofL Health providers as Health Care Heroes.

Front-line Hero:
Ruth Carrico, Ph.D., professor in the UofL Division of Infectious Diseases and a family nurse practitioner, UofL Health

Health Entrepreneur:
Suzanne Ildstad, M.D., professor, UofL Department of Surgery, director, UofL Institute for Cellular Therapeutics, founder and chief scientific officer, Talaris Therapeutics Inc., and Distinguished Professor of Transplantation Research at UofL Health - Jewish Hospital.

Innovator:
Paula Bates, Ph.D., professor of medicine at UofL School of Medicine, and Kenneth Palmer, Ph.D., professor of pharmacology and toxicology and Helmsley Charitable Trust Endowed Chair in Plant-based Pharmaceutical Research at UofL as well as director of the UofL Center for Predictive Medicine for Biodefense and Emerging Infectious Diseases and UofL’s Regional Biocontainment Laboratory.

Provider:
Valerie Briones-Pryor, M.D., medical director for the hospitalist team, UofL Health — Jewish Hospital and UofL Health — Mary & Elizabeth Hospital

Gary Weinstein, M.D., clinical associate professor for the UofL Department of Psychiatry and Behavioral Sciences, owner of Gary Weinstein MD and founder/volunteer of the Louisville Free Mental Health Clinic. Weinstein practices at Louisville VA Medical Center.

The 2021 Health Care Heroes will be profiled in the April 9 edition of Louisville Business First and recognized during a virtual event Thursday, April 8, from 11:30 a.m. to 12:30 p.m. The event also will include a panel discussion with the CEOs of Louisville's three largest health systems: Tom Miller of UofL Health, Gerard Colman of Baptist Health and Russell Cox of Norton Healthcare. Register to attend here.

Medical Schools See an Increase in Applications During the Pandemic

Medical schools across the country are reporting surges in applications. The COVID-19 pandemic has made an impact during the 2021-2022 cycle.

Prospective students are looking to join medical students like Lisa Anakwenze. Anakwenze is a first year medical student at the University of Louisville (UofL) School of Medicine. She thinks the heroism of frontline healthcare workers during the pandemic might’ve inspired more people to apply.

“Applying to medical schools is an insanely tough process, but I think that a lot of people are motivated about what was going on in the pandemic,” said Anakwenze.

Since UofL's School of Medicine is a state school, about 75% of the class is from Kentucky. Dr. Stephen Wheeler, the Associate Dean of Admissions at UofL School of Medicine, said that the school has seen a 35% increase in out-of-state applications during the past five years.

“Science has brought to the forefront in terms of helping people the past year the pandemic and that’s part of it,” Wheeler said.

Experts believe that students have more time for applications since college classes have shifted online. Many schools extended deadlines and fewer applications are taking a gap year because of limited opportunities. The interview process is cheaper due to travel restrictions — all of these factors on top of the work of frontline healthcare workers helped contribute to the trend.

“I had personal stories related to health that inspired me for a lot of students, potentially seeing the impacts of COVID[-19] in their community may have inspired them to apply as well,” said Anakwenze.

Wheeler said that usually 40% of people that take the MCAT apply to medical schools to at least get into one of the schools to which they applied. UofL’s out of state applications compete for very few spots. Out of about 4,500 applications, the school only selects 42.

“We are very selective about who we interview from out of state,” Wheeler said. “Most of the ones we interview from out of state have some connection to Kentucky."

Anakwenze’s advice for students who didn’t get into a school is to not be discouraged.

“You have to be able to continue pushing yourself and have that drive and know where you belong and what you want out of life as well as the positive impact you want to make on other people,” she said.

UofL Health and Kindred Healthcare announce plans for inpatient rehabilitation hospital

Joint venture will build and operate 40-bed hospital in Louisville, Kentucky

UofL Health and Kindred Healthcare LLC have announced a joint venture to build and operate an inpatient rehabilitation hospital in Louisville, Kentucky.

This new 40-bed inpatient rehabilitation hospital will be located at 5000 Chamberlain Lane, near the intersection of I-71 and I-265 in the northeast area of Jefferson County, and will serve the growing East End of Jefferson County and adjacent counties. The approximately 55,000-square-foot, two-story rehabilitation facility will have all private rooms and focus on acute rehabilitation for patients who suffer from stroke, traumatic brain injury, spinal cord injury, complex neurological disorders, orthopedic conditions, multiple trauma, amputation and other injuries or disorders. Large multidisciplinary therapy gymnasiums will be outfitted with the latest therapeutic technologies, including augmented reality balance training, therapy bionics and a full body exoskeleton. The hospital will also include a therapeutic courtyard with exterior amenities.

UofL Health – Frazier Rehab Institute is recognized nationally as an innovator in rehab care. For more than six decades, patients from across the world have sought out Frazier Rehab for life-enhancing treatments and therapies. The new facility is expected to help manage the growing needs of the region and will free up access to the array of specialty programs at its downtown location with one common goal – helping people of all ages with disabilities reach their fullest potential in physical and cognitive functioning.

“This new inpatient rehabilitation hospital will combine Kindred’s national expertise in rehab excellence with Frazier Rehab’s first-in-class care and leading innovation,” said Tom Miller, CEO of UofL Health. “The new hospital will increase access to our rehab services, addressing unmet needs in our growing community.”

“We are proud to partner with UofL Health to offer the Louisville community increased access to high-quality inpatient rehabilitation services,” said Jason Zachariah, Kindred’s president and chief operating officer. “Frazier Rehab has an impressive legacy, with more than 60 years in rehab care, and we are excited to work alongside them to improve patients’ lives. This new hospital will be dedicated to passionately advocating for and providing hope, healing and recovery to patients in its care.”

The partners expect the hospital to open by the fourth quarter of calendar year 2022, subject to several regulatory and other approvals.

UofL tapped for Lilly monoclonal antibody trial in long-term care facilities

Phase 3 clinical trial evaluating bamlanivimab for prevention of COVID-19 in response to increased exposure risk
UofL tapped for Lilly monoclonal antibody trial in long-term care facilities

Release and stability testing of clinical trial materials. Photo: Eli Lilly and Company

Researchers from the University of Louisville are working with Eli Lilly and Company in a clinical trial to determine whether its monoclonal antibody treatment, bamlanivimab, can reduce the risk of transmission of COVID-19 in long-term care facilities.

The Phase 3 trial enrolls residents and staff who live or work at facilities that have had a recently diagnosed case of COVID-19 and who now are at a high risk of exposure. The study, which included Essex Nursing and Rehabilitation Center in Louisville recently, is to evaluate the efficacy and safety of bamlanivimab for the prevention of COVID-19. The study also is exploring treatment of recently diagnosed SARS-CoV-2- and COVID-positive patients who are at high-risk of developing severe disease.

As the only Kentucky location for the Phase 3 clinical trial, UofL’s Division of Infectious Diseases worked with mobile units deployed by Lilly to the Louisville site to enroll and treat trial participants. Julio Ramirez, M.D., director of the division, leads the work, which includes follow-up monitoring for study participants at this facility and any others in Kentucky who may participate in the trial.

“We are thrilled to be partnering with NIH and Lilly for the implementation of their BLAZE-2 study in Kentucky. With nearly 30,000 residents in long-term care facilities in the state, there is an urgent need for therapeutic strategies to prevent the spread of COVID-19 in this vulnerable population. We are proud to be a part of this new type of clinical study for preventive treatment,” Ramirez said.

For this trial, Lilly deploys mobile research units to a long-term care site soon after an individual has tested positive for SARS-CoV-2. The unit team enrolls residents and staff members who volunteer to participate in the trial. The one-time study drug infusion and follow-up visits are administered to study volunteers at the long-term care facility. The UofL team works with the Lilly team during the initial site infusions and will monitor participants following the infusion for up to 25 weeks.

The first deployment in Kentucky was to Essex Nursing and Rehabilitation Center, where 20 residents and staff members were enrolled in the study in November.

“Our elderly population is at a much higher risk of complications from COVID-19 and our staff and residents are happy to be participating in this study. I have personally witnessed the negative impact COVID-19 has had on nursing facilities,” said Robert Flatt, R.N., B.S.N., Essex administrator. “I am extremely proud to be an active participant in this collaborative study in the hopes that we will soon put an end to this pandemic.”

The virus is known to spread rapidly among staff and residents of long-term care facilities, who account for a high percentage of hospitalizations and deaths resulting from the virus.

“I am glad to be a part of this research study with the University of Louisville to help find treatment and prevention options for COVID-19. As a member of our community, I am happy to participate in the hopes of helping others. I am also excited to participate as I am a huge fan of the University of Louisville,” said Patricia L. Rollie, an Essex resident and study participant.

Antibodies are produced naturally by the immune system in response to viruses and other foreign invaders and help the body neutralize and destroy these threats. However, it takes time for the body to produce its own antibodies. Bamlanivimab is an antibody engineered from a COVID-19 survivor. Testing and previous trials have shown that manufactured antibodies can speed recovery or possibly prevent SARS-CoV-2 infection.

“COVID-19 has had a devastating impact on nursing home residents. We’re working as fast as we can to create medicines that might stop the spread of COVID-19 to these vulnerable individuals,” said Daniel Skovronsky, M.D., Ph.D., Eli Lilly’s chief scientific officer and president of Lilly Research Laboratories. ”BLAZE-2 is a first-of-its-kind COVID-19 trial designed to address the challenging aspects of running a clinical trial in long-term care facilities, which normally do not conduct clinical trials.

As a result of a separate clinical trial, Lilly has received an emergency use authorization from the FDA for bamlanivimab to treat higher-risk patients recently diagnosed with mild-to-moderate COVID-19.

Bamlanivimab targets the spike protein of the SARS-CoV-2 virus. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus and potentially preventing and treating COVID-19. Bamlanivimab emerged from the collaboration between Lilly and AbCellera and was discovered by AbCellera and scientists at the National Institute of Allergy and Infectious Diseases Vaccine Research Center. 

 

 

Feb. 8, 2021

UofL med students aim to reduce health disparities, engage others in community project series

UofL med students aim to reduce health disparities, engage others in community project series

GROW502

Amid the turmoil of 2020, Onu Udoh, a second-year student in the University of Louisville School of Medicine, decided it was time to take action to reduce the health disparities that plague underserved communities across Louisville.

So he founded GROW502: A Health Disparities Series to highlight these disparities and begin to make changes. Two other medical students and an undergraduate student from UofL joined him to lead the project, which will include anyone from across the university and the community to who would like to participate in the project’s education, engagement and advocacy events.

First-year medical students Lisa Anakwenze and Zoha Mian, along with Chidum Okeke, a senior UofL undergraduate student and Udoh outlined a multimodal approach to transforming  the 2017 Louisville Health Equity Report into a living representation of the current state of health in Louisville. Through art, new media and virtual workshops, the group will educate community members, students, staff, faculty and health care professionals about health disparities revealed in the report, while simultaneously empowering them to enact change. 

Beginning the week of Feb 8, students across the university are invited to join project leaders and community members in weekly activities focused on education, community engagement, advocacy and edutainment focused on ways to reduce health inequity.

Education panels will be led by Udoh and medical interest groups in ob/gyn, pediatrics, nutrition, neurology and psychiatry.

Anakwenze is leading community engagement by working with community partners such as Feed the West - Change Today, Change tomorrow, Family Health Centers, Louisville Lead Prevention Program, the Kentucky State Health Department and Healthy Babies to provide direct avenues to make a change within the Louisville Metro area.

Mian will lead weekly advocacy workshops to bring local policymakers together with students to advocate for a brighter tomorrow.

Okeke’s team will work to package and market the project, using the power of creative media to present unique perspectives on health disparities in Louisville. With edutainment ranging from infographics to videos to cartoons, the marketing team will create an engaging virtual environment to increase community awareness of the disparities that exist, with the goal of reducing their effects. 

“Overall, the mission of this project is to plant seeds of information and inspiration in our local community that will lead to a long-term reduction in Louisville’s health disparities,” Udoh said. “Our role is to support the sustainable growth of our community as we GROW a better tomorrow.”

Students, professionals and community members are encouraged to participate in the events by signing up through EventBrite. The activities, both live and virtual, and a schedule of events will be published on the group’s website www.grow502.org

UofL School of Medicine creates marketing and communications position

UofL School of Medicine creates marketing and communications position

Tonya Augustine

The UofL School of Medicine has named Tonya Augustine as its first director of strategic marketing and communications.

In this new position, Augustine will develop, manage and execute a strategic plan for the School of Medicine with the goal of raising its visibility on local, state and national levels, sustaining philanthropic support and recruiting students, faculty, residents and staff. She will serve as communications liaison between the School of Medicine and the UofL Office of Communications and Marketing, UofL Health and other university and community organizations.

“Tonya’s work will be invaluable in elevating the visibility of the School of Medicine. I am very excited to welcome her to our administrative staff,” said Toni Ganzel, M.D., M.B.A., dean of the School of Medicine.

Prior to assuming this role, Augustine was a communications specialist in the Division of Infectious Diseases within the school, where she marketed education and research programs and served as managing editor for two medical journals. Previously, she served as senior director of development for Active Minds Inc., a mental health nonprofit based in Washington, dedicated to providing self-help resources for young adults. A Kentucky native, Augustine earned a bachelor of business administration from the University of Kentucky.

Augustine began her new role Feb. 1.

 

 

Feb. 1, 2021

Long-time UofL faculty member joins School of Medicine to lead anti-racism initiatives

Long-time UofL faculty member joins School of Medicine to lead anti-racism initiatives

John Chenault

John Chenault will join UofL School of Medicine Undergraduate Medical Education (UME) as associate professor-director of anti-racism initiatives on Feb. 1.

In this new position, Chenault will support anti-racism in medical student education and lead the development, implementation and evaluation of initiatives guided by the School of Medicine UME Anti-Racism Task Force. He also will provide instruction to faculty and medical students related to undoing race-based medicine, including the incorrect use of race as biological construct, and will coach faculty in developing and updating teaching and exam materials.

A long-time UofL faculty member, Chenault has served as a medical librarian in the Kornhauser Health Sciences Library for 16 years and in the Pan African Studies Department of the College of Arts & Sciences for 14 years. Chenault brings a wealth of knowledge and expertise to this new position, having developed and taught undergraduate courses on “Race, Color and Consciousness,” “American Diversity” and “Slavery and the Slave Trade” in addition to publishing and presenting on the topics of institutional and scientific racism in various venues. 

In recent years, his research has focused on the history of medicine and slavery in the United States, including medical experimentation, medical apartheid, health disparities and the role of medical practitioners and biomedical researchers in the invention of race. Chenault has lectured on this research at national and international medical education conferences and taught continuing education classes for physicians and medical school faculty.

Chenault’s accomplishments include outreach efforts to diverse constituencies in Louisville and across the state. In October 2020, he accepted a second three-year appointment by the governor to represent the State of Kentucky’s Tourism, Arts and Heritage Cabinet on the state board of the Kentucky Center for African American Heritage.

Chenault has been an active volunteer on UofL’s Commission on Diversity and Racial Equality and the University Libraries Diversity Committee and he has supported the work of the Health Sciences Center Office of Diversity & Inclusion by conducting workshops, writing articles and assisting with media and promotional efforts. He currently serves on the university’s Cardinal Anti-Racism Task Force and the School of Medicine Anti-Racism Task Force.

Chenault’s outreach activities and support of UofL initiatives also includes international service in the nations of Ghana and Senegal in West Africa, where he trained medical professionals, librarians and health sciences students, and in Panama, where he instructed undergraduate students on the history of U.S. diversity. In addition to his academic career, Chenault’s creative work in the performing arts as a musician, composer, playwright and producer spans five decades and includes commissions from the John F. Kennedy Center for the Performing Arts, the American Composer’s Forum, the International Society of Bassists and several prominent U.S. orchestras. His compositions have been performed in the U.S., Canada, United Kingdom, France, Germany and Japan.

 

 

Jan. 25, 2021

 

Living near trees may prevent vascular damage from pollution

Researchers at the University of Louisville have shown that living near an abundance of green vegetation can offset the negative effects of air pollution on blood vessel health.
Living near trees may prevent vascular damage from pollution

Living near an abundance of trees such as this one on the University of Louisville campus were shown to offset the negative effects of air pollution on blood vessel health in a recent UofL study

Researchers at the University of Louisville have shown that living near an abundance of green vegetation can offset the negative effects of air pollution on blood vessel health.

The research, led by Aruni Bhatnagar, Ph.D., professor of medicine and director of the UofL Christina Lee Brown Envirome Institute, was published ahead of print in theAmerican Journal of Physiology-Heart and Circulatory Physiology.

Previous studies have shown that proximity to green space — trees and other vegetation — can lower blood pressure levels and the risk of heart disease. A number of environmental factors may come into play, including increased opportunity for outdoor exercise, reduced mental stress and socioeconomic status. However, the relationship between vascular (blood vessel) health, green space and air pollution has not been fully explored.

In this new study, researchers looked at the arterial stiffness of adult volunteers with co-occurring conditions such as obesity, high blood pressure, diabetes and high cholesterol, that put the volunteers in the moderate-to-severe risk category for heart disease.

“Although we have known for a long time that exposure to air pollution has adverse effects on our blood vessels, this study shows that those who live in greener neighborhoods may be less affected,” Bhatnagar said. “Therefore, one way of preventing the harmful health effects of air pollution may be to make neighborhoods more green.”

Using study participants’ residential addresses and data from the U.S. Geological Survey and local Environmental Protection Agency monitoring stations, the research team analyzed environmental factors where the volunteers lived, including:

  • Vegetation index, including the amount of and variation in greenness levels within 200-meter and one-kilometer (0.62 miles) radii around each volunteer’s home.
  • Particulate matter, tiny toxic particles invisible to the naked eye, in the air.
  • Levels of ozone, a colorless, toxic gas and significant air pollutant.

At times when the particulate matter and ozone levels were high, participants had higher levels of arterial stiffness, however, those who lived in areas with more flora had better blood vessel function. Trees and other greenery offset vascular dysfunction that air pollution causes, the researchers explained.

In previous work, the researchers found that individuals who live in areas with a large amount of greenness show lower exposure to volatile chemicals and have greater household income. In the current study, they explored the relationships between greenery, air pollution and arterial stiffness and found a similar correlation between the U.S. Geological Survey’s normalized difference vegetation index and average household income. Even when adjusting for self-reported lifestyle habits such as exercise and smoking — 70% of the volunteers were nonsmokers — the researchers found that “the effects of green spaces on hemodynamic function are largely independent of median household income, physical activity levels and tobacco use.”

“These findings indicate that living in green areas may be conducive for vascular health and that the [favorable] effects of greenness may be attributable, in part, to attenuated exposure to air pollutants such as [particulate matter] and ozone,” said Daniel Riggs, UofL biostatistician and the study’s first author.

This research was conducted in conjunction with the Green Heart Project, a first-of-its-kind study of the effects of plants on human health, led by researchers at the UofL Envirome Institute.

 

Jan. 22, 2021

Beer with a Scientist features “Magic and microbes … and some COVID operations”

Virtual event via Facebook Live Jan. 20
Beer with a Scientist features “Magic and microbes … and some COVID operations”

James Collins, PhD

When the microbes in our gut are changed, it can affect our health and susceptibility to disease. At the next Beer with a Scientist, two University of Louisville researchers will help us understand how altered microbiota can influence immunity based on their research into the relationship of Clostridium difficile to the gut and human immune system. They also will discuss recent work on the gut and immunity related to COVID-19.

Bruce Yacyshyn, M.D., professor of medicine in the UofL Division of Gastroenterology, Hepatology and Nutrition, and James Collins, Ph.D., assistant professor in the UofL Department of Microbiology and Immunology, will share some of their findings on the role of gut immunity, or how the gastrointestinal tract responds to its environment, including microbes and other environmental challenges. They will explain the role of altered gut immunity in gut-centered disease such as inflammatory bowel disease, C. difficile and infectious diarrhea, as well as its potential role in diseases not centered in the gut, such as COVID-19, obesity and cardiovascular disease.

“Our gut microbiota plays a role in our daily lives in both positive and negative ways,” Collins said. “The microbiota can be shaped and adapted to the food we eat. In the case of C. difficile, a common hospital-associated, disease-causing bacteria, introducing a novel sugar to the diet may have aided the emergence and spread of two now-common – and severe disease-causing – groups of C. difficile.”

Collins and Yacyshyn also will discuss their current study of how a common medication available for more than 100 years, bismuth subsalicylate, may be effective against COVID-19.

The event will air via Facebook Live from Holsopple Brewing beginning at 6:45 p.m. on Wednesday, Jan. 20. As in the in-person versions of Beer with a Scientist, the 30-minute presentation will be followed by an informal Q&A session using Facebook comments.

To participate in the event, visit the Louisville Underground Science Facebook page Wednesday at 6:45 p.m.:  https://www.facebook.com/LouisvilleUndergroundScience/

The presentation also will be aired live on the Holsopple Brewing Facebook page:  https://www.facebook.com/holsopplebrewing/

Organizers encourage Beer with a Scientist guests to drink responsibly, even if they are participating from home.

UofL cancer researcher Levi Beverly, Ph.D., created the Beer with a Scientist program in 2014 as a way to bring science to the public in an informal setting. At these events, the public is invited to enjoy exactly what the title promises:  beer and science.

Medical students and faculty helping with city’s COVID-19 vaccination effort

Medical students and faculty helping with city’s COVID-19 vaccination effort

Members of UofL COVID-19 vaccination team

Medical, nursing and public health students and faculty have joined to assist in mass vaccinations against COVID-19 at the on-going Broadbent Arena drive-thru event on the grounds of the Kentucky Fair and Exposition Center.

Some UofL faculty have served on the Mayor’s task force for the Louisville Metro Department of Public Health and Wellness project. Other faculty and students are helping with check-in and screenings, administering vaccines, assisting with volunteer supervision and training, and observing individuals post-vaccine toensure they have no adverse reactions.

“I’m helping because I have a commitment to service,” said Master’s Entry into Professional Nursing student Matt Livers. “I believe we have an opportunity to turn the tide on this pandemic and I would much rather be doing something than waiting for something to happen.”

Livers says this experience will help him gain extra experience in giving vaccines, along with serving as a resource for those who have questions about the COVID-19 vaccine. Educating the public, he says, is key to community acceptance and willingness to become vaccinated.

This isn’t the first time nursing and other health professions students and faculty have provided the manpower for a drive-thru vaccination clinic in Louisville. In 2009, thousands of doses of the H1N1 “swine” flu vaccine were administered by UofL faculty and students at Cardinal Stadium.

Health professions students and faculty will help staff the COVID-19 vaccination drive-thru event through February, or as long as the city’s health department continues the effort. ­­­The health department’s mass vaccination site is open weekdays from 8 a.m. to 6 p.m., and is offering the Moderna vaccine by appointment only. It is first focused on the Tier 1a group, as mandated by the federal government. Frequently asked questions and answers about the mass vaccination site can be found here.

UofL’s medical students expand smart glasses virtual shadowing program

UofL’s medical students expand smart glasses virtual shadowing program

Lekha Devara and Briana Coleman, second-year medical students, wearing smart glasses

Second-year medical students Lekha Devara and Briana Coleman are working to expand a smart glasses virtual shadowing program in the School of Medicine. In this Q & A they talk about how it began, what they learned and hopes for expansion of the program.

How did you get involved with shadowing via smart glasses?

Lekha: Dr. Jeff Baker of the Emergency Department at the University of Louisville Hospital offered virtual shadowing sessions for students back in May when the quarantine period first started. We participated in one of those sessions and were amazed by how realistic the shadowing experience was, and at times we were able to see procedures and interactions between doctors and patients that are easy to miss when shadowing in person. Briana and I were talking about our individual experiences with virtual shadowing and brainstormed the possibility of making smart glasses use more accessible to students and faculty. With the uncertainty of COVID-19 and how medical education would be changed, we wanted to explore if smart glasses could be a potential innovative solution to bridging the gap between pre-clinical students and actual healthcare, since we have primarily used a virtual curriculum. With the help of various faculty members and support from the University, we were able to get funding to purchase three new pairs of glasses and work to develop a user-friendly protocol that could be widely distributed.

What facility were you in virtually?

Lekha: Our virtual shadowing experience was with the Emergency Department at the University of Louisville Hospital, but our program is available to any medical specialty that is interested in using them. We recently opened up the glasses program to all students and faculty and we hope to see more virtual shadowing sessions scheduled in the spring semester!

Who worked with you to launch the expansion?

Lekha: We worked with Dr. Jeff Baker, who served as our clinical expert, Tony Simms and Kent Gardner, who helped us integrate the program at the medical school, the ULH legal team, and Julia Onnembo, who helped us get the funding for the glasses.

Were you able to interact with the patients?

Lekha: Since the prototypical sessions were in the ED, it was difficult to directly interact with patients due to the fast-pace and conditions of the patients. However, we were able to see and hear everything the glasses-wearer was seeing, saying, and doing. It was an up-close view of how natural doctor-patient interactions work.

What was the experience like and what did you learn?

Briana: The amount of patient interactions that I was able to see during my two-hour virtual shadowing session was comparable to the number I would have seen in the ER in an eight-hour shadowing session. Dr. Baker and the ED residents have become very streamlined with the process and are able to provide students with a multitude of cases, ranging from the extremely emergent cases that one may encounter only a few time in their practice, to an array of everyday ER patients that medical students must be prepared to interact with in their daily lives as clinical students. It’s truly a great way for pre-clinical students to immerse themselves in a specialty they may be interested in.

COVID-19 has changed everything, including how education is delivered. Would you have been able to learn these particular clinical aspects had it not been for this experience?

Lekha: I don’t think we would have been as keen to develop the smart glasses program or be as inclined to participate in the initial sessions had it not been for COVID-19. The switch to virtual schooling and lack of in-person clinical experiences were driving factors in seeking other ways to enhance our medical education. Moreover, the experience of shadowing through the glasses allows students to get a first-person perspective of a practicing physician which is a priceless experience.

Do you know if other medical schools have offered this unique opportunity?

Lekha: We haven’t seen any other medical schools develop a smart glasses program like ours. This has given us the unique opportunity to apply this technology to a field that is unfamiliar to it. We’ve had the opportunity to navigate issues that have arisen along the way, and worked with professionals in various fields that we likely would not have interacted with on any other project we may be involved in.

How will smart glasses change the medical field?

Briana: The utility of smart glasses in medicine is only dependent on the imagination of those using the glasses. From bringing specialist services to rural areas, to educating hundreds of learners on an intricate procedure in real time, the possibilities of smart glasses use in medicine are endless. As medical professionals, we constantly take in updated information on how to best provide for our patients, but oftentimes, the limit of us applying that information is a geographical barrier or a communications issue. These problems are easily solved through the use of smart glasses. This technology is capable of helping us provide the best care to an even greater number of patients, a goal in which we can all be proud.

Why did you choose the medical profession?

Briana: I always loved science classes, but from a young age I knew I wanted to have a career that allowed me to challenge myself each day to think critically through different problems. Though it’s a cliché saying, there is an art to medicine. The volumes of information that we must learn in our many years of training must be applied in unique ways to each patient’s specific circumstance. That’s what I found to be the most interesting about medicine, and that’s what keeps me encouraged to try my hardest each day to train for my dream job.

Lekha: Much like Briana, the challenge of medicine is what initially drew me to the profession. Medicine is ever-changing and unique, allowing it to be just as beautiful as it is difficult. Another big reason for me was people. I find comfort in knowing that I may be able to help make someone’s life better. These are my driving forces to succeed in this career path.

Anything else you’d like to share?

Lekha: We spent a lot of time dedicated to this project because we truly believe smart glasses could open a plethora of doors in medical education. Even beyond the age of COVID-19, smart glasses have the ability to offer a new insight in medicine and be an avenue for students to view a physician in action from a first-person perspective. We hope that as the word gets around, more and more people will be inclined to give smart glasses a chance to see how they can progress their medical practice and education. We would like to thank everyone that has helped us make our idea a reality.

Read the UofL News story about the program expansion.

 

Dec. 17, 2021

UofL innovator known for drug discovery inducted into National Academy of Inventors

Trent is the seventh from UofL to achieve the recognition
UofL innovator known for drug discovery inducted into National Academy of Inventors

John Trent, Ph.D.

John Trent, Ph.D., a University of Louisville researcher and innovator known for harnessing the power of thousands of computers to discover drugs that could fight everything from cancer to coronavirus, has been named a Fellow of the National Academy of Inventors (NAI).

Fellows are selected for their “spirit of innovation” in university research, helping to generate ground-breaking inventions that have a tangible impact on quality of life, economic development and the welfare of society.

Trent is the only 2020 fellow from the state of Kentucky and the seventh from UofL. The 2020 Fellow class of 175 inventors represents 115 research universities and governmental and non-profit research institutes worldwide.

"It’s certainly an honor and I think it’s a testament to the drug discovery program we’ve built at the Brown Cancer Center and UofL through many collaborations and partnerships,” said Trent, a professor of medicine and the Wendell Cherry Endowed Chair in Cancer Translational Research. “The benefits of UofL are the support we’ve had for taking creative activities through intellectual property protection to the commercialization grant programs.”

As deputy director of basic and translational research at the UofL Health - Brown Cancer Center, Trent’s Molecular Modeling Facility uses computer predictions to understand and virtually test how drug and disease molecules might interact before real-world testing in the lab.

Trent also runs the UofL partnership with Dataseam, a company that created a grid that uses the processing power of thousands of computers in schools across Kentucky that Trent uses to screen potential drugs and compounds against cancer targets and, most recently, SARS-CoV-2 and COVID-19. The DataseamGrid has the capability to screen millions of potential compounds against molecular targets in only a few days.

Trent holds more than 50 patents, 24 of which are U.S., and numerous licenses and option agreements with potential commercial partners. Among other accolades, he received the Apple Science Innovator Award and the 2019 EPIC Innovator Career Impact Award, the latter awarded through the UofL Commercialization EPI-Center.

“We’re very proud of John, and all his work to create innovations that have the power to advance our health,” said Kevin Gardner, Ph.D., UofL’s executive vice president for research and innovation. “The fact that John and other UofL researchers before him have received this honor, the highest for academic inventors, shows our university’s commitment and leadership in research, invention and developing technologies that change and improve the way we work and live.”

Previous Fellows from UofL include Suzanne Ildstad and Kevin Walsh (2014), William Pierce (2015), Paula Bates (2016), Robert S. Keynton (2017) and Ayman El Baz (2019).

Trent’s induction, paired with Bates’ four years earlier, also makes the two of them one of only a handful of married couples to be named fellows. The duo also frequently works together, including developing the aptamer that would become the basis for innovative technologies since applied to fight cancer and novel coronavirus.

The 2020 NAI Fellow class collectively holds more than 4,700 issued U.S. patents.

Among the class are 24 recipients of National Academies of Sciences, Engineering, and Medicine honors, six recipients of American Academy of Arts & Sciences honors and two Nobel Laureates, as well as other honors and distinctions. The complete list of 2020 NAI Fellows is available here.

 

Dec. 14, 2020

UofL to develop and test nasal spray to prevent COVID-19

U.S. Department of Defense provides $8.5 million for formulation and Phase I clinical trial using UofL-developed Q-Griffithsin compound
UofL to develop and test nasal spray to prevent COVID-19

Nasal spray

The University of Louisville has received funding from the U.S. Department of Defense (DoD) to develop a nasal spray to prevent serious viral respiratory infections such as COVID-19 using Q-Griffithsin, a drug compound developed and co-owned by UofL.

The one-year project, funded through an $8.5 million agreement from the DoD, includes developing the spray, testing the formulation in lab studies and conducting a Phase I clinical trial. The researchers expect the spray to be used to protect frontline health care workers, military personnel living in close quarters and other essential workers, as well as vulnerable people for whom a vaccine might not be fully protective.

Kenneth E. Palmer, Ph.D., director of the UofL Center for Predictive Medicine for Biodefense and Emerging Infectious Diseases and the Helmsley Charitable Trust Endowed Chair in Plant-based Pharmaceutical Research at UofL, is leading the project, known as PREVENT-CoV.

“The idea is to deliver the antiviral agent to the location in the body where the virus is known to replicate first, the upper respiratory tract,” Palmer said.

Q-Griffithsin (Q-GRFT), an analog of the biologic griffithsin, discovered at the Center for Cancer Research, NCI and co-owned by UofL, the University of Pittsburgh and the National Cancer Institute, is a potent anti-viral protein that acts against multiple coronaviruses, including MERS, SARS-CoV and SARS-CoV-2, as well as pandemic threat viruses such as Nipah virus. An application using Q-GRFT to prevent HIV infection already is in Phase I clinical trial.

“The relatively short timeframe for this project is possible due to the fact that we have a supply of Q-GRFT on hand and that it already has undergone testing related to the HIV preventative,” said Joshua Fuqua, Ph.D., in the UofL Department of Pharmacology and Toxicology who will manage the program.

The UofL researchers will develop and manufacture the nasal spray, to be used once a day to prevent SARS-CoV-2 infection, in collaboration with Lisa Rohan, Ph.D., and Sharon Hillier, Ph.D., at the University of Pittsburgh and Magee-Womens Research Institute, Barry O’Keefe, Ph.D., at the National Cancer Institute and Donald Lo, Ph.D., and colleagues at the NIH National Center for Advancing Translational Sciences. The team first will formulate the compound for use as a nasal spray, then will test the newly developed spray in the lab using human samples and tissues and in animal models.

Following the preclinical testing of the spray, the UofL Clinical Trials Unit will conduct a Phase I clinical trial, directed by Gerald Dryden, M.D., Ph.D., professor of medicine in the Division of Gastroenterology, Hepatology and Nutrition, and Kevin Potts, M.D., associate professor in the Department of Otolaryngology and Head and Neck Surgery and Communicative Disorders, to test the newly developed spray in healthy volunteers in a controlled, randomized study to evaluate its safety, ease of use, drug activity and tolerability.

“We are pleased to work with the University of Louisville and hopeful about the prospect of developing Q-Griffithsin to combat COVID-19,” said Douglas Bryce, the DoD’s joint program executive officer for chemical, biological, radiological and nuclear defense. “Repurposing a medical countermeasure that is already in development as a stopgap to potentially provide pre-exposure prophylaxis is a critical component of an effective layered defense. Pursuing innovative solutions with our partners supports both our service members and the American public as we continue our fight against this and other diseases."

With positive results, the researchers would seek U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for deployment of the formulation, a step that the researchers anticipate could happen as soon as the end of 2021.

“This is a great example of how UofL researchers pivoted rapidly to address this deadly pandemic and speaks volumes about why research matters to society,” said Kevin Gardner, Ph.D., executive vice president of research and innovation at UofL. “Our state-of-the-art research infrastructure at the Center for Predictive Medicine allowed rapid efficacy testing for this and many other prospective anti-viral therapies that have real potential to prevent COVID-19 infection, reduce its transmission and treat its effects.”

 

Dec. 9, 2020

UofL researcher uses fruit for less toxic drug delivery

Suite of technologies now has commercial partner to bring them to market
UofL researcher uses fruit for less toxic drug delivery

Huang-Ge Zhang, Ph.D.

University of Louisville researchers have found a less toxic way to deliver medicines by using the natural lipids in plants, particularly grapefruit and ginger.

The resulting intellectual property portfolio consisting of 12 patent families, invented by Huang-Ge Zhang, Ph.D., of UofL’s James Graham Brown Cancer Center and Department of Microbiology and Immunology, has been licensed to Boston-based Senda BioSciences, a Flagship Pioneering company. UofL’s technology is part of Senda’s efforts to develop novel drug delivery platforms to solve the challenges of transferring therapeutics across biological barriers and throughout the body.

The UofL technologies use exosomes, which are very small fragments of living, edible plant cells, to transport various therapeutic agents, including anti-cancer drugs, DNA/RNA and proteins such as antibodies. These exosomes help ensure the drug is properly absorbed by the body. 

Current practice is to use nanoparticles or liposomes made from synthetic materials to deliver these medicines. However, these materials are more expensive to produce in large quantities and can cause adverse health effects, such as cell toxicity and chronic inflammation. The UofL edible-plant-derived exosomes don’t have these problems, Zhang said, since they come from natural, readily available sources. More importantly, these exosomes have anti-inflammatory effects. 

“Our exosomes come from fruit or other edible plants — something good for you, that you buy in the grocery store and that humans have eaten forever,” said Zhang, an endowed professor of microbiology and immunology who holds the Founders Chair in Cancer Research. “And, they don't require synthetic formulation.”

The exosomes made from fruit lipids also can be modified to target and deliver medications to specific cell types within the body — like homing missiles, Zhang said. For example, the exosomes could be engineered to deliver a cancer therapeutic directly to cancer cells.

Zhang originally experimented with other fruits, including tomatoes and grapes. His epiphany came while eating a grapefruit — he realized his breakfast was chock-full of natural lipids that could be harvested to make exosomes at a larger scale. The results of that work later were published in multiple scientific journals, including Nature Communications, and Cell Host & Microbe, and now are exclusively licensed to Senda Biosciences.

“These technologies could make a real difference in drug delivery, improving access and costs while reducing side effects, " said Guillame Pfefer, CEO of Senda Biosciences. "We look forward to working with UofL to further develop these innovations and get them to market."

Senda Biosciences holds an exclusive license to several UofL fruit-based drug delivery technologies, including technologies focused on the regulation of gut microbiota, through the UofL Commercialization EPI-Center, which works with industry and startups to commercialize university technologies. The EPI-Center team worked closely with Zhang and Senda to develop and grow the partnership.

“This is the kind of outcome we want for all our technologies,” said Holly Clark, Ph.D., deputy director of the Commercialization EPI-Center, who manages Zhang’s intellectual property portfolio. “We’ve built a great working relationship between our innovator and our commercialization partner, Senda, and together, they will advance this suite of technologies for market.”

 

Nov. 30, 2020

Latest results of the Co-Immunity Project show COVID-19 infection rate in Jefferson County increased tenfold since September

Study reveals many people with COVID-19 have no symptoms, potentially spreading the virus unknowingly and raising concerns in advance of the Thanksgiving holiday
Latest results of the Co-Immunity Project show COVID-19 infection rate in Jefferson County increased tenfold since September

Estimated number of individuals in Jefferson County with active COVID-19 infection based on Co-Immunity Project testing

Coronavirus infections in Metro Louisville likely are far higher than the already spiking rates reported by the health department according to researchers with the Co-Immunity Project at the University of Louisville’s Christina Lee Brown Envirome Institute. The latest results from the ongoing research indicate infection rates increased tenfold from September to November, rising from 0.2% to at least 2%.

Between Nov. 9 and 16, researchers at the Center for Predictive Medicine tested samples from 2,800 individuals representing all parts of Jefferson County for both active infection and antibodies, indicating previous infection. From those test results, project researchers estimate that during these dates, 1 in 50 Louisville residents were infected and that the rates of infection were nearly five times higher than the publicly reported number of cases, estimated at 0.4% of the population.

“At this rate, as many as 13,000 Louisville residents likely are infected today, many of them asymptomatic and who unwittingly may be spreading the virus,” said Aruni Bhatnagar, Ph.D., director of the institute. “These rates are startling and should make every person living in Louisville re-evaluate their personal precautions to avoid coronavirus, especially as we approach the holidays.”

Other key findings from the project’s latest round of testing:

  • Antibody testing indicates a 150% increase in antibody presence compared to documented cases.
  • Nearly 13,000 Louisville residents likely were infected between September and November.
  • About 45,000 people in Louisville likely have had a coronavirus infection at some point since the beginning of the pandemic based on antibody testing.
  • Shively and Northeastern Jefferson County currently show the highest rates of infection in the city.

Benefits of representative sampling

The Co-Immunity Project is a series of studies to estimate the true prevalence of SARS-CoV-2, the virus causing COVID-19, in Jefferson County. This phase of the project involves testing a representative sample of individuals from different areas in the city in proportion to the age and race of the population of the area. Researchers say this approach provides a more reliable estimate of the breadth and spread of coronavirus infection in different parts of the city than testing only those who have reason to believe they may have the virus. The team tested its first community sample in June, a second in September and the most recent in November.

In addition to the 2% infection rate among randomized participants, individuals who participated without an invitation showed a 3.3% rate of infection. This is higher than the random sampling because individuals self-selecting for testing are more likely to have been exposed to the virus.

“Most of the individuals we identified as having coronavirus infection did not have overt symptoms, which indicates that a large number of cases are likely to remain undetected,” said Rachel Keith, Ph.D., assistant professor of environmental medicine at UofL, who conducted the study. “We do not know for sure, but it seems likely that the recent increase in infections may be in part due to asymptomatic individuals.”

The project also tested for antibodies against the virus and found a one-and-a-half-fold increase in the number of individuals who previously had been exposed to the virus. Study researchers estimate that by Nov. 20, more than 45,000 individuals had been infected by the virus, rather than the 20,500 known cases documented so far. These data also suggest that approximately 15,000 individuals became infected between September and November.

“One reason for the recent increase in coronavirus infection may be the recent drop in temperature,” Bhatnagar said. “Our analysis of data from 55 countries shows that low temperatures promote the spread of the virus. Hence, we were expecting the rates of infection to rise in winter, but this increase is much more than we thought.

“Unfortunately, things are likely to get much worse in the coming months as temperatures dip even further. Therefore, we urgently need collective action, maybe just for a few months more. An effective vaccine is on the horizon so it seems that there is clear hope ahead that might hearten us to make the necessary sacrifices for a little longer.”

In an effort to obtain a uniform sample of city residents, investigators at the institute mailed 30,000 letters to households across Louisville for the November round of testing. The invitations were sent to individuals selected using addresses derived from U.S. Census Bureau tract boundaries in proportion to the total population in each geographic area.

In addition, any adult resident of Jefferson County was invited to participate through news and social media messages.

A total of 2,800 individuals were tested, 1,091 in response to the invitations and an additional 1,709 who booked their own appointments. The testing took place at 10 community drive-up or walk-up locations. Participants were tested both for the presence of the virus in participants’ nasal swabs and for antibodies against the virus in their blood, indicating a previous infection. Samples were analyzed at UofL’s Regional Biocontainment Laboratory (RBL) by assistant professor Krystal Hamorsky, Ph.D., and Amanda Lasnik, M.S., at the Center for Predictive Medicine for Biodefense and Emerging Infectious Diseases.

The random sampling of different neighborhoods also allowed the team to identify areas with higher prevalence of infection. Although infections were spread throughout the county, the highest rates were in the Shively area as well as northeastern Jefferson County.

The researchers are planning to conduct a fourth round of randomized coronavirus testing in Jefferson County Dec. 9-14.

This study was supported in part by the City of Louisville, the James Graham Brown Foundation, the Owsley Brown Family Foundation, Foundation for a Healthy Kentucky and others.

 

Nov. 24, 2020

UofL cell therapy startup acquired by publicly traded biotech firm

UofL to lead planned clinical trial for COVID-19-related acute respiratory distress
UofL cell therapy startup acquired by publicly traded biotech firm

Stuart K. Williams II, Ph.D.

A University of Louisville-born startup using innovative personalized cell therapies to help patients with pancreatitis and other conditions has been acquired by publicly traded biotech company, Orgenesis Inc. (NASDAQ: ORGS) in a roughly $15 million deal.

The startup, Koligo Therapeutics Inc., led by a UofL alumnus, was launched in 2016 to develop and commercialize UofL research and technology for personalized therapies using a patient’s own cells. One UofL-developed therapy for pancreatitis already is on the market and another for COVID-19-related acute respiratory distress soon will enter a multi-site phase 2 clinical trial led by UofL.

“These therapies have come a long way since that first ‘eureka’ moment in the lab at UofL,” said Stuart K. Williams II, Ph.D., a professor in the UofL Department of Physiology who co-invented the technologies, co-founded Koligo and now serves as its chief technology officer. “This acquisition supports expanded treatment of chronic pancreatitis patients and could further our cell-based treatments for COVID-19 patients throughout the United States.”

The first therapy originated in UofL’s islet transplant program with co-inventors Williams, Michael Hughes, M.D., and Balamurugan Appakalai, Ph.D., with early grant funding from the Jewish Heritage Fund for Excellence. This therapy is now marketed as Kyslecel ™ to treat chronic and recurrent acute pancreatitis, which can cause pain, inflammation and diabetes as the pancreas degrades. The technology is available today in six U.S. hospitals and so far has been used to treat 38 patients.

In the Kyslecel therapy, a surgeon removes the diseased pancreas and sends it to Koligo where the islets are extracted and preserved to make Kyslecel. The drug is then returned to the patient’s health care facility to be infused into the liver where the islets are expected to function and produce the insulin needed to regulate blood sugar. Williams said the goal for the next generation of islet cell therapies will be to deliver the islets via implant created using 3D-V, a UofL-developed bioprinting technology. 

Koligo plans to test another therapy, KT-PC-301, in treating COVID-19-related acute respiratory distress syndrome (ARDS) in a forthcoming multi-site phase 2 randomized clinical trial, pending FDA review and clearance of an Investigational New Drug application.

The planned trial, led by Mohamed Saad, M.D., chief of the UofL Division of Pulmonary, Critical Care and Sleep Disorders Medicine, is expected to enroll 75 COVID-19 patients. A list of other ongoing clinical trials at UofL is available here.

ARDS can occur in critical cases of COVID-19 when the lungs swell and fill with fluid as the body tries to fight off the infection. KT-PC-301 is a cell therapy that is derived from a patient’s own fat tissue. A small amount of fat is collected from the patient and sent to Koligo to make KT-PC-301. The product is manufactured within hours and sent back to the hospital for intravenous administration. KT-PC-301 then migrates to the patient’s lungs to reduce inflammation.

UofL licensed the Kyslecel and 3D-V technologies exclusively to Koligo through the UofL Commercialization EPI-Center, which works with startups and industry to commercialize research-born technology. Those licenses transfer to Orgenesis. UofL also maintains an equity stake in Koligo which has become an equity stake in Orgenesis after closing of that transaction.

“We look forward to continuing our strong relationship with UofL, now with an even wider reach and global scale,” said Koligo Chief Executive Officer Matthew Lehman, who also is a former UofL McConnell Scholar and political science and history alumnus. “Together, Orgenesis and UofL will further develop these therapies that have real potential to save lives.”

Schadt named to Association of Professors of Dermatology board

Schadt named to Association of Professors of Dermatology board

Courtney Schadt, MD, FAAD

Courtney Schadt, M.D., of the UofL School of Medicine has been named to the Board of Directors of the Association of Professors of Dermatology. The APD is the primary professional organization in the United States focused on the promotion of medical education, research and patient care, particularly in undergraduate and graduate dermatology training programs.

Schadt is an associate professor in the UofL Division of Dermatology, part of the Department of Medicine and a Fellow of the American Academy of Dermatology.

In addition to her clinical duties, Schadt serves as the chief of dermatology at the Robley Rex Veterans Affairs Medical Center and director of the Dermatology Residency Program and clerkship director for the Medical Student Rotation in Dermatology in the School of Medicine.

UofL Health to provide crucial detox services to Louisville’s south side

Mary & Elizabeth and Peace hospitals partner to open voluntary medical detox unit to better address the community’s opioid epidemic

Southside residents now have increased access to crucial addiction recovery services at UofL Health – Mary & Elizabeth Hospital’s new voluntary medical detox unit. Mary & Elizabeth Hospital has partnered with UofL Health – Peace Hospital to create the unit, which will be staffed with medical personnel and therapists specifically trained to treat behavioral health issues and addiction.

While detox services have long been offered at Mary & Elizabeth Hospital, the new dedicated unit allows for specialized care team to better monitor health and vital signs throughout the detox process to prevent dangerous symptoms from occurring. The team also will offer therapy groups and licensed therapists who will assist with discharge planning and aftercare services to ensure patients maintain their treatment plans to achieve long-term sobriety and increased well-being. In addition, art and music will be incorporated into support groups and guided meditation.

“The neighborhoods that encompass Mary & Elizabeth Hospital and the surrounding area experience a disproportionate amount of opioid addictions and overdoses,” said Melisa Adkins, chief administrative officer at Mary & Elizabeth Hospital. “This new detox unit will help those who suffer take the initial steps to help conquer their addiction in a convenient, supportive and safe environment.” 

Mary & Elizabeth Hospital will initially staff 12 private-bed rooms, but has the capacity to care for up to 25 patients. The unit will specialize in those detoxing off various substances such as EtOH (ethanol/alcohol abuse), opiates and benzodiazepines that may also have a comorbidity or medical complication. Referrals are expected from the Mary & Elizabeth emergency department and Peace Hospital, across UofL Health, as well as from various other emergency departments or freestanding psychiatric facilities in the Louisville area.

At discharge, a therapist/case manager will work with each individual patient to assess future needs, including community resources, placement at a long-term rehab facility and continued therapy. Just across the street, Peace Hospital offers a full complement of adult outpatient services, including specialized treatment methods with motivational interviewing, group therapy and 12-step facilitation. The program focus is on adults 18 years or older, and additional support is available such as transportation and six months of free after-care.

In addition to the voluntary medical detox unit, both Mary & Elizabeth Hospital and Peace Hospital offer long-acting injection (LAI) clinics, which provide monthly shots of long-acting medications to help patients with opioid addiction and schizoaffective disorders. Some patients will be able to have orders issued from Mary & Elizabeth physicians to receive LAI injections immediately after discharge from the detox unit but before leaving campus to assist in their ongoing recovery.

“Addiction to opioids, alcohol or any other substance is a concerning medical issue — not a moral failing — and these patients need ready access to knowledgeable, compassionate care,” said Jeff Graves, M.D., chief medical officer at Mary & Elizabeth Hospital. “By increasing access to these services to the most vulnerable populations in the area, we are doing our part to help set them up for long-term success.”

For more information regarding Mary & Elizabeth’s voluntary detox unit, please visit: www.uoflhealthnetwork.org/inpatient-medical-detox.