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

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

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

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.”

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.

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.

Cancer remains one of the most difficult and deadly challenges in human health, affecting Kentuckians at a higher rate than residents of any other state and killing more than 600,000 people each year in the U.S. alone. In recent decades, therapies that engage the immune system to treat cancer have given hope to millions of cancer patients.

Building on more than two decades of success in cancer research, the University of Louisville is poised to advance immunotherapy with a grant of $11.5 million from the National Institute of General Medical Sciences to establish the Center for Cancer Immunology and Immunotherapy (CCII). The new center will develop and improve strategies that use the immune response to fight cancer. The five-year grant also will allow UofL to establish the CCII as a National Institutes of Health-designated Center of Biomedical Research Excellence (CoBRE) to support young investigators and develop additional basic, translational and clinical research at the UofL Health – James Graham Brown Cancer Center.

“One of the university’s Grand Challenges is to advance the health of all people,” said UofL President Neeli Bendapudi. “Through this center, our cancer researchers will grow the field of immunotherapy, saving the lives of many more patients with cancer in the future.”

“Our mission is to harness the power of the immune system to eradicate cancer,” said Jason Chesney, M.D., Ph.D., director of the Brown Cancer Center. “The University of Louisville, UofL Health and the Brown Cancer Center have been at the forefront of the clinical development of a new generation of immunotherapies that have been proven to increase the survival of cancer patients. This grant from the federal government leverages our existing strengths in cancer immunology and clinical trials to accelerate the development of new immunotherapies that will translate into lives saved across the globe."

Cancer survivor Jeff Habermel received two different immunotherapies at Brown Cancer Center in the course of treatment for three different cancers, including metastasized melanoma.

“I consider myself very fortunate to have the type of care that Dr. Chesney and Dr. (Donald) Miller and the whole staff provide at the Brown Cancer Center. We have a world-class facility right in our backyard,” Habermel said. “I truly feel I am the luckiest man in the world to live in a time when we have such technologies and such amazing abilities to treat cancer in these ways.”

The newest cancer treatments often are available at Brown Cancer Center through clinical trials before they are available anywhere else. One such treatment is CAR T-cell therapy, in which a patient’s own immune cells known as T cells are modified in the lab to more effectively attack cancer cells. UofL announced the creation of the Dunbar CAR T-Cell Program at UofL in October.

“Our leading-edge cancer program improves access for patients in our region, giving them the opportunity to benefit from life-saving immunotherapies through clinical trials,” said Tom Miller, CEO of UofL Health. “Thousands of our cancer patients – our neighbors and family members – are alive today because of this early focus on drugs that activate immunity against cancer.”

Researchers within the CCII will build on expertise and resources gained from previous research at UofL to develop better cancer immunotherapies. This will be achieved in part by enabling talented junior investigators who have not yet obtained major funding to advance their research and subsequently obtain major grant awards of their own.

“One of the major goals of the center is to cultivate the next generation of cancer scientists in immunology and immunotherapy,” said Jun Yan, M.D., Ph.D., professor, director of the CCII and chief of the UofL Division of Immunotherapy. “Starting in year two, we will call for pilot projects that will bring in more researchers and investigators to work on immunotherapy and immunology.”

The young researchers are provided funding, mentorship and access to sophisticated facilities to advance their research. Once CCII-supported researchers obtain their own funding they rotate out, allowing new investigators to come in to the program.

“It’s training a cohort of new investigators who will have their own large grants and expertise,” said Paula Bates, Ph.D., professor of medicine and co-investigator for the CCII along with John Trent, Ph.D. “We are building a critical mass of well-funded researchers in the area.”

Senior UofL faculty members Robert Mitchell, Ph.D., Nejat Egilmez, Ph.D., Haribabu Bodduluri, Ph.D., Huang-Ge Zhang, Ph.D., and Bing Li, Ph.D., will serve as mentors and core directors for the CCII. In the first year of the program, four junior researchers at UofL are conducting projects to improve the effectiveness of immune therapies.

• Chuanlin Ding, Ph.D., is investigating the impact of chemotherapy on anti-tumor immunity in breast cancer order to discover effective combination regimens that improve conventional chemotherapy.

• Qingsheng Li, Ph.D., is exploring a method to improve immune checkpoint inhibitor therapy for non-small cell lung cancer. Immune checkpoint inhibitors are a type of immunotherapy that blocks proteins (checkpoints) made by immune system cells, such as T cells. The checkpoints can prevent T cells from attacking cancer cells.

• Corey Watson, Ph.D., is studying immune cells to determine which of these cells are beneficial to lung cancer patient outcomes and how they may help kill tumor cells.

• Kavitha Yaddanapuddi, Ph.D., is studying immune checkpoint inhibitor resistance in lung cancer patients. This will help in developing therapies that reduce resistance and improve treatment.

This grant may be extended for two additional five-year phases. A previous CoBRE program for cancer research at UofL was extended through all three phases, lasting 15 years. That program significantly expanded the contingent of both junior and senior investigators at UofL, including Chesney, Trent and others whose research was funded by the previous program.

“This type of funding has been truly transformative for this cancer center,” Trent said. “The research for the current generation of immunotherapeutic checkpoint inhibitors was done more than 18 years ago. This grant’s research will feed into the clinical work in time. These grants lay the groundwork for the next generation of therapies.”

To extend the impact of the CCII still further, Kosair Charities has provided an additional $200,000 to facilitate the discovery and development of immunotherapy drugs for children with cancer. This gift bridges the CCII and the UofL Kosair Charities Pediatric Oncology Research Program, allowing the CCII to focus also on immuno-oncology for children.

“Kosair Charities is proud to be the first community partner to support the UofL Center for Cancer Immunology and Immunotherapy,” said Kosair Charities President Keith Inman. “The UofL Kosair Charities Pediatric Cancer Research Program will allow this new center to include crucial pediatric cancer research as well as expand the scope to all people living with cancer – children and adults alike.”

Sept. 14, 2020

UofL medical faculty leaders have pledged $50,000 toward a $1 million goal to address long-standing racial inequities in medical education.

The University of Louisville School of Medicine’s Endowed Excellence Fund for Diversity has been established by several department chairs to address systemic racism. This is in response to UofL President Neeli Bendapudi’s challenge asking for ideas and support in making UofL the nation’s premier anti-racist metropolitan research university.

"I am proud and deeply grateful for the leadership of these faculty who are using their philanthropic and other financial resources to create a fund that will promote diversity at the School of Medicine both now and for the future," said Toni Ganzel, M.D., M.B.A., dean of the School of Medicine.

The endowment has been established by: 

• Sean Francis, M.D., M.B.A., chair of Obstetrics, Gynecology & Women’s Health
• Ronald Gregg, Ph.D., chair of Biochemistry and Molecular Genetics
• William Guido, Ph.D., chair of Anatomical Sciences & Neurobiology
• Irving Joshua, Ph.D., chair of Physiology
• Maureen McCall, Ph.D., professor of Ophthalmology and Visual Sciences
• Craig S. Roberts, M.D., M.B.A., chair of Orthopaedic Surgery

"This might have more impact at UofL than anything else I have done," Gregg said.

The endowment is expected to be used for scholarships, resident stipends, faculty recruitment and retention packages and other unforeseen opportunities. A dean-appointed selection committee composed of diverse members of the School of Medicine faculty, staff and students will help guide spending decisions.

To learn more about UofL’s anti-racism agenda and diversity efforts, please visit the following websites:

• UofL’s Cardinal Anti-Racist Agenda
• UofL School of Medicine Office of Community Engagement and Diversity
• HSC Office of Diversity and Inclusion
• UofL Office of Diversity and Equity
• Commission on Diversity and Racial Equality

Consider making a gift using the secure online giving page, follow give.louisville.edu/eefd.

Faculty and staff have the option to make contributions by payroll deduction to "UofL Endw Excellence Diversity" Click here for instructions for setting up payroll deduction through ULink. 

For questions or to establish a multi-year pledge, please contact University Advancement at 502.852.2794.

The emergence of the SARS-CoV-2 pandemic has caused tremendous upheaval throughout the world, leading to extensive efforts to reduce transmission of the virus and cases of the disease it causes, COVID-19, resulting in significant economic disruption.

Since warmer weather is known to decrease the transmission of other coronaviruses, researchers at the University of Louisville’s Christina Lee Brown Envirome Institute, the Johns Hopkins University School of Medicine and the U.S. Department of Defense Joint Artificial Intelligence Center theorized that atmospheric temperature also would affect transmission of SARS-CoV-2. To find out, they compared temperature data and logged cases of COVID-19 in 50 countries in the Northern Hemisphere between Jan. 22 and April 6.

The data showed that as temperatures rose, the rate of increase in new cases of COVID-19 decreased.

“Although this is typical and expected behavior for most members of the coronavirus family, SARS-CoV-2’s rapid spread and lethality have been atypical and unexpected. The confirmation of the SARS-CoV-2 temperature sensitivity has important implications for anticipating the course of the current pandemic,” said Adam Kaplin, M.D., Ph.D., of Johns Hopkins, an author of the study.

The researchers compared daily low temperature and relative humidity data with logged COVID-19 cases in the 50 Northern Hemisphere countries. The data showed that between 30 and 100 degrees Fahrenheit, for every 1 degree Fahrenheit increase in temperature, COVID-19 cases declined by 1%, and for every 1 degree decrease in temperature, cases would be predicted to rise by 3.7%.

“Of course, the effect of temperature on the rate of transmission is altered by social interventions like distancing, as well as time spent indoors and other factors. A combination of these factors ultimately will determine the spread of COVID-19,” said Aruni Bhatnagar, Ph.D., co-author and director of the Brown Envirome Institute.

In the United States, sharp spikes in COVID-19 have been seen over the summer, but the researchers noted that based on the data they analyzed, cooler summer temperatures may have resulted in an even higher number of cases.

“Although COVID-19 is an infectious disease that will have non-temperature dependent transmission, our research indicates that it also may have a seasonal component,” Bhatnagar said. “This means that this winter could bring a serious surge on top of the regular transmission.”

The research, Evidence and magnitude of seasonality in SARS-CoV-2 transmission: Penny wise, pandemic foolish?, published as a preprint on MedRxiv, also indicates that the correlation between temperature and transmission was much greater than the association between temperature and recovery or death from COVID-19.

Sept. 1, 2020

Fatty acid binding proteins (FABPs) serve as a type of chaperone, coordinating the transport of fatty acids and other molecules between cells. Bing Li, Ph.D., associate professor in the Department of Microbiology and Immunology at the University of Louisville and a leading researcher in understanding the role of FABPs, has created a “SnapShot” of the functions of these proteins published in the journal Cell, a highly regarded scientific journal covering cell biology.

At least nine types of FABPs, identified by the tissues and organs in which they were first discovered, are known to have numerous roles in lipid metabolism. While they are responsible for important functions in maintaining health, obesity can result in higher levels of these proteins, igniting disease.

“When people are obese, FABPs in different cells and tissues are upregulated, resulting in changes in lipid metabolism and responses,” Li said.

Li’s research focuses the role of FABPs in chronic inflammation, obesity and cancer development. He recently published a proposed mechanism for how increased levels of one of these proteins, FABP4, resulting from higher amounts of fat tissue, promote breast tumor growth.

“Studies from my laboratory demonstrate that FABP family members, especially FABP4 and FABP5, are critical in mediating obesity-associated diseases by regulating immune cell functions,” Li said. “Thus, our studies on FABPs not only uncover the underlying mechanisms by which obesity undermines human health, but also provide new targets for novel immunotherapeutic strategies for clinics.”

Editors of the journal Cell invited Li to create the SnapShot to illustrate the functions of all known FABPs in health and disease with an emphasis on their role in obesity, chronic inflammatory disease and cancer. SnapShots are graphic diagrams designed to serve as quick reference guides for researchers on a specific topic.

“The SnapShot format offers a great deal of opportunity for creativity and can be printed and pinned above lab benches to jog researchers’ memories,” Li said. “While our studies open a window to see the important functions of FABP family members in some disease contexts, a lot of questions remain unexplored in this field. I hope this piece will encourage more young scientists to contribute their talents to combat obesity and obesity-associated diseases.”

Aug. 20, 2020

Mary Nan S. Mallory, M.D., M.B.A., has been elected president of the American Board of Emergency Medicine (ABEM). Mallory is vice dean for clinical affairs for the University of Louisville School of Medicine, a professor in the Department of Emergency Medicine and an attending physician at UofL Health - UofL Hospital.

Mallory has been a member of the ABEM Board of Directors since July 2012 and was elected to the Executive Committee in 2019. She has served ABEM as chief examiner and editor for the Oral Certification Examination and co-editor of the In-training Examination, as well as secretary-treasurer and chair of the Finance, Bylaws and Continuing Certification committees.

"I look forward to my role as ABEM president and continuing conversations with diplomates and candidates, navigating certification examination transitions and ensuring certification standards and value as we move through these challenging times together" Mallory said.

Mallory received her medical degree from the Joan C. Edwards School of Medicine at Marshall University and completed residency training in emergency medicine at UofL. She also earned an M.B.A. from UofL College of Business.

August 10, 2020

Mike Onu Udoh, a second-year UofL medical student, has been appointed vice chair of the Minority Issues Committee in the American Medical Association’s Medical Student Section. The standing committee charged with addressing issues of concern to minority populations through policy development, health education and service, as well as identifying minority student needs and ways to increase membership awareness and knowledge of minority issues.

Udoh also is president of the American Medical Association/Kentucky Medical Association chapter at University of Louisville and the health care representative for the class of 2023 in the School of Medicine Student Government.

August 8, 2020

The third cohort of the Leadership and Innovation in Academic Medicine (LIAM) program completed an 11-month course to develop faculty leaders by presenting their projects designed to improve academic work or health care at the University of Louisville. LIAM is one of the most popular programs offered by the HSC Office of Faculty Development.

The 25 members of the class of 2019-2020, organized in five teams, outlined plans for improving faculty research productivity, patient access, employee recognition, communication and active learning in July. This was the first LIAM class to include faculty from the Belknap Campus.

The mission of the LIAM program is to develop the next generation of leaders at UofL by teaching them the skills needed first to lead themselves, then lead with others and finally, lead an organization. Faculty members enroll in an 11-month training program that includes regular discussions and the capstone team projects.

“Leadership is a set of skills that you can practice. It’s not something you are born with or not born with, but there is a set of definable skills, and with any skill, if you practice it, you get better at it,” said Gerard Rabalais, M.D., M.H.A., who developed and directs the LIAM program with Staci Saner, M.Ed.

LIAM originally was designed as a program for faculty in the School of Medicine, but has evolved quickly to include faculty members across the university.

“Our five-year goal is for 15 percent of the faculty at the Health Sciences Center campus to complete this program. Once you get to that tipping point, synergy is going to start to kick in,” Rabalais said. “That is the result of the cross-disciplinary relationships that develop, meeting and working with people they would never have worked with before from different departments or across colleges. Now that we have increased interest from faculty on the Belknap Campus, with 16 people completing the program by July 2021, we likely will set the same target for Belknap Campus.”

During the event, the program’s fourth cohort of 40 faculty members was introduced. It is the largest class in the program’s history and includes 11 members from Belknap Campus and 9 from Health Sciences Center schools other than the School of Medicine.

Projects and team members in the LIAM class of 2019-2020:

Improving Faculty Research Productivity:
David Brown, Ph.D., Linda Fuselier, Ph.D., Brandon McCormack, Ph.D., Susan Ryan, Ph.D., Siobhan Smith-Jones, Ph.D.

Patient Access at UofL Physicians:
Jennifer Daily, M.D., Luz Huntington-Moskos, Ph.D., Marija Sasek, D.M.D., Maria Mendoza, M.D., Rodolfo Zamora, M.D.

Employee Recognition:
HimaBindu Dukka, B.D.S., M.S.D., M.P.H., Arpita Lakhotia, M.D., W. David Lohr, M.D., Suzanne McGee, M.D., Michael Sweeney, M.D.

Communication:
Brit Anderson, M.D., Tamer Mohamed, Ph.D., Kimberly Pate, M.D., William Tse, M.D., Ph.D.

Driving Active Learning:
Michael Egger, M.D., James Harrison, D.M.D., Chithra Ram, M.D., Jennifer Stiff, M.D., Tracy VanMeter, M.D., Beverly Williams-Coleman, D.N.P., A.P.R.N., FNP-C

LIAM program class of 2020-2021:

• Jason Gainous, PhD                                              Arts & Sciences
• Kandi Walker, PhD                                                Arts & Sciences
• Regina Roebuck, PhD                                            Arts & Sciences
• Benjamin Mast, PhD, ABPP                                  Arts & Sciences
• Kevin Gawley                                                        Arts & Sciences
• Dawn Heinecken, PhD                                          Arts & Sciences
• Amy Flint, PhD, MEd                                             Education and Human Development
• Douglas Craddock, PhD                                        Education and Human Development
• Andrew McCart, PhD, MBA                                  Education and Human Development
• Ishwanzya Rivers, PhD                                          Education and Human Development
• Brigitte Burpo, PhD, MEd                                     Education and Human Development
• Jill Steinbach-Rankins, PhD                                  Speed School of Engineering
• Matthew Fox, MD                                                 Medicine
• Adam Ross, MD                                                    Medicine
• Ashley Iles, MD                                                     Medicine
• April Herrity, PhD                                                  Medicine
• Beatrice Ugiliweneza, PhD                                   Medicine
• Timothy Ford, DPM                                               Medicine
• Siddharth Shah, MD                                             Medicine
• Becca Hart, MD                                                     Medicine
• Kelly Jackson, MS                                                  Medicine
• Sunnye Mayes, PhD                                              Medicine
• Jeff Meyer, MD                                                     Medicine
• Courtney Smith, PhD                                            Medicine
• Joshua Sparks, MD                                                Medicine
• Rebecca Starr Seal, DO                                         Medicine
• Amanda LeBlanc, PhD                                           Medicine
• Leslie Sherwood, DVM                                          Medicine
• Samuel Carson, MD                                              Medicine
• Clayton Tyler Ellis, MD                                          Medicine
• Kellen Choi, DO                                                     Medicine
• Cynethia Bethel-Jaiteh, DNP, APRN, CPNP, CLC   Nursing
• Muna Hammash, PhD, RN                                    Nursing
• Imelda Wright, PhD, RN, CNOR                            Nursing
• J'Aime Jennings, PhD                                            Public Health and Information Sciences
• Brian Marrillia, DMD                                             Dentistry
• Lavina Myers                                                         Dentistry
• Juhi Bagaitkar, PhD                                               Dentistry
• Gill Diamond, PhD                                                Dentistry
• Ashley King-Tinsley, DMD                                     Dentistry

A University of Louisville-born therapy that helps people with Type 1 diabetes stay off immunosuppressants by re-educating the body’s immune system to accept transplanted insulin-producing cells now has a commercial partner.

iTolerance Inc., a San Mateo, Calif.-based biotech company, has signed an exclusive license and intends to develop the therapy toward clinical use. The technology was co-invented at UofL and at the Georgia Institute of Technology with support from the National Institutes of Health and JDRF, which funds Type 1 diabetes (T1D) research.

“Our goal is to help people with Type 1 diabetes, so they don’t have to suffer the side effects that come with immunosuppressants,” said Haval Shirwan, Ph.D, inventor and gratis professor in the UofL Department of Microbiology and Immunology.

In Type 1 diabetes, a condition affecting some 1.6 million Americans, the body’s immune system attacks cells in the pancreas that produce insulin, a hormone that regulates blood sugar. As a result, patients that receive pancreatic islet transplants need to be placed on immunosuppressants and cope with the possible side effects, including loss of appetite, nausea and increased risk of infection.

The technology works by training the immune system to accept insulin-producing cells through transplanted islets — cells taken from the pancreas. The islets are laced with a recombinant protein pioneered by Shirwan and Esma S. Yolcu, Ph.D., a gratis faculty member at UofL, known as Fas ligand (FasL), which “teaches” the immune system to see new graft as beneficial rather than a threat.

Once the immune system has been re-trained, the idea is to transplant healthy islet cells so the patient again can produce insulin on their own.

The UofL scientists teamed up with researchers at Georgia Tech to generate a hydrogel formulation delivering FasL to the graft site to ward off rejection. The technology has the potential to be an “off-the-shelf” treatment, and the hydrogels which hold the islets can be prepared up to two weeks ahead of the transplant. The islets also don’t need to be modified for the individual patient.

“We look forward to leveraging the technology to locally and durably induce immune tolerance of organ transplants,” said Cameron Gray, Ph.D., J.D., founder and chairman of iTolerance. “We believe the technology has potentially far-ranging implications for engraftment."

iTolerance holds an exclusive license to the technology through Georgia Tech and the UofL Commercialization EPI-Center, which works with startups and industry to commercialize university-born technologies.

IMAGE: Immunomodulatory signal presentation via synthetic hydrogel material promotes generation of T regulatory cells (green) in the local graft microenvironment (CD3+ T cells in red, and nuclei staining in blue) after implantation into a clinically relevant transplant model for the treatment of Type 1 diabetes. (Image courtesy Georgia Tech)

August 6, 2020

Amid efforts to stem the spread of the COVID-19 pandemic, social isolation and loneliness have emerged as a significant public health crisis, particularly for older adults. Isolation and loneliness affect those living in facilities as well as those living on their own in the community.

In addition to the mental health implications such as depression, studies gathered by the National Institute on Aging demonstrate that prolonged social isolation can lead to other health complications, including cognitive decline, high blood pressure, heart disease and a weakened immune system. These side effects are particularly concerning during COVID-19 when such comorbid conditions put individuals at higher risk for adverse reactions from the virus. 

The University of Louisville Trager Institute is developing technologies and services to reduce social isolation while maintaining social distancing. 

“Social distancing does not have to mean social isolation,” said Anna Faul, Ph.D., executive director of the UofL Trager Institute. “We are working with community partners to bring technology and social supports to older adults facing increased social isolation due to the current pandemic.”

In April, for example, the UofL Trager Institute and Brent Wright, M.D., of the UofL School of Medicine, introduced SmartGlasses technology to long-term facilities and primary care offices. This technology allows a health care professional who is with the patient to put on the web-connected glasses and dial in with an attending physician. A camera and microphone attached to the glasses allow the physician to see and interact directly with the patient in real time.

Recent awards of nearly $190,000 from multiple organizations will allow the Trager Institute to support the expansion of additional resources, including:

• Telehealth and teletherapy for residents in long-term care facilities
• Training of staff and students to offer virtual interdisciplinary care coordination and chronic disease management
• Caregiver resources such as training, support groups and counseling services focused on Jefferson County and surrounding rural counties 
• Specialized mental health services for older adults to reduce social isolation and depression (PEARLS program)
• A state-wide virtual-friendly visitor program that provides patients, families, caregivers and nursing home residents and staff with resources to reduce social isolation

The funding is provided by the Geriatric Workforce Enhancement Program CARES Act, the National Family Caregiver Program Title IIIE (Administration on Aging) the Health Promotion and Disease Prevention Title IIIE (Administration on Aging) as well as others throughout Kentucky. These grants have created statewide partnerships and expanded the footprint of the institute and of the university.

“Given the expansion of social isolation in our community, our team has prioritized the dissemination of technology to community-dwelling older adults,” Faul said. “In addition to the currently funded efforts, we are looking forward to the possibility of additional funds that will allow us to provide iPads and Bluetooth technology to vulnerable community-dwelling older adults in Jefferson County and several rural counties, to establish a mini-virtual health clinic network across multiple Appalachian counties and to disseminate innovative contact tracing efforts through app-based, wearable devices and AI-based services.” 

The Trager Institute hosts weekly COVID-19 information sessions that focus on the experiences of older adults, caregivers and people with chronic conditions during the pandemic. The Aug.4 information session will explore the broader efforts of our community to address social isolation through technology innovation. This session will feature Wright, associate dean for rural health innovation in the UofL School of Medicine, and Rebecca Brown Rice, director of operations at the Louisville Healthcare CEO Council. This session will explore the innovative ways technology is used to reduce social isolation and loneliness both during and after the COVID-19 pandemic. As part of this conversation, the speakers will explore the latest developments in technology, such as SmartGlasses, and creative ways to re-imagine existing technology.

The virtual session will be held Tuesday, Aug. 4, at 10 a.m., at https://zoom.us/j/884298617.

If you or someone you know is experiencing social isolation or loneliness, contact the care team at the Republic Bank Foundation Optimal Aging Clinic at the UofL Trager Institute for assistance. The care team can be reached at 502-588-4340, Option 1, Option 1, or at tragerinstitute@louisville.edu. Additional resources are available at Community Action Kentucky Partnership and Area Agencies on Aging and Independent Living, which provide social interaction programs as well as other essential services such as in-home care and food delivery programs. 

You may be confident in your potential to pursue a career in biomedical research when the National Institutes of Health funds your work before you receive your Ph.D.

Two doctoral students in the University of Louisville Department of Anatomical Sciences and Neurobiology, Zach Whiddon and Kyle Whyland, have received funding from the NIH to support their research projects. The highly competitive F31 predoctoral training awards help set the researchers on a path to a career in research, requiring the same rigorous application process that seasoned investigators must go through to obtain NIH funding for their research.

“The receipt of an F31 award is an excellent credential and is an important part of building a career in science,” said Robin Krimm, Ph.D., a professor of anatomy and neurobiology and Whiddon’s mentor. “The award of an F31 also enable the student to be become more independent; their salary is paid from their own grant and they are responsible for reporting their research progress to the NIH.”

Whiddon, who moved to Louisville to pursue his Ph.D. after completing his master’s degree in cell and molecular biology at Eastern Michigan University, is working in Krimm’s lab to capture images of nerve cells within taste buds using a specialized technique Aaron McGee, Ph.D., another faculty member in the department, brought to UofL.

Neurons send long projections from the base of brain to the taste buds on the tongue, where terminal arbors, or branches, undergo rapid structural change. Using the technique McGee introduced, two-photon laser scanning microscopy, Whiddon developed a method to capture high resolution images of the branches as they connect to taste buds in live animal models and to document how those branches change over days and weeks.

“Taste bud cells have a very short life span, maybe 10 days. How do these neurons connect with replacement taste cells? To answer that we needed to be able to watch the neurons over time,” Whiddon said. “No one in the taste field has even attempted to look at the neurons over time. They did not think it was possible – until now.”

Already the research is showing that structural change happens much more rapidly than previously thought.

“We saw that in just a 12-hour period the arbors can add or subtract new branch ends, as much as 10 microns in length, which is very quick in terms of neural plasticity,” Whiddon said.

He plans to continue this field of research after he completes his Ph.D.

“Not a lot of people are doing this work, which is what makes it so exciting,” Whiddon said. “I think this research will be a good basis for a career – to adapt it and answer more questions. I’m interested in the plasticity aspect and what is controlling the structural rearrangements.”

Whyland’s research is focused on describing poorly understood brain circuits related to vision. The Jeffersonville, Ind., native earned a bachelor’s degree from Indiana University, majoring in psychology. Now working toward his Ph.D. with Professor Martha Bickford, Ph.D., Whyland is investigating how two specific parts of the brain, the superior colliculus and the parabigeminal nucleus, work together to process visual information and to control motor reflexes and defensive behaviors such as freezing or fleeing.

“We are trying to reverse engineer a little piece of wiring in the brain to give a model for how that might work in similar areas of the brain,” Whyland said.

Whyland’s research also takes advantage of specialized techniques being used in the labs at UofL.

“During the completion of his project, Kyle will receive training in a variety of neuroanatomical techniques, in vitro physiology and a technique called optogenetics in which specific brain cells can be activated with light pulses to interrogate brain circuit function,” Bickford said.

Both Whyland and Whiddon are grateful for the funding provided by the NIH – about $32,000 per year each – as well as the opportunity to learn the ropes of funding applications.

“If Kyle and Zach continue as research-active faculty members, they will be applying for grants throughout their careers,” Bickford said. “The F31 application gives students their first in-depth exposure to the NIH application process, including stringent reviews by a panel of experts.”

As with any competitive process, success is validating. For Whyland, however, the opportunity to revise and resubmit a project that initially was rejected was one of the most rewarding aspects of the experience.

“The first time I submitted it, it wasn’t even scored. By addressing the NIH reviewers’ specific concerns, I was able to resubmit it and get it funded,” Whyland said. “It was very satisfying to know that if you don’t get discouraged and try to address the criticisms, you can be rewarded. It was really motivating.”

 PhD student Kyle Whyland

Results from the second phase of the University of Louisville’s groundbreaking project to track COVID-19 in Jefferson County show that 4 to 6 times more people than previously reported may have been exposed to the virus since the beginning of the pandemic.

From June 10-19, researchers conducting Phase II of the Co-Immunity Project tested members of the Louisville community for both the presence of the novel coronavirus in the participant’s nasal passages and for antibodies against the virus in their blood. Samples were collected at five community drive-up locations across Louisville by UofL Health and researchers from the University of Louisville’s Christina Lee Brown Envirome Institute. Samples were analyzed by UofL’s Center for Predictive Medicine for Biodefense and Emerging Infectious Disease (CPM) in its Regional Biocontainment Laboratory (RBL).

To obtain a representative sample for the study, households in Jefferson County were organized into geographic regions based on U.S. Census Bureau tract boundaries. Households within each region were sent invitations to participate in proportion to the population of that region. Within the regions, areas that had higher concentrations of non-White residents were sampled at a higher rate to increase their representation.

Invitations were mailed to a total of 18,232 addresses. Based on the ages and sexes of all adults in the household as provided by those responding to the invitation, one adult from each household was asked to provide a sample.

The researchers tested 509 people who responded to the mailed invitations. An additional 1,728 community members booked appointments on their own and were tested after hearing about the study in the news or on social media. Many individuals who were invited to participate did not book an appointment. 

Of the 2,237 individuals who were tested, 10 percent were non-White. The ages of tested individuals was as follows:

• 21 percent between 18-34
• 40 percent between 35-59
• 40 percent age 60 or older

Residential locations of the 2,237 participants are shown in Map 1.  Overall, nearly 0.4 percent of the population of Jefferson County was sampled.

Analysis of the study data found that at least 0.05 percent of the participants had an active infection during the time of the study and approximately 4 percent (5.1 to 3.2 percent) of people had detectable levels of antibodies in their blood, indicating they had been exposed to the virus earlier in the year.

“These results allow us, for the first time, to more accurately estimate the spread of coronavirus within our community. If we extrapolate the results from this study to the general population, it would suggest that as many as 20,000 people may have been exposed to the virus – many more than the 3,813 cases reported in the city by the end of June,” said Aruni Bhatnagar, Ph.D., director of the Brown Envirome Institute.

This difference may be due to the fact that people did not have symptoms and were not aware they were infected.

“We were told by several participants that they believed they had COVID-19 before testing was widely available. Nonetheless, our preliminary data suggest that the estimated number of people who have had COVID-19 may be 4-6 times higher than those who have tested positive to-date,” said Rachel Keith, Ph.D., assistant professor of environmental medicine at UofL who conducted the study. “This suggests that the virus is much more widespread in our community than previously estimated. I believe this indicates a need for continued and widespread testing, including antibody testing, which plays an important role in understanding the spread of disease.”

“The random sampling of the population also allows us to calculate the true mortality associated with COVID-19,” Bhatnagar said. “Previous estimates of COVID-19-related mortality have varied from 0.5 to 15 percent. However, given that the city had reported 209 deaths by the end of June, our results suggest that the rate of mortality associated with the virus, at least in Kentucky, may be 1.3 percent. This is significantly higher than the 0.65 percent rate suggested by the CDC. Our research suggests that many who are infected with the virus nationwide have not been tested and that there is urgent need to continue random testing so that we can calculate the most accurate mortality rate,” Bhatnagar said.

The study data also provide an estimate of the spread of the infection in Louisville.

“Because participants were drawn from all parts of the city, we could estimate which areas have had the highest rates of infection,” Keith said. “Although we are still analyzing all our data, our early results show that the highest cluster of individuals exposed to the virus is in Western Louisville. (See Map 2).  We found that the prevalence of exposure was twice as high in non-White participants as in White participants. Most (54 percent) of those who tested positive for the antibody were between the ages of 35-59 years old,” she said.

The researchers cautioned that because so little is known about SARS-CoV-2 and because the rates of community infection and exposure are changing rapidly, the results of this survey are applicable only to the period of June 10-19.

“Although many individuals had detectable levels, the amount of antibodies in blood varied greatly among the participants,” said Kenneth Palmer, Ph.D., director of the CPM. “As a result, we are not sure to what extent they are protected from re-infection. Indeed, some of our early results show that the levels of antibodies decline rapidly within a month. Therefore, we are planning to re-measure individuals who had antibodies in their blood to see if those levels are maintained over time and if so, for how long.”

Currently, the researchers are repeating the antibody test in those health care workers who were found to have anti-SARS-CoV-2 antibodies during Phase I of the Co-Immunity Project. They also plan to repeat community-wide testing in Jefferson County in September.

This study was supported in part by the James Graham Brown Foundation. The Co-Immunity Project is a collaboration of the UofL Christina Lee Brown Envirome Institute, the Louisville Healthcare CEO Council and three health systems in Louisville – Baptist Health, Norton Healthcare and UofL Health.

A University of Louisville-born invention that may help treat cancer now has a commercial partner.

Qualigen Therapeutics Inc., a California biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, has signed a license agreement for the technology and plans to fund continued development with UofL to ready it for market.

The technology works by targeting the RAS protein, which sends signals that regulate when and where the body produces and grows new cells. When mutated, the protein turns into a “stuck accelerator pedal,” according to UofL researcher Geoffrey Clark, Ph.D., who co-invented the technology with colleagues John Trent, Ph.D., and Joe Burlison, Ph.D.

“Normally, it gets pressed when you need to grow and then the foot comes off and the cell slows down,” said Clark, professor of pharmacology and toxicology at UofL. “When it becomes mutated, the accelerator’s jammed on, with cells continuing to grow and ultimately becoming a cancerous tumor.”

The drug targets only the active RAS protein and, so far, has little toxic effect on healthy cells. Many current non-targeted treatments, such as chemotherapy, can hurt both healthy and cancerous cells, leading to painful side effects. By some estimates, targeting this mutation could stop the growth of at least a third of human tumors.

“The patient impact could be extremely broad because RAS is involved in a lot of different cancers,” Trent said. “It’s one of the holy grails that there has been limited success in targeting.”

Trent leads the Molecular Modeling Facility (MMF) at UofL Health – James Graham Brown Cancer Center and the UofL partnership with Dataseam, a non-profit with a network of school computers across the state. When the computers aren’t being used by students, they’re connected to act as a distributed supercomputer, allowing researchers to process and analyze huge amounts of data.

Trent used that capability to run through millions of cancer-fighting drug possibilities in a matter of days. The result was a drug that could inhibit the deregulated RAS protein. Development of the technology was supported by the UofL NIH REACH ExCITE program.

Qualigen holds an exclusive license to the technology through the UofL Commercialization EPI-Center, which works with startups and industry to commercialize university-owned technologies. This license agreement builds on a sponsored research agreement with Qualigen for the development of several small-molecule RAS Inhibitor drug candidates. Qualigen also has licensed and is developing other UofL technologies for fighting COVID-19 and cancer.

“Partnering on this new cancer-fighting technology is another example of the relationship we’ve developed with the University of Louisville,” said Michael Poirier, CEO of Qualigen. “We look forward to working with UofL and to advancing this important clinical program with the goal of developing an effective treatment for this unmet need."

If you are interested in supporting this cancer research at UofL, visit give.louisville.edu/JGBCC-Enhancement or contact Elea Fox at elea.fox@louisville.edu.

The University of Louisville is conducting a clinical trial on a new treatment for critically ill COVID-19 patients meant to lessen some of the most severe and deadly respiratory effects.

The treatment, a new formulation of Aviptadil (RLF-100), produced by Pennsylvania-based NeuroRx and Relief Therapeutics Holding, SA, of Geneva, works by combating “cytokine storm,” an unchecked overreaction of the body’s immune response. These storms can cause severe lung inflammation and stiffening that make it difficult, if not impossible, for patients to breathe on their own.

“We want to mitigate these storms,” said the clinical trial lead, Rainer Lenhardt, M.D., associate professor of anesthesiology and critical care in the UofL School of Medicine. “We’re doing anything we can to improve outcomes.”

COVID-19 is primarily a respiratory disease and about 80 percent of cases are mild to moderate, according to WebMD. But in severe and critical cases, the lungs can swell and fill with fluid as the body tries to fight off the infection. This severe respiratory failure is a major cause of COVID-19-related death.

“These patients are terribly ill,” said Forest W. Arnold, D.O., M.Sc., an investigator on the clinical trial and an associate professor in the UofL Division of Infectious Diseases. “And because this virus is so novel, options for treatment are just now being developed. This gives us another option.”

In this Phase 2b/3 trial, UofL and other sites will treat at least 144 patients. To be eligible, participants must be patients at UofL Hospital receiving intubation and mechanical ventilation due to COVID-19-induced severe respiratory failure. Phase 2 and Phase 3 trials determine effectiveness and monitor for adverse reactions. A list of other ongoing clinical trials at UofL is available here.

The drug has previously been used for other indications, but in this formulation, it acts as an anti-inflammatory agent. The formulation is believed to protect alveolar type-2 cells in the lungs which are essential to oxygen exchange and are thought to be a major target of the SARS-CoV-2 virus.

In Phase 1 trials, designed to assess safety and dosage, seven of eight patients with acute respiratory distress caused by sepsis were taken off breathing machines after receiving the drug and six eventually left the hospital.

“Our No. 1 goal is to provide a potentially life-saving therapy to critically ill patients with COVID-19. The FDA has granted fast-track designation for RLF-100 underscoring the urgent need for new treatment options,” said Jonathan Javitt, M.D., M.P.H., CEO and chairman of NeuroRx. “We are excited to work with UofL and leverage its clinical research and infectious disease expertise to advance research in COVID-19.”

Since the coronavirus pandemic began, UofL has taken a leadership role in investigating and developing innovative ways to prevent, diagnose and treat the virus. Researchers are working to block coronavirus from infecting human cells, launching groundbreaking initiatives for testing, building robots that can sanitize high-risk areas and more. If you are interested in supporting this or other COVID-19 research at UofL, contact Lisa Warner at lisa.warner@louisville.edu or visit give.louisville.edu. 

Joern B. Soltau, M.D., has been named the Dr. William H. and Mrs. Blondina F. Evans Endowed Chair of the Department of Ophthalmology and Visual Sciences in the University of Louisville School of Medicine.

Soltau served as acting chair of the department since November 2018 and has been a member of the UofL faculty since 1998. In clinical practice, Soltau is a glaucoma specialist with UofL Physicians – Eye Specialists. He is board certified by the American Board of Ophthalmology.

Soltau was born in Hong Kong and grew up in Germany. He earned his M.D. from Ruprecht-Karls Universität in Heidelberg, Germany, in 1988, followed by an internship in ophthalmology at Klinikum Mannheim in Germany. After spending two years in research at UofL in the Kentucky Lions Eye Center, he completed his residency at Washington University School of Medicine in St. Louis, followed by a year as chief resident at the same institution. He then completed a glaucoma fellowship at the Bascom Palmer Eye Institute in Miami.

At UofL, Soltau served as residency program director from 2001-2016. He received the American Academy of Ophthalmology Achievement Award in 2018 and was listed among Louisville’s Top Surgeons in Louisville Magazine for Cataract Surgery in 2010 and 2018.

“I am confident Dr. Soltau will continue to be a good fit for leading the department into the future, building on its strong tradition of research, clinical care and education,” said Toni Ganzel, M.D., M.B.A., dean of the School of Medicine.

Soltau’s appointment as chair of the department was effective April 1.