CRO sells to Singapore company see more
A Charleston-based medical firm that conducts clinical research for the biopharmaceutical industry is being acquired by a Singapore company that’s looking to expand its reach in the U.S. market.
Novotech, which has an office in Boston but has primarily provided contract-based clinical services in the Asia-Pacific region, will take on NCGS’ roughly 300 employee and a client base that has been built over the past 38 years. Financial terms of the sale were not disclosed.
The Charlotte Street company said on its website that it has conducted research for 80 approved drug, biologic, diagnostic and device products for the medical industry.
“We have a similar cultural fit and focus on excellence, so joining Novotech will be seamless for both ours and Novotech’s clients,” NCGS founder Nancy C.G. Snowden said in a written statement.
Snowden, a onetime owner of Carolina’s restaurant on Exchange Street in downtown Charleston, said the two companies have previously collaborated on research.
“NCGS focuses on complex areas of clinical development, oncology, hematology, infectious disease and CNS (central nervous system) in both adult and pediatric populations,” Snowden said. “Our lean organizational structure and nimble operational model with highly tenured staff have been specifically designed to overcome the challenges inhibiting our industry today. We have the ability to pivot in real time as the needs of the trial evolve.”
Novotech CEO John Moller said called the acquisition “a strategic move to provide U.S.-based expertise and infrastructure for our U.S. clients wanting trials” in both the Asia-Pacific and domestic markets, as well as for Asia-Pacific clients wanting to U.S. clinical programs.
“Clients will receive seamless service, with a unified approach to systems and standard operating procedures well developed,” he said.
Privately held NCGS is headquartered at 16 Charlotte St. on the peninsula’s historic Wraggsborough neighborhood. It bought the building for $4.95 million in July 2016, when the business was based on Broad Street, and spent $10 million on renovations before the site became operational in the spring of 2017.
NCGS is the third major acquisition for Novotech in recent years. The company in 2018 bought out the Clinical Network Services research group, which gave it a customer base in the U.S., New Zealand and Australia, according to a report by Endpoints News. In 2020, the company raised $59 million in venture capital to purchase London-based ASLA Venture, which had backed oncology-based companies Epsilogen and Oxford Biotherapeutics, according to Endpoints.
Prior to founding NCGS, Snowden was the senior nursing lead for a National Institutes of Health and National Cancer Institute grant at the Medical College of Georgia/University Hospital. She also established a community clinical oncology program at the hospital, and oncology trials were an early focus for her company.
Long-standing partnership between Clemson University and MUSC paying off see more
South Carolina is strengthening its position as a hub for high-impact biomedical research with a new multi-million-dollar project that undergirds the long-standing partnership between Clemson University and the Medical University of South Carolina (MUSC) and loops in crucial support from the National Institute of Dental and Craniofacial Research (NIDCR) at the National Institutes of Health (NIH).
Researchers will study temporomandibular joint (TMJ) function, how the TMJ functions in different craniofacial developmental disorders that seem to put the joint at risk for degeneration and how the joint responds to surgical correction of these disorders, researchers said.
The TMJ makes it possible to move the lower jaw to eat and talk. Understanding the stresses on the TMJ before temporomandibular joint disease (TMD) occurs will unlock the mechanisms that put certain individuals at risk for TMD.
The focus of the research aligns with the recommendations made by an ad hoc committee on temporomandibular disorders that was formed under the auspices of the National Academies of Sciences, Engineering, and Medicine’s Health and Medicine Division.
Four of the researchers involved in the new project are connected to the Clemson-MUSC Bioengineering Program. As part of the program, Clemson bioengineering faculty and students are based at MUSC’s Charleston campus where they collaborate closely with MUSC researchers and clinicians.
The new project, funded by a $3.18-million U01 grant from NIDCR, has two principal investigators. Hai Yao, serves as the Ernest R. Norville Endowed Chair and professor of bioengineering at Clemson, professor of oral health sciences at MUSC, the associate department chair for the Clemson-MUSC Bioengineering Program and a member of the national temporomandibular disorder ad hoc committee. Janice Lee is the clinical director of the NIDCR and chief of the Craniofacial Anomalies and Regeneration Section within the NIH intramural research program.
Yao said the project is possible only because of the synergy and complementary strengths of Clemson, MUSC and NIDCR.
“Clemson and MUSC work together so seamlessly it’s as if we are one university, and we both collaborate closely with NIDCR,” he said. “This project is the latest example of how these strategic partnerships are making South Carolina a hub of biomedical research that is recognized globally. Through these partnerships, we are well positioned to address urgent healthcare needs identified by the NIDCR and the National Academy of Medicine.”
Lee said the researchers are uniquely positioned for success.
“The U01 is an extremely competitive grant that requires intra- and extra- mural collaboration utilizing the world-renown resources at the NIH Clinical Center,” Lee said. “It is extra special as this is a first for NIDCR intramural as well. Temporomandibular joint disorders are debilitating conditions, and I am thrilled to be working with Hai Yao and his team to truly move the research forward. His team brings outstanding bioengineering technology to examine craniofacial musculoskeletal function to the Clinical Center; our discoveries will be translated and, ideally, will initiate first-in-human therapies for TMD at the NIH.”
Lee continued: “NIDCR is committed to working with world-class partners such as Clemson and MUSC to advance translational research into temporomandibular disorders. This project will help improve understanding of these disorders, thereby improving outcomes for patients.”
This is particularly important to Lee as she is the oral and maxillofacial surgeon who will be providing the surgical treatments and is acutely aware of the impact that surgery can have on TMD, she said.
Özlem Yilmaz, chair of the Department of Oral Health Sciences at MUSC, said the new project presents an important venue to help patients debilitated with TMJ disorders and underpins South Carolina’s leading position in temporomandibular disorders research.
“New measurement tools and computational models will be tested on patients at the NIH Dental Clinic,” Yilmaz said. “These novel technologies, stemming from more than a decade of teamwork bringing together bioengineers, oral surgeons, and oral biologists at MUSC and Clemson, will push the boundary of the current temporomandibular disorders research.”
Sarandeep Huja, dean of the College of Dental Medicine at MUSC, said the new project further solidifies MUSC’s partnership with Clemson and NIDCR.
“This partnership will help us innovate the future of oral health and wellness,” Huja said. “We will not only be advancing knowledge of temporomandibular disorders but also expanding knowledge for the next generation of oral health providers and researchers. As a practicing clinician and orthodontist, I frequently encounter patients with temporomandibular disorders, in the very type of patients that will be recruited in this study. It is critical we find evidence based treatments for these patients.”
The vice presidents of research at Clemson and MUSC are crucial to the institutions’ partnership, Yao said. Tanju Karanfil is vice president of research at Clemson, and Lori L. McMahon is vice president for research at MUSC.
“We look forward to solidifying the strong foundation that Clemson and MUSC have built,” Karanfil and McMahon said in a joint statement. “These large, high-impact projects are advancing knowledge and creating a new generation of talent, while strengthening the state’s national and international reputation for biomedical research and education.”
Researchers are calling their project “Assessment of Temporomandibular Joint Morphology, Mechanics, and Mechanobiology in Class II and III Target and Surgical Phenotypes.”
Part of what makes the project unique is the collaboration that maximizes the expertise of the investigators.
“Dr. Lee and her craniofacial team at NIDCR will recruit the large number of patients that will be required for the research, characterize the patients, and support their travel and treatment costs,” Yao said.
Clemson and MUSC will perform analysis of temporomandibular joint biomechanics and mechanobiology and put that information into context to better understand patients’ health status and the potential for future problems
Martine LaBerge, chair of Department of Bioengineering at Clemson, said the U01 grant that funds the new project is the first of its kind at Clemson.
“This grant is a testament to the strength of the biomedical research enterprise that Clemson and MUSC are building in partnership with federal collaborators, especially the National Institutes of Health,” she said. “Dr. Yao’s leadership has been crucial to the partnership’s success, and it remains in good hands with him at the helm.”
The project is the latest major NIH grant led by Yao. He is also principal investigator on South Carolina Translational Research Improving Musculoskeletal Health (SC TRIMH), a Center for Biomedical Research Excellence that was founded with an $11-million NIH grant in 2018. Researchers associated with the center have accounted for $8 million in NIDCR awards over the past year.
Anand Gramopadhye, dean of the College of Engineering, Computing and Applied Sciences, said the success underscores the high quality of research that has come out of interdisciplinary partnerships such as the Clemson-MUSC Bioengineering Program.
“Working together in collaboration with federal partners is elevating South Carolina’s position as a place for top-tier biomedical research and predoctoral and postdoctoral education,” he said. “Dr. Yao and his team have built a high-impact program and are continuing to climb. I offer them my whole-hearted congratulations.”
New HQ set for life science consultancy see more
EverGlade Consulting has opened an office location in Charleston, South Carolina as part of its expansion into the Southeast, formalizing its headquarter's location.
EverGlade recently announced the appointment of Charleston resident Andrew Stiles as Principal in the group and will use this new location as a means of recruiting local talent and new clients into the firm. The company currently works with a variety of life sciences and defense companies in the Southeast and plans to use its new Charleston location to further expand into this important region.
"While EverGlade has its roots in Washington, D.C. as a virtual company, Charleston is home," commented Daniel Paterson, Chief Operating Officer and Charleston resident. "The industrial base matches the profile of companies we are hoping to attract. New and fast-growing companies in the life sciences, defense, and technology sectors are choosing the Southeast and cities like Charleston. As such, we felt we needed a physical presence to grow our business alongside these exciting companies and truly have boots-on-ground where the novel technology and ideas are being developed."
"Since 2017 South Carolina is a clear leader in the growth of life sciences in the Southeast, and the addition of professional service firms like EverGlade to our state's ecosystem is key in continuing to support the sector and its growth," noted SCBIO CEO James Chappell.
EverGlade expects to officially open the office on April 4. The company plans to recruit for positions in regulatory affairs, quality assurance, program management, project management, and government contract administration and compliance as part of its Southeast expansion plan.
EverGlade Consulting is a consulting firm with employees across the country, that helps clients navigate the federal landscape. We are inspired by technology-driven companies whose focus is to secure non-dilutive funding from the federal government. We offer services ranging from opportunity identification and proposal support through post-award contract management and compliance with federal regulations at agencies including ASPR, BARDA, NIH, CDC, DHS, FEMA, JPEO, DTRA, DLA, and DARPA.
For additional information about EverGlade Consulting, visit: https://www.EverGlade.com.
Enzyme and protein biotech leader creates, manufactures, distributes next gen products see more
South Carolina’s Integrated Micro-Chromatography Systems, Inc. (IMCS), a leader in recombinant enzymes and micro-chromatography technologies, was awarded $1.8 million for Phase II of its Fast-Track Small Business Innovation Research (SBIR) grant from the National Institutes of Health/ National Institute of General Medical Sciences (NIH/NIGMS).
Combined with earlier SBIR funding, the grant will provide scientists access to affordable gangliosides that aid in developing therapeutics and diagnostics for neurological diseases including Huntington's Disease, Parkinson's Disease, and Alzheimer's Disease.
The NIH/NIGMS previously awarded IMCS a 4-year, $2.56 million Fast-Track Small Business Technology Transfer (STTR) grant to expand the glycan toolkit and build an extensive array of sialoglycans that advance glycobiology-related research. The combined Fast-Track grants for the projects now exceeds $5.25 million. These projects will provide the scientific community access to affordable, easy-to-use reaction kits to facilitate synthesis of various glycans to advance research into potential diagnostics and therapeutics for neurodegenerative diseases.
The SBIR project is headed by L. Andrew Lee, Ph.D., co-founder and Chief Scientific Officer of IMCS, along with Xi Chen, Ph.D., Professor of Chemistry at the University of California, Davis. The STTR project is in collaboration with Hai Yu, Ph.D., Project Scientist at the UC-Davis.
Glycobiology, the study of the biological impact of sugars, has gained momentum in recent years. The surfaces of viruses, bacteria, and cells of our bodies are decorated with unique sugars or glycans. Some viruses and bacteria can exploit glycans to wreak havoc on our bodies, while a lack of glycans can result in disease progression. Studies suggest that modifications to certain glycans in molecules related to the brain are implicated in the onset and progression of neurodegenerative diseases.
To date, the high cost of reagents and materials needed for glycobiology research have contributed to few tools to study glycans. Glycan-modified cell membranes (glycolipids) and gangliosides (a component of brain matter critical to research) must be harvested from pigs, sheep, and cows as there is currently no cost-effective manufacturing process. The biosynthetic manufacturing technology used for these projects will result in animal-free gangliosides.
Matthew Macauley, Ph.D., Assistant Professor of Chemistry at the University of Alberta, is eager to access significant quantities of gangliosides. "Some experiments with glycolipids are cost-prohibitive, but scalable and facile access to glycolipids would make such experiments financially feasible,” he noted.
While not involved in the grant, Dr. Macauley’s lab studies glycan-binding proteins called Siglecs and their impact on disease states such as Alzheimer’s. Noting that commercially available glycolipids do not capture the diversity needed in research, he notes that reaction kits funded by the grant could be “a tremendous help for a lab that doesn't have expertise with glycan synthesis and doesn’t want to invest in getting all these enzymes expressed.”
Research reported in this press release was supported by the National Institute of General Medical Sciences of the National Institutes of Health under Award Numbers R44GM139441 and R42GM143998. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Integrated Micro-Chromatography Systems, Inc is a privately held biotechnology company that strives to address the growing needs of clinical and research laboratories through innovative technologies and custom solutions designed to increase testing efficiency. IMCS creates, manufactures, and distributes next-generation biotechnology products to clinical and forensic toxicology, academic research facilities, US Government agencies, and health science companies around the world.
Premier Medical Laboratory Services, in Partnership with the Clemson University, Reports Omicron Variant Now Present in Upstate, SCPremier Medical, Clemson detect latest variant in Upstate region see more
December 20, 2021 – Today, Premier Medical Laboratory Services (PMLS), headquartered in Greenville, SC, reports their findings that the Omicron variant is now confirmed to be present in the Upstate. The laboratory has been surveilling for Omicron and other novel variants through Next Generation Sequencing (NGS) in partnership with the Clemson University Bioengineering Department. Clemson University REDDI Lab has collected samples for COVID-19 testing from throughout the upstate community and was funded through the National Institutes of Health (NIH) to then have the COVID-19 positive specimens undergo NGS at PMLS. NGS is the process of decoding the genetic make-up of the virus to track how it is mutating and spreading throughout the population.
“As a proactive and solutions-driven company, we implemented Next Generation Sequencing to meet the needs of our population with preparedness for novel variants like Omicron,” said Kevin Murdock, CEO and Founder of Premier Medical Laboratory Services. “Through partnerships like ours with Clemson University, we are happy to increase the amount of data for South Carolina and the entire nation which is vital for vaccine efficacy and our understanding of the virus.”
Knowing the importance of accumulating data in the continued fight against the pandemic, PMLS implemented one of the largest sequencing initiatives among any lab in the nation – with the capability to sequence up to 42,000 samples per week. Many labs that are conducting COVID-19 testing have not developed the capabilities to conduct sequencing, and new variants cannot be fully identified via COVID-19 diagnostic testing methods alone. PMLS will continue working to uncover any further novel variants and mutations that COVID-19 presents and notify health officials.
Other ways PMLS has helped to meet demands during the pandemic:
- Processing lab for Human Health Services surge sites and several state health departments
- Blue Cross Blue Shield preferred COVID-19 testing lab in several states
- Reached one of the highest testing capacities in the nation with the capability to process over 300,000 tests per day
- Developed medical data management software that communicates directly from laboratory equipment for faster HIPAA compliant delivery of data to healthcare providers and patients
- Shifted production to add in-house manufacturing of COVID-19 testing kits
- Donated thousands of COVID-19 tests to children's diabetes summer camps throughout the nation
- Donated hundreds of thousands of masks to local law enforcement, paramedics, fire departments, hospitals, and the Shriners organization and has provided free testing to first responders during the pandemic
For more information, please visit www.premedinc.com or call 1.866.800.5470.
ABOUT PREMIER MEDICAL LABORATORY SERVICES
Premier Medical Laboratory Services (PMLS), based in Greenville, South Carolina, is an advanced molecular diagnostics lab fully certified by top laboratory accrediting organizations, including CLIA and COLA. With the most advanced laboratory information systems (LIS) easy to read one-page test result reports are generated with higher accuracy and a customizable report for each client. PMLS prides itself on having some of the most rapid turnaround times for testing results in the industry. Their expansive testing menu includes Pharmacogenomics, COVID-19 testing, Advanced Cardiovascular Testing, Diabetes, Women's Wellness panels, Allergen Specific Ige Blood Testing, Toxicology, and highly advanced diabetes test, MDDiabeticPro. For more information, please visit www.PreMedInc.com
Researchers awarded $120,000 grant see more
SC INBRE is pleased to announce that a team of South Carolina biomedical researchers has received an NIH NIGMS collaboration award. This goal of this one-year funding opportunity is to encourage collaborations between IDeA programs investigators while providing students a broad continuum of research opportunities. The team of Dr. Austin Shull from Presbyterian College and Dr. Antonis Kourtidis from the Medical University of South Carolina were awarded approx. $120,000 for their project. Dr. Shull is a current recipient of an SC INBRE Developmental Research Project Program (DRP) award; Dr. Kourtidis is a member of CDLD [Center for Biomedical Research Excellence (COBRE) in Digestive and Liver Disease]. This is the third consecutive year NIH NIGMS has offered collaborative awards and the third consecutive team from South Carolina to have received one.
As described in the project proposal, “Loss of epithelial integrity is common in cancer. However, mechanistic understanding of how compromised epithelial architecture promotes aberrant cell behavior, is still incomplete.” The collaboration team will be investigating a novel functional interaction between the adherens junctions, which are guardians of epithelial integrity, with ribonucleoprotein complexes, which has the potential to significantly advance their knowledge in the field. “Collectively, the experimental approach will aide in making considerable strides for understanding the downstream intracellular consequences that induce a mesenchymal-like cancer cell state when disrupting the adherens complex via PLEKHA7 suppression.”
Said the collaborators, “Since meeting at an SC INBRE Symposium in Columbia, SC in 2020, we have been in communication about initiating a collaborative research project between our labs which will advance our mutual interests in investigating the molecular consequences in disrupting cell-cell junction in epithelial cells that contribute to cancer progression. This collaborative project will support the long-term trajectory of our labs by leveraging our different research backgrounds and combining our technical expertise to address fundamental gaps in the field’s current knowledge about the molecular changes that take place during disruption of cell junctions. In addition, the findings from this project will serve as critical pilot data for a larger follow-up proposal to support this collaborative work.”
Presbyterian College undergrads will perform the vast majority of experiments and data analysis. Dr. Shull has a strong track record of mentoring undergrads with many students being leading presenters of their personal work at national meetings (ex: American Association for Cancer Research). Shull is fully committed to continuing his mentorship of undergrads and advancing their exposure to novel techniques, growing research areas, and quality experts within their respective fields through this collaborative project. For the first Aim of this project (COBRE Investigator-led efforts – Examine increased mRNA translation activity in PLEKHA7-depleted epithelial cells), Presbyterian College undergrads (along with Shull) will travel to MUSC to perform experiments under the training and guidance of Dr. Kourtidis. The students will be able to leverage the expertise of the MUSC Cell Models Core in developing gene-edited cell lines pertinent for the proposal. For the second Aim (INBRE investigator-led efforts – Determine the DNA methylation changes caused by translocation of PIWIL2 from the adherens junctions to the nucleus), Presbyterian College undergrads will perform experiments at Presbyterian College under the guidance of Shull with samples received from MUSC.
Genetic Center a key initiative at Clemson University see more
The sequencing of the human genome in 2000 gave rise to the vision of personalized medicine. Realizing the importance of this landmark achievement, Clemson University established Human Genetics as a major pillar of its long-term strategic ScienceForward plan. This vision was realized in 2016 with philanthropic support of Self Regional Healthcare and the Self Family Foundation, leading to the construction of Self Regional Hall on the Partnership Innovation campus of the Greenwood Genetic Center (GGC).
Self Regional Hall is a 17,000 sq. ft. state-of-the-art facility designed to provide a collaborative environment that is conducive to spontaneous interactions among students and faculty. The Clemson Center for Human Genetics was formally inaugurated in the facility on August 8, 2018.
In the short period of three years, the Center for Human Genetics has flourished under the leadership of its inaugural director, Dr. Trudy Mackay.
The Center started with two faculty — Dr. Mackay and spouse and long-term collaborator, Dr. Robert Anholt — two staff scientists, and two doctoral students. With strong support from Clemson University, the Center recruited four assistant professors from Yale University, Stanford University, the University of Chicago, and the University of North Carolina at Chapel Hill. This enabled the Center to expand rapidly to six faculty and a cohort of 16 graduate students on the Greenwood campus and eight affiliated members on the main campus of Clemson University.
In 2021, the Clemson University Center for Human Genetics, in collaboration with the GGC, received a grant from the National Institutes of Health for over $13.5 million total cost to establish a Center of Biomedical Research Excellence (COBRE) in Human Genetics to promote the professional development of young investigators.The Center’s Goals for Genetic Research
The goals of the Clemson Center are two-fold:
1. to leverage comprehensive systems genetic approaches and comparative genomics to elucidate fundamental principles of the genetic underpinnings of human complex traits, including disease risk.
2. to promote precision medicine by developing advanced mathematical models to predict disease risk and assess therapeutic benefits based on genetic and environmental factors.
To enable these activities, the Center has established the most advanced genomics facility in South Carolina with capabilities for short- and long-read DNA sequencing as well as analyses of gene expression networks in single cells. The Center also contains a microscopy facility, a bioinformatics facility, and its own high performance computing cluster for analyses of large datasets.
Faculty in the Center use comparative genomics approaches to gain insights in human disorders. Such approaches include studies on the fruitfly (Drosophila) model, which enables sophisticated genetic experimentation, zebrafish (in collaboration with the GGC), which is a powerful model for developmental genetics, and human cell lines. These systems have complementary advantages, so combined insights from studies on these systems can be applied to patients and human populations.
Studies in the Center focus on substance use disorders — including cocaine, methamphetamine, and alcohol — cardiovascular disease, cancer, and neurodegenerative disorders. Most genetic studies to date have focused on genes that code for proteins, structural components of our cells and enzymes that catalyze reactions that sustain intermediary metabolism and the formation of macromolecules, such as our DNA.
However, protein coding genes comprise only ~2% of the human genome and there is a growing realization that non-protein coding elements of the genome play an important role in gene regulation in health and disease. Thus, a major focus of the Center’s studies is dedicated to elucidating the contributions of noncoding elements of the genome to disease manifestation. Another major focus of faculty in the Center is to develop computational methods to predict disease susceptibility based on genetic and environmental information, a critical prerequisite for personalized medicine. The Center also interacts closely with the GGC to obtain insights in the pathology of rare pediatric diseases.
The Clemson Center for Human Genetics seeks to develop local, regional, national, and international collaborations to advance human genetics and is currently part of a large international consortium funded by the European Commission to study the genetics of susceptibility to environmental toxins. As part of a major research university, the Center is also strongly committed to educating the next generation of human geneticists by providing educational opportunities for high school students, their teachers, undergraduate and graduate students, postdoctoral fellows and visiting scientists, and to promote public understanding of human genetics through community outreach.
Zylö Receives $1,700,000 NIH Phase II Grant to Advance Erectile Dysfunction Program into Human TrialsFunds to be used for scale-up, implementation of cGMP quality system see more
Zylö Therapeutics Inc., developer of the transformational Z-pod™ topical delivery platform, has been awarded a $1,700,000 Small Business Innovation Research (SBIR) grant to advance Zylö’s proprietary nitric-oxide-releasing topical drug candidate into clinical trials. The grant, titled “Development of microparticle-based topical treatments for treating erectile dysfunction [‘ED’] in patients refractory to oral PDE5 inhibitors,” was sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (a division of the NIH).
The principal investigator of the project is Andrew Draganski, Ph.D., Zylö’s head of product development and adjunct professor at Clemson University; the primary collaborator is Kelvin Davies, Ph.D., professor of urology and professor of physiology and biophysics at Albert Einstein College of Medicine.
Using ~$225,000 of NIH funds from a Phase I award, Zylö demonstrated compelling results in a radical prostatectomy rat model of ED, whereby the cavernous nerve of the rat is surgically severed such that the rat is sexually dysfunctional and does not respond to sildenafil (a.k.a. Viagra®) and other PDE5 inhibitors. With a single topical application of the nitric-oxide-releasing Z-pod™ formulation, the rats experienced 2.0 erections on average during the 60-minute observation period immediately following topical administration; when the rats were pre-dosed with a 1/10th human-equivalent dose of sildenafil/Viagra, the average number of erections increased to 4.6 and the time-to-initial-erection was approximately cut in half.
The goal of this Phase II work is to (i) test other PDE5 inhibitors (Cialis®, Levitra®, Stendra®), (ii) scale-up the manufacturing process and to overlay a cGMP quality program, (iii) conduct certain toxicity testing required for an Investigational New Drug [IND] application, and (iv) hold a pre-IND meeting with the FDA to secure feedback critical to successful development of the program.
If eventually approved, this Z-pod™-based drug candidate will target two distinct market segments, as follows:
- Men with ED secondary to radical prostatectomy: It has been reported that 86% of men that have undergone radical prostatectomy (which typically impacts the cavernous nerve) will suffer from ED, with no approved treatment available to them (just like with rats with severed cavernous nerves, these men do not respond to Viagra et al.)
- Men with the more typical ‘age-related’ ED symptoms that either do not respond well to the PDE5 inhibitors or cannot take the medication due to medication side-effects or drug interactions.
In the U.S. alone, these two market segments represent an addressable market of over $2 billion per year.
Andrew Draganski Ph.D. commented, “Zylö’s nitric-oxide technology is a potential breakthrough in the treatment of ED in men that are refractory to the PDE5 inhibitors such as Viagra. This commitment by the National Institute of Diabetes and Digestives and Kidney Diseases is quite validating, and we are grateful to the NIDDK for their funding.”
Added Jay Blankenship MD, Zylö’s head of business development, “We are enthused by the opportunity afforded by the NIH to advance our innovative approach to delivering nitric oxide through topical administration. This patent-pending technology holds great promise not just for ED, but for a myriad of other clinical applications such as wound-healing, atopic dermatitis, gingivitis, and sports recovery.”
About Zylö Therapeutics: Zylö has developed the Z-pod™ technology platform, a disruptive topical delivery system that extends the duration of effect, improves the solubility/targeting, and enhances the product performance of many therapeutic and cosmetic agents. Notably, the Z-pod™ technology has successfully harnessed the therapeutic potential of nitric oxide, one of the most powerful—and short-lived—biomolecules produced by our bodies. For more details, please visit our website, www.zylotherapeutics.com, and follow us on Twitter (@ZyloTherapies).
Greenwood Genetic Center, Clemson share important genetic research news see more
Genetic networks define an individual’s unique characteristics that – coupled with lifestyle habits and other environmental factors – determine susceptibility to cancers, hypertension, high cholesterol, arthritis, diabetes, Alzheimer’s disease and numerous other ailments. The National Institutes of Health (NIH) has tasked Clemson University with unlocking these genetic codes through a new $10.6 million grant to establish the Center of Biomedical Research Excellence (COBRE) in Human Genetics in collaboration with the Greenwood Genetic Center (GGC).
The award funds an initial five-year phase of a COBRE, which can continue for 15 years, positioning the Clemson-GGC collaboration as a global leader in the scientific advancement of human genetics. The NIH COBRE program provides a long-term investment in the advancement of medical research around a central theme. This is NIH’s first COBRE specifically focused on human genetics.
Trudy Mackay, the Self Family Endowed Chair of Human Genetics, will lead the COBRE in Human Genetics along with Robert Anholt, provost’s distinguished professor of genetics and biochemistry, and Richard Steet, director of research at Greenwood Genetic Center (GGC).L-R: Robert Anholt, Trudy Mackay, Richard Steet
The Greenwood Genetic Center provides clinical services to more than 5,000 patients annually, and diagnostic laboratory testing, educational programs and research in medical genetics. Clemson’s Center for Human Genetics has collaborated closely with GGC since opening in 2018.
“Merging the expertise of Clemson’s genome science with the patient-driven focus of the Greenwood Genetic Center is very powerful,” Steet said. “The theme of this COBRE is comprehensive – covering common disorders like cardiovascular disease, cancer, neurodegenerative diseases as well as very rare genetic disorders. We take a lot of pride in that breadth, as it gives our collaborations and the efforts of this COBRE room to grow.”
At the heart of the COBRE in Human Genetics is a robust mentoring platform for early-career faculty. Leading scientists at several of the nation’s premier laboratories will serve as project mentors, including St. Jude Children’s Research Hospital, the National Cancer Institute, Duke University and the Center for Comparative Genomics and Bioinformatics at The Pennsylvania State University.
Initially, the COBRE in Human Genetics will feature four core research projects and numerous pilot projects. The following investigators lead the four core projects:
Andrei Alexandrov, assistant professor of genetics and biochemistry at Clemson, will analyze human nuclear long non-coding RNAs to identify potential targets for new treatments for cancer and viral diseases. A former scientist at Yale University, Alexandrov developed an ultra-high throughput method that enables the discovery of genes involved in human RNA surveillance.
Heather Flanagan-Steet, director of functional studies at the Greenwood Genetic Center, will study genetic mutations that can cause neurological and cognitive impairment, skeletal abnormalities and even early infant death. Her work on rare diseases largely involves the generation of zebrafish models to investigate gene function and disease pathogenesis. She pioneered the use of zebrafish to model rare inherited diseases.
Miriam Konkel, assistant professor of genetics and biochemistry at Clemson, will work to understand why and how transposable elements, sometimes called “jumping genes,” can move around the human genome and alter genetic expression. The movement of transposable elements may contribute to neurodegenerative diseases like Alzheimer’s.
Fabio Morgante, assistant professor of genetics and biochemistry at Clemson, will analyze genetic data from 500,000 people as part of a project to develop phenotypic models that can predict cardiovascular disease. His models will take into account ancestry, ethnicity and environmental factors that can affect disease susceptibility.
The COBRE in Human Genetics will support numerous pilot projects related to human genetics and expand its research as the COBRE progresses and attracts additional investigators.
The team is planning an annual symposium and a yearly retreat for the COBRE in Human Genetics participants to share knowledge and ideas. Already, renowned scientists worldwide, including members of the National Academy of Sciences, are participating in a monthly lecture series organized by the Center for Human Genetics.
“GGC is honored to be part of this first-ever NIH COBRE in the field of human genetics,” said Steve Skinner, MD, GGC Director. “By combining the Greenwood Genetic Center’s 47 years of expertise in providing quality medical genetics services with the research talent and computational power of the Clemson Center for Human Genetics, patients and families impacted by both common and rare genetic diagnoses will reap the benefits.”
“This grant truly raises the profile of both Clemson University and the Greenwood Genetic Center, and I am proud that our collaboration has the potential to make a difference for so many people. It is powerful to think of how many lives might be saved by learning more about the genetics behind some of these devastating diseases,” said Clemson University President Jim Clements.
Research reported in this publication is supported by the National Institute of General Medical Sciences of the National Institutes of Health under Award Number P20GM139769. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
5-year Phase II COBRE grant will result in more funding to support research conducted at USC see more
The National Institutes of Health (NIH) has awarded the University of South Carolina a five-year grant totaling more than $11.2 million to support the COBRE Center for Targeted Therapeutics based at the College of Pharmacy. This is Phase II of the COBRE grant, and follows the five-year Phase I portion of the research grant, which concluded this year.
The COBRE Center for Targeted Therapeutics (CTT) is directed by SmartState endowed chair and drug discovery and biomedical sciences professor Dr. Igor Roninson, an internationally-recognized researcher in cancer therapeutics.
“Dr. Roninson is an exceedingly accomplished scientist and has been successful in navigating the transition of this Center from the Phase I stage to the Phase II, which is not an easy task. Less than one-half of the Phase I COBREs are successfully converted into a Phase II program,” said Dr. Stephen J. Cutler, Dean of the College of Pharmacy. “Under the Phase I Center, Dr. Roninson has directed the advancement of young faculty members into independently funded scientists, supported the growth of a critical mass of investigators focused on the design and discovery of new therapeutic agents, and enhanced the development of new research cores at the University of South Carolina. Under the Phase II Center grant from NIH, Dr. Roninson should be able to strengthen the Center for Targeted Therapeutics at the UofSC.”
Dr. Roninson was awarded the five-year Phase II COBRE grant of $2,235,000 annually from the National Institutes of Health to support the CTT. This Center was created to attract and foster the professional development of talented junior scientists dedicated to research in the treatment of debilitating diseases and to develop the infrastructure for targeted therapeutic studies.
“Dr. Roninson’s Phase I COBRE-CTT established a cadre of highly talented and successful junior faculty in the College of Pharmacy, College of Arts and Sciences, and the School of Medicine, whose research efforts focused on the discovery of new drug targets,” said Dr. Kim Creek, Associate Dean of Research at the College of Pharmacy. “The impact of the COBRE-CTT on research productivity at UofSC is substantial and far reaching. The Phase II award will provide funding for the COBRE-CTT for an additional five years and will support the hiring of additional junior faculty in the area of targeted therapeutics and allow for overall growth of this thriving Center.”
The Center for Targeted Therapeutics includes three resource cores, including the Functional Genomics Core, the Drug Design and Synthesis Core and the Microscopy and Flow Cytometry Core. A core director is assigned to each of the research cores. These experts provide scientific advice in project development, along with technological support.
For more information on the College of Pharmacy’s COBRE Center for Targeted Therapeutics, visit: https://tinyurl.com/yyy72s6c
MUSC continues advances in telehealth see more
The Medical University of South Carolina has received a $3.6 million grant to support the development of a national telehealth research network.
As opposed to supporting a specific clinical research study, the grant seeks to establish an easily accessible support structure around telehealth research, including tools, resources, collaboration, education and advocacy materials to anyone across the country who wants to study telehealth programs.
“We expect this network to become the preeminent source for evidence-based policy and outcomes data,” said Brook Yeager McSwain, health policy consultant for the project and manager of the S.C. Children’s Telehealth Collaborative, in a news release. “Our national and state legislators have seen the benefits of telehealth for certain populations and regions. We have to demonstrate to them that this works across the country and has the potential to dramatically impact health care delivery models.”
The five-year National Institutes of Health grant builds on work already underway as part of the Supporting Pediatric Research on Outcomes and Utilization of Telehealth project, known as Sprout. The grant will support telehealth research efforts, metric development, identification of best practices and the development of collaborative policy and advocacy materials across the country.
Sprout is a network of institutions and pediatric providers operating within the American Academy of Pediatrics, which is a sub-awardee of the grant. The other sub-awarded institutions are the University of Colorado – Children’s Hospital Colorado, Children’s Hospital of Philadelphia and Mercy Hospital in St. Louis.
“This is a huge step forward in the development of safe and impactful telehealth programs across the country,” said Dr. S. David McSwain, the primary investigator for the NIH grant, in the release. “Academic research into the real impact of telehealth services is a critical component of developing and growing programs with the greatest potential to improve our health care system.”
In 2015, McSwain, who is also an MUSC Children’s Health physician, MUSC chief medical information officer and associate professor of pediatric critical care, collaborated with a small group of pediatric physicians across the country to form Sprout, which has since completed and published the nation’s first broad assessment of pediatric telehealth infrastructure across the country.
The grant is a Collaborative Innovation award through the National Center for the Advancement of Translational Science. The program will operate in collaboration with Clinical and Translational Science Awardsites across the country to facilitate research development and support telehealth researchers to develop projects and find funding.
Multimillion-dollar grant to support heart health research at Clemson University see more
Clemson University bioengineers picked Valentine’s Day to announce $4.1 million in grants to support new heart health research.
Will Richardson and Naren Vyavahare are conducting research with the potential to affect millions of patients who suffer from many forms of cardiovascular disease and related illness, including heart failure, hypertension, chronic kidney disease and Type 2 diabetes, according to a university news release.
Richardson, an assistant professor of bioengineering, is creating computer models aimed at providing better treatment for cardiac fibrosis, a condition that contributes to heart failure. As many as 60% of patients die within five years of developing heart failure, which afflicts 6.5 million Americans, Richardson said in the news release.
No drugs have been approved to treat cardiac fibrosis specifically, and doctors are often left with trial-and-error experimentation when treating patients who have it, he said in the release.
Richardson said he hopes his research will lead to a day when measurements from a patient’s blood or tissue sample can be plugged into mathematical equations based on how molecules interact in the body. Overnight, patients would have personalized risk assessments and treatments plan, he said in the release.
Details about his research is available online.
Vyavahare, the Hunter Endowed Chair of Bioengineering, is working on what could be the first treatment to reverse vascular calcification, a condition that occurs when mineral deposits build up on blood vessel walls and stiffen them, according to the news release. It is most prevalent in aging patients and those with chronic kidney disease and Type 2 diabetes, Vyavahare said. Complications from vascular calcification can range from hypertension to death.
The nanoparticles that Vyavahare is developing are many times smaller than the width of a human hair and would deliver two medicines to calcified blood vessels. One medicine would remove the mineral deposits that cause blood vessels to become calcified, and another would return elasticity to the blood vessels.
More details about his work is online.
The Richardson and Vyavahare projects were both funded through the National Institutes of Health’s R01 program. Richardson is receiving $1.9 million, and Vyavahare is receiving $2.2 million, the news release said.
Anand Gramopadhye, dean of the College of Engineering, Computing and Applied Sciences, congratulated Richardson and Vyvahare on their grants.
Agneta Simionescu, an assistant professor of bioengineering, has also received $1.38 million through the R01 program. The Simionescu award was announced in November and is aimed at better understanding cardiovascular disease in patients with diabetes, the news release said.
Richardson and Simionescu were among the faculty members trained as part of SC BioCRAFT, a National Institutes of Health Center of Excellence. The center’s primary goal is to increase the number of South Carolina biomedical researchers who are supported by grants from the National Institutes of Health.
Vyavahare leads SC BioCRAFT, which stands for the South Carolina Bioengineering Center for Regeneration and Formation of Tissues.