Skip to Main Content

clinical trials

  • sam patrick posted an article
    First release of 3D-PREDICT clinical study data fuels momentum of company’s glioblastoma program see more

    GREENVILLE, SC – December 17, 2020 – KIYATEC, Inc. today announced the first clinical use of its response-prediction test to improve outcomes in relapsed brain cancer patients. Test results that measure the effect of cancer drugs on a patient’s live cancer cells are available in just seven days, thereby enabling oncologists to select drugs informed by patient-specific evidence of response before treatment begins.

    Lindsay Lipinski, MD, Assistant Professor of Oncology and a neurosurgeon at Roswell Park Comprehensive Cancer Center (Buffalo, NY), presented her and her colleagues’ findings at the 2020 Society of Neuro-Oncology meeting in November. A case series of seven patients with recurrent high-grade gliomas – six with glioblastoma multiforme (GBM) and one with anaplastic astrocytoma – was detailed.

    “In this early experience, tools that can predict a tumor cell’s responsivity to a variety of chemotherapy or other therapeutic agents have already been extremely valuable in guiding treatment decision-making for patients with recurrent high-grade gliomas at our center,” said Dr. Lipinski. “Our results show that we are far along in the paradigm shift toward individualized medicine.”

    Today, when these cancers return following a patient’s initial treatment, oncologists do not have evidence-based guidelines to choose which drug therapy to use next. Across several drug options, the typical expectation for the time in which these recurrent patients will remain cancer-free (i.e., median progression free survival or PFS) is only 4 months. The use of KIYATEC’s test results to inform drug selection approximately doubled the typical expectation, achieving a group median PFS of 7.9 months, a significant improvement over expected PFS in these patients.

    KIYATEC’s test results informed two of the seven patients’ successful treatment with dabrafenib, a targeted agent. Notably, neither had a typically associated genetic mutation, demonstrating that the test can uncover effective drug options that would have normally been missed.

    “Our vision is to successfully translate these study findings into the GBM population at large, including newly diagnosed patients – a population that we’re also actively enrolling and testing in our study,” said Matthew Gevaert, PhD, CEO of KIYATEC. “Today’s positive results in relapsed patients, with a median age of 60 and some having had two or even three relapses, paves the way to do this.” 

    This first release of data from KIYATEC’s active 3D-PREDICT (ClinicalTrials.gov ID NCT03561207) clinical study coincides with the continued addition of new sites at which high-grade glioma patients can enroll, bringing this study to nine institutions across the United States.
     

    About KIYATEC, Inc.
    KIYATEC leverages its proprietary ex vivo 3D cell culture technology platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors. The company’s Clinical Services business is currently engaged in the validation of clinical assays as well as investigator-initiated studies in ovarian cancer, breast cancer, glioblastoma and rare tumors, in its CLIA-certified laboratory. The company’s Drug Development Services business works in partnership with leading biopharmaceutical companies to unlock response dynamics for their investigational drug candidates across the majority of solid tumor types.

     

    Citation:

    Lindsay Lipinski, et al., INNV-16. Clinical applicability of individualized drug response profiling utilizing ex-vivo tissue-derived 3D cell culture assays in high-grade glioma: a single institution case series using 3D-PREDICT results, Neuro-Oncology, Volume 22, Issue Supplement_2, November 2020, Pages ii119–ii120, https://doi.org/10.1093/neuonc/noaa215.499.

     

  • sam patrick posted an article
    SE Life Sciences launches new initiative designed to expand clinical trial diversity see more

    Compliments of Columbia Business Monthly & Greenville Business magazines

    National polls show that anywhere from 51 percent to 64 percent of Americans would be willing to be vaccinated against coronavirus.

    But the number is far lower for minorities.

    Some 49 percent of African Americans and 37 percent of Hispanics say they won’t take the vaccine, according to the Kaiser Family Foundation.
       
    About 39 percent of Blacks cited safety concerns in the poll, while 35 percent cited distrust of the health care system.

    That distrust goes back decades to the Tuskegee Experiment, a federal study that allowed syphilis in Black men to go untreated so scientists could observe its progression.

    And it affects the way many African Americans view the health system today, with low participation clinical trials - just 5 percent to 7 percent nationally – among the consequences, according to SE Life Sciences, a trade group representing life science companies in the Southeast.

    Enjoy reading the full article here...

  • sam patrick posted an article
    SE Color initiates “We Are In” Campaign to encourage minority participation in Clinical Trials see more

    On September 9, Southeast Life Sciences announced the formation of SE Color, an organization dedicated to support minority life science entrepreneurship, increase investment in minority-owned life science businesses, and improve minority access to information and clinical opportunities.

    The founding advisory board members are Jayne Morgan MD, Clinical Director, Covid Task Force at Piedmont Healthcare, Kornelius Bankston, Managing Partner with techPLUG, and John Newby, Chief Executive Officer for Virginia BIO. As executive director of Southeast Life Sciences, Jason Rupp will staff the organization.

    SE Color’s initial effort will focus on increasing the number of minorities in clinical trials. In an article published in Healthcare Tech Outlook, Dr. Morgan notes that, “African Americans make up 13.4 percent of the US population, yet only 5 – 7 percent of clinical trial participants nationally.”

    Dr. Morgan further states, “Nearly every advance in medicine today was first evaluated in a clinical trial. Clinical trials offer our best and most forward thinking and can be the gateway to provide earlier access to life saving medicines and therapies years ahead of FDA approval. Equitable participation in clinical trials is therefore a critical call to action in ensuring that medicines, devices, and vaccines that are developed are relevant to all populations.”

    Although there are many aspects to facilitate minority recruitment in clinical trials, SE Color will initially focus on education through the “We Are In” campaign. The initial priority will be to share information on clinical trials available throughout the southeast. SE Color will partner with state associations in the region to ensure we have updated information and extend the network.

    Southeast Life Sciences recognizes the great need for effort in these areas and though we will only be one part of the solution, we will be part of it. In closing, Bankston adds “I believe the greatest social injustice in modern history is health inequalities which disproportionately impact people of color. We can create more effective therapeutics, applications and medicines for all populations- by addressing the systemic issues in clinical research.”

  • sam patrick posted an article
    Biopharma research is an important source of jobs, tax revenue and research spending in SC see more

    New findings show biopharma research companies a source of jobs, tax revenue and research spending in state

     

    GREENVILLE, S.C., October 4, 2018 – This week, the Pharmaceutical Research and Manufacturers of America (PhRMA) released a new report that finds there are more than 572 active clinical trials in the South Carolina, and the life science industry supports 29,500 high-quality jobs and contributes $7.9 billion to South Carolina’s economy. These clinical trials can be responsible for more than half of the $2.6 billion average cost of developing one new medicine. They are investigating some of the biggest health care challenges South Carolinians face, including arthritis, cancer, diabetes, cardiovascular disease, and Alzheimer’s disease.

    The report, titled “Research in Your Backyard: Developing Cures, Creating Jobs, Pharmaceutical Clinical Trials in South Carolina,” was released at a press event held at the Westin Poinsett today, which featured a panel discussion including researchers and executives from the Greenville Health System, KIYATEC, the Hollings Cancer Center at MUSC, and the Greenwood Genetic Center, moderated by SCBIO President and CEO, Sam Konduros.

    “Clinical trials offer patients novel medical treatments right here in the Palmetto State, while also allowing biopharma research organizations to innovate and grow,” said Konduros. “Across South Carolina, the life sciences and healthcare industries have had a profound impact on our economy and citizens, that continues to rapidly increase.”

    Clinical trials are a vital component of bringing new life-saving drugs and treatments to market. On average, it takes approximately a decade for new medicines to go through the rigorous Food and Drug Administration (FDA) approval process. Only 12 percent of drugs successfully make it through clinical trials. Since 2004, biopharmaceutical research companies have conducted or are currently conducting more than 4,700 clinical trials in South Carolina. In 2013 alone, the nearly 1,100 active clinical trials in the state generated an estimated economic impact of $540 million.

    “One of the most important things we want people to understand about medicine development is that clinical trials rely on patient participation,” said Nick McGee, Director of Public Affairs for PhRMA. “It’s incredibly important that patients are aware of ongoing trials and learn how they can help become part of finding a cure for the toughest chronic conditions and diseases we face today.”

    In the United States, there are more than 7,000 open clinical trials being sponsored by the biopharmaceutical industry, universities, individuals and organizations combined. In South Carolina, of the 572 open clinical trials involving the biopharmaceutical research industry, the University of South Carolina Medial School is collaborating on more than 143 clinical trials and the Medical University of South Carolina is collaborating on more than 142.

    “Many top research and medical universities call South Carolina home and are centers of innovation,” Bob Quinn, Executive Director of the South Carolina Research Authority, said. “Maintaining strong partnerships between our universities and life science companies allows us to foster developments right here in South Carolina that can then help save lives far beyond our state lines.”

    You can read the complete report, “Research in Your Backyard: Developing Cures, Creating Jobs, Pharmaceutical Clinical Trials in South Carolina,” here.

    ###

    About PhRMA
    The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested more than $600 billion in the search for new treatments and cures, including an estimated $71.4 billion in 2017 alone.

    About SC BIO
    SCBIO is South Carolina’s investor-driven public/private economic development organization focused on building, advancing, and growing the life sciences industry in the state.  With an $11.4 billion annual economic impact in the Palmetto State, with more than 400 firms and 15,000 professionals directly involved in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products that make a difference across the Palmetto State and around the world.  Visit us at SCBIO.org.

  • sam patrick posted an article
    Clinical trials are saving lives in South Carolina see more

    When he was diagnosed with stage 4 lung cancer in 2011, Jimmy Alexander wasn’t expected to live more than a year.

    So doctors enrolled him in a clinical trial of a new chemotherapy cocktail hoping it might make a difference.

    Eight years later, the Simpsonville man is still enjoying Clemson football and time with his family, including two daughters, five grandchildren and six great-grandchildren.

    And now the program that helped Alexander is being expanded into the Midlands with an $8.2 million grant awarded Friday by the National Cancer Institute’s Community Oncology Program, or NCORP.

    “People just don’t realize what clinicals may be able to do,” Alexander said. “They can be a lifesaver.”

    Clinical trials are conducted to determine whether a treatment works while offering patients a shot at experimental therapies that aren’t otherwise available through normal channels.

    They provide physicians with new weapons in the battle against cancer, said Dr. Larry Gluck, medical director of Prisma Health-Upstate’s Cancer Institute in Greenville, which was awarded the grant.

    “Because of our NCI designation and support,” he said, “we can offer hundreds of leading-edge clinical trials that can provide treatments to patients years before approval by the FDA for general use.”

    More than 300 clinical trials are underway at Prisma’s Cancer Institute at any time and the hospital has been awarded more than $30 million in NCI grants since 1995, according to Prisma, formerly Greenville Health System.

    “What we learn from one patient helps that patient – but also many many more,” said Dr. Jeff Giguere, a Prisma oncologist.

    “A unique aspect of research via the NCORP grant is that it interrogates every point on the cancer continuum from diagnosis, treatment, supportive care," he said, "as well as proactively evaluates cancer prevention and more effective and efficient ways of delivering cancer care.”

    The latest six-year grant will enable trials for lymphoma, leukemia and solid tumors to begin in the Midlands this fall. 

    “Our goal ... is to continue to serve our Upstate patients with strengthened options here and extend our reach and expertise to the legacy Palmetto Health institutions via Prisma Health,” said Giguere. “We hope to meet an unmet need for our state.”

    There was no guarantee when Alexander was enrolled in the trial that he would benefit from the drugs. But the 78-year-old said he would have participated anyway in case it would help others.

    “If whatever I am doing helps other people, I was glad to do it,” he said. “But here I am eight years later.”

    Alexander said his cancer is stable, thanks to a weekly infusion of a drug called Erbitux, which is provided through the trial.

    Fortunately, the retired engineer was able to live to see a great-granddaughter born seven months ago.

    “I’m doing pretty good. The only problem I have is old age,” he says with a chuckle. “I’m still around to play with her. It’s a great, great thing.”