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clinical trials

  • sam patrick posted an article
    Takeover of Clinical Research Hamburg intended as first of a series of deals across Europe see more

    Europe is the key to clinical trial recruitment success, says site organization Velocity Clinical Research, which has acquired a clinical research location in Hamburg, Germany.

    The deal will see Clinical Research Hamburg, a provider of phase 2 through 4 research services in therapeutic areas including pain management, allergology, smoking cessation and hypertension, become part of Velocity. Financial terms were not disclosed.

    The takeover will be the first of a series of deals across the U.K. and Germany, Durham, North Carolina-headquartered Velocity said. The planned acquisitions, which Velocity has not detailed publicly, reflect the role Europe plays in global pharmaceutical development, says Dominic Clavell, executive vice president of European operations at Velocity.

    “The U.S. pharma sales market may be twice the size of Europe’s but the latter contributes a similar percentage of patients to global trials each year," Clavell said. "For any clinical trials business, developing an EU presence is paramount to its success.”

    He also said the deal is a testament to Velocity’s ability to negotiate site purchases outside North America, claiming that this is the first time a U.S. sites business has "scaled to expand into Europe." U.S.-based companies previously have had a tough time navigating the complex regulatory environment in the EU, Clavell noted. 

    The Hamburg facility is the 32nd site in Velocity’s network. The firm’s strategy is to develop sites that have a centralized infrastructure and common technology backbone on the basis that it will allow for superior patient enrollment and consistent, high-quality data delivery.

    Velocity also claims its approach allows the clinical research organizations and pharmaceutical companies it works with to benefit from simplified access to international clinical research. 

    Last year, Velocity expanded into South Carolina and California through the acquisition of VitaLink Research and the National Research Institute, adding 11 clinical trial sites to its roster. Velocity itself was bought by London healthcare venture firm GHO Capital last year. 

  • sam patrick posted an article
    MUSC, Lexington Medical to partner see more

    Lexington Medical Cancer Center has formed a partnership with the Medical University of South Carolina Hollings Cancer Center in Charleston. 

    The two organizations say the affiliation will provide Lexington Medical Center’s patients with comprehensive cancer services, as well as access to more than 200 clinical trials underway through the National Cancer Institute and designated to MUSC, according to a news release.

    As one of 71 National Cancer Institute-designated cancer centers, MUSC serves as a home to more than 120 cancer researchers from institutions across the country. 

    “MUSC Hollings Cancer Center is committed to improving the care of cancer patients across our state,” Dr. David Zaas, CEO of MUSC Health Charleston Division, said in the news release. “We are excited to partner with Lexington Medical Center to help ensure patients can access innovative clinical research trials and new approaches to care, including state-of-the art therapies closer to home.” 

    The partnership will advance Lexington Medical Cancer Center, according to its medical director, Dr. Quillin Davis.

    “As the Midlands’ only hospital providing comprehensive cancer care, we are excited about the benefits our affiliation with MUSC Hollings Cancer Center brings to our patients,” Davis said in the release. “Having access to their National Cancer Institute-designated clinical trials and research expertise will allow our patients to receive the latest, most innovative treatment while staying here in their community.” 

    Lexington Medical Cancer Center is located in West Columbia and employs more than 7,800 health care professionals.  

    Lexington Medical Center named top metro hospital

    U.S. News & World Report has named Lexington Medical Center the best hospital in the Columbia metro area and the second-best hospital in South Carolina.

    Lexington Medical was also ranked as high-performing in the treatment of 11 adult procedures and conditions, including back and colon cancer surgery, diabetes, heart attack, stroke, and heart and kidney failure.

    “Recognition as a Best Hospital by U.S. News & World Report reflects our dedication to delivering advanced medicine and state-of-the-art treatments to promote the health and well-being of our patients and their families,” Dr. Brent M. Powers, senior vice president and chief medical officer at Lexington Medical Center, said in a news release. “Achieving this prestigious ranking takes years of collaboration and innovation among specialties and providers throughout our organization. We are proud of our exceptional physicians, nurses, clinicians and staff for their continued commitment to providing quality health services that meet the needs of our communities.”

    The annual Best Hospital rankings, now in their 33rd year, reflect an evaluation of more than 4,500 hospitals across 15 specialties and 20 procedures and conditions.

  • sam patrick posted an article
    MUSC teams up for new clinical trial see more

    A combination of up to five drugs normally used to treat conditions ranging from HIV to Type 2 diabetes could destroy cancer cells yet be less toxic than a chemotherapy drug used for recurring ovarian cancer.

    After promising preclinical results, researchers at MUSC Hollings Cancer Center are now launching a phase 1 clinical trial to establish safe levels of various combinations of the drugs in patients with advanced solid tumors.

    Hollings researchers Joe Delaney, Ph.D., and Michael Lilly, M.D., are collaborating on the Combination of Autophagy Selective Therapeutics (COAST) trial, which already has enrolled its first patient.

    Autophagy is a cellular recycling process that occurs in all human cells, Delaney explained. Although the drugs in question – hydroxychloroquine, nelfinavir, metformin, dasatinib and sirolimus – were developed to treat, respectively, malaria, HIV, Type 2 diabetes and chronic myeloid leukemia and to prevent organ rejection in kidney transplant patients, what they all have in common is that they affect this cellular recycling process.

    “All the drugs on this trial affect autophagy in one way or another. Even though they were originally designed for these other diseases, we’ve learned from the decades of studying them that they actually impact this process of autophagy, which all human cells have,” Delaney said. “That’s true of our normal cells. And that’s also true of cancer cells. It’s just that the cancer cells cannot perform that recycling nearly as well as our normal cells can. And so, to us, that was our therapeutic window.”

     

      This slide illustrates Delaney's concept for utilizing the effect on autophagy by drugs already approved to treat other conditions.

    The National Cancer Institute encourages researchers to look into repurposing approved drugs, Lilly said. Already approved drugs have established safety records, whereas many potential new cancer drugs fail in early trials because they’re too toxic, Delaney said.

    Repurposed drugs, on the other hand, have already been used by potentially millions of patients. “It really puts you many years ahead in the developmental pathway,” Lilly said.

    In a paper published in June in Frontiers in Toxicology, Delaney showed that 14 doses of these five drugs were less toxic than Doxil, a chemotherapy drug used to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi’s sarcoma. Now, the phase 1 trial will show safety levels in humans.

    “We’re really enthusiastic that this might be that opportunity to try multiple drugs,” Delaney said. “Since we started from that side effect profile to begin with, hopefully we have something that has much less toxicity. And of course, we’ll be finding out in the coming months if that’s actually true or not.”

    The drugs will be tested in a series of various combinations. Previous studies of drugs that target autophagy have mostly focused on adding one autophagy drug to a chemotherapy regimen or immunotherapy regimen, Lilly said. By combining multiple autophagy-targeting drugs, this trial hopes to identify a combination that prevents the cancer cells from evolving resistance to the drugs.

    “We have very good evidence that it’s a synthetic lethal combination for cancer cells, which is what everybody in cancer wants, but it’s just never been tried in people before. And so, we’re really excited to see this combination in a cancer setting,” Delaney said.

    Synthetic lethality refers to when mutations in two genes together result in cell death, but a mutation in only one of the partner genes does not.

    This human trial is a result of work in the lab that was funded by both the National Cancer Institute and donor Matt Prisby, who established a fund at Hollings for research into women’s cancers after his wife died of cervical cancer in 2014.

    “This trial couldn’t have happened without Matt Prisby and everyone who donated to his fundraisers,” Delaney said. “Dedicated funding programs like the one he established at Hollings are critical for investigators to get the early results that will convince large funding entities to invest in continued research along these lines.”

    Delaney also hopes that a combination of these drugs will prove effective for a broad swath of patients. Operating within the concept of precision oncology, researchers have been looking for ways to target mutations in patients whose tumors have been sequenced. Yet fewer than 10% of patients are eligible for precision therapy, Delaney said, referring to an area of medicine that uses information about a patient’s own genes to develop specific treatments that, in terms of cancer, target that individual’s tumor.

    This trial targets aneuploid gene changes – an extra or missing chromosome – which is common in cancer cells, ranging from 20% to 95% in advanced solid tumor patients.

    “If it works, many, many more patients could be eligible than for other targeted therapies,” Delaney said.

    The phase 1 trial is accepting patients with an advanced solid tumor of any type. Once the trial moves to phase 2, the researchers will focus on specific cancer types. Lilly said early indications are that these drugs might be particularly effective against ovarian and prostate cancers.

    Lilly, who treats patients with prostate cancer and runs his own lab focused on advanced prostate cancer, said that this collaboration with Delaney would only be possible at an academic cancer center like Hollings, where researchers work alongside the doctors who provide care to patients. Delaney and Lilly, each with their own areas of expertise, can share ideas, and patients have access to early trials like this.

    “Sherlock Holmes once referred to bits of data as having cumulative force when you have three or four different things, each of which points in the same direction,” Lilly said. “And that’s the power of collaborative research at Hollings.”

    The first video shows high-grade serous ovarian cancer cells grown in the lab and labelled with fluorescent proteins to measure how the molecular recycling process of autophagy is working in live cells.

    When the movie starts, the cells had just begun a treatment of a version of COAST therapy. As the movie progresses, the cells try to turn on autophagy in response to these COAST drugs - they fluoresce brighter.

    However, properly recycling autophagy would fluoresce red, whereas these cells fluoresce yellow, indicating their recycling system is jammed and cannot complete its function. As a result, these cancer cells accumulate too much cellular debris and pop, as seen by a sudden darkening of a single cell.

    The second video shows high-grade serous ovarian cancer cells grown in the lab and labelled with fluorescent proteins that label the nucleus of each cell in both green and blue.

    In the center top of the start of the movie, a cancer cell physically latches onto another cancer cell. Astonishingly, the cell is able to absorb the blue nucleus of this attached cell, thereby adding a whole extra genome to its own genome in the process. This is a live observation of one reason why cancer cells can evolve to resist chemotherapy: once they acquire that second genome, it is easier to shuffle genes around in a way that optimizes cancer cell growth.

  • sam patrick posted an article
    Aims to improve access, engagement and participation of people with disabilities see more

    Bristol Myers Squibb (NYSE:BMY) today announced, in collaboration with Disability Solutions, a U.S.- based non-profit organization that supports companies globally to achieve true disability inclusion, the launch of the Disability Diversity in Clinical Trials (DDiCT) initiative. This new initiative aligns with Bristol Myers Squibb’s broader inclusion and diversity health equity commitments to address health disparities, clinical trial diversity, supplier diversity, employee giving, and workforce representation between 2020 and 2025.

    The DDiCT initiative initially aims to make recommendations on how to effectively improve access, engagement, speed of enrollment, and participation of people with disabilities in clinical trials, to ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies. This project was initiated by the Bristol Myers Squibb People & Business Resource Group DAWN (Disability Advancement Workplace Network) and will be co-led by DAWN and the Global Drug Development Team.

    "Through this work, Bristol Myers Squibb can set the standard and stage for access to life-changing and life-saving medicines for people with disabilities,” said Samit Hirawat, M.D., executive vice president and chief medical officer, Global Drug Development, Bristol Myers Squibb. “The long-term goal of our DDiCT program is to develop and pilot trials that are accessible to the widest variety of patients.”

    Current common clinical trial practices exclude up to one-fourth of the U.S. population-based on disability status. According to a study published in the Journal of the American Medical Association, in 338 phase III and IV studies, 12.4% of people with intellectual or developmental disabilities and 1.8% of those with physical disabilities failed to be included due to explicit exclusion criteria. The study also identified that additional barriers for disability diversity within clinical trials are caused by inaccessible trial sites, medical equipment, and ableist biases which deter this community from receiving potentially life-saving treatments.

    “People with disabilities are omitted from conversations about diversity and inclusion, despite being the largest underrepresented group in the world and the only underrepresented group anyone can join at any given moment. Therefore, it’s essential that we broaden the scope of medical trials and research,” said Tinamarie Duff, DAWN Global People & Business Resource Group Lead, Bristol Myers Squibb. “The launch of the DDiCT, especially during Disability Pride Month, supports Bristol Myers Squibb’s overall commitment to address every dimension of diversity, which means making the most effective medicine to include people with disabilities at all stages of access/trials.”

    About Bristol Myers Squibb

    Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us LinkedInTwitterYouTubeFacebook, and Instagram.

    About Disability Solutions

    Disability Solutions is a division of Ability Beyond and works directly with forward thinking and inclusive companies who have identified the value of being inclusive of people with disabilities in all facets of their organization. Disability Solutions works with more than 60 companies globally to drive true disability inclusion. Their motto is “Changing Minds and Changing Lives”. Disability Solutions understands that when corporate leaders engage with the value and humanity the disability community brings forward, they will be able to drive life-changing – and in this case – life-saving change which will echo across the world. You can learn more about Disability Solutions at www.disabilitytalent.org.

    About Disability Solutions Parent Company: Ability Beyond, Inc. is a nonprofit 501(c)3 organization whose mission is to provide health and human services to adults with disabilities throughout Connecticut and Westchester County, NY. Founded more than 60 years ago, Ability Beyond has its headquarters in Bethel, CT, and Chappaqua, NY. Ability Beyond employs 1,200 people and has an annual budget of $71,000,000. Jane Davis, President/CEO, and her Executive Team manage the agency, with oversight from the Ability Beyond Board of Directors. Major revenue sources include Medicaid, Medicare, government contracts, fees for service, and philanthropic support. You can learn more about Ability Beyond at www.abilitybeyond.org.

  • sam patrick posted an article
    Excellent Safety and Tolerability Profile for iNexin™ for the Treatment of Corneal Injury see more

    Xequel Bio, Inc., a clinical stage biopharmaceutical company developing ophthalmic and dermatologic therapeutics utilizing its patented new chemical entity aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide), announced positive results from its Phase 1b clinical trial with iNexin™ (aCT1 ophthalmic solution) for the treatment of corneal injury in patients with dry eye disease. The study demonstrated that iNexin was safe and well-tolerated at the doses tested, and early efficacy signals were observed.

    This Phase 1b trial was a single-center, randomized, double masked, vehicle-controlled clinical study to assess the safety and exploratory efficacy of iNexin for the treatment of corneal injury in patients with dry eye disease. There were no serious adverse events or dose-limiting toxicities associated with iNexin treatment. Improvements in both signs (e.g., corneal staining) and symptoms (e.g., ocular discomfort) of dry eye disease were observed within two weeks of treatment in both the environment and Ora’s controlled adverse environment (CAE®) model, which exacerbates signs and symptoms of dry eye disease in a safe and standardized manner for greater precision in predicting treatment efficacy.

    “These results support our belief that iNexin, our novel aCT1 ophthalmic solution, has the potential to improve patient outcomes by regulating the inflammatory response to promote improved ocular healing,” said Jerry St. Peter, Chief Executive Officer. “We are extremely pleased that the key goals of this study were met, providing clinical evidence of safety, tolerability, and also early signs of efficacy in patients with corneal injury. This data provides a strong basis to further refine our therapeutic focus and dosing regimen as we progress our ophthalmic development program, including designing our Phase 2 clinical trial.”

    Dr. Gail Torkildsen, MD, board certified ophthalmologist at Andover Eye Associates, said, “This study provides an initial look at the safety, tolerability, and potential biological activity of iNexin in treating dry eye disease, with a mechanism of action suggesting additional application in treating ocular injury and inflammation. The results are encouraging and indicate the potential for aCT1 to restore Connexin43, which plays a critical role in the inflammatory cascade. iNexin could represent an innovative solution to treat patients with corneal injuries by promoting healing and rebuilding healthy tissue through accelerated re-epithelialization.”

    This Phase 1b trial was a single-center, randomized, double masked, vehicle-controlled clinical study to assess the safety and exploratory efficacy of iNexin compared to Vehicle in patients with dry eye disease. A total of 36 participants, with a subject-reported history of dry eye disease in both eyes, were enrolled and randomized in a 2:1 allocation for each of three concentrations of iNexin (0.08%; 0.4%; 2.0% aCT1) to Vehicle (eye drop formulation without aCT1), administered bilaterally twice a day for 14 days. The primary objective of the trial was to evaluate the safety and tolerability of iNexin. The secondary objective was to compare the efficacy of iNexin to Vehicle for the treatment of the signs and symptoms associated with dry eye disease.

    This trial was managed and monitored by Ora, Inc., a leading full-service ophthalmic drug and device development firm, and was supported by the Department of Defense Defense Health Program, Congressionally Directed Medical Research Program through Vision Research Program Award W81XWH-20-1-0879.

    About Xequel’s aCT1 Technology Platform

    Xequel Bio’s aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) technology platform is designed to develop drugs that will enable physicians to better manage a variety of indications involving inflammation and the body’s response to injury. aCT1 is a patented new chemical entity, based on the C-terminal sequence of Connexin43, designed to selectively and reversibly inhibit protein binding of endogenous Connexin43 to key binding partners. Connexin43 plays critical roles in multiple aspects of the injury response, including spread of injury signals, extravasation of immune cells, granulation tissue formation and fibrosis. aCT1’s unique, targeted mechanism of action has been demonstrated to restore the coordination of cellular communication, reinforce junctional integrity and temper excessive inflammatory responses in injured tissues for optimal injury response and tissue repair. aCT1 is currently in clinical development for multiple indications across dermatology and ophthalmology, as well as in ongoing preclinical research in pulmonology.

    About Xequel Bio, Inc.

    Xequel Bio, Inc. is a clinical stage biopharmaceutical company advancing its proprietary aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) technology platform to develop drugs that will enable physicians to better manage a variety of indications involving inflammation and the body’s response to injury. aCT1 is a patented new chemical entity currently in development for multiple indications. The Company’s lead clinical programs include Granexin® gel in dermatology and iNexin™ ophthalmic solution in ophthalmology. The Company also has ongoing preclinical research in pulmonology. For more information, please visit www.xequel.com.

    About Ora, Inc.

    Ora is the world's leading full-service ophthalmic drug and device development firm. For over 40 years, their expert teams have proudly helped clients across the globe earn more than 55 product approvals. Ora's unique methodologies and strategies have been proven across thousands of programs to maximize the likelihood of success and efficiently bring new products from concept to market. For more information, please visit www.oraclinical.com.

  • sam patrick posted an article
    Kiyatec invited to present at prestigious conference see more

    Kiyatec, a leader in functional precision oncology, announced new clinical evidence of its proprietary ex vivo 3D cell culture technology use in high-grade glioma will be presented at ASCO 2022. As a first-time ASCO presenter and exhibitor, Kiyatec will present its Clinical Services and Drug Development Services capabilities at ASCO’s first-ever Innovation Hub at kiosk #IH01. The ASCO meeting will be held in Chicago June 3-7, 2022.

    In this updated cohort of 42 patients with high grade glioma, 3D Predict™ Glioma prospectively predicted patient response to standard of care temozolomide (TMZ), regardless of MGMT methylation status. In a subgroup analysis of the 23 MGMT unmethylated patients, test-predicted responders had a relative median progression-free survival advantage of 5.9 months versus test-predicted non-responders (p = 0.0018). This data provides additional evidence of 3D Predict™ Glioma predictivity and its potential to provide additional information for glioma patient treatment options including clinical trial enrollment, alternative therapies indicated for use in glioma or combination therapy with TMZ.

    Kiyatec Chief Executive Officer Matthew Gevaert, PhD, said, “This enhanced cohort adds to our body of clinical evidence demonstrating the predictive insights 3D Predict™ Glioma can provide to neuro-oncologists planning treatment for glioblastoma patients. With it, we’ve advanced our mission is to disrupt cancer care by accurately predicting patient-specific response and non-response before treatment begins.”

    High grade gliomas, including glioblastoma, are among the most aggressive brain cancers, with patients exhibiting highly variable treatment responses in both newly diagnosed and recurrent disease. TMZ with radiation therapy is the guideline-directed standard of care in the newly-diagnosed setting, which has remained relatively unchanged for over 15 years despite variable patient responses.

    Kiyatec’s ex vivo KIYA-Predict™ pre-clinical platform and 3D Predict™ clinical assays are leading the functional precision oncology space with published, clinically-correlated evidence to prospectively predict glioma patient therapeutic response prior to initiation of therapy.

    Clinical application of a functional 3D ex vivo test to predict therapeutic response in patients with HGG: A progression-free survival analysis
    Central Nervous System Tumors
    Sunday June 5 8:00 – 11:00am
    Abstract ID 2031

    About Kiyatec

    Kiyatec is a functional precision oncology company that measures the response of each patient’s live cancer cells to inform oncologists’ treatment selection decisions. The company’s Clinical Services offers clinical testing for high-grade glioma, and is developing assays for use in ovarian, breast, non-small cell lung cancers, and rare tumors in its CLIA-certified lab. The company’s Drug Development Services works in partnership with leading biopharmaceutical companies to unlock response dynamics for their pre-clinical investigational drug candidates across the majority of solid tumor types. For more information, visit www.kiyatec.com and connect with us on LinkedIn and Twitter.

  • sam patrick posted an article
    Xequel, formerly First String Research, adds top executives see more

    Xequel Bio, Inc. (formerly FirstString Research, Inc.), a clinical stage biopharmaceutical company developing dermatologic and ophthalmic therapeutics utilizing its patented new chemical entity aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide), announced today the appointments of Jerry St. Peter as Chief Executive Officer and Wes Brazell as Chief Financial Officer.

    “As we embark on a new corporate phase focused on clinical development and approval of novel treatments, we have brought in two seasoned executives, Jerry St. Peter, and Wes Brazell, to lead these efforts,” said Tony Bartsh, Chairman of Xequel’s Board of Directors and partner at Park West Asset Management. “Jerry’s proven track record in building successful, fully integrated biopharmaceutical companies, partnered with Wes’ financial management and operations expertise, provide the right combination to design and execute our strategic transformation. Both Jerry and Wes bring extensive corporate leadership, business development execution and entrepreneurial acumen to Xequel. With these exciting leadership appointments, we have also rebranded the organization from FirstString Research to emphasize our emergence as a growing biopharmaceutical company in late-stage clinical development.”

    “It is a pleasure to join Xequel at such a pivotal moment in its evolution,” said Jerry St. Peter, Chief Executive Officer and Board Member. “Our talented team of scientists and clinical development professionals have established a cutting-edge technology platform culminating in a robust pipeline of product candidates backed by strong preclinical and clinical research. We have also created a strong corporate identity under the Xequel Bio name, reflecting our strategic move into the Company’s next chapter.”

    “Our proprietary aCT1 technology platform provides tremendous opportunity to address unmet needs for patients in dermatologic and ophthalmic treatments. We have multiple, novel late-stage programs with near-term inflection points as well as preclinical research in other valuable target disease states. Wes and I look forward to working with our dedicated team to implement our growth plan, advance our pipeline, deliver meaningful patient outcomes and successful business results,” concluded Mr. St. Peter.

    The Company is in the process of developing a new corporate website and updated social media accounts reflecting the Xequel Bio name.

    Jerry St. Peter, Chief Executive Officer and Board Director

    Jerry St. Peter brings over 30 years of specialty biopharma executive leadership implementing strategic planning, commercial operations, financial management, fundraising, business development, and overall general management. Prior to joining Xequel, Mr. St. Peter was the Chief Executive Officer and President of Eyevance Pharmaceuticals (a Santen Company), a global ophthalmic company focused on serious, unmet treatment needs by developing innovative solutions that protect and restore vision. Mr. St. Peter was Co-founder, Chief Executive Officer, and Board Member of Eyevance Pharmaceuticals prior to its acquisition by Santen for $225 million in 2020. Established in 2017, Eyevance was a private equity backed venture solely focused on ophthalmic diseases that affect millions of patients every day. Prior to co-founding Eyevance, Mr. St. Peter was the Senior Vice President and Head of Sun Pharmaceuticals’ newly formed Ophthalmics division. Before Sun, he was the Executive Vice President and General Manager for Nicox’s Ophthalmic business in the United States and formerly served as the Senior Vice President and Head of the Ophthalmic division at Inspire Pharmaceuticals before Merck acquired Inspire for $450 million in 2011.

    Wes Brazell, Chief Financial Officer

    Wes Brazell brings three decades of leadership and expertise in pharmaceuticals and medical devices with broad experiences in operations management, financial management, business development, portfolio management, corporate finance, international operations and corporate strategy. Prior to joining Xequel, Mr. Brazell was Chief Financial Officer for Eyevance Pharmaceuticals, a private equity backed pharmaceutical company which was acquired by Santen for $225 million in 2020. Prior to Eyevance, Mr. Brazell was the Chief Financial Officer of TearLab, a NASDAQ-traded company focused on the marketing and development of tear related diagnostic products. Mr. Brazell previously spent 21 years in multiple financial management positions with Alcon, a multi-billion-dollar ophthalmology focused pharmaceutical and medical device company, including Vice-President of Finance for Alcon’s business in the United States, Vice-President of Finance for Alcon’s Europe, Middle East and Africa business as well as Vice-President of Corporate Financial Planning and Analysis.

    About Xequel’s aCT1 Technology Platform

    Xequel Bio’s aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) technology platform is designed to develop drugs that will enable physicians to better manage a variety of indications involving inflammation and the body’s response to injury. aCT1 is a patented new chemical entity, based on the C-terminal sequence of Connexin43, designed to selectively and reversibly inhibit protein binding of endogenous Connexin43 to key binding partners. Connexin43 plays critical roles in multiple aspects of the injury response, including spread of injury signals, extravasation of immune cells, granulation tissue formation and fibrosis. aCT1’s unique, targeted mechanism of action has been demonstrated to restore the coordination of cellular communication, reinforce junctional integrity and temper excessive inflammatory responses in injured tissues for optimal injury response and tissue repair. aCT1 is currently in clinical development for multiple indications across dermatology and ophthalmology, as well as in ongoing preclinical research in pulmonology.

    About Xequel Bio, Inc. (formerly FirstString Research)

    Xequel Bio, Inc. is a clinical stage biopharmaceutical company advancing its proprietary aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) technology platform to develop drugs that will enable physicians to better manage a variety of indications involving inflammation and the body’s response to injury. aCT1 is a patented new chemical entity currently in development for multiple indications. The Company’s lead clinical programs include Granexin® gel in dermatology and iNexin™ ophthalmic solution in ophthalmology. The Company also has ongoing preclinical research in pulmonology. For more information, please visit www.xequel.com.

    Source: Xequel Bio, Inc.

  • sam patrick posted an article
    Long term impacts of COVID-19 across the health care spectrum are still to be determined see more

    12.02.2021

    Clinical research is one of the foundations of the Life Sciences industry as it involves the scientific investigation and treatment of diseases and other medical conditions in order to improve medical knowledge related to the diagnosis, treatment, and prevention of such diseases and medical conditions. Clinical research is the underlying process that results in the development of ground breaking new drugs and treatments that cure or treat diseases that improve all of our lives. One of the best and most recent examples of the importance of clinical research is the development of vaccines for the COVID-19 virus which to date has taken the lives of over 5 million people across the globe since early 2020.

    The impact of the COVID-19 pandemic on the clinical research industry has been profound and in some respects may prove to be an inflection point for the Life Sciences industry.

    The COVID-19 pandemic created massive disruption within the world of clinical research. In 2020, over 79% of ongoing clinical trials were disrupted in one way or another by COVID-19[1]. The disruptions ranged from stopping ongoing trials, pausing recruitment of ongoing trials and pausing the development of new clinical study sites[2]. Enrollment in clinical trials dropped dramatically during the early stages of the pandemic as potential participants were reluctant to make trips to hospitals or other research sites. In addition, many investigators, sub-investigators, and research staff had to shift focus to COVID related support instead of working on clinical research efforts.

    Beyond the disruption to existing clinical research studies, however, COVID-19 has had other impacts on the clinical research industry that could have a potentially positive impact on how clinical research is conducted in the future.

    COVID-19 Resulted in an Acceleration of the Clinical Research Process

    When faced with the rapidly spreading COVID-19 virus, pharmaceutical companies and governments collaborated to accelerate the clinical research process in order to develop a vaccine that would work against COVID-19. Previously, the fastest a vaccine had been developed in the U.S. was four years when the vaccine for the mumps virus was developed in the 1960s[3]. In light of the global health emergency created by the COVID-19 pandemic, researchers were able to reduce the normal time to arrive at a vaccine by years. How was this done? One of the reasons for the rapid development of the COVID-19 vaccine was the years of prior research on vaccine development for other viruses, like HIV[4]. Researchers were also able to quickly determine the specific genetic makeup of the SARS-COV-2 virus by early 2020 and they used technology from RNA-based templates to develop a potential vaccine[5]. Another important factor in streamlining the development for the COVID-19 vaccine was the hundreds of thousands of people who volunteered to participate in the clinical studies for the vaccine development. In addition, the U.S. Government implemented Operation Warp Speed which provided very large government contracts and research grants to pharmaceutical companies to research and produce vaccines. The U.S. Government also had the FDA advance all COVID-19 vaccine clinical research studies to the front of the regulatory approval line through the use of emergency use authorizations (EUAs). This lead to the development of multiple COVID-19 vaccines that were ready for mass distribution within 1 year of the identification of the COVID-19 virus, which is a remarkable accomplishment. The FDA also used EUA to expedite other responses to COVID-19 by approving new testing and additional sources and types of personal protective equipment (“PPE”). The development and distribution of the vaccine was a groundbreaking accomplishment that reflected the resilience and innovation of the clinical research industry. According to some clinical researchers, the rapid creation of COVID-19 vaccines is “a sea change in how to develop vaccines in the future[6].”

    As we continue to work through the COVID-19 pandemic, it remains to be seen how much faster future clinical research studies will be accelerated in the future based on our COVID-19 clinical research experience. The FDA is under both political and media pressure to accelerate its approval process because of the COVID-19 experience and the clinical research industry is looking at its normal processes to determine if things can and should be done in a different way in order to streamline and accelerate the overall process while at the same time maintaining safety and scientific integrity.

    A New Focus on the Clinical Research Participant

    Another potential change in clinical research that was caused in part by COVID-19 is an effort by clinical trial sponsors to focus more on the clinical trial participant and their experience during the clinical trial. This includes trying to reduce the administrative burden on clinical trial participants and making the process simpler and easier for participants to navigate. Clinical trial sponsors are also evaluating trials with more of a focus on quality of life for the participants and increasing the use of patient support groups or patient advocates so it is easier for clinical trials to recruit new participants and to keep the participants engaged throughout the life of the clinical trial[7].

    Use of More Decentralized Clinical Research

    A decentralized clinical trial (DCT) is defined as a clinical study executed through telemedicine and mobile /local healthcare provider processes and technologies that brings the trial’s activities to the patient at home rather than using the traditional model of bringing patients to a trial site[8]. Because much of the world was in lockdown mode to deal with the implications of COVID-19, clinical researchers increased the use of DCTs during 2020. This included the use of more virtual encounters and technology to connect clinical trial participants with the investigators. It is anticipated that this will occur more in the future as researchers can gather better data when it is easier for patients to report the data. With DCTs, patients can report data via their smart phone or tablets from home instead of having to be physically present at a clinical research site[9]. Use of DCTs is also seen as a successful tool in recruiting the appropriate patient populations by  increasing both access to clinical trials and the overall diversity of trial participants[10].  Having a diverse group of clinical trial participants can help ensure that the drug or device being tested is safe and effective[11].

    Increased use of Digital Technology

    The use of digital technology by patients and participants in clinical trials has steadily increased over the last several years. During COVID-19 and with the increase in DCTs, the use of mobile devices such as smart phones or tablets, digital wearables or other types of biosensors have steadily increased[12]. The use of this digital technology provides clinical researchers with access to continuous data for longer periods of time and it is easier for clinical trial participants to use this technology on a daily basis without disruption to their daily lives. The use of digital technology has also increased the opportunity for clinical trial sponsors to obtain real-world data (RWD) and real-world evidence (RWE) from clinical study participants. This result stemmed in part from the FDA’s launch of a program focused on the increased use of RWD and RWE[13]. This kind of information has been used to support clinical trial designs and studies to generate innovative approaches to clinical studies[14].

    Is there a silver lining from COVID-19 when it comes to clinical trials?

    The long term impacts of COVID-19 across the health care spectrum still remain to be determined, but one of the short term impacts of this global pandemic could prove to be potentially significant and positive changes in the way that the clinical research industry operates. These changes could lead to a faster clinical research process that embraces the use of new technology such as digital therapeutics and development of a broader and more diverse base of clinical participants.

    For a look at the regulatory framework for clinical trials in the life science industry and the risks faced by companies within the industry – including a discussion of potential future changes caused by the pandemic – watch Nexsen Pruet’s on-demand webinar, “Understanding Clinical Research Framework and Challenges in the Life Sciences Industry,” presented by Matthew Roberts of Nexsen Pruet and Rakel Meir of Biogen.

  • sam patrick posted an article
    Clemson researchers pursue cutting-edge science and targeted medicine to improve lifespan, quality see more

    In the last 25 years, rigorous research, broad medical collaborations and lifesaving interventions have made huge strides for cancer treatment. That means survival rates are up across the board for almost all forms of cancer, including the two most common ones for South Carolinians: breast and prostate cancer.

    As recently as the late 1990s, there were clinical trials, and there were heroic efforts, but there were very few effective treatments for combatting some of the most highly aggressive forms of cancer. Twenty-five years later, some of those same cancers have a more than 80 percent survival rate. 

    Clemson can point to health innovation through research that has played notable roles in improving health outcomes for patients statewide. And that’s because cancer intervention isn’t isolated to bedside care from a nurse or petri-dish analysis from the lab.

    Today, cancer treatment is:

    • Powered by huge data sets that build the artificial intelligence needed to identify root causes of and precision cures for cancer. 
    • Innovative approaches, such as precision radio frequency that targets cancer cells rather than an IV drip administering chemotherapy drugs.  
    • Cellular research to develop new methods of finding and eliminating cancer faster, more safely and more efficiently. 
    • Identifying and preventing the side effects of treatment drugs and improving quality of life for patients even as they and their health care teams aggressively fight cancer. 

    Read the rest of this article by clicking here.

  • sam patrick posted an article
    Investment from large investors attracted into SMO industry see more

    Velocity Clinical Research ("Velocity") today announces it has acquired two multi-site companies, VitaLink Research ("VitaLink") and the National Research Institute ("NRI"), for an undisclosed amount. The double acquisition adds 11 sites to Velocity's existing 18, making it the largest fully integrated site management organization in the world and signaling the next phase in the evolution of the industry.

    South Carolina-based VitaLink Research operates a network of six (6) sites in the central and western part of the state, including the Greenville/Spartanburg corridor. California-based National Research Institute has five (5) facilities in the greater Los Angeles area. The combination of VitaLink and NRI will further boost Velocity's therapeutic reach and recruiting power. Velocity's goal to reach more minority populations is particularly enhanced through NRI's Los Angeles-area locations and bilingual staff.

    Dr G. Paul Evans, Chief Executive and President of Velocity Clinical Research, said: "Velocity has moved into the next phase of its development. We have accelerated the pace of site acquisitions this year, bringing VitaLink and NRI's experience into our fully integrated site network.

    "When consolidators start buying up the consolidators, it signals a maturing market. The clinical trials site landscape is going to look very different a year from now. We anticipate most of the large site organisations will change ownership in the coming months, as large investors take an increased interest in the sector."

    Velocity will provide additive business development effort and streamlined service delivery to VitaLink and NRI, which have already demonstrated they can perform well in high volume studies. Combined, the companies will multiply their strengths with enhanced therapeutic expertise and shared operational functions. Prior to acquisition, Velocity, VitaLink, and NRI independently enrolled over 10% of the COVID vaccine volunteers in the U.S.

    Evans added: "Patient recruitment is a key factor in speeding up drug development. The site management industry attempted to consolidate back in the 90s but this time, it's different. The focus now is on site integration rather than affiliation, allowing for greater control and leading to more efficient data collection and delivery.

    "The race to find a COVID vaccine provided impetus to speed up clinical research and demonstrated the benefit it has in getting drugs to market faster. Our goal is to offer big pharma companies access to a range of integrated sites that have a range of therapeutic capabilities through one single contact point, making site selection easier. This will ultimately change the way pharmaceutical companies approach global drug development and the reason why we believe more capital is flowing into the sector now."

    Management from both companies will occupy key roles within Velocity, strengthening its senior management bench. Steve Clemons, CEO of VitaLink, is Velocity's new SVP of Client Delivery. Samira Moran, CEO of NRI, is Velocity's new SVP of Specialist Care Delivery.

    All of Velocity's sites are fully integrated via a centralized infrastructure and common technology backbone, allowing for superior patient enrollment and consistent, high quality data delivery.

    Notes to editors:

    • A full list of Velocity's sites can be found on its website.
    • Velocity has extensive experience in vaccines, general medicine, neurology, dermatology, endocrinology, gastroenterology, and women's health.

    About Velocity Clinical Research

    Velocity Clinical Research, headquartered in Durham, NC, is the leading integrated site organization for clinical trials, offering dedicated site capabilities to help biopharmaceutical and contract research organization customers find the right patients for their studies. Velocity supports global drug development in primarily conducting phase II and phase III clinical trials. The company has 30 U.S. locations across 14 states.

    We place the care of the patient at the heart of everything we do. With over 35 years of experience running sites and more than 7000 studies completed, Velocity has refined its patient recruitment strategies while maintaining a focus on delivering timely and reliable data quality. For more information visit our website at https://velocityclinical.com.

    About VitaLink Research

    Founded in 2004, VitaLink has six dedicated sites in South Carolina: Greenville, Spartanburg, Union, Gaffney, Anderson, and Columbia. They specialize in vaccines, dermatology, respiratory and pulmonary diseases, women's health, and internal medicine, with over 31,000 volunteers in their database. https://vitalinkresearch.com

     September 24, 2021
  • sam patrick posted an article
    Expanded use of test builds on previous month’s publication of successful interim clinical data see more

    Functional precision oncology innovator Kiyatec announced today that it is initiating use of the 3D Predict™ Glioma test outside of its 3D-PREDICT clinical study. Recently published peer-reviewed data demonstrated successful use of this test for patients with either newly diagnosed or recurrent high-grade gliomas, which includes glioblastoma (GBM).

    In choosing July 21, 2021, to announce the expanded use of its test, KIYATEC joins the country in shining a light on glioblastoma, which is the most common, treatment-resistant, and deadliest type of brain cancer. A recent bipartisan U.S. Senate resolution declared today as Glioblastoma Awareness Day in order to highlight the severity of GBM, and show support for individuals who are currently living with GBM, as well as caregivers and families. Additionally, the resolution encourages continued investment into glioblastoma research and treatments.

    “At the core of KIYATEC’s mission is the desire to improve cancer patients’ lives. We’re excited to take the next step in fulfilling this mission by expanding the use of our testing for patients with GBM, which is such an aggressive cancer with few treatment options,” said Lillia Holmes, Chief Operations Officer at KIYATEC.

    In a patient, the biological interaction between their live cancer cells and the administered therapy drives treatment outcomes. Measurement of this interaction, before prescribing a treatment plan, is not typically part of today’s cancer treatment paradigm. KIYATEC’s test results add this measurement into the information that informs oncologists’ treatment decisions for a given patient. This approach translated to patient benefit while demonstrating clinically relevant accuracy, as documented in the June Neuro-Oncology Advances publication.

    The 3D Predict™ Glioma test is designed to work within the current framework of standard of care for high-grade glioma patients. Since live cells are required for the test, a patient’s oncologist must sync sample submission with the timing of the first surgery for newly diagnosed patients, or recurrent surgeries for relapsed patients. Oncologists interested in the potential use of the test to inform their decision-making, or requesting test kits to provide samples, should contact the company at medical.affairs@kiyatec.com.

    “Our goal is to provide oncologists with a more effective decision-making tool, by combining individual patient’s cancer cells with potential treatment drugs,” said Stephen Shuford, first author on the company’s recent Neuro-Oncology Advances publication.

    The Senate resolution recognizes that:

    • The five-year survival rate for GBM patients is 7%,
    • The median length of survival is 8 months,
    • Approximately 13,000 Americans will be diagnosed with GBM in 2021,
    • Brain cancer has the highest per-patient initial cost of care, and
    • Despite being first described over a century ago, there are only four FDA approved drugs and one device for GBM.

    KIYATEC aims to make a meaningful impact for patients who are facing this challenging cancer.

    About KIYATEC

    KIYATEC is a functional precision oncology company that measures the response of each patient’s live cancer cells to inform oncologists’ treatment selection decisions. The company’s Clinical Services business offers or is developing clinical tests for high-grade glioma, ovarian, breast, and non-small cell lung cancers, and rare tumors in its CLIA-certified lab. 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.

  • sam patrick posted an article
    Life sciences booming in Spartanburg, Upstate see more

    Spartanburg County – and the entire Upstate – are welcoming a growing interest and investments from life sciences companies. The Upstate has a long-established history and infrastructure that have supported life sciences companies with raw materials, production and packaging operations, and distribution.

    Now, new research and innovation businesses are further supporting industry growth and fueling an ecosystem ripe for start-ups.

    More than 670 life sciences firms of all sizes call the Upstate home, with 13 companies announcing new locations in the area in the last few years.

    The newest of those companies in Spartanburg is Epica International, the leader in advanced, ultra-high-resolution mobile medical imaging and robotic applications for human and animal health, and industrial enterprises.

    The company announced its headquarters and operations in Spartanburg, covering its subsidiary companies Epica Human Health, Epica Animal Health and Roboticom. Epica established corporate, imaging and robotic system demos at its facility, currently located inside the Spark Center SC on the Tyger River Campus of Spartanburg Community College.

    “Epica’s investment in Spartanburg goes hand-in-hand with a diversified economic development strategy we’ve put in place countywide, targeting specifically investments from bioscience and life sciences industries,” said OneSpartanburg, Inc. Chief Economic Development Officer Katherine O’Neill. “These types of advanced, heavy-technology industries coming to our county gives us a considerable strategic advantage for future development and job growth.”

    Another life sciences company – Pall Corporation – announced its intent to invest in Spartanburg County earlier in 2021. Pall announced its Spartanburg County operations would create 425 new jobs and $30.2 million in investment.

    Pall serves the needs of customers across the broad spectrum of life sciences and industry and works with clients around the world to advance health, safety and environmentally responsible technologies. The company’s Spartanburg facility supports the rapid development of vaccines and therapeutics, including COVID-19 vaccines.

    "Spartanburg County provides Pall with the diverse workforce we need to manufacture life-saving therapeutics and vaccines. We look forward to building our presence in this county,” said Pall Life Sciences President Joseph Repp at the time of the company’s announcement.

    Statewide, South Carolina has a significant presence in the medical device sector. And the manufacturing supply chain is robust when it comes to life sciences, mirroring the strength of the area’s overall manufacturing prowess.

    From 2015-2019, medical devices and equipment companies added 35% more jobs and accounted for 11.5% of the new companies coming to the Upstate. And on top of that, more than 700 clinical trials are being undertaken across the Upstate at any given time in the fields of oncology, companion diagnostics, genetics and more.

    The Upstate in particular has a network of acclaimed hospitals, technical training schools and more than 26 colleges and universities actively working with industry leaders and educators on all levels to ensure access a highly-skilled workforce for decades to come.

    “Spartanburg’s historic advantages when it comes to infrastructure, distribution capabilities and even the county’s location, make it a favorable home for continued investments from biosciences and life science industries,” said O’Neill. “That positions us well for the future as these industries continue to bring higher-wage, knowledge-based jobs to Spartanburg.”

  • sam patrick posted an article
    Validated platform with clinically actionable results creates real possibilities to improve care see more

    Validated platform with clinically actionable results creates real possibilities to improve care for glioblastoma (GBM) and other high-grade glioma patients

     

    GREENVILLE, S.C. – June 17, 2021 – KIYATEC, Inc. announced today the publication of new peer-reviewed data that establishes clinically meaningful prediction of patient-specific responses to standard of care therapy, prior to treatment, in newly diagnosed glioblastoma (GBM) and other high-grade glioma (HGG) patients. The results, the interim data analysis of the company’s 3D-PREDICT clinical study, were published June 16, 2021 in Neuro-Oncology Advances, an open access clinical journal.

    A goal of the study, which continues to enroll, was for the test’s prospective, patient-specific response prediction to achieve statistical significance for predictive accuracy. The 3D-PREDICT study met this goal early, at its interim data analysis, an achievement that is uncommon for innovations in oncology. For clinicians and payors, the publication establishes the successful analytical validation and early clinical validation of KIYATEC’s 3D Predict™ Glioma assay.

    The recent bipartisan resolution passed by the US Senate designating July 21, 2021 as Glioblastoma Awareness Day highlights the severity of this aggressive brain cancer. Fewer than 10% of patients survive longer than five years. Pharmaceutical and clinical efforts have only resulted in modest increases in overall survival since the disease was first described in the 1920s. Today, most newly diagnosed patients receive the same treatment regimen (radiation therapy and temozolomide), presenting an opportunity to improve care through shifting the paradigm toward individualized medicine for HGG treatment.

    KIYATEC’s test results accurately identified the patients as future temozolomide responders or future non-responders prior to the initiation of drug treatment. The future responder group had a statistically significant 6-month comparative increase in overall survival. Since test results are available only seven days after surgery, this creates an opportunity to improve outcomes for each predicted non-responder by providing the possibility of patient-specific treatment strategies. In the future, KIYATEC’s results may also prove useful to improve outcomes for each predicted responder through patient-specific combination strategies.

    Successful response-prediction for newly diagnosed patients follows the company’s previous success with predicting treatment response in recurrent high-grade glioma patients. In December 2020, KIYATEC announced a clinical case series demonstrating that use of their test doubled these patients’ median time to progression over what would be expected without use of the test. In addition, the earlier announcement demonstrated successful clinical use of the targeted agent dabrafenib in two patients that were not identified by genetic sequencing. By identifying successful response to drugs that would have been missed by today’s testing, KIYATEC’s results expanded the successful treatment options for these patients.

    “Decision making in our framework is based on patient-specific evidence, embodying truly personalized medicine. Evidence of response before the first dose is administered creates options that were not previously available when it comes to treatment,” said Matthew Gevaert, PhD, CEO of KIYATEC.

    Versus other approaches, tests developed using KIYATEC’s 3D ex vivo cell culture platform demonstrate increased biological fidelity, which was first reported in 2019 in ovarian cancer. In newly diagnosed ovarian cancer patients, KIYATEC’s test prospectively and accurately predicted response to first-line chemotherapy with 89% accuracy. The new GBM results now establish comparable predictive accuracy in two solid tumors, with eight additional cancers in the company’s pipeline.

    About KIYATEC
    KIYATEC leverages its proprietary ex vivo 3D cell culture platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors. The platforms are positioned to address the gap-defining limitations of current cancer drug selection. 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.

  • 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...