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Monday, June 17, 2019

New treatment for pancreatic cancer

If the American Cancer Society’s projections prove accurate, more people will die from pancreatic cancer than from breast, brain, ovarian or prostate cancer this year.
One reason pancreatic  is so lethal is its resistance to traditional chemotherapy. But West Virginia University surgical oncologist Brian Boone is exploring whether FOLFIRINOX—a new combination of cancer drugs—can improve outcomes in whose pancreatic cancer is “borderline resectable,” meaning that a tumor may be too close to a blood vessel to be removed safely.
“The way pancreatic tumors sit, they’re very close to several important blood vessels that you really can’t live without. That’s where chemotherapy comes into play,” said Boone, an assistant professor in the School of Medicine’s Department of Surgery. “We try to shrink the tumor off of the vein and change it from borderline resectable to resectable, or removable by surgery.”
In a recent meta-analysis of 24 studies, Boone and a team of researchers considered 313 cases of borderline resectable pancreatic cancer that physicians treated with FOLFIRINOX. They analyzed the patients’ overall . They also evaluated how frequently tumors shrank enough to be surgically removed. The team found that FOLFIRINOX prolonged patients’ lives, on average, and made surgery possible in more instances. Their findings appear in the Journal of the National Cancer Institute.
“There’s no , but when you compare it to what we’ve historically seen in patients that are borderline resectable and that we take straight to surgery, FOLFIRINOX resulted in better survival and better rates of resection,” Boone said.
More than two-thirds—or 67.8 percent—of the cancers included in the study responded well enough to FOLFIRINOX that they could be completely removed surgically. “Historically, complete removal of the tumor is accomplished in a far lower number of patients without treatment before surgery and often requires removal of a portion of the vein,” he said.
On average, patients who took FOLFIRINOX survived for 22.2 months overall. Without the drug, patients with borderline resectable cancer tend to survive for about 12 months, based on Boone’s .
“There’s really been a paradigm shift for pancreatic cancer, now that we have better drugs,” he said.
Despite these improvements in treatment, pancreatic cancer is currently the fourth deadliest, and “it’s climbing the ladder in terms of the number of people it kills,” said Carl Schmidt, chief of the Surgical Oncology Division. “In my 10 years of being in practice, there’s been more interest in pancreatic cancer, but moving the needle is really hard.”
To that end, Boone, Schmidt and their colleagues are pursuing studies that span the laboratories where scientists conduct basic-science experiments, the infusion rooms where patients receive treatment and the operating rooms where oncologists perform .
“We’re developing a full spectrum of  research. That’s why we do the basic science: we’re identifying patients at the bedside and trying to find solutions in the lab,” Boone said. “And it’s all driven by trying to make outcomes better for patients that we take care of every day.”
Explore further
More information: Quisette P Janssen et al, Neoadjuvant FOLFIRINOX in patients with borderline resectable pancreatic cancer: a systematic review and patient-level meta-analysis, JNCI: Journal of the National Cancer Institute (2019). DOI: 10.1093/jnci/djz073
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Sunday, June 16, 2019

Study participants recruited on Facebook bring in larger, more diverse pool

The researchers behind the ongoing Genes for Good genetic study have found that recruiting participants from Facebook and offering them free DNA reports has solved many of the issues associated with study samples, they wrote in the American Journal of Human Genetics this week.
Since the study was launched at the University of Michigan in Ann Arbor in January 2015, more than 27,000 people who signed up through the Genes for Good Facebook app have returned their at-home DNA testing kits. Participation in the study is mutually beneficial: The scientists receive more data to analyze in further genetic research and, in return, participants receive a free genetic report based on that data.
According to the authors, the 20,000 participants whose data have been analyzed so far come from all 50 states and from a wide variety of ethnic backgrounds, and carry rates of chronic disease indicators representative of the U.S. population. Not only is the pool therefore larger, more diverse and more representative than many other studies but, since participants are voluntarily recruited through Facebook, recruitment has also been considerably less expensive.
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Silk Road Medical: Positive final phase 2 results in revascularization procedure

Final Results Presented in Late-Breaking Sessionat Society for Vascular Surgery 2019 Vascular Annual Meeting
Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced positive final results for the company’s ROADSTER-2 post-marketing study evaluating real world use of the ENROUTE® Neuroprotection and Stent Systems in TransCarotid Artery Revascularization (TCAR) procedures.
In the late-breaking session at the Society for Vascular Surgery 2019 Vascular Annual Meeting (VAM), Dr. Vikram Kashyap, Chief of Vascular Surgery and Endovascular Therapy at University Hospitals Case Medical Center (Cleveland, OH) and National Co-Principal Investigator of ROADSTER-2, reported that the study demonstrated compelling patient outcomes with low stroke and combined stroke and death rates of 0.6% and 0.8%, respectively, in 632 high surgical risk patients enrolled across 42 sites. Seventy percent (70%) of patients enrolled in the study were from physicians new to TCAR.
“The results of ROADSTER-2 continue to demonstrate the safety, effectiveness and clinical advantages of TCAR, especially given that a majority of the TCAR procedures were performed by a broad group of physicians with no previous TCAR experience,” Dr. Kashyap said. “The study results highlight the short learning curve of the TCAR procedure and its remarkable consistency and reproducibility, and, I believe, will further encourage physicians to broadly adopt the TCAR procedure.”
Designed as a follow-on study to the pivotal ROADSTER trial, ROADSTER-2 is a prospective, multi-center study designed to assess the real-world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the TCAR procedure. The study met its primary endpoint of procedural success, defined as acute device and technical success in the absence of stroke, death or myocardial infarction (MI) at 30 days, at 97.9%.
Significant findings from the study showed TCAR to have low rates of 30-day major adverse events, including:
  • 1.7% stroke, death and MI
  • 0.8% stroke and death
  • 0.6% stroke, including 0.6% in symptomatic patients, 0.5% in females, and 1.1% in patients age greater than 75
In addition, ROADSTER-2 showed lower rates of acute (1.3%) and permanent (0.5%) cranial nerve injury than is typically observed for patients receiving carotid endarterectomy (CEA), the current standard of care.
“The mounting clinical evidence base demonstrates the compelling patient benefits of TCAR, which we believe will further support physician confidence and adoption. The data from ROADSTER-2, taken together with recent updated results from the TCAR Surveillance Project, supports the case for TCAR as the standard of care in high surgical risk patients,” said Erica Rogers, Silk Road Medical’s Chief Executive Officer.
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Prosecutors drop Flint, Michigan water charges over ‘flawed’ probe

Michigan prosecutors on Thursday dropped all criminal charges over the deadly contamination of the city of Flint’s water, saying a more thorough investigation was needed before they could proceed with the case.
The charges were brought by the Office of Special Counsel (OSC), a federal prosecutorial agency, and were based on an investigation that state prosecutors described as “flawed.”
“Dismissing these cases allows us to move forward according to the non-negotiable requirements of a thorough, methodical and ethical investigation,” Michigan’s Solicitor General Fadwa Hammoud and Wayne County Prosecutor Kym Worthy said in a statement.
Eight former state and city officials, including Michigan’s chief medical officer Eden Wells, faced criminal charges for their roles in the water crisis which killed 12 people and sickened over 70, one of the worst man-made environmental disasters in U.S. history.
According to the prosecutors, the OSC made agreements that gave law firms representing state agencies and officials a role in deciding what information would be turned over to law enforcement during their investigation. As a result, not all evidence was pursued, they said.

Additional investigation by the prosecution team has already identified more individuals of interest in the case, they said.
Flint’s troubles began in 2014 after the city switched its water supply to the Flint River from Lake Huron to cut costs. Corrosive river water caused lead to leach from pipes, contaminating the drinking water and causing an outbreak of Legionnaires’ disease.
Prosecutors said they dropped charges “without prejudice,” meaning they could be brought again once a new investigation is completed.
“Justice delayed is not always justice denied,” Michigan Attorney General Dana Nessel said in a statement.
But Michigan Senate Minority Leader Jim Ananich, a Democrat who represents Flint, expressed his disappointment.

“Months of investigation have turned into years, and the only thing to show for it is a bunch of lawyers who have gotten rich off the taxpayers’ dime,” he said in a statement. “The people of Flint believe that they will never see justice, and sadly, so far they’ve been proven right.”
The U.S. Supreme Court in March allowed two class-action lawsuits filed by Flint residents, who are pursuing civil rights claims against local and state officials.
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New drug target for liver disease treatment

A possible drug target for chronic liver disease has been identified by an international research collaboration involving a University of Queensland team.
Professor Matt Sweet and Dr. Divya Ramnath from UQ’s Institute for Molecular Bioscience (IMB) worked with the study’s senior author Dr. Ekihiro Seki from Cedars-Sinai in Los Angeles, to identify genes linked to the progression of chronic liver disease.
Dr. Ramnath said they helped confirm that a molecule called hyaluronan (HA), used as a marker for liver disease, also has a role in disease progression.
“Testing for HA levels in the blood can indicate the severity of liver disease in patients, but until now its exact role in  had not been completely understood,” Dr. Ramnath said.
“Using clinical samples provided by Professor Elizabeth Powell from UQ’s Faculty of Medicine, we were able to confirm that an enzyme which makes HA was at higher levels in patients with later stages of the disease.
“This means it’s not just a marker, it’s now a potential drug target.”
Chronic liver disease is reaching  proportions with up to 30 percent of the world’s population experiencing fat build up in the liver, known as non-alcoholic fatty  (NAFLD).
A proportion of NAFLD patients progress to a more severe form of the disease called non-alcoholic steatohepatitis (NASH).
“NAFLD can be slowed by changes in diet but if untreated constant liver damage and inflammation can lead to a condition associated with cirrhosis and  cancer.
“There are currently no medications to treat some forms of  so new drug targets are desperately needed,” Dr. Ramnath said.
Professor Sweet said it is now understood that short forms of the HA molecule could create an immune response, causing inflammation and increased severity of the disease.
“It has been very rewarding working with Dr. Seki from Cedars-Sinai, who has gone on to show that if HA production is inhibited in mice, the severity of the disease is reduced,” he said.
“This international collaboration has advanced our knowledge of this complex and prevalent , and the findings from this study may ultimately provide a strategy to develop much needed treatments.”
The study has been published in Science Translational Medicine.
Explore further
More information: Yoon Mee Yang et al. Hyaluronan synthase 2–mediated hyaluronan production mediates Notch1 activation and liver fibrosis, Science Translational Medicine (2019). DOI: 10.1126/scitranslmed.aat9284
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Synapse-boosting factors found in young blood

A team of researchers at Stanford University has found synapse-boosting factors in the blood of young mice. In their paper published in Proceedings of the National Academy of Sciences, the group describes their study of the rejuvenating impact of blood from young mice when transfused into older mice, and what they learned about it.
Prior research has shown that transfusing blood from young (12 to 15 months old) into older mice can reverse some of the signs of aging in the brain and sometimes other parts of the body—a process called parabiosis. While researchers have studied the effect, it is still not clear which factors in young blood provide the rejuvenating effects. In this new effort, the researchers looked deeper into the phenomenon and found two possible answers.
To learn more about parabiosis in mice, the researchers transfused serum from mice between the ages of 12 and 15 months into older mice to study its impact. They also did the same with 15-day-old mice. In so doing, they found that the youngest mouse blood resulted in more pronounced neuronal dendrite branching, a bigger increase in the number of , and a bigger increase in the release of neurotransmitters compared to blood from less . They also found that it provided more improvements in N-methyl-D-aspartate receptor-mediated synaptic function in the older mice. They next found that applying the  to neurons cultured in the lab did the same. And finally, they found that doing so also boosted synaptic connectivity. Conversely, they found that applying serum from older mice to younger mouse neurons had the opposite effect.
To isolate the properties in the young serum that were behind the rejuvenating effect, the team looked at samples using tandem —they isolated two proteins (thrombospondin-4 and SPARC-like protein-1) that appeared richer in the younger serum. When the two proteins were applied to the older , some of the same rejuvenating effects took place, suggesting that they were at least two of the factors responsible for the rejuvenating effect. The researchers suggest that the blood of young mice likely holds many kinds of synapse-promoting factors that decline as mice age.
More information: Kathlyn J. Gan et al. Specific factors in blood from young but not old mice directly promote synapse formation and NMDA-receptor recruitment, Proceedings of the National Academy of Sciences(2019). DOI: 10.1073/pnas.1902672116
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IBM in $15M settlement in false claims allegations related to Maryland exchange

IBM will pay $14.8 million to settle allegations from the Department of Justice that it misrepresented the capabilities of software technology during the development of Maryland’s health insurance exchange website and IT platform, in violation of the False Claims Act.
Authorities say the case relates to the contract award process for developing Maryland’s health insurance exchange (HIX) website, which was plagued with problems when it initially launched in October 2013, according to Maryland state officials. IBM and Cúram Software served as subcontractors in the initial rollout of the health exchange’s website.
IBM acquired Cúram on December 19, 2011, and on that same day submitted a proposal to the state to be a subcontractor on the HIX website development project.
The online health insurance exchange site failed within minutes of its Oct. 1, 2013 launch, The Washington Post reported, blocking residents who were trying to get health insurance. The site continued to be beset by problems and Maryland fired the contractor, Noridian Healthcare Solutions, in February 2014. State officials said at the time that the online health insurance marketplace had so many structural defects that the state might have to abandon all or parts of the system.
State officials also reported that the significant flaws could result in at least $30.5 million in unnecessary Medicaid spending, The Washington Post reported.
Noridian was hired in 2012 under a five-year deal and was paid at around $70 million, most of which came from federal grants, according to the Baltimore Business Journal. Noridian settled with the state for $45 million in 2015.

Maryland ended up adopting technology used by Connecticut instead, at a cost of between $40 million and $50 million, according to the BBJ.
As of press time, representatives with IBM did not respond to requests for comment.
State and federal officials allege that Cúram, with IBM’s knowledge and as part of the bid evaluation process in January 2012, demonstrated its software capabilities for health insurance exchange website. That included conducting eligibility determinations for health assistance coverage, calculating applicable tax credits, addressing changes in life events and the ability to integrate its software with another subcontractor’s health plan shopping software.
The agreement settles claims that from January 2011 to May 2014 Cúram-IBM mispresented the development status of the Cúram for Health Care Reform and the integration of Cúram software with other software needed to provide a properly functioning HIX website, according to state and federal officials.
The settlement, announced by state and federal officials Friday, is not an admission of liability by IBM or a concession by the federal government that its claims were not well founded, according to a DOJ release.
The case was investigated by the DOJ’s civil division’s commercial litigation branch, the U.S. Attorney’s Office for the District of Maryland, the Department of Health and Human Services Office of Inspector General, and the Office of the Attorney General of Maryland.

“When companies misrepresent their products and capabilities in order to win government contracts, they enrich themselves at taxpayers’ expense,” U.S. Attorney Robert K. Hur said in a statement.  “Today’s resolution demonstrates our continuing commitment to hold companies accountable for their actions.”
“Companies are expected to be candid about products, skills, and abilities during contract negotiations,” Maureen R. Dixon, Special Agent in Charge for the HHS OIG said. “We will continue to work with the U.S. Department of Justice to ensure taxpayer dollars are only spent for honest, high-quality health care products and services.”
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