Baird initiates coverage on Marinus Pharmaceuticals (NASDAQ: MRNS) with an Outperform rating and a price target of $15.00.
Analyst Brian Skorney commented, “We think upcoming Phase 2 data for ganaxolone in post-partum depression will lay out a path for an IV and oral option in this unmet medical need. Sharing almost identical characteristics to Sage Therapeutics’s (not covered) brexanolone and SAGE-217, we think clinical results, expected later this year, should also look similar, leading the company to a much higher valuation.”
One out of every three U.S. adults has high blood pressure that should be treated with medication, under guidelines recently adopted by the two leading heart health associations.
The American College of Cardiology and American Heart Association redefined high blood pressure at 130/80 in November, down from the previous level of 140/90, based on new evidence supporting a lower threshold.
Under the new guidelines, nearly 46 percent of U.S. adults now would be considered to have high blood pressure, a new study reported.
Further, 36 percent would be recommended for blood pressure medication, the study authors said.
That means the number of American adults diagnosed with high blood pressure would grow to 105 million from 74 million, and those who should be taking medication to 83 million from 72 million.
Full implementation of the new guidelines would mean 156,000 fewer deaths each year, and 340,000 fewer heart attacks, strokes and other heart-related ailments, the researchers concluded.
“Our study shows the benefit of risk reduction overweighs the potential risk of adverse events in the U.S. population,” said study author Dr. Jiang He.
“We highly recommend practitioners to try to adhere to the new guidelines,” said He, who is chairman of epidemiology with the Tulane University School of Public Health and Tropical Medicine in New Orleans.
Some debate has occurred since adoption of the new guidelines regarding risks associated with blood pressure medication, said Dr. Clyde Yancy, chief of cardiology with the Northwestern University Feinberg School of Medicine in Chicago.
“Whenever there is a change in the approach to a common problem that requires an entire rethink of what has been a standard of care, there’s going to be some argument, some pushback, some hesitancy,” Yancy said.
But the new study reveals that the potential benefits of the new guidelines far outweigh the risks, he added.
The researchers reported that doctors need to treat 70 people to prevent one case of heart attack or stroke, and 129 people to prevent one death.
By comparison, treatment numbers that would increase side effects associated with blood pressure medication are much higher:
468 people would need to be treated to cause one case of kidney injury.
603 treated to cause one case of dangerously low blood pressure.
1,171 treated to cause one person to pass out from a fall in blood pressure.
1,189 treated to cause one case of abnormal electrolyte levels in the blood.
“The number needed to harm is hundreds or thousands, but the number needed to benefit is not only less than 100, but it’s exactly in keeping with the threshold set for statin therapy for primary prevention,” Yancy said.
“We’ve already decided when the number needed to treat to improve outcomes is less than 100, that qualifies an important public health imperative,” Yancy explained
He noted that 9 percent of people now considered to have high blood pressure would not be recommended for medication. Instead, they would try to lower their blood pressure through exercise, diet and other lifestyle changes.
Under the new guidelines, everyone with stage 1 high blood pressure should be evaluated for heart disease. Only those with heart disease or at high risk for developing it during the next decade would be prescribed drugs.
“The majority of people who are newly diagnosed ought to be able to be managed with non-drug regimens,” Yancy said. “We should not dismiss those approaches. There is substantial benefit to be had by appropriately deploying these lifestyle and dietary changes.”
Both Yancy and He said doctors should embrace the new guidelines, since many more lives would be saved.
“If your reason for reluctance is about risk, we’ve done the risk assessment,” Yancy said. “The data reflect one big step toward better implementation and better outcomes.”
The new study was published online May 23 in JAMA Cardiology.
More information: Jiang He, M.D., Ph.D., chairman of epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans; Clyde Yancy, M.D., chief of cardiology, Northwestern University Feinberg School of Medicine, Chicago; May 23, 2018, JAMA Cardiology, online
Recovery after severe spinal cord injury is notoriously fraught, with permanent paralysis often the result. In recent years, researchers have increasingly turned to stem cell-based therapies as a potential method for repairing and replacing damaged nerve cells. They have struggled, however, to overcome numerous innate barriers, including myelin, a mixture of insulating proteins and lipids that helps speed impulses through adult nerve fibers but also inhibits neuronal growth.
But in a new paper, published in the May 23 online issue of Science Translational Medicine, researchers at University of California San Diego School of Medicine report that adult rat myelin actually stimulated axonal outgrowth in rat neural precursor cells (NPCs) and human induced pluripotent (iPSC)-derived neural stem cells (NSCs).
“It’s really a remarkable finding because myelin is known to be a potent inhibitor of adult axon regeneration,” said Mark Tuszynski, MD, Ph.D., professor of neuroscience and director of the UC San Diego Translational Neuroscience Institute. “But that isn’t the case with precursor neurons or those derived from stem cells.”
Tuszynski’s lab, with colleagues in Germany and Singapore, monitored neurite outgrowth from NPCs and NSCs growing on a myelin substrate in Petri dishes. Neurites are projections from the cell bodies of neurons, either axons (which carry signals outward to other neurons) or dendrites (which receive the signals). In both cases, they found outgrowth enhanced threefold.
In subsequent studies using rats with spinal cord injuries, the researchers found that rat NPCs and human iPSC-derived NSCs implanted at the injury site both extended greater numbers of axons through adult central nervous system white matter than through gray matter, and preferentially associated with rat host myelin.
Paring away some of the myelin molecules known to strongly inhibit axonal growth, Tuszynski and colleagues identified a molecule called reuronal growth regulator 1 or Negr1 as a potential mediator between axons and myelin, permitting the former’s growth. Negr1 is involved in the process by which cells attach to neighboring cells and interact. The growth factor plays an important role during embryological development, when neurons are growing rapidly but before myelin begins to have an inhibitory effect.
Mark Tuszynski, MD, PhD, professor of neuroscience and director of the UC San Diego Translational Neuroscience Institute. Credit: UC San Diego Health
“When we implant neural stem cells into sites of spinal cord injury, they extend tens of thousands of axons out of the injury site for distances of up to 50 millmeters,” said Tuszynski. “Adult axons on the other hand, when coaxed to grow, extend 100 axons for a distance of one millimeter. These findings identify why axon outgrowth from neural stem cell implants is so much better than injured adult axons.”
The findings support the developing approach of using neural precursor cells and iPSC-derived stem cells as a viable and promising method for repairing spinal cord injuries, wrote the study authors. More specifically, they point to the need to further investigate the stimulatory effects of myelin on NPCs and NSCs, which “could potentially be exploited for neural repair after spinal cord injury.”
The United States is seeking better access for imports of genetically modified crops into China as part of a trade deal currently under discussion between the two sides, said two people familiar with the matter.
The subject, long a major irritant in agricultural trade between the countries, is a main issue for the U.S. Department of Agriculture, said a biotech industry source with knowledge of USDA discussions.
“I can say with full confidence that biotech is one of the key issues for USDA in this conversation with the Chinese,” the source said.
The USDA did not respond to requests for comment on Wednesday.
China’s Ministry of Agriculture and Rural Affairs, which regulates approvals of genetically modified, or GMO crops, did not respond to a fax seeking comment on whether such demands had been made.
China’s Ministry of Commerce also did not respond to a fax on the issue.
After months of escalating trade tension that led Beijing to threaten hefty tariffs on imports of major U.S. farm products, the two sides are nearing a deal that could see China buying more American farm goods, sources said on Tuesday.
Those goods are expected to include top U.S. farm products such as soybeans and grains, as well as beef and other meat. U.S. exporters are currently grappling with tough Chinese quarantine requirements on many of their products, including corn, soybeans and pork.
China will import record volumes of U.S. oil and is likely to ship more U.S. soy after Beijing signalled to state-run refiners and grains purchasers they should buy more to help ease tensions between the two top economies, trade sources said on Wednesday.[nL2N1SU296]
While the specific demands regarding U.S. biotech are not known, Washington has repeatedly cited the issue in trade talks with Beijing in recent years.
China does not permit planting of GMO food crops, but it does allow the import of GMO soybeans and corn for use in its huge animal feed industry.
However the approval process for new GMO strains is slow, unpredictable and not based on science, the biotech industry has said.
As the world’s top buyer of soybeans and a major buyer of other grains, China’s slow approval process stalls trade by forcing agrichemical firms to restrict sales of new products to American farmers until they get Beijing’s go-ahead.
That can take several years, according to earlier industry complaints.
China promised to speed up a review of pending applications during 100-day trade talks with the United States last year, and it approved four new GMO products for import in the weeks following those talks.
But it has not approved any other products since then. The industry had expected another meeting of its scientific panel, the National Biosafety Committee, to take place late last year, but no meeting occurred, according to industry sources.
“Biotech was among one of the key issues in the 100-day plan last year and there’s still a lot of unresolved issues from that plan,” the source with knowledge of USDA’s discussions said.
DowDuPont Inc is waiting for China to approve imports of U.S. biotech soybeans under its Enlist brand, which have tolerance to a chemical called 2,4-D, used as a herbicide.
Without Beijing’s approval for Enlist E3 soybeans, the company launched the seed in the United States this year under a programme that restricts where farmers deliver their harvests, limiting sales. Dow first submitted E3 soybeans to China for import approval in 2013 and had previously hoped to launch them in the United States in 2015.
Syngenta, which is now owned by Chinese chemical company ChemChina [CNNCC.UL], is waiting for Beijing to approve imports of a variety of U.S. biotech soybeans known as 0H2, which were submitted for review in 2014, a Syngenta spokesman said. Last year, China cleared imports of Syngenta’s Agrisure Duracade corn as part of the 100-day plan.
Monsanto Co has been seeking approval for two alfalfa products since 2011 and one since 2015, according to the company. Bayer, which is close to acquiring Monsanto, is waiting for Beijing to clear a canola product the company originally submitted for review in 2012.
Another industry source said China needed to overhaul its regulatory system, and not simply approve some pending applications.
“Results in the past year were not satisfactory,” he added.
Beijing has in the past held back approvals of imported GMO products amid concerns about anti-GMO sentiment in the country.
New government data show U.S. death rates rose last year, suggesting 2017 will mark the third straight year of decline in American life expectancy.
Death rates rose for Alzheimer’s disease, diabetes, flu and pneumonia, and three other leading causes of death.
The Centers for Disease Control and Prevention posted the statistics online Wednesday.
Full-year data is not yet available for drug overdoses, suicides or firearm deaths. But partial-year statistics in those categories showed continuing increases.
Just as important, there was little change in the death rate from the nation’s No. 1 killer: heart disease. In the past, steady annual drops in heart disease death rates offset increases in other causes. But experts say that offset is no longer happening.
National insurer Anthem on Wednesday said it is buying non-hospice palliative-care provider Aspire Health.
The agreement marks another in a slew of deals that see insurers stepping into the provider space in hopes of reducing costs by shifting patient care away from hospitals and other expensive settings.
Anthem said it is acquiring Nashville-based Aspire to further its ability to offer integrated care and improve outcomes while reducing health costs. The financial terms of the deal, which the companies expect to close in the third quarter of 2018, weren’t disclosed.
“Aspire Health shares our perspective on the increasingly important role of integrated care and has built a unique model that provides palliative care and support services for patients and their families,” Anthem CEO Gail Boudreaux said in the announcement.
Aspire, which contracts with more than 20 health plans and serves customers in 25 states, joins Anthem’s other provider assets, including primary care provider CareMore Health and care management company AIM Specialty Health.
Aspire supports seriously ill patients by assigning them a care team of physicians, nurses, social workers and chaplains to coordinate care with medical professionals and address symptoms, patient-family communication and advance care planning. It emphasizes providing care in the home. An Anthem spokeswoman said Aspire employs about 700 people, including physicians, other clinicians and non-clinical workers.
“Several studies have repeatedly demonstrated how advanced illness programs can provide high patient and family satisfaction, reduce hospitalization and decrease costs,” Aspire CEO Brad Smith said. “As part of Anthem, we believe we will be able to further scale our model and positively impact the lives of even more consumers and families, making home-based advanced illness care available to patients who need it.”
Aspire was founded in 2013 by Smith and former U.S. Senator William Frist. Aspire has raised $53.5 million in venture capital. Its latest funding round in 2016 was led by a Google’s investment arm, which invested $32 million in the company.
Death rates from cancer continue to drop in the U.S., but within this overall picture there are winners and losers, with mortality from certain types of cancer on the rise and certain populations remaining at increased risk of dying from malignancies.
From 1999 to 2015, cancer mortality decreased each year by 1.4% in women and 1.8% in men; and in children, the yearly rate decreased 1.5% from 2011 to 2015, according to the annual report on cancer in the U.S. from the National Cancer Institute (NCI) and others.
“This year’s report is an encouraging indicator of progress we’re making in cancer research,” said NCI Director Ned Sharpless, MD, in a statement. “As overall death rates continue to decline for all major racial and ethnic groups in the United States, it’s clear that interventions are having an impact.”
In both men and women, the rates of cancer mortality decreased from 2011 to 2015 for those with lung, colorectal, esophageal, kidney, and gastric cancers, and leukemia, melanoma, and non-Hodgkin’s lymphoma (NHL).
In men alone, cancer mortality also decreased for laryngeal cancer, multiple myeloma and prostate cancer (though it leveled off from 2013 to 2015, see more below). In women only, cancer mortality also decreased for breast, ovarian, cervical, gallbladder, bladder, and oral cavity and pharyngeal cancers.
“The overall reduction in cancer mortality has been dramatic,” said Stephen Edge, MD, of Roswell Park Comprehensive Cancer Center in Buffalo, New York, who was not involved with the report. “This welcome news can be attributed to a combination of screening and improved treatment, and is likely to decrease further with broad application of new therapies, including immunotherapy.”
The report is a collaboration by the NCI, CDC, American Cancer Society, and North American Association of Central Cancer Registries (NAACCR).
Published in Cancer, the report also highlights areas where more work is needed, said Sharpless.
With 5-year death rate trends during this period described by average annual percent change (AAPC), a number of common cancers in men increased from 2011 to 2015:
Non-melanoma skin cancer (AAPC 2.8%)
Liver cancer (1.6%)
Oral cavity and pharyngeal cancer (1.0%)
Soft-tissue sarcoma (0.8%)
Brain and central nervous system (CNS) tumors (0.5%)
Pancreatic cancer (0.2%)
And in women, increased death rates were seen in the following:
Liver cancer (AAPC 2.7%)
Uterine cancer (1.9%)
Brain and CNS tumors (0.5%)
Pancreatic cancer (0.2%)
“The fact that death rates from several cancers are still on the rise means we need to keep working to find strategies to encourage prevention and continue to make improvements in screening and treatment,” said NAACCR Executive Director Betsy A. Kohler, MPH, in a statement.
And while mortality from cancer continues to decrease overall, “concerning disparities persist relating to people’s social and ethnic background,” said Edge.
Black men (239.9 per 100,000) and black women (159.0 per 100,000) had the highest rates of cancer mortality, according to the report. Black men also had the highest rates of cancer incidence (558.2 per 100,000), but among women, whites had the highest cancer rates (428.7 per 100,000).
From 2008 to 2014, the incidence rates of cancer in the U.S. dropped by an average of 2.2% each year in men, while no decrease was observed in women. Overall, men had a higher incidence of cancer than women (502.0 versus 420.6 per 100,000). In children, rates of cancer incidence increased by 0.8% each year from 2010 to 2014.
Prostate Cancer Trends
In a study that accompanied the annual report, researchers looked closer at prostate cancer trends, revealing that from 2013 to 2015, mortality from the disease stopped falling after two decades of decline.
And from 2010 to 2014, the incidence of distant-stage disease increased from 7.8 to 9.2 cases per 100,000 men, reported Serban Negoita, MD, DrPH, of the NCI’s Surveillance Research Program, and colleagues.
“We’ve seen a concerning increase in the rates of men with advanced prostate cancer, a trend that could be related to changes in the use of prostate cancer screening,” said Edge.
Notably, new cases of prostate cancer in the U.S. dropped from 163 per 100,000 in 2007 to 104 cases per 100,000 in 2014 (average decrease of 6.5% per year) — raising questions about whether it’s a consequence of the U.S. Preventive Services Task Force’s (USPSTF) 2012 guidelines recommending against prostate-specific antigen (PSA) screening for asymptomatic men.
“The increase in late-stage disease and the flattening of the mortality trend occurred contemporaneously with the observed decrease in PSA screening in the population,” said Negoita in a statement. “Although suggestive, this observation does not demonstrate that one caused the other.”
However, the report found no increase in Gleason 9-10 disease, suggesting the increase in distant-stage disease could in part be due to better initial work-up of patients. “There are many factors that contribute to incidence and mortality, such as improvements in staging and treating cancer,” Negoita said.
Bobby Liaw, MD, of the Icahn School of Medicine at Mount Sinai, who was not involved with the study, said that with the recent change in USPSTF recommendations, there might eventually be a course correction, where again prostate cancers are caught at an earlier stage.
“The pendulum is coming back,” Liaw told MedPage Today. “We went from screening everyone to screening no one, now we’re coming back to a more middle ground.”
Liaw highlighted that the plateauing of the survival — even with a slightly higher number of newly diagnosed advanced prostate cancer cases — speaks to the effectiveness of newer therapies in prostate cancer. “I actually take that as a promising sign that we’re still able to keep things steady,” he said.
The study was funded by the NCI, CDC, American Cancer Society, and NAACCR.
