BMO Capital analyst Gary Nachman kept his Outperform rating and $14 price target on scPharmaceuticals after its Q2 results, saying the investors’ focus remains on the company working through the FDA complete response letter for its Furoscix drug. The analyst notes that the management intends to address the issues raised by the FDA with its September 24th update, adding that after a 1-2 year delay, he still expects the drug to reach the market.
Monday, August 20, 2018
Audentes Therapeutics initiated at Citi
Audentes Therapeutics initiated with a Buy at Citi. Citi initiated Audentes Therapeutics with a Buy and $40 price target.
Can a Maple Leaf Help You Look Younger?
A maple leaf extract may help prevent wrinkles, scientists say.
In a new study, researchers found that certain compounds in maple leaves block the release of an enzyme called elastase, which breaks down a protein called elastin as people age. Elastin helps maintain skin elasticity.
Previous work by the same University of Rhode Island researchers found that these same compounds in maple leaves might help protect skin from inflammation and lighten dark spots, such as freckles or age spots.
“You could imagine that these extracts might tighten up human skin like a plant-based Botox, though they would be a topical application, not an injected toxin,” principal investigator Navindra Seeram said in an American Chemical Society (ACS) news release.
Such products would provide a new option for people who want natural, plant-based skincare products, and also might provide economic benefits in the United States and Canada, the researchers said.
“Many botanical ingredients traditionally come from China, India and the Mediterranean, but the sugar maple and the red maple only grow in eastern North America,” Seeram said.
Woodlot owners who currently only harvest sap from the maple trees could use the leaves as an additional source of income. The process would be sustainable because the leaves could be collected during normal pruning or when they fall from the trees in autumn, Seeram said.
The team’s research is continuing, and it’s also formulating the findings into a patent-pending product.
The study findings are scheduled for presentation Monday at the annual meeting of the ACS, in Boston. Research presented at meetings should be considered preliminary until published in a peer-reviewed journal.
More information
The U.S. National Institute on Aging has more about skin care.
SOURCE: American Chemical Society, news release, Aug. 20, 2018
MediciNova: NIH awards research grant to UCLA for alcohol abuse med trial
MediciNova announced that the National Institute on Alcohol Abuse and Alcoholism, which is part of the National Institutes of Health, will fund a Phase 2b clinical trial to evaluate MN-166 as a potential treatment to decrease alcohol consumption in treatment-seeking patients with alcohol use disorder. This study is a randomized, double-blind, placebo-controlled outpatient trial which will enroll up to 132 patients. The NIAAA R01 research funding was awarded to Principal Investigator Dr. Lara Ray, PhD, ABPP, at the University of California, Los Angeles’ Departments of Psychology, and Psychiatry and Biobehavioral Sciences Brain Research Institute, based on her recent findings that MN-166 was associated with mood improvements during stress- and alcohol-cue exposures, significantly decreased alcohol-induced stimulation and positive mood, decreased overall craving for alcohol in non-treatment seeking volunteers, and was safe and well-tolerated. MediciNova will provide drug supply and regulatory support for the clinical trial.
Adult Congenital Heart Disease Guidelines Get Major Overhaul
The American Heart Association (AHA)/American College of Cardiology (ACC) have released a major update to the first US guidelines on the management of adult congenital heart disease, published a decade ago.
“Since 2008 a lot of work has been done on trying to risk stratify adult congenital patients and has identified a lot of physiologic factors that are independent of their anatomy to some degree,” said guideline writing committee chair, Karen K. Stout, MD, University of Washington, Seattle. “We used that to articulate a classification system that should allow providers to think a little bit more clearly about their patients individually and then do follow-up based on that classification and may guide thinking around therapies as well.”
The new classification system for adult congenital heart disease (ACHD) retains the three previous anatomic categories of “simple,” “moderate,” or “great” complexity in the 2008 guideline but adds the physiologic classification of A through D — fairly similar to the AHA heart failure stages.
For example, a patient with tetralogy of Fallot who is extremely functional, who has no arrhythmias, and whose heart looks good on imaging would be classified as IIA, she said. A second patient with the same diagnosis who has several arrhythmias, some degree of heart failure, limited exercise capacity, and some kidney and liver dysfunction would be class IID.
“Those are such clearly different patients and should be followed differently, but the old system only used the fact that they had tetralogy of Fallot,” said Stout. “The new classification system gives everyone that comes in contact with an ACHD patient a different way of thinking about them and a different way of engaging an ACHD cardiologist.”
“I think it’s the biggest change but also the most practical change.”
The updated guideline was published online August 16 in the Journal of the American College of Cardiology and copublished in Circulation.
It was developed in collaboration with the American Association for Thoracic Surgery, American Society of Echocardiography, Heart Rhythm Society, International Society for Adult Congenital Heart Disease, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.
Improved survival in children diagnosed with CHD has swelled the population of patients with ACHD in the United States to about 1.4 million. A national accreditation program for the subspecialty was launched last year at 11 US centers, but the sticky wicket is that there are now only about 300 board-certified adult congenital cardiologists.
Nonetheless, the new guidelines recommend that patients with moderate to complex disease — ACHD AP classification IB-D, IIA-D, and IIIA-D — should be managed in collaboration with an ACHD cardiologist. This need for specialized care is noted throughout the guidelines and is something Stout suggests may prompt the most pushback.
“We actually did get pushback in the review of the guidelines on that because whether you agree with the need for an ACHD cardiologist or not, there’s a general concept that guidelines shouldn’t recommend who sees patients, but rather recommend what should be done,” she said. “But in this particular patient population, which is so new and isn’t something that all adult cardiologists are familiar with, there really is some evidence that expertise can be really helpful in the care of these patients.”
Writing committee vice chair, Curt J. Daniels, from the Ohio State University Heart Center and Nationwide Children’s Hospital, Columbus, agreed the recommendation may be controversial.
“I hope that the message is that we need to work closely with general cardiology; that these patients are going to be seen by them and the guidelines are a guide to how to follow and how to treat ACHD patients from general cardiology,” he said. “But also that they are so unique, there are so many nuances that you can’t put within the guidelines, that ACHD consultation is necessary.”
Another potentially controversial aspect of the guidelines is the suggestion that closure of atrial septal defects (ASDs) is reasonable for some patients but not necessary for all ASDs. That is a shift from the long-standing idea, Stout said, that once you find an ASD big enough to enlarge the right heart, you should just close it.
“It’s not so much that we say you shouldn’t, that’s totally reasonable, but there’s just not enough data to say we are clearly benefiting patients in the long run by closing their ASDs, besides the [reduction in] arrhythmia risk, which is not inconsequential,” she said. “It’s a class IIA indication but a couple of our class II indications people practice as if they’re class I. So I think that’s going to catch people’s eye.”
The guidelines task force also examined the question of whether patients with ACHD with systemic right ventricles benefit from medical therapy, such as β-blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, and aldosterone antagonists.
Ultimately, the guideline committee balked at making a recommendation, citing a lack of sufficient data. Although small studies have suggested a benefit, part of the problem in evaluating drugs is the tremendous variability in anatomy and physiology, even within a diagnostic category.
“It’s not that they don’t work, but more that we haven’t drilled down to which patient population really is going benefit,” Stout said. “Because we all have a sense there is one; we just haven’t studied it and been able to prove it.”
The 2018 guidelines feature a variety of charts and tables as well as lesion-specific sections, all designed to be easy to use.
“We also created treatment algorithms, which weren’t in the first guidelines but are consistent with more recent guidelines,” Daniels said. “So you can have a patient with tetralogy of Fallot, for instance, and go to the algorithm and find out how best, and more visually, to treat the patient to pulmonary valve replacement.”
While the guideline committee made a point of making the report more accessible as a point-of-care document, Stout said what she really appreciates is that it will allow for more real-time updates.
“One good example of that is one of our recommendations says closing an ASD in someone with severe pulmonary hypertension is a class 3 because it can cause harm, but there are groups out there that are using the pulmonary vasodilator therapies to treat patients, bring their pulmonary pressures down, and then close their atrial septal defect,” she said. “As soon as that data gets published, then there’ll be an opportunity to update the guideline just for that one thing.”
“It’s not really interactive, but in that ‘What’s different now than 10 years ago,’ that’s huge. It’s actually the main reason the whole guideline was redone, to allow that real-time updating.”
Finally, the 2018 guidelines highlight the need for more data, particularly the importance of long-term data. Both Stout and Daniels note that the Canadians and Europeans are further ahead in this area, in part because of the ability to track patients through universal healthcare.
There have been conferences with the Centers for Disease Control and Prevention and National Institutes of Health to create a unique identifier to track patients with CHD through the lifespan, but this costs money and requires organizational infrastructure, Daniels said.
“There are many, many datasets out there for congenital heart disease, such as surgical datasets, interventional, but there are no prospective datasets that we are collecting,” he said. “It is an important area that we are still missing if we are ever going to get to the point of preventive care, improving care on a wider scale.”
Stout reports no relevant conflict of interest. Daniels reports a relationship between his institution and Actelion. Disclosure information for other committee members is listed in the paper.
J Am Coll Cardiol. Published online August 16, 2018. Full text
Circulation. Published online August 16, 2018. Full text
Blue Light Damages Retinal Cells in Lab Study
A new study has illuminated one possible underlying mechanism by which blue light can damage retinal cells.
Kasun Ratnayake, MS, a PhD student from the University of Toledo in Ohio, and colleagues found that retinal cells are sensitive to blue light because they contain a protein called retinal. Blue light excites the retinal protein, which then irreversibly alters a signaling protein in the cell membrane. The distorted membrane-bound signaling protein, in turn, causes an increase in intracellular calcium, excessive cellular shape change, and ultimately cell death.
The researchers examined the effect of other wavelengths of light on the cells in culture, but found that only blue and ultraviolet light caused damage to cells. Ratnayake and colleagues published their results July 5 in Scientific Reports.
The authors emphasize that the findings do not suggest that light from digital devices causes similar damage to vision or possible blindness in humans. Rather, their study evaluated the effect of blue light on one type of experimental cell derived from the eye and did not directly measure potential damage to the human retina caused by blue light. In addition, the intensity of the light used in their experiments may not necessarily be the same as the light emitted from devices such as computers and smart phones.
“Whether blue light from mobile devices and digital screens induces similar toxicity levels is an unanswered question and is currently under investigation,” senior author Ajith Karunarathne, PhD, an assistant professor of chemistry and biochemistry at the University of Toledo, told Medscape Medical News in an email.
“Even if such a scenario is found, since the studies are done in cultured cells, that would not indicate that these devices can cause similar damages to the vision. Nevertheless, some literature suggests that removal of the blue component from intense light can reduce vision damage,” he added.
Both the cornea and lens of the human eye are transparent to blue light, which means theoretically that blue light can reach the retina, but how these results translate to humans is not straightforward, agreed Joshua Dunaief, MD, PhD, Adele Niessen Professor of Ophthalmology at the University of Pennsylvania in Philadelphia. Although Dunaief’s laboratory group has done research on the damaging effects of blue light, he was not involved in this study.
Other evidence supports the idea that light can damage the retina, and that blue light may be the most damaging wavelength. For example, previous experiments in laboratory cell lines have suggested that exposure to blue light may damage cells in the retina. Moreover, studies in mice have found that changes to the retinal protein caused by exposure to intense light can lead to age-related macular degeneration, retinopathy, night blindness, and other retinal disorders.
“The state of the field of blue light toxicity suggests that there may be some risk [from regular exposure to lower levels of blue light emitted by computer or smartphone screens,] but it’s not certain whether there is,” Dunaief said. “It’s very hard to determine whether levels of light that people are typically exposed to are causing damage.”
People have several options if they are concerned and want to protect themselves from possible risk caused by exposure to blue light.
“Ophthalmologists generally recommend that people should wear sunglasses when out in bright light, especially when at the beach or out on the water, and especially if they are at risk for macular degeneration because of family history,” Dunaief said.
Sunglasses should be dark gray or brown, which will block blue light and other wavelengths that can get to the retina. Although ultraviolet light is blocked by the cornea and lens and can’t reach the retina, ultraviolet light can increase the risk for cataracts, so it’s also a good idea to wear ultraviolet-blocking sunglasses.
Other options include the use of blue light filters in front of computer screens. Computer software called Flux also exists that can allow users to adjust the colors emitted by their screens away from the blue spectrum and toward the red and green spectrum.
Blue light also sets circadian rhythms, and exposure to it late at night may interfere with sleep, Dunaief cautioned. So it’s best to avoid looking at computers or smartphone screens before bedtime.
The authors and Dunaief have disclosed no relevant financial interests.
Sci Rep. 2018;8:10207. Full text
World’s first artificial retina
Scientists have developed an ultrathin artificial retina that could provide a superior alternative to the visual implants currently available to the blind.
Image Credit: Africa Studio / Shutterstock
It is hoped that the device, which will be described today at the 256th National Meeting & Exposition of the American Chemical Society (ACS), could one day enable the millions of people with retinal disease to regain their sight. Furthermore, the implant could be used to monitor activity in the brain and heart.
Researcher Nanshu Lu from the University of Texas at Austin says this is the first demonstration showing that 2D materials such as graphene and molybdenum disulphide can be used to create an artificial retina.
Although this research is still in its infancy, it is a very exciting starting point for the use of these materials to restore vision.”Nanshu Lu, University of Texas at Austin
In the retina, photoreceptors called rods and cones convert light into nerve impulses that reach the brain via the optic nerve and are translated into visual images.
Retinal diseases such as macular degeneration or retinitis pigmentosa can damage this retinal tissue, which can lead to vision loss.
Many retinal diseases cannot be cured, but silicon-based retinal implants have enabled some people to partly regain their vision.
However, these devices are rigid and fragile, meaning they do not properly mimic the retina’s natural curvature and they often produce blurred or distorted images. They can also strain and damage surrounding tissue in the eye.
Now, Lu and her colleague Dae-Hyeong Kim from Seoul National University have used graphene, molybdenum disulphide and thin layers of gold, alumina and silicon nitrate to produce a more flexible and thinner device that better replicates the shape, size and function of the retina, without causing any mechanical disruption.
Upon testing the device in laboratory experiments and animal models, Lu and Kim found that photodetectors on the device absorbed light and passed it through an external circuit board that digitally processed the light, stimulated the retina and obtained impulses from the visual cortex.
The tests showed that the artificial retina successfully replicated the features of the human eye and was biocompatible.
Next, Lu plans to investigate how the technology can be incorporated into electronic tattoos on the surface of the skin to collect health data in real time.
She says that by adding transistors to the tattoos, they can amplify signals from the brain or heart to make them easier to monitor and treat. The implants could also be placed on the heart surface to aid the detection of arrythmias.
They even have the potential to be programmed to behave like pacemakers and generate electrical impulses to correct the arrythmia.
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