NIH Using Vaccines from Startup FluGen in New Clinical Trial

Researchers are testing a flu vaccine developed by FluGen, a Madison, WI-based startup, to determine whether it can protect recipients against strains of the virus that vary from the predominant strain flu predicted by health experts each year.

Many people get a flu shot this time of year in hopes that it will help them avoid catching the virus during flu season, which typically begins in October or November. The Centers for Disease Control and Prevention (CDC) recommends that everyone six months of age or older get a seasonal flu vaccine, and the most recent flu season in the U.S. was the worst in nearly a decade.

But even those who get vaccinated sometimes fall ill. Forecasts by the CDC, World Health Organization, and other groups that predict what the predominant flu strain will be in the coming season sometimes miss the mark. Such forecasts influence how vaccine manufacturers formulate the flu shots tens of millions of Americans get each year.

The challenge of predicting which strain of the virus will predominate in a given flu season is one reason investors and research organizations have been funding companies seeking to commercialize a “universal” flu vaccine that could protect people against most strains of the disease.

FluGen has made progress in early-stage trials of its vaccine, which it calls RedeeFlu. Meanwhile, the startup is also providing flu vaccines for a current clinical trial. The National Institute of Allergy and Infectious Diseases, which is one of the National Institutes of Health (NIH), and researchers at Saint Louis University are co-managing the trial. It began in August but was not announced publicly until earlier this week.

The NIH and university researchers are conducting and managing the study, but FluGen is providing the vaccines that some participating patients will receive, says Paul Radspinner, co-founder and CEO of FluGen.

That distinguishes the trial from past and ongoing trials of RedeeFlu, which FluGen has led. Radspinner notes, however, that his startup hasn’t been acting alone. FluGen has had “funding partners” for the trials it has conducted previously, including the U.S. Department of Defense, he says.

The phase 1 trial the NIH is co-managing is aimed at assessing the safety of RedeeFlu, and whether its recipients produce an immune response, according to the agency. Fifty children ages nine to 17 are enrolled, the NIH says.

The design of RedeeFlu is aimed at giving the vaccine the ability to protect against so-called drifted—or mismatched—flu strains. That versatility could allow the vaccine to protect against strains of the virus that vary from the one the CDC and other forecasters predict will predominate in a particular season.

FluGen is not charging the NIH or its collaborators for the RedeeFlu vaccines they’ll give to some subjects, Radspinner says. For FluGen, one likely benefit of providing vaccines used in the trial will be learning how younger patients’ immune systems respond to RedeeFlu. Radspinner says that up to this point, FluGen has only studied the effects of RedeeFlu on adults.

The trial is the first FluGen has done in conjunction with the NIH, Radspinner says.

Half of the subjects in the trial will be dosed with RedeeFlu, a nasal spray manufactured with a strain of flu that was used in vaccines during the 2008 through 2010 flu seasons. The other half will receive a placebo. About three months after subjects are dosed, they will receive this flu season’s recommended vaccine.

Radspinner says the results of the study could reveal what effect, if any, receiving a different flu vaccine three months later has on subjects’ immunology, Radspinner says. That’s something FluGen has not tested previously, he says.

Depending on the results of the NIH- and Saint Louis University-led trial, the two organizations may conduct subsequent studies of flu vaccines in younger patients. The next subjects would be five- to nine-year-olds, Radspinner says.

The live flu virus in RedeeFlu has been altered so it is missing a key protein, M2. Without it, the virus will live in the body long enough to trigger an immune response, but it won’t be strong enough to cause the disease’s severe effects or infect others, FluGen says.

https://www.xconomy.com/wisconsin/2018/09/19/nih-using-vaccines-from-madison-startup-flugen-in-new-clinical-trial/

57% Say OK with Genetically Engineering Animals for Organ Transplants

A recent survey by the Pew Research Center found that 57 percent of Americans surveyed thought it was appropriate to use genetically engineered animals to grow organs for human transplants. However, 41 percent said they thought that was going too far. It’s possible, that with modern developments in 3D printing and other technologies, it won’t be necessary.

The Pew Research Center says, “The findings are part of a larger pattern that reveals Americans are more likely to support the bioengineering of animals if it benefits human health.”

Pew points out that in 2017, more organ transplants were performed than ever in the U.S., and organs were recovered from more than 10,000 donors, an increase of more than 25 percent over the past decade. The increase is largely attributed to breakthroughs in medical technology that have made it possible to harvest organs that were previously found to be unsuitable.

Based on individual responses, the objections had to do with the ethics of using animals in a “factory-like” manner, comparing it to how they are treated for food sourcing. One individual stated, “When you mix human and non-human genetics I believe that will cause extreme problems down the road.”

Researchers, however, are working on different approaches. One is 3D bioprinting. Typical 3D printing uses carbon fiber as a source material, but there are examples of 3D printing using biological source materials to create biologically-active or interactive materials.

In June 2018, France-based Poietis, along with another company, Prometheus, a division of Skeletal Tissue Engineering in Leuven, Belgium, signed a two-year Collaborative Research Agreement to develop high-precision 3D Bioprinting of tissue engineered Advanced Therapeutic Medicinal Products (ATMPs) for skeletal regeneration.

Essentially, the companies are working to “print” bone that can be used in transplants or other orthopedic, musculoskeletal or spine-related applications.

A San Diego company, Organovo, is working with researchers at Amgen and Medikine to develop new applications for Organovo’s ExVive Liver and Kidney Tissue. It uses 3D printing to create functional human tissues and hopes to someday be able to print tissues that could be transplanted into the human body.

Also in June of this year, San Francisco-based Prellis Biologics recorded a speed and resolution record for its attempts to print human tissue with viable capillaries. Its holographic 3D printing technology creates complex microvascular scaffolding that allows human tissue to survive.

InvivoSciences, located in Madison, Wisconsin, has developed micro-engineered heart tissues, now called NuHeart. It uses 3D culture technology, not bioprinting, which is similar to growing specific heart tissues out of stem cells. It can reconstitute muscle, such as skeletal, cardiac, or smooth muscles, as well as connective tissue like dermis of the skin in micro-well plates.

And in May, Emulate signed a deal with AstraZeneca’s Innovative Medicines and Early Development (IMED) Biotech Unit to embed its Organs-on-Chips technology within the laboratories of the IMED Drug Safety organization. Initially, the two companies will use Emulate’s Liver-Chip to evaluate drug candidates’ safety. The companies also hope to develop three other Emulate Organ-Chips — the Lung Tumor-Chip, Lung-Chip, and Glomerulus Kidney-Chip.

And in September, researchers at the University of California, San Diego (UCSD) published their work in the journal Stem Cells and Development describing a fast, cost-effective method to grow human cortical organoids in Petri dishes using primary cells. Because of ethical considerations as well as physiological limitations of animal models, work on the brain can be difficult. However, recently there have been in vitro human organoids, which are three-dimensional, miniaturized, simplified version of an organ developed and grown from pre-programmed stem cells.

“And that includes the brain,” said Alysson R. Muotri, professor in the UC San Diego School of Medicine departments of Pediatrics and Cellular and Molecular Medicine, and director of the UC San Diego Stem Cell Program, in a statement. “Cerebral organoids can form a variety of brain regions. They exhibit neurons that are functional and capable of electrical excitation. They resemble human cortical development at the gene expression levels.”

Early progress in the area is typically to use the organs or mini-organs and tissues as models for research and drug development. Perhaps in the future, as the research grows more mature, they will be used for transplants. It’s not inconceivable that artificially-grown brain tissue could be used at some time in the future to treat brain injuries.

https://www.biospace.com/article/cp8r-57-percent-of-americans-ok-with-genetically-engineering-animals-for-organ-transplants/

Biotech IPOs Are Booming … But For How Long?

According to BioPharmCatalyst, there have been (or soon will be) 58 biopharma initial public offerings (IPOs) in 2018, and there’s still more than three months to go. The first listed on the BioPharmCatalyst database was Menlo Therapeutics on January 25, 2018. The most recent listing was Elanco Animal Health, whose offer date is September 21, 2018.

A recent Bloomberg article described 38 new U.S. stock listings by biotech companies, noting they had raised almost $3.9 billion, the highest marked since 2000. The 2000 boom was related to genetic therapies. In July, Crunchbase noted that in the second quarter of 2018, there were at least 16 U.S. venture-backed biotech and healthcare IPOs, compared to only 11 tech IPOs in the same period this year.

Bloomberg writes, “This time around, amid the recent approvals of the world’s first gene therapy and Alnylam Pharmaceuticals, Inc.’s RNA-interference drug, investor enthusiasm isn’t confined to any one area. Companies that sold stock for the first time in 2018 include Translate Bio Inc.,which is using messenger RNA to develop drugs for rare diseases such as cystic fibrosis, and Neon Therapeutics Inc., which describes itself as a platform for developing cancer immunotherapy treatments.”

The upcoming Elanco Animal Health IPO isn’t typical of biotech public launches. Most tend to be relatively recent biotech startups that have raised venture capital and brought a compound or therapy through proof-of-concept, or sometimes even into Phase I clinical trials. They are looking for more funding to pay for the larger and more expensive Phase II and III clinical trials.

Elanco is part of Eli Lilly, and it expects to raise up to $1.45 billion in its IPO. Elanco has been part of Lilly for 65 years and is being spun off. The Indianapolis Business Journal reported, “But Elanco has been struggling, ringing up losses of more than a half-billion dollars in the past three years, much of it connected to restructuring and other special changes. The new management’s first challenge will be to stabilize the company, launch new products and win back market share it has been losing to competitors.”

Compare that to one of this year’s most successful biotech IPOs, Cambridge, Massachusetts’ Rubius Therapeutics, which raised $240 million in its July IPO. Rubius Therapeutics’ focus is on genetically engineered long-circulating Red-Cell Therapeutics (RCT) products. They are genetically engineered, enucleated red blood cells that have broad therapeutic applications for cancer, enzyme replacement therapy, and autoimmune diseases.

Bloomberg suggests that even though many companies are rushing to the stock market, others are waiting. “One reason is that thanks to low interest rates and a hunt for higher returns by institutional investors, biotech startups have access to more capital than ever. Founders of several startups told Bloomberg News in recent weeks that they are raising more money earlier than expected.”

Which isn’t without its drawbacks. One of the primary business models for biotech startups is getting to Phase I or Phase II and either partnering with a large pharmaceutical company or be acquired by one. But Bloomberg observes that larger drugmakers have been complaining recently about the high valuations some of these biotech companies have.

For investors who pick the right biotech at the right time, it can be a big win. For example, in 2014, Juno Therapeutics raked in $176 million in its first large financing round. A few months later its IPO gave it a valuation of $1.9 billion. And where some biotechs drop quickly, Juno took off, jumping 46 percent on the first day of trading to give the company a valuation of $2.7 billion. Then in January 2018, Celgene acquired the company for $9 billion.

An example from this year would be Tilray, which is something of an outlier. Tilray focuses on medical cannabis research, cultivation, processing and distribution. Shares launched at $17 per share in July 2018, and have since risen over 463 percent, trading on September 12, 2018 for $104.36.

But others may not be so wonderful. Eyenovia, which launched in January 2018 at $10 per share, has dropped more than 51 percent. This Reno, Nevada-based company is focused on changing the delivery of drugs for eye diseases, such as glaucoma, dry eye, allergic eye disease and others, using a piezo-dispersion and microdosing technology. Shares are trading on September 12 for $4.80. On the other hand, at least two analysts cited by Zacks Investment Research give it a “strong buy” rating, suggesting they believe it’s ready to pop.

All this is probably good news for biotech companies, who indicate that the ready supply of investment capital allows them to focus on research. For example, Kaleido Biosciences raised $101 million, which the company’s executive chairman, Michael Bonney, said should carry them through at least 2020. “The general understanding of human biology and what’s driving various diseases is improving, and that creates a broader audience to go to and try to find the funding that we need,” Bonney told Bloomberg.

However, investors should know what they’re getting into when it comes to biotech stocks. Notoriously volatile, investments don’t always pay off with actual commercial products—ever—or for many years. Investing in biotech companies is a gamble on many things, including good science, market needs, competition and government regulation.

And Bloomberg points out that previous booms have corrected quickly, noting drops of more than 10 percent in the Nasdaq Biotechnology Index after run-ups in 2000 and 2014. And some analysts are wondering if this year’s boom is close to an end.

Hartaj Singh, an analyst with Oppenheimer & Co., told Bloomberg, “We’ve already had a really good 12- month period. They don’t tend to be much longer than that.”

https://www.biospace.com/article/ip3o-biotech-ipos-are-booming-but-for-how-long-/

Bayer Steps Up Legal Fight Over Weed Killer Blamed for Cancer

Bayer AG is stepping up the legal defense of its flagship weed killer, after a verdict in a recent case alleging the chemical causes cancer sent shares down sharply and raised the prospect of costly plaintiff payouts.

Bayer on Tuesday said it wants a California state court judge to overturn the jury’s verdict, order a new trial or reduce damages, according to a court filing. The company aims to defeat a $289 million award in August in one of the first of thousands of cases filed by gardeners, farmers and others claiming Bayer’s Roundup herbicide gave them cancer.

The jury in that case ruled unanimously in favor of a former groundskeeper who sought to hold the maker of Roundup liable for his non-Hodgkin lymphoma. The verdict came only two months after the German pharmaceutical and chemical conglomerate sealed its takeover of Monsanto, the U.S. agriculture giant that invented the herbicide.

Bayer shares have dropped about 22% since the verdict to five-year lows. Investors fear a lengthy legal battle and more damage awards could cost the company billions of dollars. Some have questioned whether Bayer Chief Executive Werner Baumann properly evaluated the risks of taking over Monsanto in a 2016 deal valued at more than $60 billion, the biggest ever by a German company.

Bayer now faces 8,700 plaintiffs in the U.S., up from a few hundred in the spring of 2016. Bayer has said it expects that number to grow.

“Werner Baumann must ask himself if Bayer took too lightly the lawsuits against Monsanto,” said Winfried Mathes, a corporate expert from Bayer shareholder Deka Investment. The share-price drop has also rattled employees inside the Leverkusen, Germany-based company, according to people familiar with their thinking.

Mr. Baumann has told investors that Bayer’s arguments about science proving the weed killer’s safety will prevail. “We stand behind the product and the science backing it up,” he said on a conference call in August.

In its filing on Tuesday with the California state court, Bayer argued that the plaintiff’s lawyers relied on flimsy scientific evidence that doesn’t support a link to cancer, and that jurors were swayed by overly emotional and speculative arguments from the plaintiff’s lawyers.

Pedram Esfandiary, an attorney for Baum Hedlund Aristei and Goldman PC, which is representing the plaintiff in the case, said the jury verdict demonstrated that Monsanto’s scientific case wasn’t convincing. “I think the odds are very slim of them prevailing,” he said.

Judge Suzanne Ramos Bolanos is expected to rule on Bayer’s requests by late October or early November.

Bayer entered deal talks with Monsanto in 2016 aware of the problems facing Roundup, people familiar with the negotiations said. Still, there were legal limits to how much information Monsanto could share before antitrust officials approved the merger, Bayer has said.

Representatives for the European Union’s competition authority and the U.S. Department of Justice had no immediate comment.

Bayer first learned of dozens of internal Monsanto emails discussing glyphosate’s safety and strategies to publicly defend it as part of U.S. court proceedings. Those emails include what plaintiffs’ lawyers say is evidence of Monsanto ghostwriting articles for outside scientists to defend the chemical’s safety.

After assuming control of Monsanto this summer, Bayer found no “smoking gun” in Monsanto’s internal communications, Mr. Baumann told investors last month. Lawyers representing cancer victims used those internal communications “out of context on purpose,” he said. Monsanto’s scientists and the article authors denied ghostwriting allegations, Bayer said.

The deal made Bayer the world’s biggest supplier of pesticides and seeds for farmers, which now generate nearly half of group sales. Profit margins are slim for Roundup, its top-selling crop spray, but the bulk of the nearly $11 billion in crop seeds Monsanto sells annually are genetically engineered to withstand glyphosate, the potent weed-killing chemical in Roundup.

The International Agency for Research on Cancer, part of the World Health Organization, in 2015 classified glyphosate as likely having the potential to cause cancer. Monsanto fought back, pointing to studies by academics and agencies like the U.S. National Institutes of Health and Environmental Protection Agency that showed no cancer risk.

Legal academics said successful challenges to jury verdicts aren’t uncommon. Last October, another California state judge overturned a $417 million judgment against Johnson & Johnson after a woman alleged that the company’s baby powder contributed to her developing ovarian cancer.

In January, a judge in Pennsylvania state court overturned a jury’s verdict and $28 million in damages and ruled in Bayer’s favor in a lawsuit alleging the company and Johnson & Johnson didn’t properly warn about internal bleeding risks from the drug Xarelto.

“For Bayer, the most important thing is to have a judge say the science doesn’t hold up,” said Alexandra Lahav, law professor at the University of Connecticut.

Bayer has sometimes settled product lawsuits. In 2005, Bayer paid $1.15 billion to settle some 3,000 death and injury claims over its withdrawn cholesterol-lowering drug Baycol.

The company also spent over $2 billion to settle thousands of cases claiming it didn’t adequately inform women of the risk of thrombosis and other side effects from its hormone-based contraceptive pills Yaz, Yasmin and Yasminelle.

https://www.marketscreener.com/BAYER-436063/news/Bayer-Steps-Up-Legal-Fight-Over-Weed-Killer-Blamed-for-Cancer-27280669/?countview=0

Viking has more catalysts in store this fall

Positive results from a mid-stage clinical trial sent Viking Therapeutics Inc. shares soaring 87% on Tuesday.

But don’t tell Viking Therapeutics Chief Executive Brian Lian VKTX, +87.30%  . As of midday, when he spoke to MarketWatch, he hadn’t even checked the stock price.

“It gets distracting if you start checking it all the time,” Lian said, comparing it to when someone has recorded a show and doesn’t yet want to find out what happened.

In the company’s phase 2 trial for non-alcoholic fatty liver disease (NAFLD), Viking Therapeutics’ VK2809 showed reductions in LDL-C and liver fat content, which were the trial’s primary and secondary endpoints, respectively. Though Tuesday’s results pertained to a relatively small number of patients, or 47 across subgroups, NAFLD is a large disease area seen as a big opportunity for drugmakers.

The primary and secondary endpoints required baseline and postbaseline measures, and patients who didn’t get both weren’t included in the analysis. To that end, only 45 patients were included in the primary endpoint; the company didn’t disclose the patient population for the secondary endpoint but said around 37 was a fair estimate.

The drug, which is taken orally, had a good safety profile, according to the company, and no serious side effects were reported from trial participants. VK2809 could also have potential benefits for heart health, Lian said, which is significant because non-alcoholic fatty liver disease has been linked to cardiovascular disease.

NAFLD is caused by fat buildup in liver cells at higher-than-normal levels and is not linked to alcohol use, according to the American Liver Foundation. It affects an estimated 100 million people in the U.S., and a subgroup of those individuals have a more serious form of the disease called non-alcoholic steatohepatitis (NASH).

More news should be coming from the company, in what Maxim Group analyst Jason McCarthy has described as a “busy autumn.”

The biotech hopes to present more information about reductions seen in LDL-C at an upcoming conference in November, which is why the company hasn’t yet released a more detailed breakdown, Lian told MarketWatch.

More data may also be released at a European conference in April, and the company plans to meet with the FDA to discuss its next clinical study in the first half of 2019.

In future studies, Lian would like to see VK2809 show improvements in other features of the disease, like inflammation and damage to liver cells, something that takes more time to demonstrate.

Viking Therapeutics additionally plans to present results from a phase 2 trial of VK5211 in patients with hip fractures at the end of this month, and the company is also testing VK2809 in a condition called glycogen storage disease.

There has also been plenty of speculation about big drugmakers acquiring or partnering in this area. Viking rival Madrigal Pharmaceuticals Inc. MDGL, -9.25%whose shares dropped 11% in Tuesday trade, has been discussed as a potential target because small biotech companies don’t really have resources to make a big drug commercially successful

Lian told MarketWatch that bringing a product like VK2809 to market is a big endeavor. At the same time, any opportunities should be considered on a case-by-case basis, he said.

“I think any small company has to be prepared to move realistically into a large phase 3 study, but I also think you have to be open-minded and opportunistic when a partner approaches and proposes something that makes sense for shareholders,” he said. “A company always has to be prepared to move alone if the partnerships never materialize.”

Viking shares have surged 60.8% over the last three months, compared with a 4.8% rise in the S&P 500 SPX, +0.54%  and a 5.2% rise in the Dow Jones Industrial Average DJIA, +0.71%  .

https://www.marketwatch.com/story/viking-therapeutics-stock-rose-87-on-results-for-its-liver-disease-drug-and-the-company-has-more-in-store-this-fall-2018-09-18?siteid=rss&rss=1

Colon cancer is caused by bacteria and cell stress

“With our study we originally wanted to study the role of bacteria in the intestines in the development of intestinal inflammation,” explains Professor Dirk Haller from the Department of Nutrition and Immunology at the Weihenstephan Science Centre of the TUM. “However, the surprising result for us was the discovery that bacteria together with stress in cells caused tumours (exclusively in the colon) and without the involvement of inflammation.”

The investigations were initially carried out using the mouse model. In germ-free (i.e. sterile) animals, in which the activated transcription factor ATF6 regulated stress in the intestinal mucosa (intestinal epithelium), no change could be observed. But as soon as the microbiota, i.e. all the microorganisms in the intestine, were transplanted back into germ-free animals, tumours developed in the colon of the mice. Using Koch’s postulates, Haller and his team were able to show that microorganisms are involved in the development of cancer in the colon.

The transcription factor ATF6 regulates stress in cells, and the intensity and duration of activation is increased with diseases. “However, it is not cell stress alone that leads to tumour growth, but the combination of stress and microbiota that favours cancer growth,” says Haller, head of ZIEL — the Institute for Food & Health at TUM.

ATF6 incidence found to be increased in colon cancer patients

Subsequently, in cooperation with the clinic on the right side of the Isar (Prof. Janssen), the data of 541 patients with colon cancer were examined. In those cases where the level of transcription factor ATF6, which triggers cell stress, was significantly increased, the recurrence rate after surgery increased: About ten percent of patients were at risk of getting colon cancer a second time.

“In certain patients, the protein ATF6 could serve as a diagnostic marker for an increased risk of colon cancer and could indicate the start of therapy at an early stage,” said Prof. Haller — “a microbial therapy is conceivable, when we know more about the composition of the bacterial flora. What now became clear, however: Chronic inflammation has no effect on cancer development in the colon.”

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Story Source:

Materials provided by Technical University of Munich (TUM). Note: Content may be edited for style and length.

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Journal Reference:

1. O.I. Coleman, E.M. Lobner, S. Bierwirth, A. Sorbie, N. Waldschmitt, E. Rath, E. Berger, I. Lagkouvardos, T. Clavel, K.D. McCoy, A. Weber, M. Heikenwalder, K.P. Janssen, D. Haller. Activated ATF6 Induces Intestinal Dysbiosis and Innate Immune Response to Promote Colorectal Tumorigenesis. Gastroenterology, 2018; DOI: 10.1053/j.gastro.2018.07.028

https://www.sciencedaily.com/releases/2018/09/180918110908.htm

Zapping Airway Nerves May Help COPD Patients Breathe

 Thousands of Americans struggling with chronic obstructive pulmonary disease (COPD) may have a new treatment option to help them breathe easier.

COPD, which is often linked to smoking, is a progressive deterioration of lung function that involves a combination of bronchitis and emphysema symptoms. It’s the third leading cause of death in the United States, and while treatments can ease symptoms, there is no cure for COPD.

However, researchers on Tuesday presented promising new findings from a phase 2 clinical trial. The trial focused on a new COPD treatment called targeted lung denervation (TLD).

In this therapy, doctors disrupt nerves lying on the outside of the patients’ airways.

The new trial involved 82 COPD patients treated at medical centers in six European countries. According to the researchers, the treatment reduced problematic symptoms by more than 50 percent compared to patients who got a sham treatment.

“We have been able to significantly reduce chronic respiratory symptoms such as shortness of breath, exacerbations of the disease, infections and hospitalizations in a group of COPD patients who are already on aggressive medical therapy,” said lead researcher Dr. Dirk-Jan Slebos, of the University Medical Centre Groningen, in the Netherlands.

In addition, patients saw a better quality of life and improved lung function, he said.

One expert in respiratory care said new treatment options are needed for COPD patients.

Dr. Len Horovitz is a pulmonary specialist at Lenox Hill Hospital in New York City. He explained that TLD works by inactivating nerves lying outside the airways. This results “in dilatation of previously constricted airways, and less production of mucous,” he explained.

“While there is medication that COPD patients use to accomplish the same effect, the addition of TLD appears to confer additional therapeutic benefit,” said Horovitz, who wasn’t involved in the new trial.

The study was funded by Nuvaira, the Minneapolis-based maker of TLD technology. The findings were scheduled for presentation Tuesday at the European Respiratory Society International Congress, in Paris.

In the treatment, a catheter is passed through a tube called a bronchoscope into the lungs. The catheter delivers an electric charge to the nerves on the outside of the airways, altering their normal function.

This allows the airways to relax and widen, make less mucus and also eases inflammation to the airway wall. The catheter and bronchoscope are then removed.

When combined with drugs designed to relax the airway, TLD appears to have an even greater effect, the researchers said.

Among the 82 patients in the trial, the investigators found that in the six months after the procedure, 71 percent of those who received the sham treatment experienced a serious flare-up of their COPD, compared with only 32 percent of those who were treated with TLD.

“Furthermore, the positive benefit has continued in those receiving TLD treatment, with the number of patients hospitalized for respiratory complications in the first year reduced by more than half in the treatment arm versus the sham arm,” Slebos said in a meeting news release.

The study team reported that no patients died. Among those receiving TLD, five patients experienced side effects that included nausea, abdominal bloating and digestion discomfort. These problems were short-lived and gone within six months.

According to Horovitz, the invasive nature of the procedure may not make TLD appropriate for all COPD patients. “This procedure would be contemplated in patients who are very symptomatic with shortness of breath and frequent exacerbations,” he said.

A much larger, phase 3 trial is being planned for 2019, the researchers said.

Experts note that research presented at medical meetings should be considered preliminary until published in a peer-reviewed journal.

More information

For more about COPD, visit the American Lung Association.

SOURCES: Len Horovitz, M.D., pulmonary specialist, Lenox Hill Hospital, New York City; European Respiratory Society, news release, Sept. 18, 2018

https://consumer.healthday.com/diseases-and-conditions-information-37/copd-966/zapping-airway-nerves-may-help-copd-patients-breathe-737813.html