StemCell Therapy

A promising University of Virginia scientist, Ku-Lung (Ken) Hsu, an assistant professor of chemistry, has earned one of the National Science Foundations coveted Early Career Development Program Awards, which support junior faculty members who perform outstanding research and are regarded as exceptional teachers.

Part of the grant is used to integrate education and research in academic activities. Hsus award is for $681,000.

Hsu uses chemistry to control biological systems, particularly to modify the immune system to become an active combatant against cancer. His work understanding and controlling the inflammation response spans the search for new non-addictive drug options for treating pain, to modifying immune cells so they can recognize and kill cancer cells.

The five-year NSF CAREER grants are among the most prestigious available to young faculty in science and engineering, and are designed to provide significant resources to the early stage development of careers.

Many of Hsus laboratory studies are conducted in collaboration with clinical researchers in the School of Medicines Cancer Center as part of UVAs efforts to enhance research into precision medicine using immunotherapy to target life-threatening diseases at the fundamental molecular level.

Hsu discusses here his research and grant for readers of UVA Today.

Q. What drew you to this area of chemistry?

A. Chemical biology is an exciting area of chemistry because it is very creative, highly interdisciplinary and allows scientists to answer fundamental questions that ultimately improve human health through drug discovery and other new therapies. I enjoy the opportunity to work with experts in so many different fields, including pharmacology, pathology, neurology and cancer biology. As a result, I learn something new from each project.

My students also benefit greatly from being in this field because of an emphasis on collaborations, which increases diversity through individuals they interact with and expands the skillsets they obtain during their training. Medical research is becoming increasingly collaborative, so my students are becoming well-prepared for the research environments in which they will spend their careers.

Activating the immune response to fight cancer represents a very exciting treatment modality and UVA is well-positioned to be a leader in this front. The UVA Cancer Center has been a major supporter of my research program, and I look forward to continued interactions and collaborations in this community.

- Ken Hsu

Q. Describe the most compelling aspects of your latest research.

A. I am excited about two recent discoveries that embody research from our group in the field of chemical biology. Both reports are published in the journal Nature Chemical Biology.

In our first paper, we describe a new chemical reaction with broad applications for synthetic chemistry and drug discovery. The reaction we discovered possibly could come into common use for developing new treatments for cancer and other diseases in the future. This finding was especially rewarding because I teach related material in my organic chemistry course and our paper describes a new methodology for synthetic chemists and chemical biologists to tune chemical reactions for diverse real-world applications. This is compelling for my students, to know that what they are learning in class is also current and active to catalyze breakthrough research in our labs.

In our second report, our findings are directed toward fundamental discoveries in the realm of fat (lipid) molecules, which play a major role in the bodys metabolism at the cellular level. We used protein engineering to design artificial lipid kinase enzymes a specialized protein involved in cell growth, proliferation and other functions that can include the growth of cancers in order to better understand how cells regulate their fat composition. To our surprise and delight, we narrowed in on a very specific region of these lipid kinases that allow us to control how they operate in cells. Our findings will teach us and others in the field a more effective way to design therapeutics to combat these enzymes when they misbehave.

Q. How will this grant allow you to connect your research with teaching?

A. The NSF CAREER Award will provide new opportunities for applying our chemistry and technologies to study how individual cells control the metabolism of fats and lipids. We plan to develop compounds that attach to enzymes to illuminate how cells are similar or distinct based on their metabolism kind of like a molecular fingerprint. Our long-term goal is to create new opportunities for cell type discovery and push the boundaries of cell engineering.

The research is intimately connected to an educational outreach program designed to broadly impact Native American student communities by providing opportunities for UVA graduate students to teach how lipid biochemistry influences healthy food choices and eating behaviors in society.

Q. Where do you see your research going from here?

A. In the next five years, I am looking forward to applying our chemistry and technologies toward deeper understanding of lipid biology and metabolism in physiologically relevant models. We remain committed to discovery of new molecular pathways for immune system modulation, and our recent findings represent important steps toward our long-term goal.

Q. How promising is the future regarding immune system modulation?

A. Activating the immune response to fight cancer represents a very exciting treatment modality and UVA is well-positioned to be a leader in this front. The UVA Cancer Center has been a major supporter of my research program, and I look forward to continued interactions and collaborations in this community.

I believe the chemistry we are pursuing will provide new opportunities and technologies for exploring creative ways to study and control the immune system. Support from the NSF CAREER Award will pave the way for new ways to engineer immune cells for cancer and other potential disease indications.

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Q&A: Chemical Biologist Ken Hsu to Use NSF CAREER Award to Fight Cancer - University of Virginia

We usually think of viral respiratory infections, like the common cold, as mild nuisances that pass in a few days. But the Wuhan coronavirus has proven to be different. Of those infected, around 2% are reported to have died but the true mortality is unknown.

Theres much were yet to learn about this new virus, but we know it often causes pneumonia, an infection of the lungs which produces pus and fluid and reduces the lungs ability to absorb oxygen.

Of the first 99 people with severe infection, three-quarters had pneumonia involving both lungs. Around 14% appeared to have lung damage caused by the immune system, while 11% suffered from multi-organ system failure, or sepsis.

Others are at risk of complications from being treated in hospitals, such as acquiring other infections.

Read more: How contagious is the Wuhan coronavirus and can you spread it before symptoms start?

At this stage, we know some people develop only a mild infection, while others become critically ill, but the exact proportion of each is not yet clear.

Overall, there are four key ways the Wuhan coronavirus can cause severe disease and some can occur at the same time.

For the SARS (severe acute respiratory syndrome) coronavirus, direct viral damage was probably the most common way the infection caused disease. This is likely the case with the Wuhan coronavirus.

Early studies have found the Wuhan coronavirus attaches to a particular receptor found in lung tissue. This is like a lock and key mechanism allowing the virus to enter the cell, and is the same receptor the SARS coronavirus used.

Viruses hijack the host cells mechanisms to make more copies of itself. Damage results from either viruses taking over the cell completely and causing it to die, or immune cells recognising the viral infection and mounting a defence, triggering cell death.

If large numbers of cells die, then the affected organ cant function effectively.

Studies from patients who died from SARS coronavirus showed the virus caused damage to not only the lungs, but also other organs in the body. Early research suggests the Wuhan coronavirus can also damage other organs, including the kidneys.

While were still piecing together the relationship between the Wuhan coronavirus and pneumonia, theres much we can learn from influenza.

Influenza is a virus but it commonly leads to bacterial pneumonia this is whats known as a secondary infection.

Its thought the influenza virus weakens the usual protective mechanisms of the lung, allowing bacteria to establish and multiply. This is especially true in children, older people and those with compromised immune systems.

Secondary bacterial pneumonia is more severe than influenza alone in hospitalised patients, around 10% of those with influenza and pneumonia die, compared to around 2% of those who dont have pneumonia.

The Wuhan coronavirus appears to cause pneumonia in two ways: when the virus takes hold in the lungs, and through secondary bacterial infections, however, the first way appears to be more common.

Sepsis is a serious condition that can be caused by many infections.

When we get an infection, we need to mount an immune response to fight off the pathogen. But an excessive immune response can cause damage and organ failure. This is what happens in the case of sepsis.

Read more: What is sepsis and how can it be treated?

Although it can be difficult to determine whether organ damage from the Wuhan coronavirus is a result of direct viral infection or indirect collateral damage from the immune system, initial reports suggested around 11% of people severely ill with the Wuhan coronavirus experienced sepsis with multi-organ failure.

So far no drugs or interventions have been able to dampen this immune response. Although several treatments have been proposed for Wuhan coronavirus, none have yet been shown to work.

Finally, patients who require hospital care may have complications. These include infections from intravenous lines (for drips/medication) or urinary catheters (flexible tubes inserted into the bladder to empty it of urine), pneumonia, or non-infectious complications such as falls or pressure sores.

Studies have found 10% of patients in hospital have some sort of health care-acquired infection, and around 5% have a pressure sore.

Hospitals work hard to try to prevent these complications, by making sure health care workers disinfect their hands and other equipment. However, complications still occur, particularly in patients who are debilitated from long hospital stays.

Read more: 1 in 10 patients are infected in hospital, and it's not always with what you think

While most respiratory viral infections are mild, some can trigger serious complications, either directly or indirectly. Its too early to tell how often this occurs with the Wuhan coronavirus. While we have initial data on those who were severely affected, many others may not have required medical care.

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How does the Wuhan coronavirus cause severe illness? - The Conversation AU

Safety concerns and manufacturing shortcomings aside, existing CAR-T therapies Novartis Kymriah and Gileads Yescarta simply dont work in 10% to 20% of patients with B cell malignancies. What factors underpin this resistance to CAR-T therapy? The main culprit could be the cancer cells themselves, according to a team of researchers at Penn.

CAR-T therapies are engineered to work in this way: Cells are extracted from the patient and then manipulated in a lab where chimeric antigen receptors are added to direct the patients own T cells to snuff out specific cancer cells once re-infused back into the patient. But in a fraction of patients, the armed immune attack does not obliterate the disease. By targeting CD19, a marker present on almost all B cells, CAR-T therapies have shown remarkable potency and durability in a number of blood cancers, including acute lymphoblastic leukemia (ALL).

Research so far suggests that resistance to CAR-T therapies is related to the loss of CD19. When CD19 disappears from leukemic cells, they become invisible to CAR-T therapies, noted the studys co-senior author Marco Ruella, an assistant professor of hematology-oncology at the University of Pennsylvania, in an interview with Endpoints News.

That explains maybe half of the relapses in leukemia and maybe a third in lymphoma so there is still a vast majority of patients where we simply dont know whats going on, he said.

Another factor driving resistance was dysfunctional T cells, he added. What we are hypothesizing here is that there can be a third mechanismthat even in the presence of CD19 those leukemic cells are unable to die when they are triggered by CAR-T.

The constant presence of the leukemic cells that basically cannot die theyre sort of highlanders causes dysfunction in the T-cells. To start with the CAR-T (cells) are okay but then they keep trying to kill leukemic cells that intrinsically cannot die, and then, over time, they become dysfunctional.

The findings were published on Thursday in Cancer Discovery, a journal of the American Association for Cancer Research.

In the Penn study, researchers performed a genome-wide CRISPR/Cas9-based screen of an ALL cell line to isolate pathways associated with resistance. Cells were edited for loss of function of single genes and combined with CAR-T cells for 24 hours to identify the pathway driving the primary resistance. The in vitro data showed thatin the ALL cells that resisted the CAR-T attack, there was a shortage of genes involved in activating the cell death pathway and a spike in genes necessary for evading the cell death pathway.

Instead of interrogating samples from patients that have failed to benefit from CAR-T therapies, the plan was to model a genome-wide resistance mechanism and then confirm it in patients. Many patients are now being treated with CAR-Ts, but still, the numbers are limited so this approach was used to discover aberrations that the limited number of patient samples would not be powered to identify, Ruella said.

We started with an unbiased genome-wide approach to study resistance and we saw that the new CRISPR/Cas9 genome knockout libraries were perfect because they would allow you to explore knockouts in the whole genome and interrogate it for resistance to CAR-T.

The findings were amplified in animal models. The researchers then tried to make sense of the results by using pediatric patient samples from previous CAR-T trials by analyzing the genes in leukemia cells and in T cells pre- and post-infusion from responders and non-responders. The data were stark: previously identified signaling pathways in cancer cells were directly associated with responses to CAR therapy, suggesting that death receptor signaling is a key regulator of primary resistance to CAR T cell therapy in ALL, the authors concluded.

This mechanism appears to rely on two phases: an initial resistance to death receptor-driven killing, followed by an antigen-driven, progressive impairment in CAR-T cell function. Together this leads to CAR T cell failure that perpetuates disease progression, they wrote.

Despite their abundant promise, the adoption of CAR-T therapies Novartis Kymriah and Gileads Yescarta has underwhelmed initial expectations.

The uptake of Kymriah was plagued by manufacturing problems, and despite Novartis attempt to expand its capacity, sales continue to disappoint commercially, giving Yescarta an edge in the market. Meanwhile, big side effects notably life-threatening episodes of cytokine release syndrome and neurotoxicity as well as the therapies expensive price tags have also limited their use. Other drug developers have taken note of these constraints and are developing off-the-shelf CAR-T therapies, designed to smoothen manufacturing complexities by using healthy donor cells.

But the team at Penn cautioned that the practice may not necessarily help the subset of patients whose cancer cells carry this proportion of unfavorable genes.

A possible implication of our observations is that the use of healthy donor (i.e. allogeneic donor or universal donor) T cells as a substrate for CAR T cell manufacturing may face the same barriers as autologous products, the authors wrote. Understanding how intrinsic and acquired T cell dysfunction cooperate to cause therapeutic failure will be critical to the design of the next generation of cellular therapies.

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UPDATED: Resistant to CAR-T therapies? It's the cancer, not your immune system study - Endpoints News

20 years ago, scientists for Celera Genomicsand the Human Genome Project sequenced the human genome. To accomplish this task, 30,000 genes were sequenced. It was a very big deal, and it opened the door to a new wave of biotech gene therapies.

Fast forward to today, Seattle-based companyAdaptive Biotechnologies(NASDAQ:ADPT)is sequencing the human immune system. This is far more difficult than mapping the human genome. Forget 30,000 -- your immune system houses 100 million genes. And on top of that, the company is mapping more than 30 billion immune receptors. (Adaptive has data rights to 20 billion of those receptors.)

All of this genetic sequencing requires massive amounts of computational power, artificial intelligence (AI), and machine learning. And that's whereMicrosoft(NASDAQ:MSFT) comes in.

Image source: Getty Images.

In 2017, Microsoft and Adaptive signed a collaboration agreement. The companies are uniting to create a universal blood test that will allow doctors to read your immune system and find out what diseases your body is fighting. If you have cancer, for instance, your body is aware of the threat and your immune system is fighting the cancer cells. The idea is to have a blood test that allows doctors to hack into a person's immune system and find out what it knows. This will enable doctors to diagnose diseases early before symptoms develop. This early diagnosis would enable doctors to prescribe medicines that boost the immune system and cure the disease.

Adaptive calls this technology immunoSEQ Dx. Once Adaptive has mapped the immune characteristics of several diseases, it will be possible to look at an individual's immune system and determine what, if any, diseases the person's immune system is currently fighting. The idea is that your doctor can take a blood sample and screen for infectious diseases, autoimmune disorders, and cancer. CEO Chad Robins is forecasting the arrival of the universal blood test in six to eight years.

As part of the collaboration agreement, Microsoft invested $45 million in thebiotechstart-up.At a recent price of $30 a share, Microsoft's investment in Adaptive is now worth about $135 million. But Microsoft is doing more than just providing financing and equipment to Adaptive -- the software giant has also provided people. A joint team of about 50 employees built the AI from scratch. Co-founders Chad and Harlan Robins led the team from Adaptive; Jonathan Carlson, senior director of immunomics at Microsoft, and Desney Tan, the general manager of Microsoft Healthcare, headed up the software side. Speaking at a Geekwire summit, Tan said, "We really integrated ourselves as a single team. We've got offices in each other's facilities."

While the immunoSEQ Dx project with Microsoft might be the most exciting work Adaptive is doing, it's several years away. In the meantime, the AI engine is already producing diagnostic kits for the market. Using Adaptive's clonoSEQ technology, doctors can now test for minimal residual disease (MRD) in blood cancers. The Food and Drug Administration has already cleared clonoSEQ for a blood cancer called multiple myeloma and acute lymphoblastic leukemia. The company is submitting clonoSEQ to the FDA for chronic lymphoblastic leukemia as well.

Adaptive is also using immunoSEQ to create a diagnostic kit for research labs and biotech companies. According to Adaptive, more than 2,000 academic researchers are now using its technology. More than 125 biotech companies are using immunoSEQ, and this technology has facilitated 480 clinical trials.These revenue streams brought in $26 million in the third quarter, up 52% year over year.The company is estimating $85 million in revenues for the full year.

Adaptive also received $300 million in cash fromGenentech, a subsidiary ofRoche(OTC:RHHBY), last year. Genentech wants to use Adaptive's technology as the foundation of a new treatment paradigm for cancer. The idea is to tailor an individualized treatment for each patient based on what's discovered via the patient's immune system. The Roche deal could be worth over $2 billion to Adaptive if certain commercial milestones are hit.The alliance with Microsoft and the massive Genentech deal are a real validation of the underlying science.

In 2020, Adaptive plans to submit the first immunoSEQ diagnostic kits to the FDA for review. While the "universal blood test" is several years away, Adaptive will add indications one at a time. The company is starting with Lyme disease, celiac disease, and ovarian cancer.

As Tan said, "These guys are going to change the world, and we're thrilled to be a part of it."

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Why Is Microsoft Investing in Adaptive Biotechnologies? - The Motley Fool

By Jim Logan for UCSB | February 4, 2020 | 3:16 p.m.

Humans and hookworms have had a complicated relationship since the first day we stepped barefoot in the equatorial regions where the little parasites are endemic. Hookworms infect humans through skin contact. Larvae travel through the circulatory system before attaching to the small intestine, where they mature and feed on tissue and blood.

The result: anemia, a deficiency in red blood cells.

The consequences of hookworm infection are well known. Anemia affects more than 40 percent of pregnant women globally, with 25 percent of pregnant women infected with hookworm (species Necator americanus and Ancylostoma duodenale).

Though hookworm and other intestinal worms are usually associated with tropical regions of the developing world, the U.S. South was infested with hookworm up through the 20th century.

Despite hookworm affecting upwards of 750 million people worldwide, little is known about the interactions between hookworm and pregnancy, or the effects on maternal and fetal health.

A paper in the American Journal of Human Biology led by UC Santa Barbara scholars investigates the relationship between hookworms and pregnancy in indigenous Tsimane women of the Bolivian Amazon.

The Tsimane are forager-farmers who live in a tropical rain forest environment, and so are exposed to many diverse pathogens including endemic hookworm. Tsimane women also have high fertility the average woman has nine births over her lifetime.

By analyzing longitudinal data, the researchers sought to determine if theres a tradeoff between mounting an immune response to hookworm and having a successful pregnancy.

Hookworm is such a common infection in many parts of the world and its a really ancient infection, said Amy S. Anderson, a UCSB anthropology doctoral student and lead author. And so its one that in a certain sense, our immune systems have become quite tolerant towards.

Local coverage of Santa Barbara projects and policy.

"But the way that our immune system shifts when were tolerating a chronic hookworm infection has some similarities with the way our immune system needs to tolerate the non-self that is a fetus growing during pregnancy.

As Anderson explained, a fetus is like a foreign organism that the mothers body has to both recognize as such and tolerate to sustain a successful pregnancy. Because hookworms and fetuses share immunological characteristics, the papers authors hypothesized that changes in maternal immunity aimed at ensuring fetal tolerance may dampen immune responses to hookworm during pregnancy.

They wondered if as a result, pregnant women might be more susceptible to new hookworm infections and higher morbidity, especially anemia, from existing infections.

To test their hypothesis, the researchers analyzed a mix of cross-sectional and longitudinal data on hemoglobin, hookworm infection, several markers of parasite-induced inflammation, and whether a woman was pregnant and in which trimester.

Their findings, though preliminary, show some support for the hypothesized interaction between pregnancy and hookworm infections: pregnant women are slightly more likely to experience hookworm infection, and possibly worse health effects of that and other infections she may be exposed to during pregnancy.

The effects are small and mostly concentrated in the first trimester, especially the excess hemoglobin loss and immune modulatory changes," Anderson said. But they support the idea that immune shifts in the first trimester navigate a slight trade-off between responding to hookworm infection and tolerating a fetus, because a first-semester fetus is more likely to get caught in friendly fire from moms immune system.

"In the eyes of the immune system, the cluster of [fetal] cells at the beginning of pregnancy appears to have more similarities to parasites like hookworm than a third-trimester fetus does.

Further, Anderson said, the findings indicate that we may want to keep a closer watch on pregnant women in their first trimester, because we dont know what the long-term implications of a womans first trimester disruptions are on her or her childs health down the line.

As Michael Gurven, a senior author on the paper and professor of anthropology at UCSB, explained, Consequences of hookworm infection on pregnancy and immune function, and of pregnancy on infection and immunity this is unexplored territory. Yet pre-natal exposures are now recognized as having lots of different downstream health impacts across the life course.

The role of our wormy old friends in modulating immune function in ways that dont just harm but might even protect against certain chronic conditions is also changing how we think about infection, Gurven said. We still have much to learn about the health ecology of mom, baby and worms, and this study is just the beginning.

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UCSB Scholars Study Effects of Pregnancy on Hookworm Infections in Bolivian Amazon - Noozhawk

FINDINGS

In a UCLA-led phase I clinical trial, a new plant-based drug called APG-157 showed signs of helping patients fight oral and oropharyngeal cancers. These cancers are located in the head and the neck.

APG-157 is made up of multiple compounds produced by plants, including curcumin. UCLA Jonsson Comprehensive Cancer Center researchers found that treatment with this botanical drug resulted in high concentrations of curcumin and its byproducts circulating in the blood and absorbed by tumor tissues within three hours after being taken orally.

APG-157 reduced the concentration of cytokines proteins involved in inflammation in the saliva when administered to cancer patients. The therapy also reduced the relative abundance of Bacteroides species, a group of gram-negative bacteria. Gram negative refers to a group of dangerous bacteria that have an outer layer which hides them from the immune system. The relative abundance of gram-negative bacteria compared to the presence of other types of bacteria is correlated with oral cancer.

APG-157 also resulted in the expression of genes that are associated with attracting immune system T cells to the tumor area. This therapy could have a beneficial effect when used in combination with immunotherapy drugs that help immune system T cells recognize and kill tumors.

The treatment did not have any adverse effects on the studys participants.

Cancers of the head and neck account for 4% of all cancers. About 650,000 new cases are reported each year around the world. People with advanced head and neck cancers have a low survival rate and current treatment options such as surgery, radiation and chemotherapy can have adverse effects. Therefore, more effective and less toxic therapies are needed to help improve the quality of life and outcome for those with these cancers.

APG-157 is a botanical drug developed under the FDAs Botanical Drug Guidance, which includes requirements for production of plant-based therapies that are marketed as prescription medications. The drug is made up of botanical compounds including curcumin from the Curcuma longa plant, which is commonly referred to as turmeric and is a member of the ginger family.

Curcumin is one of the medicinally active or therapeutic molecules that has been tested as a possible treatment to help fight multiple cancers because it is an antioxidant that reduces swelling and inflammation. However, there is poor absorption into the bloodstream when curcumin is taken orally. In this study, UCLA researchers found that when APG-157 is taken through oral mucosal absorption, patients have high levels of curcumin circulating in their blood and absorbed by cancer tissues.

UCLA researchers conducted the study of APG-157 comparing 12 people who had oral and oropharyngeal cancer with a control group of 13 people who did not have cancer. The reason both the people with cancer and without cancer were part of the study was to show that the drug was not toxic to either people with cancer or those without cancer.

The medication was given each hour for three hours and was delivered as a lozenge that slowly dissolved in the mouth. Blood and saliva samples were collected beforehand each of the three hours the medication was administered and 24 hours after the last dosage. The medication was given to 12 people (some who had cancer and some who did not) and a placebo was given to 13 people. Blood and electrocardiogram tests did not show increased toxicity in the people who took the active medication in comparison with the people who took the placebo, regardless of whether they had cancer or not.

For the cancer patients who took the medication, there was a decrease in Bacteroides and an increase in T cells in the tumor tissue as compared to cancer patients who took the placebo. Neither the subjects nor the investigators knew whether the drug or a placebo was given when reviewing the blood and saliva test results of the blinded study.

APG-157 is a botanical drug that has low toxicity. It works effectively to reduce inflammation that contributes to the growth of cancer cells. It also attracts T cells to the tumor micro-environment. When used in combination with immunotherapy drugs, APG-157 might have the ability to make the immune system more effective in attacking head and neck cancers. With potential to inhibit the growth of Bacteroides species, APG-157 could also improve cancer therapy through oral microbial changes.

Dr. Marilene Wang from UCLA was the corresponding author. Other UCLA authors include: Saroj Basak, Alexander Yoon, Marco Morselli, Chan Jeong, Anela Tosevska, Tien Dong, Hassan Nasser, Venu Lagishetty, Rong Guo, Dipti Sajed, Kym Faull, Jonathan Jacobs, Matteo Pellegrini, Daniel Sanghoon Shin and Eri Srivatsan. Authors from Uniformed Services University of the Health Sciences in Maryland and Aveta Biomics also participated in the study.

The research is published in CANCER, a journal published by the American Cancer Society.

Funding for the study was provided by Aveta Biomics.

Authors Parag Mehta, Sharmila Mudgal and Luis Avila are employed by Aveta Biomics. They had no role in the recruitment of people for this study or the collection and analyses of the samples. They, as with all the authors, did not have any information on the subjects, therapy or placebo given until completion of the study.

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Botanical drug is shown to help patients with head and neck cancers - UCLA Newsroom

As the Novel Coronavirus 2019 (nCoV-2019) has become an alarming global pandemic, with two cases now being reported in the Philippines, taking precautions towards ones health and wellbeing has become essential. Besides not being able to report to work, the risky possibility of infecting others is also there.

Apart from having frequently clean hands through regular washing, plus avoiding close contact with anyone who has fever and cough, one effective way to avoid falling ill is by boosting your immune system. And while a cure for 2019-nCoV is still being developed; thankfully, there exists a natural, scientifically-proven method of immune system strengtheningthe intake of coconut oil!

According to a paper entitled The Potential of Coconut Oil as an Effective and Safe Antiviral Agent Against the Novel Coronavirus (nCov-2019) authored by Fabian M. Dayrit, Ph.D, of the Ateneo de Manila University, and Mary T. Newport, M.D., of Springhill Nematology of Florida, USA, they have confirmed what has been known for many years: that Lauric acid (C12), a medium-chain fatty acid which makes up about 50% of coconut oil, and its derivative, monolaurin, a metabolite that is naturally produced by the bodys own enzymes upon ingestion of coconut oil and is also available in pure form as a supplement, possesses significant antiviral activity.

Specifically, Sodium lauryl sulfate, a common surfactant that is made from lauric acid, has been shown to have potent antiviral properties. Coconut oil and its derivatives have been shown to be safe and effective antiviral compounds in both humans and animals, both eminent authors state. They therefore suggest that Coconut Oil be considered as a general prophylactic against viral and microbial infection.

On a consumer level, what then are the best sources of C12 Lauric Acid? Theres coconut cooking oil which has 45% Lauric Acid; Coconut milk which has 15-25%; Desiccated Coconut and whole coconuts which have 16%; and Virgin Coconut Oil or VCO which has 45% Lauric Acid + Polyphenol antioxidants.

Of course, it is worth stressing that not all VCOs are created equal. The VCO you take has to be USDA certifiedorganic, non-GMO, unbleached and unrefined, and should not be deodorized. For this, theres only ProSource products!

Founded in 1995, ProSource International now readily serves customers in North America, Asia, Australia, and Europe, providing an extensive range of the highest quality organic and conventional coconut products, all Halal and Kosher certified, and manufactured under GMP and HACCP systems.

Among the healthful products you can enjoy include ProSource Extra Virgin Coconut Oil, NUCO Coconut Crunch, a grain-free cereal, and NUCO Coconut Wraps that come in original, cinnamon, turmeric and moringa flavors!

For more information, visitprosourcecoconut.comor their Facebook page athttps://www.facebook.com/ProSourceVCO/.

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Give your immune system a boost with ProSource Virgin Coconut Oil and Nuco coconut-based products - Business Mirror

If you watch the news you have likely heard of the Coronavirus outbreak. The 12th US case of coronavirus reported in Wisconsin today.The 2019-nCoV outbreak has led to nearly 25,000 illnesses and 500 deaths in mainland China, as well as more than 200 illnesses and two deaths outside of mainland China.

What is the Coronavirus?

Symptoms of the new coronavirus include fever, cough and difficulty breathing, according to the CDC.It's estimated that symptoms may appear as soon as two days or as long as 14 days after exposure, the CDC said. The NEJM study published on Jan. 29 estimated that, on average, people show symptoms about five days after they are infected.

How can you protect yourself and others?

In general, the CDC recommends the following to prevent the spread of respiratory viruses: Wash your hands often with soap and water for at least 20 seconds; avoid touching your eyes, nose, and mouth with unwashed hands; avoid close contact with people who are sick; stay home when you are sick and clean and disinfect frequently touched objects and surfaces.

Strengthen your immune system. There are several ways to boost your own immunity in order to protect your health.

Nourish Your Body. It is important to be consciously aware of what you are putting in your body daily. Incorporating certain foods to your daily diet can boost the overall immune system for your body. A balanced diet is the most important factor to build a strong immune system. Also, eat lots of vegetables, fruits, nuts, and seeds, which will give your body nutrients and fulfill your immune system needs.We all should make sure to keep our diet in check and in doing so this can prepare the bodyto have a higher immunity to fight off any outside threats.Consult your doctor to learn what is best for your personal blood and specific body type.

Stay Active. It is always good to keep your blood flowing and exercise daily. Taking time to go for a walk, or jump rope, or even stretch can not only boost your overall body health but also provide mental clarity and reduce stress levels.

Stay Hydrated. Drinking natural spring water or organic herbal teas have several health benefits. The best time is in the morning when you wake up or in the evening before bed. Do your own studying for this topic as you all already know discoveries are made daily and it's important to stay informed.

Essential oils including sage for cough or sore throat, also helps with other respiratory issues. Oregano oil has a high amount of vitamin and nutrients thus to strengthen the immune system, mint has antioxidants that can aid in the process of boosting an immunity to prepare the body for fighting off any outside threats to the overall health of the body.

Life is a giftand everyday we have an opportunity to grow healthier andhappier. Remember to pray, stay humble, repent and be grateful for every breath of fresh air. Lets all take moment to pray away any other forms of a virus that could cause harm to humanity, power of prayer.

Blessings of Peace for Prosperity of Spirituality.

_____________

All information is intended to motivate readers to make their own nutrition and health decisions after consulting with their health care provider.

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Coronavirus has reached the US Now what? | Health & Wellness - CL Charlotte

From inside FirstHealths Clara McLean House blares James Browns I Feel Good.

Who feels good in here? asks a bubbly Rachel Shell, MT-BC, of her troupe of men and women, all with Parkinsons disease. As the song progresses, Shell leads them to march their feet, swing their arms to the beat and sing along, if they choose.

Next on the playlist is New York, New York by Frank Sinatra with instructions for participants to kick up their legs while seated. I see some Rockette wannabes in here, Shell cajoles.

A dance party? Perhaps, but this party has specific purposes.

People with Parkinsons disease often experience muscle freezing and have a difficult time initiating movement, says Shell. As humans, we are naturally rhythmic beings and the rhythmic beat of music helps patients with Parkinsons move more naturally and easily. Shell is a certified music therapist and owner of Birdsong Music Therapy who was hired by FirstHealth of the Carolinas to complement patients overall health care plans.

The use of music as a healing influence began as early as 500 B.C. but the idea took hold as a profession when community musicians played at the bedsides of World War I and World War II veterans who suffered from physical and emotional trauma. The patients improvement was so notable that doctors requested their hospitals hire musicians.

As demand among health care providers grew, so did empirical evidence proving that music therapy can help alleviate numerous physical and emotional issues, including pain, impaired speech and mobility, depression, short-term memory loss and much more.

Now board-certified music therapists are recognized health care professionals who use music activities, both instrumental and vocal, to facilitate changes that are not musical in nature.

Music therapy can be wonderful for patients who are experiencing pain and symptoms that are difficult to control through traditional medical interventions, reports Shell, a Moore County native and Pinecrest High School graduate who earned a bachelors degree in music therapy from Queens University in Charlotte. Because music therapy is a non-invasive and non-threatening medium, unique outcomes are possible for individuals of all ages.

Music therapy got its official start at FirstHealth in 2017 as an outgrowth of the health care systems Parkinsons Support Group of the Sandhills.

We learned that music can be beneficial for individuals with Parkinsons, so we asked Rachel to start a monthly program here, said Laura Kuzma, MSW, former Foundation for FirstHealth Volunteer and Care NET coordinator and current Oncology Support Services and Patient Navigation supervisor. When Rachel started the programs, FirstHealth didnt have much experience in music therapy. But when we saw her in action, we realized just how powerful music can be and how it positively affects patients and their caregivers.

Kuzma noted that patients who came in with difficulty speaking, moving and remembering left with significant improvementso much so that many were talking, singing and dancing. They also enjoyed a meaningful social outlet.

Now in addition to a monthly music therapy session for patients with Parkinsons, Shell conducts Claras Choir for individuals with Parkinsons, dementia and aphasia, a language impairment that affects patients ability to produce or comprehend speech.

We have so much fun, said Shell. It looks like were just singing, but were really connecting with each other and working through some speech and cognitive challenges. Plus, with all the good neurochemicals were producing, were also fighting the blues and promoting a healthy immune system. There are so many benefits of singing with others.

Rachel is gifted in making music meaningful for our patients, their caregivers and our staff, said Kathryn McEntire, Foundation of FirstHealth program coordinator at Claras House. After seeing how music impacted patients with Parkinsons, Kuzma and McEntire asked Shell to assist in other areas of the health care system. Now Shell assists patients, families and the nursing staff at FirstHealth Hospice and provides stress management services for nurses during National Nurses Week.

Most recently Shell started singing weekly at the FirstHealth Outpatient Cancer Center in Pinehurst, where cancer survivor Nancy Scaggs receives monthly treatments to support her immune system.

I always enjoy my time at the Cancer Center because everyone is so sweet, said the Pinehurst resident. But one day I just wasnt feeling tip-top. My nurse-friends asked if I wanted a nice lady to come sing. Normally I would have agreed but I declined. Then I heard someone playing Country Roads on the guitar and knew I had to meet her. The native West Virginian and Shell crooned numerous songs together, mainly Scaggs requests for Motown hits. We had the best time, said Scaggs. I just love her.

Shell noted that music is a great people connector. Once at the outpatient cancer center I was playing an Elvis tune, and that got patients, family members and staff throughout the floor talking about their favorite Elvis hits. She said the lively conversation continued long after she left. They might not have started talking if it werent for Elvis, Shell quipped.

Music therapy at FirstHealth is funded by the Foundation of FirstHealth, the health care systems division that envisions and guides philanthropy programs and activities. Health care budgets are tight and its difficult to determine whats essential, said Foundation President Kathy Stockham. Thats the leverage the Foundation offers. We can fund small pilot projects to see what works, and music therapy certainly does.

What Rachel offers today is just the start of how FirstHealth would like to incorporate music therapy as an everyday modality of care, said Stockham, noting a particular goal of offering music therapy throughout the new, four-story comprehensive cancer center to be built on Page Road in Pinehurst. Thanks to financial gifts from the community, the Foundation can help make that happen. This is a community effort.

Music therapy allows us to help not just patients, but their families and our own staff. Its a natural extension of FirstHealths mission to care for people, said McEntire. We just need five more Rachels.

For information about the Parkinsons Support Group of the Sandhills, Claras Choir or music therapy offered at FirstHealth of the Carolinas, go to https://www.firsthealth.org/clara-mclean-house/programs-services-patient-support-groups-advocacy, email Kathryn McEntire at KMcEntire@firsthealth.org or call (910) 715-4230.

Courtesy feature photo: Rachel Shell, MT-BC, certified music therapist and Nancy Scaggs, a patient at the FirstHealth Outpatient Cancer Center.

Contributed

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'Dance Parties' at Clara's House serve as welcome therapy for Parkinson's patients - Sandhill Sentinel

CHICAGO, Feb. 5, 2020 /PRNewswire/ --Kellie Antinori-Lent, MSN, RN, ACNS-BC, BC-ADM, CDCES, FADCES was officially recognized last week at the meeting of the board of directors as the 2020 president of the newly rebranded Association of Diabetes Care & Education Specialists (ADCES). Antinori-Lent brings 30 years of experience in diabetes care, with a background in nursing and passion for relationship-based care.

"It's a big year for the association with a new name and title for the specialty, so I'm excited to work with members and partners to leverage this once-in-a-century opportunity," said Antinori-Lent. "My hope as the 2020 president is to use my passion for motivation and focus on person-centered care to get members excited, not just about the work we do, but about the work we can do! There are so many opportunities to ensure every person working in diabetes care is able to reach their maximum potential and can access the right tools to optimize care for the person with diabetes, prediabetes or cardiometabolic conditions."

Antinori-Lent brings with her a strong background in volunteerism, having served as president in her local ADCES Western Pennsylvania State Coordinating Body before joining the ADCES board of directors. Her passion for technology and focus on professional growth for members comes as the association continues to expand into diabetes tech training, through Danatech.org, and partnerships that have created resources like the ADCES and American Association of Nurse Practitioners' Professional CGM Implementation Playbook.

Antinori-Lent is currently a programmatic nurse specialist at the UPMC Nursing Education and Research Department where she serves as a diabetes care and education specialist and represents the hospital in systemwide diabetes work.

About the Association of Diabetes Care & Education Specialists ADCES is an interdisciplinary professional membership organization dedicated to improving prediabetes, diabetes and cardiometabolic care through innovative education, management and support. With more than 12,000 professional members including nurses, dietitians, pharmacists and others, ADCES has a vast network of practitioners working to optimize care and reduce complications. ADCES offers an integrated care model that lowers the cost of care, improves experiences and helps its members lead so better outcomes follow. Learn more at DiabetesEducator.org, or visit us on Facebook or LinkedIn (Association of Diabetes Care & Education Specialists), Twitter (@ADCESdiabetes) and Instagram (@ADCESdiabetes).

Contact: Matt Eaton, 312-601-4866, meaton@adces.org

SOURCE Association of Diabetes Care & Education Specialists

http://www.diabeteseducator.org

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New president officially recognized at the Association of Diabetes Care & Education Specialists - PRNewswire

The performance of the European Society of Cardiology (ESC) algorithm, ESC 0/1-h, in ruling out acute myocardial infarction (AMI) without ST-elevation was comparable in patients with and without diabetes mellitus (DM), according to a study published in Diabetes Care.

The ESC 0/1-h and 0/3-h algorithms are used to diagnose patients with suspected acute non-ST-elevation myocardial infarction (NSTEMI). The levels of high-sensitivity cardiac troponin (hs-cTn) are often chronically elevated in individuals with DM, rendering it difficult to identify NSTEMI in this patient population. Investigators sought to assess whether the presence of DM affects the diagnostic abilities of 2 ESC algorithms in patients presenting to the emergency department with symptoms indicative of AMI.

In this secondary analysis of 2 studies, the Biomarkers in Acute Cardiac Care (BACC) and stenoCardia trials (ClinicalTrials.gov identifiers NCT02355457 and NCT03227159, respectively), 3,681 patients (mean age, 64.0 years; 64.2% men) with prospectively evaluated suspected acute NSTEMI with (n=563) and without DM, were enrolled. Data from the Advantageous Predictors of Acute Coronary Syndromes study (APACE; n=2895; ClinicalTrials.gov identifier NCT00470587) were used to calculate and externally validate alternative cutoffs for the algorithms.

The levels of hs-cTn were measured at admission, 1 hour (only in the BACC study), and 3 hours (in both studies). Negative and positive predictive values (NPV and PPV, respectively) for NSTEMI were calculated for both algorithms. The studys primary safety outcome was the NPV for NSTEMI (ie, for ruling out the condition), and the primary efficacy outcome was the PPV for ruling in NSTEMI. The sensitivity and specificity of both algorithms were the studys secondary endpoints.

Of 563 participants with DM, 137 (24.3%) had comorbid acute NSTEMI, compared with 15.9% of patients without DM (P <.001). Participants with DM were older and had more cardiovascular risk factors and comorbidities.

The ESC 0/1-h algorithm had a comparable NPV for NSTEMI in patients with and without DM (absolute difference [AD], -1.50; 95% CI, -5.95 to 2.96; P =.54), but the ESC 0/3-h algorithm had a lower NPV in patients with vs without DM (AD, -2.27; 95% CI, -4.47 to -0.07; P =.004). The diagnostic performance to rule-in NSTEMI was comparable for patients with vs without DM with both algorithms: ESC 0/1-h (AD, -6.59; 95% CI, -19.53 to 6.35; P =.34) and ESC 0/3-h (AD, 1.03; 95% CI, -7.63 to 9.7; P =.88).

The sensitivity for ruling out NSTEMI was comparable in patients with vs without DM with both ESC0/1-h (AD, -0.9; 95% CI, -5.1 to 3.3; P =1.00) and ESC 0/3-h (AD, -4.0; 95% CI, -10.4 to 2.4; P =.19) algorithms. The specificity for ruling in NSTEMI was higher for patients without vs with DM when using both the ESC 0/1-h (AD, -6.9; 95% CI -12.5 to -1.2; P =.0035) and ESC 0/3-h (AD, -4.4; 95% CI, -8.2 to 0.6; P =.01) algorithms. The use of alternative cutoffs improved the PPV of both algorithms.

Study strengths include large sample sizes and external validation of proposed alternative cutoffs. Study limitations include the sole use of data from the BACC study to evaluate the 0/1-h algorithm, possible misclassification of AMI and DM, and a lack of accounting for disease duration.

Although alternative cutoffs might be helpful, patients with DM remain a high-risk population in whom identification of AMI is challenging and who require careful clinical evaluation, noted the authors.

Reference

Haller PM, Boeddinghaus J, Neumann JT, et al. Performance of the ESC 0/1-h and 0/3-h algorithm for the rapid identification of myocardial infarction without ST-elevation in patients with diabetes. Diabetes Care. 2019;43(2):460-467. doi: 10.2337/dc19-1327

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Evaluating the Impact of Diabetes on the Performance of Algorithms for the Detection of AMI Without ST-Elevation - The Cardiology Advisor

Mobile apps might help some obese or overweight people with type 2 diabetes shed excess pounds (lbs), but a recent review also suggests that results may be modest at best.

For thepaper, published in January 2020 in Obesity, researchers looked at changes in waist circumference, weight, and body mass index (BMI) in 2,129 people with type 2 diabetes who participated in one of 14 different clinical trials testing a variety of mobile apps for diabetes self-management. These trials randomly assigned some participants to use apps, while others did not, and interventions lasted between 3 and 12 months.

By the end of the trials, people who used diabetes apps lost an average of 0.84 kilograms (about 1.9 lbs) more than participants who didnt. With mobile apps, people also reduced their waist circumference by 1.35 centimeters (about inch) more on average.

BMI appeared lower with apps than without these tools, but the difference was too small to rule out the possibility that it was due to chance.

Reductions in weight, waist circumference, and BMI appeared more pronounced when people were obese and when participants used apps in combination with other interventions designed to promote healthy eating and exercise habits. Some of the trials in the analysis allowed participants to pursue other approaches to weight loss with or without also using a mobile app to manage diabetes.

Mobile application interventions combined with other behavior components lead to a larger magnitude of weight loss, says senior study author Mingzi Li, PhD, of Peking University in Beijing. However, the mobile application functionalities do not moderate weight loss significantly.

Face-to-face or supervised lifestyle modification programs have long been considered a cornerstone of diabetes care, Dr. Li and colleagues wrote. Obesity is a risk factor for developing diabetes and for experiencing potentially serious complications, like blindness, amputations, kidney failure, heart attacks, and strokes.

People who lose at least 5 percent of their body weight in the first year after a diabetes diagnosis may cut their 10-year risk of events like heart attacks and strokes roughly in half, according to a study published in May 2019 in Diabetologia.

And people who lose less weight may still see benefits. Patients with diabetes who lost no more than 2.5 percent of their body weight, for example, were able to lower their blood sugar, cholesterol, and blood pressure, according to a review and meta-analysis published in June 2016 in Obesity Reviews.

RELATED: The Best Apps for Managing Diabetes

In the current study, people typically lost less than 2.5 percent of their body weight. This doesnt seem like much, but it might be enough for them to see improvements in blood sugar, cholesterol, and blood pressure, Li and colleagues wrote.

Weight loss didnt appear to be influenced by whether apps had certain features, like tracking physical activity, logging food, counting calories, monitoring weight, or monitoring or recording blood sugar levels.

This might be because all studied mobile apps had four to five functionalities on average, and it is therefore difficult to distinguish between individual effects, Li said.

At the start of the trials, participants were 58 years old on average and had an average BMI of 30, meaning they typically had obesity.

People who started out with a higher BMI appeared to benefit more from using apps. For each additional unit in BMI as measured at the start of the trials, people using apps achieved of 0.15 kilograms (about 0.3 lbs) more weight loss on average.

RELATED: Most Type 2 Diabetes Apps Fall Short in Helping Users Manage Blood Sugar

Even though the current study pooled results from randomized controlled clinical trials considered the gold standard for medical research there are still some limitations.

One big drawback is that the studies didnt provide long-term weight loss outcomes, particularly because so many people who lose weight struggle to keep it off.

Another limitation is that the results dont show what types of apps or features within apps might help the most with weight loss.

More research is needed to determine whether apps might help people who dont have time or money to do face-to-face appointments with psychologists, nutritionists, or other clinicians who might help them develop and stick to a weight loss plan, Li and colleagues pointed out.

Its possible, they argue, that apps might help some busy people stick with weight loss efforts because its easier and more convenient to use a smartphone every day to monitor progress than it is to go to checkups.

People with diabetes who try and fail to lose substantial amounts of weight using only an app shouldnt be discouraged that they dont get results, says Susan Roberts, PhD, a professor of nutrition at Tufts University in Boston and founder of iDiet.

Dont feel guilty if an app isnt helping you, Dr. Roberts says. They dont help the average person much based on these results, and there are other ways to lose weight.

Whether or not people use apps, regular monitoring of progress with lifestyle changes and weight loss efforts is one key to success, according to the Centers for Disease Control and Prevention.

Besides mobile app interventions, there has been a growing evidence that interventions like step counters could be effective in weight loss as well, Li said. If combined with additional behavior change components, including multidisciplinary diabetes care management or health coaching, they will be more effective.

RELATED: Smart Health: I Tried Noom for Weight Loss and It Worked

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Type 2 Diabetes Apps Help With Modest Weight Loss, Review Finds - Everyday Health

By Grace Lieberman, Cronkite News | Tuesday, Feb. 4, 2020

PHOENIX Cooking equipment at the ready, Mallory Smith stands before a table loaded with fresh greens, nuts and fruit.

Has anyone used the apple slicer before? she asks the dozen people gathered this weekday morning at Native Health. Might take a little bit of practice.

Over the next hour, Smith chopped, mixed and scooped as she demonstrated how to make a chicken Waldorf salad as part of a new class to encourage diabetes-friendly cooking to help diabetics manage their blood sugar.

A lot of people in the Native American community and in the Phoenix community, they get diagnosed with diabetes but arent necessarily educated on it, Smith said. Having this class helps them find out what diabetes is, what kind of foods they can eat with diabetes, what can help them for their overall health.

Video by Jordan Elder/Cronkite News

The 20-week course, which is free and open to anyone, is held morning and evening every Thursday through June 4. Each week, Smith demonstrates a new recipe, and participants will go home with free groceries to replicate the dishes at home.

Food for Thought is part of Native Healths diabetes management program for the Native American community. Michelle Hill, a certified diabetes educator at Native Health, said the goal is to show patients that eating properly can be easy, accessible and economical.

More than 30 million Americans have diabetes, according to the American Diabetes Association. That includes 695,000 Arizonans or 12.5% of the adult population.

Both nationally and in Arizona, Native Americans have the highest rates of the disease, followed by blacks and Hispanics. More than 19% of adult Native Americans in the state have been diagnosed, the Arizona Department of Health Services reports.

Type 1 diabetes is a condition in which the body does not produce any insulin, which helps regulate blood sugar. In the more common type 2 diabetes, the body produces insulin but does not use it properly. Some people only need to maintain a healthy diet and exercise regimen to manage the disease, while others might need insulin injections or other medicines.

Michelle Hill, a registered dietician and certified diabetes educator, explains how to read nutrition labels at Native Health in Phoenix on Jan. 23. (Photo by Alicia Moser/Cronkite News)

In order to properly regulate their blood sugar, diabetics are cautioned against eating foods high in processed sugar, such as white bread, sugary cereals and flavored yogurt and drinks. Hill told participants they should not be afraid to eat the natural sugar found in whole fruits.

Glorene Barton learned about Food for Thought from her health care providers during a recent appointment at Native Health.

I was asking about snacks, because Im a diabetic and I forgot to bring a snack with me. So she told me about this class that might be interesting for me, Barton said. I learned a few different things about eating and grams and carbs and things of that nature. It was interesting.

Another participant, Marla Wilson, said her son motivates her to keep up with a healthy diet. She thought this program was a great opportunity to learn how.

I have a son whos very health-conscious. So Im sure hell like it, too, because we were just talking about eating more salads and the health benefit, Wilson said.

Hill kicked off the morning by providing some tips about managing diabetes. Participants learned they can test their bodies reaction to new foods by trying them over a few days, then checking their blood sugar levels two hours later each time.

The finished product: a chicken Waldorf salad made with fresh produce. (Photo by Alicia Moser/Cronkite News)

Then it was time to get cooking. Smith guided the group through the process of making the salad, explaining some basic knife work, how to substitute in healthy ingredients and portioning.

The ingredient that surprised people the most was nonfat yogurt, which was used along with lemon juice to dress the salad. Smith said yogurt is an excellent substitute for less healthful ingredients, such as sour cream.

At the end, participants were able to take home both dry goods and fresh produce funded by the Mobilize AZ project from Blue Cross Blue Shield of Arizona.

Being diabetic is a very expensive way of being, and so this is a plus, Wilson said. We get what we need to make our dinner tonight.

Added Barton: Its the learning thats more important to me. Im tired of eating the same thing all the time, so this is great.

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Native Health offers cooking classes to address high rates of diabetes - Cronkite News

EXPERT ANALYSIS FROM DPSG-NA 2019

WASHINGTON Pharmacologic treatment of gestational diabetes remains controversial, with the American College of Obstetricians and Gynecologists and the American Diabetes Association firmly recommending insulin as the preferred first-line pharmacologic therapy, and the Society of Maternal-Fetal Medicine more accepting of metformin as a "reasonable and safe first-line" alternative to insulin and stating that there are no strong data supporting metformin over the sulfonylurea glyburide.

If there's one main take-away,Mark B. Landon, MD,said at the biennial meeting of the Diabetes in Pregnancy Study Group of North America, it was that "the primary concern" about the use of oral agents for treating gestational diabetes mellitus (GDM) is that there is limited long-term follow-up of exposed offspring.

"The claim that long-term safety data are not available for any oral agent is probably the most valid warning [of any of the concerns voiced by professional organizations]," said Dr. Landon, Richard L. Meiling professor and chair of the department of obstetrics and gynecology at The Ohio State University Wexner Medical Center, Columbus.

Otherwise, he said, there are not enough data to firmly prioritize the drugs most commonly used for GDM, and "the superiority of insulin over oral agents simply remains questionable."

ACOG's 2017 level A recommendation for insulin as the first-line option when pharmacologic treatment is needed for treating GDM(Obstet Gynecol. 2017;130[1]:e17-37)was followed in 2018 by another updated practice bulletin on GDM (Obstet Gynecol. 2018;131[2]:e49-64) that considered several meta-analyses published in 2017 and reiterated a preference for insulin.

Those recent meta-analyses of pharmacologic treatment of GDM show that the available literature is generally of "poor trial quality," and that studies are small and not designed to assess equivalence or noninferiority,Mark Turrentine, MD,chair of ACOG's committee on practice bulletins, said in an interview. "Taking that into account and [considering] that oral antidiabetic medications are not approved by the Food and Drug Administration [for the treatment of GDM], that they cross the placenta, and that we currently lack long-term neonatal safety data ... we felt that insulin is the preferred treatment."

In its 2017 and 2018 bulletins, ACOG said that metformin is a "reasonable alternative choice" for women who decline insulin therapy or who may be unable to safely administer it (a level B recommendation). The 2018 practice bulletin mentions one additional factor: affordability. "Insurance companies aren't always covering [insulin]," said Dr. Turrentine, of the department of obstetrics and gynecology, Baylor College of Medicine, Houston. "It's a challenge no question."

ACOG says glyburide should not be recommended as a first-line pharmacologic treatment, "because, in most studies, it does not yield outcomes equivalent to insulin or metformin," Dr. Turrentine emphasized.

Dr. Landon took issue with ACOG's stance on the sulfonylurea. "Frankly, I think this [conclusion] is debatable," he said. The trend in the United States "at least after the 2017 ACOG document came out" has been toward use of metformin over glyburide when an oral agent is [used], but "I think glyburide has been unfairly trashed. It probably still has a place."

As Dr. Landon sees it, research published in 2015 put a damper on the use of glyburide, which "had become the number one agent" after an earlier, seminal trial, led by Oded Langer, MD, had shown equivalent glycemic control in about 400 women with GDM who were randomized to receive either insulin or glyburide (N Engl J Med. 2000;343;1134-8). The trial was not powered to evaluate other outcomes, but there were no significant differences in neonatal complications, Dr. Landon said.

One of the 2015 studies a large, retrospective, population-based study of more than 9,000 women with GDM treated with glyburide or insulin showed a higher risk of admission to the neonatal intensive care unit (relative risk, 1.41), hypoglycemia in the newborn (RR, 1.40), and large-for-gestational age (RR, 1.43) with glyburide, compared with insulin (JAMA Pediatr. 2015;169[5]:452-8).

A meta-analysis of glyburide, metformin, and insulin showed significant differences between glyburide and insulin in birth weight, macrosomia (RR, 2.62), and neonatal hypoglycemia (RR, 2.04;BMJ. 2015;350;h102). However, "this was basically a conglomeration of studies with about 50 [individuals] in each arm, and in which entry criteria for the diagnosis of GDM were rather heterogeneous," said Dr. Landon. "There are real problems with this and other meta-analyses."

The authors of a 2018 multicenter, noninferiority, randomized, controlled trial of about 900 women concluded that their study failed to show that the use of glyburide, compared with insulin, does not result in a greater frequency of perinatal complications. The authors also wrote, however, that the "increase in perinatal complications [with glyburide] may be no more than 10.5%, compared with insulin" (JAMA. 2018;319[17]:1773-80).

That increase, Dr. Landon said, was "not an absolute 10%, but 10% of the complication rate, which probably translates to about 2%." The only component of a composite outcome (including macrosomia, hypoglycemia, and hyperbilirubinemia) that was significantly different, he noted, was hypoglycemia, which affected 12.2% of neonates in the glyburide group and 7.2% in the insulin group.

Glyburide's role may well be substantiated in the future, Dr. Landon said during a discussion period at the meeting, through research underway at the University of Pittsburgh aimed at tailoring treatment to the underlying pathophysiology of a patient's GDM.

TheMATCh-GDMstudy (Metabolic Analysis for Treatment Choice in GDM) is randomizing women to receive usual, unmatched treatment or treatment matched to GDM mechanism metformin for predominant insulin resistance, glyburide or insulin for predominant insulin secretion defects, and one of the three for combined mechanisms. The study's principal investigator,Maisa Feghali, MD,of the department of obstetrics, gynecology, and reproductive sciences at the University of Pittsburgh, stressed in a presentation on the study that GDM is a heterogeneous condition and that research is needed to understand the impact of GDM subtypes on treatment response.

Concerns about the impact of metformin on short-term perinatal outcomes focus on preterm birth, Dr. Landon said. The only study to date that has shown an increased rate of prematurity, however, is the "seminal" Metformin in Gestational Diabetes (MiG) trial led by Janet A. Rowan, MBChB, that randomized 751 women with GDM in Australia and New Zealand to treatment with metformin or insulin. The researchers found no significant differences between a composite of neonatal complications but did establish that severe hypoglycemia was less common in the metformin group and preterm birth was more common (N Engl J Med. 2008;358:2003-15).

A 2016 systematic review and meta-analysis of short- and long-term outcomes of metformin, compared with insulin, found that metformin did not increase preterm delivery (Diabet Med. 2017;34[1]:27-36). And while the 2015 BMJ meta-analysis found that metformin was associated with higher rates of preterm birth (RR, 1.50), the increased risk "was all driven by the Rowan study," Dr. Landon said. The 2015 meta-analysis also found that metformin was associated with less maternal weight gain and fewer infants who were large for gestational age.

Metformin is also tainted by high rates of failure in GDM. In the 2008 Rowan study, 46% of patients on metformin failed to achieve glycemic control. "But this is a classic half-full, half-empty [phenomena]," Dr. Landon said. "Some people say this isn't good, but on the other hand, 54% avoided insulin."

Indeed, the Society of Maternal-Fetal Medicine (SMFM), in its 2018statementon the pharmacologic treatment of GDM, said that oral hypoglycemic agents that are used as monotherapy work in "more than half" of GDM pregnancies. The need for adjunctive insulin to achieve glycemic control ranges between 26% and 46% for women using metformin, and 4% and 16% for women using glyburide, it says.

In the society's view, recent meta-analyses and systemic reviews "support the efficacy and safety of oral agents," and "although concerns have been raised for more frequent adverse neonatal outcomes with glyburide, including macrosomia and hypoglycemia, the evidence of benefit of one oral agent over the other remains limited."

The society says that the difference between its statement and the ACOG recommendations is "based on the values placed by different experts and providers on the available evidence," and it adds that more long-term data are needed.

But as Dr. Landon said, the SMFM is "a little more forgiving" in its interpretation of a limited body of literature. And clinicians, in the meantime, have to navigate the controversy. "The professional organizations don't make it easy for [us]," he said. At this point, "insulin does not cross the placenta, and the oral agents do cross it. Informed consent is absolutely necessary when choosing oral agents for treating GDM."

Of greater concern than neonatal outcomes are the potential long-term issues for offspring, Dr. Landon said. On the one hand, it is theorized that metformin may protect beta-cell function in offspring and thereby reduce the cross-generational effects of obesity and type 2 diabetes. On the other hand, it is theorized that the drug may cause a decrease in cell-cycle proliferation, which could have "unknown fetal programming effects," and it may inhibit the mTOR signaling pathway, thus restricting the transport of glucose and amino acids across the placenta, he said. (Findings from in vitro research have suggested that glyburide treatment in GDM might be associated with enhanced transport across the placenta, he noted.)

Long-term follow-up studies of offspring are "clearly needed," Dr. Landon said. At this point, in regard to long-term safety, he and other experts are concerned primarily about the potential for obesity and metabolic dysfunction in offspring who are exposed to metformin in utero. They are watching follow-up from Dr. Rowan's MiG trial, as well as elsewhere in the literature, on metformin-exposed offspring from mothers with polycystic ovary syndrome.

A follow-up analysis of offspring from the MiG trial found that children of women with GDM who were exposed to metformin had larger measures of subcutaneous fat at age 2 years, compared with children of mothers treated with insulin alone, but that overall body fat was the same, Dr. Landon noted. The investigators postulated that these children may have less visceral fat and a more favorable pattern of fat distribution (Diab Care. 2011;34:2279-84).

A recently published follow-up analysis of two randomized, controlled trials of women with polycystic ovary syndrome is cause for more concern, he said. That analysis showed that offspring exposed to metformin in utero had a higher body mass index and an increased prevalence of obesity or overweight at age 4 years, compared with placebo groups (J Clin Endocrinol Metab. 2018;103[4]:1612-21).

That analysis of metformin-exposed offspring in the context of polycystic ovary syndrome was published after the SMFM statement, as was another follow-up analysis of MiG trial offspring this one, at ages 7-9 years that showed an increase in weight, size, and fat mass in one of two subsets analyzed, despite no difference in large-for-gestational age rates between the metformin- and insulin-exposed offspring (BMJ Open Diabetes Res Care. 2018;6[1]: e000456).

In 2018, a group of 17 prominent diabetes and maternal-fetal medicine researchers cited these findings in a response to the SMFM statement and cautioned against the widespread adoption of metformin use during pregnancy, writing that, based on "both pharmacologic and randomized trial evidence that metformin may create an atypical intrauterine environment ... we believe it is premature to embrace metformin as equivalent to insulin or as superior to glyburide, and that patients should be counseled on the limited long-term safety data and potential for adverse childhood metabolic effects" (Am J Obstet Gynecol. 2018;219[4]:367.e1-7).

This article first appeared on MDEdge.com.

Read more:
Gestational Diabetes: The Treatment Controversy Rages On - Medscape

"I was doing the exact opposite of a traditional diabetes modelI was eating more carbohydrate energy than I'd ever eaten before," Khambatta explains. "I was eating 600 grams of carbohydrate energy per day, and my insulin use got cut by 35 to 40%."

"I started eating lots of fruits and vegetables," Barbaro adds. "I increased my carbohydrate content and had a 22-to-1 carbohydrate-insulin ratio." In case you aren't familiar with the technical language, that means his insulin sensitivity changed by 600%.

It's important to note the distinction between whole carbs and processed, refined carbs here (it's always good to have a reminder!). Barbaro and Khambatta are partial to the four main carbohydrate categories: fruits,starchy vegetables, beans and legumes, and whole grains.

"The type of carbohydrate you eat absolutely matters," Khambatta says. That said, these experts are encouraging you to eat sweet potatoes, not french fries.

There is some nuance (Khambatta is partial to chickpeas and lacinato kale, while Barbaro loves his sweet potatoes), but the two agree that carbs are essential for long-term health. In terms of their favorite carbs to have on their plates, they agree on fruit as the No. 1 option. "Bananas, mangoes, papayas, pears, jackfruit, you name it. That's our personal favorite, no question."

Even if you don't necessarily suffer from type 1 diabetes, these whole carbohydrate-rich foods are packed with vitamins, fiber, and phytochemicals that increase your overall nutrient densitysomething we all ultimately want, no?

Read more from the original source:
How These Diabetes Experts Stabilized Their Blood Sugar With Food Alone - mindbodygreen.com

EXPERT ANALYSIS FROM THE WCIRDC 2019

LOS ANGELES Although menopausal hormone therapy is not approved for the prevention of type 2 diabetes because of its complex balance of risks and benefits, it should not be withheld from women with increased risk of type 2 diabetes who seek treatment for menopausal symptoms, according toFranck Mauvais-Jarvis, MD.

"During the menopause transition, women accumulate metabolic disturbances, including visceral obesity, systemic inflammation, insulin resistance, dyslipidemia, and hypertension," Dr. Mauvais-Jarvis, director of the Tulane Diabetes Research Program at Tulane University Health Sciences Center, New Orleans, said at the Annual World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. "They also lose muscle mass. Some of these abnormalities are partially explained by chronological aging, but they are also caused by estrogen deficiency. There's a synergism between aging and estrogen deficiency."

The best evidence of this synergy comes from older trials. Nearly 30 years ago, researchers examined the association between postmenopausal hormone use and the subsequent incidence of noninsulin dependent diabetes in a prospective cohort of 21,028 postmenopausal U.S. women aged 30-55 years, who were enrolled in the Nurse's Health Study and followed for 12 years (Ann Epidemiol. 1992;2[5]:665-73). They found that study participants on hormone therapy experienced a 20% reduction in the incidence of type 2 diabetes. In a more recent trial, researchers examined the association between use of hormone therapy and new-onset diabetes in 63,624 postmenopausal women who were enrolled in the prospective French cohort of the Etude Epidemiologique de Femmes de la Mutuelle Gnrale de l'Education Nationale (E3N) and followed for 15 years (Diabetologia. 2009;52[10]:2092-100). It found that study participants on hormone therapy experienced a 20% reduction in the incidence of type 2 diabetes.

In the Heart and Estrogen/Progestin Replacement Study, researchers evaluated the effect of hormone therapy on fasting glucose level and incident diabetes in 2,763 postmenopausal women with coronary heart disease (Ann Intern Med. 2003;138[1]:1-9). At 20 U.S. centers, the study participants received 0.625 mg of conjugated estrogen plus 2.5 mg of medroxyprogesterone, or placebo, and were followed for 4 years. The researchers found that the use of hormone therapy reduced the incidence of diabetes by 35%.

According to Dr. Mauvais-Jarvis, the strongest data come from the Women's Health Initiative (WHI), a randomized, double-blind trial that compared the effect of daily 0.625 mg conjugated estrogen plus 2.5 mg medroxyprogesterone acetate with that of placebo during 5.6 years of follow-up (Diabetologia. 2004; 47[7]:1175-87). It showed a 20% decrease in the incidence of diabetes at 5 years. More recently, researchers found that, whether WHI participants took estrogen plus medroxyprogesterone or estrogen alone, the protection from diabetes was present (N Engl J Med. 2016;374:803-6).

In 2006, researchers published results from a meta-analysis of 107 trials in an effort to quantify the effects of hormone therapy on components of metabolic syndrome in postmenopausal women (Diabetes Obes Metab. 2006;8[5]:538-54). In women without diabetes, hormone therapy reduced the HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) score by 13% and incidence of type 2 diabetes by 30%. In women with diabetes, hormone therapy reduced fasting glucose by 11% and HOMA-IR by 36%.

The mechanisms by which estrogens improve glucose homeostasis are yet to be fully understood. "One of the most important [mechanisms] is a decrease in abdominal fat, which improves insulin resistance and systemic inflammation," Dr. Mauvais-Jarvis said. "However, in the WHI, it was clear that the improvement in HOMA-IR was independent from the body weight and fat. Estrogen has also been found to increase insulin clearance and sensitivity, increase glucose disposal and effectiveness and decrease sarcopenia. There are fewer than 20 studies looking at beta-cell function. Half of them have shown that estrogen improves insulin secretion."

Route of estrogen administration also comes into play. For example, oral estrogens increase liver exposure to estrogen, increase triglycerides, and increase clotting factors. "That is why oral estrogens are not indicated in women with risk of deep venous thrombosis," Dr. Mauvais-Jarvis said. "They also increase inflammatory factors like C-reactive protein. Advantages are that they decrease LDL cholesterol levels and increase HDL cholesterol levels more than transdermal estrogen does."

The main advantage with transdermal delivery of estrogen, he continued, is that it does not raise triglycerides, clotting factors, or inflammatory factors, and it confers less exposure to the liver. "That's why it's the preferred way of administration in women who are obese, who have a risk of DVT, or who have cardiovascular risk factors," he said. "It has a lower suppression of hepatic glucose production, it increases circulating estradiol, and the delivery to nonhepatic tissue is increased. The oral form of estrogen is cheaper, compared with the transdermal form, though. This is a factor that is always taken into account."

Dr. Mauvais-Jarvis and colleagues were first to evaluate the effect of conjugated estrogens plus bazedoxifene in mice (Mol Metab. 2014;3[2]:177-90). "The idea was that by combining estrogen and bazedoxifene, you have the beneficial effect of estrogen in the tissues but you block estrogen in the breast and in the uterus, and therefore, you prevent the risk of cancer," he said. "We found that tissue-selective estrogen complexes with bazedoxifene prevent metabolic dysfunction in female mice. It increased energy expenditure and decreased fatty liver."

In a subsequent pilot study, he and his colleagues assessed the effect of 12 weeks' treatment with bazedoxifene/conjugated estrogens, compared with placebo, on glucose homeostasis and body composition in 12 postmenopausal women (NCT02237079). "We did not find any significant alterations in the IVGTT [Intravenous Glucose Tolerance Test] but we observed improved fasting beta-cell function and serum glucose in menopausal women with obesity," Dr. Mauvais-Jarvis said (J Endocr Soc. 2019;3[8]:1583-94).

In a separate, randomized, double-blind, placebo-controlled, crossover trial that he and his colleagues performed in eight postmenopausal women with obesity, the primary endpoint was insulin action as measured by a two-step hyperinsulinemic-euglycemic clamp. Secondary endpoints were body composition, basal metabolic rate, ectopic fat, and metabolome. "We did not find any difference in systemic insulin action, ectopic fat, or energy expenditure," he said. "But we found something very interesting. We did a metabolic analysis and found that oral estrogens increase hepatic de novo lipogenesis and liver triacylglycerol production. In other words, the oral estrogens were increasing [triacylglycerol] synthesis from glucose, but it does not accumulate in the liver."

Dr. Mauvais-Jarvis disclosed that he has received research support from the National Institutes of Health, the American Diabetes Association, the Department of Veterans Affairs, and Pfizer.

This story originally appeared onMDedge.com.

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Menopause Hormone Therapy Found to Delay Type 2 Diabetes - Medscape

MORGANTOWN, W.Va. The risk of going blind is all too real for diabetics but a WVU project is hoping to mitigate that risk for West Virginians.

The West Virginia Practice-Based Research Network is the organization behind trying to stop or limit diabetic retinopathy, or blindness as a result of diabetes. Stacey Whanger, the Networks assistant director said their work has been going on since 2016 and that they have been engaging primary care providers to offer a new screening for diabetic patients.

The patients that need the screenings from physicians are the ones that are not necessarily seen by an eye doctor, Whanger said, so theyre actually providing care to folks who may not have access to an early screening.

Its recommended that patients with diabetes have yearly eye exams because diabetic retinopathy starts very smallvery subtle changes so patients may not recognize that its happening until the disease is later in the stages, Whanger said. So its important to get that early screening done so then treatment can be provided earlier to the patient and hopefully have better success and save the sight as long as possible.

According to a WVU press release, it is projected that one in three Americans with diabetes will experience diabetic retinopathy by the year 2050. The projection may be frightening but early detection reduces the risk of severe vision loss by 90 percent.

Whanger said the project is also trying to reach out to diabetic patients from the moment when they are diagnosed with diabetes in order to get them in touch with an eye care specialist. The reason being that a regular doctor cannot treat diabetic retinopathy, they can only do an initial screening to see if the eyes are normal.

Moving forward, Whanger said, they are hoping to expand the project to more sites around the state.

We cover a good portion of areas around the state but were hoping to expand to other primary care sites to really deliver the care to patients that are not receiving their annual eye exams and to be able to provide that care to them, Whanger explained. We also are really creating a network across the state between eye care professionals and primary care providers so this could really extend to other diseases that have systematic and ophthalmic conditions and how it goes hand in hand. It just works as a nice partnership between all the different providers that a patient might come in contact with.

See more here:
WVU project works toward preventing blindness in diabetic patients - WBOY.com

BUFFALO, N.Y. (WKBW) Fourteen-year-old Ben Cornell was diagnosed with type 1 diabetes when he was ten years old. He's now advocating for research funding to find a cure for the autoimmune illness.

He will be among the guests attending Tuesday night's State of the Union Address after receiving an invite from Congressman Tom Reed.

"It's a struggle it's not very easy, and it's always like, there. You never really get a break," he said. "I didn't want to have it anymore, and just anything anybody can do to help it just makes us that much closer."

Supporting Cornell is Edward Dickey, Board President of the WNY chapter of the Juvenile Diabetes Research Foundation. His daughter has type 1 as well.

"Thankfully there's technologies that have come along in the last ten years that have made life easier to live with but it is by no means a cure," he said. "Insulin is by no means a cure, we need to continue to fund research and try to find a cure for diabetes."

Another major issue type one diabetics face is insulin affordability. The price of the vital drug has skyrocketed over the last decade, leading people to crossing over the border to Canada to get it for a cheaper price, or more dangerously - rationing their insulin.

But Dickey is hopeful a cure will be found.

"In the last six months the Special Diabetes Program, the SDP, was approved by Congress and gave us $97 million over the last six moths to help find a cure for diabetes," he said.

Dickey said it's important to get a multi-year approval of that agreement so JDRF does not have to worry about research money.

Continued here:
Local teen with type 1 diabetes invited to State of the Union Address - WKBW-TV

OTTAWA, Feb. 5, 2020 /CNW/ -

Summary

IssueApotexInc.. is recalling eight lots of its 500 mg extended release metformin tablets ("APO-Metformin ER") because they contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) above the acceptable limit. Apotex Inc. has tested all lots of its 500 mg extended release tablets; only the affected lots are being recalled (see table below). There are also alternative metformin products on the Canadian market manufactured by other companies.

Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes.

Individuals taking metformin, including a recalled product,should not stoptaking it unless they have spoken to their health care provider as the risks from not having adequate diabetes treatment outweigh any possible effects of exposure to the levels of NDMA found in the recalled products.

NDMA is classified as a probable human carcinogen. We are all exposed to low levels of nitrosamines through a variety of foods (such as smoked and cured meats, dairy products and vegetables), drinking water and air pollution. NDMA is not expected to cause harm when ingested at low levels. A person taking a drug that contains NDMA at or below the acceptable level every day for 70 years is not expected to have an increased risk of cancer.

In December 2019, Health Canadacommunicatedthat it is assessing the issue of NDMA in metformin products, after some metformin products available outside Canada were detected to contain NDMA above the acceptable limit. The Department asked companies to test their metformin products and is conducting testing in its own laboratories. Health Canada is also working closely with international regulatory partners, including the U.S. Food and Drug Administration and the European Medicines Agency, to inform its assessment. Health Canada continues to assess this issue, and will update the table below and inform Canadians should any additional recalls be necessary.

Health Canada has beenworkingto address the issue of NDMA and other nitrosamine impurities found in certain medications since the summer of 2018. Health Canada continues to work closely with international regulatory partners to address the issue. The Department will take action if a new risk to Canadians is identified, and will continue to inform the public of new safety information.

Who is affectedPatients who are taking an affected metformin drug.

What consumers should do

Affected productsThe following is a list of metformin drugs being recalled in Canada at this time:

Company

Product Name/ActivePharmaceutical Ingredient(API)

DIN

Strength

Lot

Expiry

Apotex Inc.

APO-Metformin ER(Metformin HydrochlorideExtended-Release Tablets)

02305062

500 mg

NV3242

04/2020

NV3244

04/2020

NV3245

04/2020

NV3243

04/2020

NV3247

04/2020

NV3248

04/2020

PX5334

01/2021

PX5335

01/2021

Related links

galement disponible en franais

SOURCE Health Canada

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Information Update - Apotex Inc. recalls certain lots of the diabetes medication APO-Metformin ER (extended release) 500 mg tablets - BioSpace

MIRAMAR, Fla., Feb. 04, 2020 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (GNBT) is pleased to announce that the companys subsidiary Olaregen Therapeutix, an emerging regenerative medicine company, has begun shipping Excellagen to the Indian Health Services in Arizona, following approval by the value added committee (VAC). Native American Indian adults are almost three times more likely to have diabetes and 2.5 times more likely to die from the complications of diabetes than the majority of other Americans. Excellagen wound conforming gel matrix is FDA cleared to manage 17 types of wounds including diabetic foot ulcers and venous leg ulcers, which are prevalent in the diabetic patient population. The Indian Health Service (IHS), an agency within the U.S. Department of Health and Human Services, provides care to over 2.2 million Native Americans in more than 560 recognized tribes across the country.

Anthony J. Dolisi, President and Chief Executive Officer of Olaregen said, We are excited that Excellagen has been approved by the Indian Health Services Value Added Committee, which not only enables us to begin selling Excellagen in Arizona, but which also opens the door to VAC approval across the IHS. We continue to make gains in the VA hospitals, where Excellagen is achieving some fantastic results for veterans who are dealing with hard to heal wounds, and we expect to achieve a national footprint by the end of the year. Additionally, we have begun the VAC approval process in the private sector and have just signed a new hospital in Texas.

About Generex Biotechnology Corp. Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.

In addition to advancing a legacy portfolio of immune-oncology assets, medical devices, and diagnostics, the Company is focused on an acquisition strategy of strategic businesses that complement existing assets and provide immediate sources of revenue and working capital. Recent acquisitions include a management services organization and medical device companies with new and approved products.

About Olaregen TherapeutixOlaregen Therapeutix, Inc. is a regenerative medicine company focused on the development, manufacturing and commercialization of products that fill unmet needs in the current wound care market. Generex aims to provide advanced healing solutions that substantially improve medical outcomes while lowering the overall cost of care.Olaregen's first product introduction, Excellagen (flowable dermal matrix) is a topically applied product for dermal wounds and other indications.Excellagen is a FDA 510K cleared device for a broad array of dermal wounds, including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/ grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds, enabling Olaregen to market Excellagen in multiple vertical markets. Additionally, Excellagen can serve as an Enabling Delivery Platform for pluripotent stem cells, antimicrobial agents, small molecule drugs, DNA-Based Biologics, conditioned cell media and peptides. Olaregen's initial focus will be in advanced wound care including diabetic foot ulcers (DFU), venous leg ulcers and pressure ulcers. Future products focusing on innovative therapies in bone and joint regeneration comprise the current pipeline. Generex's mission is to become a significant force in regenerative medicine and advance the science of healing.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

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Generex Contact:

Generex Biotechnology Corporation

Joseph Moscato 646-599-6222

Todd Falls 1-800-391-6755 Extension 222 investor@generex.com

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Generex Biotechnology Subsidiary Olaregen Therapeutix Receives VAC Approval and Ships Excellagen to the Arizona Indian Health Service - Yahoo Finance