Roche Diabetes Care partners with digital therapeutics firm Ieso

Roche’s diabetes arm is working with Ieso Digital Health to test the Cambridge, UK-based digital therapeutics firm’s mental health programme in type 2 diabetes patients in the UK and Ireland.

The Swiss pharma company hopes a version of Ieso’s online cognitive behavioural therapy can identify, and help treat, those diabetes patients that also have mental health issues, such as depression and anxiety.

Brett Lewis, general manager of Roche Diabetes Care UK and Ireland, said: “I’m delighted to be embarking on this important research programme with Ieso, whose pioneering cognitive and behavioural interventions are already demonstrating very positive results in treating depression and anxiety. We look forward to getting started and in bringing forward much-needed help for people with diabetes.”

Ieso said its therapists would help change patients’ attitudes and behaviours and improve their quality of life. In an initial pilot phase of the programme, the partners will study how overcoming psychological or mental health issues can improve physical outcomes and reduce health care costs.

Dr Andy Blackwell (pictured), group chief science and strategy officer of Ieso Digital Health, said: “We’re very excited to announce this research collaboration with Roche Diabetes Care, which we believe will deliver an integrated behavioural change solution that can really help improve the lives of people with diabetes.”

Nearly one in five people with diabetes also has clinical depression and for those with anxiety and/or depression health care costs increase by around 50%, according to NHS England.

Ieso, which says it is the UK’s largest provider of digitally-enabled, evidence-based mental health care, has treated over 30,000 NHS patients suffering from common mental health disorders to date using its text-based technology platform.

For Roche it’s the next step of its exploration of digital therapeutics. Earlier this year it extended its French cancer pact with Voluntis and launched a multi-centre clinical study of the company’s Zemy solution ahead of seeking regulatory clearance for it.

https://pharmaphorum.com/news/roche-diabetes-care-ieso-digital-health/

Pentagon Building Tech Allowing Troops To Control Machines With Their Minds

Transhumanism is well on its way to becoming a reality in the United States military, as the Pentagon has announced that it’s working on a new “neural interface” technology that would connect human brains directly to machines as a way to control them.

The Defense Advanced Research Projects Agency, also known as DARPA, says the technology, known as Next-Generation Non-Surgical Neurotechnology, or N3, will allow troops to connect to special military control systems using just their brainwaves. The technology will allow for humans to not only control military machines with their minds, but also the inverse – military machines would be able to transmit information to users’ brains as well.

The goal is to combine “the speed and processing power of computers with humans’ ability to adapt to complex situations,” according to DARPA. It will allow people to “control, feel and interact with a remote machine as though it were a part of their own body.”

“From the first time a human carved a rock into a blade or formed a spear, humans have been creating tools to help them interact with the world around them,” says Al Emondi, the program manager at DARPA’s Biological Technologies Office.

“The tools we use have grown more sophisticated over time … but these still require some form of physical control interface – touch, motion or voice. What neural interfaces promise is a richer, more powerful and more natural experience in which our brains effectively become the tool.”

Mark of the beast: melding humans with machines

DARPA claims that the technology is completely innocent, as similar iterations of it for disabled veterans are already in use. “Revolutionizing Prosthetics,” as it’s called, is a program by DARPA that implants electrodes into disabled veterans’ brains, allowing them to control prosthetic limbs simply by thinking about it.

But isn’t that always how egregious new forms of transhumanism typically start? Positive anecdotes about how invasive technologies are “helping people” almost always functions as the gateway to more government control over humans – in this case, military servicemen who are being told that implantable technologies stand to benefit humanity.

DARPA’s rhetoric would have us all believe that combining man with machine is somehow beneficial and even “natural,” even though its true implications are more “mark of the beast” than they are revolutionary breakthrough.

Consider that with N3, able-bodied members of the military would need to ingest “different chemical compounds,” according to reports, in order to activate external sensors that both read and write information to the brain. This technology has to be “bidirectional,” claims DARPA, though the agency has not fully revealed precisely why this is the case.

It’s the type of thing one might expect to see in a sci-fi movie, except it’s now happening in real life. In the future, as openly admitted by DARPA, members of the military will be able to control attack drones with their brains, or deploy robot warriors using just brain motor signals and thoughts.

The technology is even being designed to provide real-time feedback about events happening in the world, such as cyber attacks. Users will purportedly be able to “feel” these events inside their bodies through “sensations.”

“We don’t think about N3 technology as simply a new way to fly a plane or to talk to a computer, but as a  tool for actual human-machine teaming,” Emondi admits.

“As we approach a future in which increasingly autonomous systems will play a greater role in military operations, neural interface technology can help warfighters build a more intuitive interaction with these systems.”

For more information about the agenda of the military-industrial complex to combine man with machine, be sure to see Transhumanism.news.

https://www.zerohedge.com/news/2018-09-29/pentagon-building-technology-allowing-troops-control-machines-their-minds

Women: Don’t Ignore These 3 Subtle Heart Attack Symptoms

We always associate chest pain with heart attacks, and for good reason, but it’s not the whole story — especially for women. While chest pain is the most common symptom of a heart attack, women can have symptoms that aren’t related to chest pain at all. They need to be on the lookout for other, subtler symptoms.

Also, we need to dig deeper into the symptom of chest pain for both men and women as it relates to heart attacks. It is seldom as dramatic as you might think, and it can feel like pressure or heart burn that  comes on over time.

Below, find three symptoms you should watch for, including information about how to tell if they are benign or cause for concern.

1. Unusual fatigue

Like many women, you’re probably busy most of the time. You may take care of a family, run a household, work outside the home and care for aging parents. You are probably also tired a lot of the time. Most likely this is normal.

But you should pay attention to fatigue if it is new or dramatic. Here’s what to watch out for:

• You are suddenly worn out after your typical exercise routine.
• You aren’t exerting yourself, but have fatigue or a “heavy” chest.
• Simple activity like making the bed, walking to the bathroom or shopping makes you excessively tired.
• Although you feel exceptionally tired, you also experience sleep disturbance.

2. Sweating and/or shortness of breath

As women age, a lack of exercise and gradual weight gain cause issues like shortness of breath. Hot flashes are a common complaint for many women during menopause.

But these symptoms can signal a heart problem when they happen in certain situations:

• Sudden sweating or shortness of breath without exertion
• Breathlessness that continues to worsen over time after exertion
• Shortness of breath that worsens when lying down and improves when propping up
• “Stress” sweat (cold, clammy feeling) when there is no real cause for stress
• Sweating or shortness of breath accompanied by other symptoms such as chest pain or fatigue

3. Neck, jaw, back pain

As intricate as our body’s systems are, they are very adept at giving signals when there is something wrong. When there is a problem with the heart, it triggers nerves in that area, but you sometimes feel pain elsewhere.

Pain in the jaw, back or arms may signal a heart condition, especially if the origin is hard to pinpoint (for example there is no specific muscle or joint that aches). Also, if the discomfort begins or worsens when you are exerting yourself, and then stops when you quit exercising, you should get it checked out.

Here are some other signs to look out for:

• Women, in particular, can have pain in either arm — not just the left one like many men.
• Pain in the lower or upper back often starts in the chest and spreads to these areas.
• The pain is sometimes sudden, not due to physical exertion, and can wake you up at night.
• You may feel pain that is specific to the left, lower side of the jaw.

What to do if you notice symptoms

Women often say they noticed some of these three warning signs weeks or a month before a heart attack.

The sooner you report a problem, the better the chances are of catching an issue before it becomes a full-blown heart attack. If you experience any of these symptoms, take note and visit your doctor as quickly as possible.

When you see your doctor:

• Bring a list of your symptoms and when they are occurring.
• Let him or her know about any related family history.
• Talk about stress or anything going on in your life that might contribute to a problem.

Your doctor likely will listen to your symptoms and check your pulse and blood pressure. He or she may order blood work, which will show whether your heart is damaged.

Your doctor also may use an electrocardiogram (EKG) to tell whether the electrical activity of your heart is normal, or an echocardiogram to view images of the heart to see if damage has occurred. 

All this is important in identifying any problems and taking steps to intervene before a possible heart attack.

When to call 9-1-1

Get help right away if you have chest pain or discomfort along with any of these symptoms, especially if they last longer than five minutes:

• Pain or discomfort in other areas of the upper body, including the arms, left shoulder, back, neck, jaw, or stomach
• Difficulty breathing or shortness of breath
• Sweating or “cold sweat”
• Fullness, indigestion, or choking feeling (may feel like heartburn)
• Nausea or vomiting
• Light-headedness, dizziness, extreme weakness or anxiety
• Rapid or irregular heart beats

https://health.clevelandclinic.org/women-dont-ignore-3-subtle-heart-attack-symptoms/

Affimed, MD Anderson in Immuno-Oncology Development Collaboration

Affimed N.V. (Nasdaq:AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, and The University of Texas MD Anderson Cancer Center today announced an exclusive strategic clinical development and commercialization collaboration to evaluate Affimed’s TandAb technology in combination with MD Anderson’s natural killer cell (NK) product.

NK-cells are white blood cells which monitor the body for infected and cancerous cells. The technology to grow NK-cells from umbilical cord blood was developed at MD Anderson.

This collaboration will leverage MD Anderson’s expertise in NK-cells and translational medicine, and Affimed’s capabilities to develop tumor-targeting bispecific TandAb immune cell engagers.

“In our effort to broaden the applications of our NK-cell engager products, we are excited to partner with the world-leading NK-cell experts at MD Anderson to investigate their unique product together with our first-in-class NK-cell engager AFM13 in Hodgkin lymphoma,” said Adi Hoess, Ph.D., CEO of Affimed. “Harnessing the advantages of both antibody-based and cell therapy approaches has the potential to better exploit the therapeutic activity of NK-cells. We believe this partnership could benefit many hematological malignancies, including in multiple myeloma, where Affimed is developing AFM26, a BCMA/CD16A bispecific antibody. For us, this partnership is an important step in executing our strategy to develop transformative cancer therapies.”

Collaborative studies will research, develop, and eventually commercialize novel oncology therapeutics resulting from this combination of products. MD Anderson will be responsible for conducting preclinical research activities aimed at investigating its NK-cells derived from umbilical cord blood in combination with Affimed’s lead NK-cell engager, the CD30- and CD16A-targeting TandAb AFM13. These are intended to be followed by a Phase 1 clinical trial. Affimed will fund research and development expenses for this collaboration and the agreement includes a provision for the potential expansion of the partnership. Affimed holds an option to exclusive worldwide rights to develop and commercialize any product developed under the collaboration.

“We look forward to joining the cord blood-derived NK-cells developed at MD Anderson with our collaborator’s technology which we believe will benefit our patients,” said Katayoun Rezvani, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson.

AFM13 is a bispecific NK-cell TandAb simultaneously targeting CD16A on NK-cells and CD30 on tumor cells. AFM13 is designed to treat CD30-positive malignancies including Hodgkin lymphoma (HL) and T-cell lymphoma (TCL) and is currently in Phase 2 development in HL patients. Based on its safety profile, AFM13 is being developed both as monotherapy and in combination with other therapeutics such as Merck’s checkpoint inhibitor KEYTRUDA^®.

Elizabeth Shpall, M.D., professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson, and Rezvani’s co-leader on the project, believes the collaboration “holds true potential to produce a novel cellular therapeutic for the treatment of high-risk Hodgkin lymphoma.”

https://globenewswire.com/news-release/2017/01/04/903097/0/en/Affimed-and-MD-Anderson-Announce-Clinical-Immuno-Oncology-Development-Collaboration.html

Olfactory Ensheathing Cells May Open New Route to Glioblastoma Therapy

A special type of cell essential to the ability of olfactory neurons to regenerate may be genetically engineered to deliver anticancer therapy to glioblastomas, according to Massachusetts General Hospital (MGH) researchers who published their study (“Olfactory Ensheathing Cells: A Trojan Horse for Glioma Gene Therapy”) in the Journal of the National Cancer Institute. The team describes using olfactory ensheathing cells (OECs) to deliver an anticancer agent only to tumor cells and how the treatment reduced tumor size and prolonged survival in a mouse model.

“We show for the first time that autologous transplantation of OECs can target and deliver therapeutic transgenes to brain tumors upon intranasal delivery, the natural route of OECs to the CNS, which could be extended to other types of cancer,” write the investigators.

“Glioblastomas are the most aggressive and malignant type of brain tumors, and despite intensive treatment with surgery, chemotherapy, and radiation therapy, they almost always recur, leading to a five-year survival rate of less than 10%,” says senior author Bakhos Tannous, PhD, associate professor of neurology at Harvard Medical School, and associate neuroscientist at the neuro-oncology division in the MGH department of neurology. “Olfactory ensheathing cells, which are present in the nose throughout life in all mammals, including humans, can migrate from the nasal cavity to sites of inflammation and have the potential of acting as a ‘Trojan horse,’ delivering cell-killing therapies that bypass the barriers that keep other anticancer agents out of the brain.”

Olfactory neurons have the ability to regenerate, which is rare within the nervous system. New neurons in the nasal cavity must project axons to the olfactory bulb within the brain itself. OECs surround the growing axons, assisting in their regeneration and also engulfing debris from dead and damaged cells. The ability of OECs to promote neural regeneration has led to studies of their potential in the treatment of spinal cord injuries and the neurodegenerative disorder amyotrophic lateral sclerosis.

Because of the direct connection between the nasal cavity and the brain, intranasal drug delivery is being studied as a means of bypassing the blood-brain barrier. The ability of OECs to travel into the brain and their attraction to inflammatory molecules, including those secreted by tumor cells, led the MGH team to investigate their potential use against glioblastomas. They first showed that labeled OECs introduced into the nasal cavity of mice with experimentally induced human gliomas not only traveled to sites where tumor cells had been injected but also followed tumor-initiating cells as they infiltrated adjacent brain tissue.

The team then genetically engineered OECs to express fusion protein CU that converts nontoxic prodrug 5-FC into a cell-killing chemotherapy agent (5-FU). After confirming in cellular experiments the ability of CU-expressing OECs to convert 5-FC to 5-FU, leading to the death of tumor cells, the team administered either CU-expressing OECs or a control agent into the nasal cavities of mice a week after tumor-initiating cells had been injected into the animals’ brains. Seven days later, both groups of animals received daily injections of 5-FC for another seven days. Two weeks after that, mice that had received the transgenic OECs has significantly smaller tumors at the injection site, less tumor migration through the brain, and greater death of tumor cells than the control group. The single OEC treatment also led to significantly longer average survival among the treated mice.

“Our findings indicate that, upon intranasal delivery, CU-expressing OECs migrate through their natural route towards the brain, target brain tumors in a very specific manner and convert 5-FC into an active 5-FU drug at the tumor site, leading to an efficient, tumor-cell-killing effect through what is called a ‘bystander effect’,” says Litia Carvalho, PhD, a postdoctoral fellow in Dr. Tannous’s lab and the lead author of the study.

Dr. Tannous adds, “Due to their strong attraction to inflammatory cues secreted by tumor cells, we believe OECs could be used as a therapeutic tool against different types of brain cancer and tumors located in other parts of the body, something we are actively investigating.”

https://www.genengnews.com/gen-news-highlights/olfactory-ensheathing-cells-may-open-new-route-to-glioblastoma-therapy/81256278

Best way to avoid back pain? Lift heavy things

Most people think that the human spine is one of evolution’s great flaws. After all, around 80 per cent of adults suffer from lower-back pain. What more evidence do you need? The truth is, the spine is a robust structure. We’re just using it incorrectly.

Everybody “knows” that you put your back out if you lift objects that are too heavy. As a result, many workplaces have introduced lifting training and ergonomic equipment, such as hoists, in an effort to reduce back injuries.

The common advice from lifting training is to avoid heavy lifting where possible. However, research has shown that such training is largely ineffective at reducing back pain and back injury. It seems that a different approach is needed.

Human tissue needs to be exposed to loads to become strong – and the spine is a good example of this. Regular loading prepares the joints, muscle and ligaments for normal tasks. Nobody would expect to run a marathon without preparing the body for such loading, so it seems logical that to be able to lift a weight requires exposure to that activity.

Lack of loading has been shown to have damaging effects on the spine. Studies on astronauts have shown that lack of exposure to loading in microgravity causes muscle wasting, spine stiffness and disc swelling. These previously healthy astronauts developed back pain after space flight. Prolonged unloading caused an unstable or weak spine leading to back pain.

A lack of load causes back problems for astronauts (Getty)

Those teaching that lifting should be avoided, indicate that it is not just the one-off heavy lift that is the problem. Repeated and regular bending and lifting of the spine is cited as a risk for back injury, particularly when combined with twisting. Research in elite rowers examines this concept.

  

Elite rowers fully flex and load their lower backs hundreds of times a day every time they train. Around one-third of this group will complain of an episode of back pain in a 12-month period, of which the vast majority will recover fully.

This shows that most rowers do not injure their lower back and that the spine is very tolerant of this activity. It does, however, suggest that bending and loading is indeed an activity that can be associated with the onset of back pain, but that there must be more to the story.

There appears to be a loading “sweet spot” where the lower back is gradually trained to cope with the load. Rapid increases in training load with poor recovery is associated with onset of back pain in rowers. Rowers who move well through their hips, knees and other joints are less likely to get back pain.

Another finding in rowers, which contradicts traditional “manual handling” training, is that they load their backs with a bent spine. The fact that the lower back is tolerant to being loaded in this position can be explained.

The spine is in fact a more stable structure when it is curved. Advice to keep the back straight and bend at the hips when lifting is to encourage the use of the large muscles around the hips and in the legs, to help with the load. This advice may be misguided if these muscles are weak due to misuse. The emphasis should be on strengthening these muscles.

People are becoming less active and more overweight, which means they are becoming less fit and less able to tolerate the activity and loading for which we were designed. Recent expert advice highlights that the best way to prevent back pain is with exercise.

Rather than advise people to avoid lifting, they should be taught to make regular lifting part of their everyday routine. To build the muscles of the spine, the load must be heavy enough, as with any weight training.

https://www.independent.co.uk/life-style/health-and-families/health-news/best-way-avoid-back-pain-lift-heavy-things-a8291446.html

Boehringer, Puma repurposing lung cancer drugs in leukemia

EGFR inhibitors, which block a key signaling pathway in solid tumor growth, are best known as treatments for lung cancer. But a new study led by scientists at the University of Liverpool found that some of them could potentially be used against blood cancers, too.

Their effectiveness in blood cancers is not related to the EGFR mechanism, they believe. Instead, it’s the drugs’ off-target effect on a pseudo-kinase known as TRIB2, which is part of a protein family called Tribbles, named after the small, fluffy fictional species from Star Trek. Just like tribbles in the sci-fi universe move slowly but reproduce rapidly, Tribbles in the real biology world are unable to catalyze chemical reactions. That’s why they are sometimes referred to as “zombie” enzymes. But they do promote cell survival and drug resistance in both solid tumors and blood cancers.

In their study, the researchers found that the unique disposition of cysteine residues in TRIB2 makes it vulnerable to destabilization by several seemingly unrelated FDA-approved EGFR inhibitors, including Boehringer Ingelheim’s Gilotrif, Puma Biotechnology’s Nerlynx and AstraZeneca’s Tagrisso. The researchers described their findings in the journal Science Signaling.

Using a human acute myeloid leukemia cell line, the team showed that Gilotrif and Nerlynx could successfully kill blood cancer cells in vitro. The drugs, which are actually dual EGFR/HER inhibitors, are 10- to 20-fold more effective at cell killing compared to two EGFR-specific inhibitors, Astellas and Genentech’s Tarceva and AstraZeneca’s Iressa.

EGFR mutation is associated with about 30% of non-small cell lung cancers. Gilotrif was first approved by the FDA in 2013, having been shown to delay tumor growth 4.2 months longer than what was seen in patients receiving chemotherapy. The drug has yielded share to new generations of EGFR inhibitors such as Tagrisso.

Repurposing could give drugs like Gilotrif a second life, the authors of the new study believe. “A long-standing goal in cancer research is drug-induced degradation of oncogenic proteins. Our study highlights how information obtained with ‘off-target’ effects of known drugs is potentially useful because it might be exploited in the future to help eliminate a protein that is involved in a completely different type of cancer,” said Patrick Eyers, the study’s senior author, in a statement.

Interestingly, not all dual EGFR/HER2 blockers examined by the team worked in the same way or showed the same level of potency. Novartis’ Tykerb and Takeda’s investigational TAK-285 actually stabilized TRIB2 in vitro rather than disrupting it.

The preliminary data opens the possibility of using EGFR inhibitors as TRIB2-degrading agents. For future studies, the researchers plan to better quantify the effects of these drugs on the TRIB2 protein by studying clinical samples from patients “as part of broader proteomics approaches to establish all the intracellular targets of such compounds,” they wrote in the study.

https://www.fiercebiotech.com/research/star-trek-protein-helps-repurpose-egfr-lung-cancer-drug-for-leukemia