Cancer is a leading cause of death worldwide, accounting for about 1 crore deaths in 2020, according to the World Health Organisation (WHO). Many of those losing battles against cancer find the cost of diagnosis and treatment very high. Now, the health authorities in Britain have launched a trial that can help reduce the cost of cancer diagnosis and treatment significantly in several countries including India.

The National Health Service (NHS), Britain’s state-run organisation, has launched the world’s biggest trial of Grail Inc’s flagship Galleri blood test, which could detect over 50 cancers even before symptoms appear in a person. The trial, if successful, could substantially reduce the cost of cancer detection and treatment in countries including India.

Carried out as a “quick and simple blood test,” says NHS chief executive Amanda Pritchard, “This could mark the beginning of a revolution in cancer detection and treatment here and around the world.””By finding cancer before signs and symptoms even appear, we have the best chance of treating it and we can give people the best possible chance of survival,” Pritchard said.”What it means to India and even to the rest of the world is that the investigations being performed will have a precursor to them, so their cost will come down considerably for investigations themselves,” said Dr Mamta Rao, Consultant Radiologist in the UK, practising in the UK for over 20 years.

Dr Rao said, “Early detection of lesions will mean quicker treatment bringing the costs further down.”Harriet Buckingham, a photographer living in England who was first told about her breast cancer in 2013, said the trial would have made a world of difference for her had her cancer detected early. “By the time I found my lump, cancer had travelled to my lymph nodes. Had my cancer been detected earlier my treatment would have been less scary perhaps,” said Harriet, who has now fully recovered.

The International Agency for Research on Cancer (IARC) estimates that, while in 2018 there were 17 million new cancer cases and 9.5 million cancer deaths worldwide. “By 2040, the global burden is expected to grow to 27.5 million new cancer cases and 16.3 million cancer deaths.”

Meanwhile, the National Cancer Registry programme in India estimates that “one in 68 males to have lung cancer, 1 in 29 females to have breast cancer and [overall] 1 in 9 Indians will develop cancer during their lifetime”.The trial results are likely to work wonders for certain cancers where even screening programmes are not available such as those in head, neck, bowel, lung, pancreatic and throat areas.Talking about its special significance in the cancer landscape of India Dr Preetha Arvind, who is an oncologist working with the NHS, said, “This test endeavours to pick up earlier cancers that would not be detected routinely.”

“Screening programmes pick up only certain types of tumours but this one could possibly detect cancers that don’t have screening programmes.”

“In India, the top five cancers in men are oral cavity, lung, stomach, colorectal and oesophagus and in women, it is the breast, oral cavity, cervices, lung and gastric cancers.”

“Oral cavity, stomach and gastric are some of the cancers that don’t yet have any screening programmes. Therefore, a blood test like this could be a gamechanger,” Dr Preeta Arvind said.The NHS-Galleri blood test is a Randomised Control Trial (RCT), where half the participants will have their blood sample screened with the Galleri test right away. The other half will have their sample stored and may be tested in the future. This will allow scientists to compare the stage at which cancer is detected between the two groups.

The science rests on finding chemical changes in fragments of genetic code-cell-free DNA (cfDNA) that leak from tumours into the bloodstream. Initial results of the study are expected by 2023 and, if successful, the NHS in England plans to extend the rollout to a further 1 million people in 2024 and 2025.If all goes according to plans the tests will likely be available by 2026, said Dr Mamta Rao.

Source: www.msn.com/en-in/health

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The Union ministry of health and family welfare, during a regular press briefing on efforts against the Covid-19 pandemic, announced a new vaccine tracker is being developed in India that would contain week-by-week data and update on vaccine doses administered. Union health secretary Rajesh Bhushan made the announcement and director-general of the Indian Council of Medical Research Dr Balram Bharagava said that the tracker would be available on the ministry’s official website in a “few days’ time.”

“As the health secretary (Bhushan) has said, we have tried to develop [the] India Covid-19 vaccine tracker,” Dr Bhargava said. He added that the tracker has been done for having data synergy between CO-Win portal, the Union health ministry’s Covid-19 portal and the ICMR’s national Covid-19 testing database. “These data have been synergised based on the ICMR identification number and on the basis of mobile numbers and we have been able to get a vaccine tracker which is going to be online very soon in the ministry of health’s website,” he further said.

Here is what we know so far about the Covid-19 vaccine tracker being developed, which Bhushan called an “ambitious intervention.”

• The vaccine tracker would show the vaccinations done and along with evidence and data, would also be a scientific system for monitoring breakthrough infections,said Rajesh Bhushan, while announcing the tracker.
• Data from the Union ministry of health and family welfare’s Covid-19 portal, CO-Win digital platform for vaccinations and also the testing data from the ICMR would be synergised.
• ICMR’s identification number and the mobile number have been used in synergising the data between the three portals.
• The tracker will also have data on weekly data on Covid-19 vaccinations,
• Briefing on the protective effect of vaccines against deaths, Dr Bhargava said that based on data from April 18, 2021 to August 15, 2021, vaccines were found to be 96.6% effective in preventing mortality after one dose and 97.5% effective after two doses.
• Weekly data for the number of doses administered, beneficiaries inoculated and the number of deaths after receiving one or both doses and the same data for different age groups would also be available.
• The ICMR chief also said that the number of deaths among people who were not vaccinated was higher than those vaccinated with at least one dose of the vaccine.

Meanwhile, more than 716 million vaccine doses, including the 8,651,701 doses in the last 24 hours, have been administered in the country as of 7am on the day (Sept 9, 2021), the Union health ministry said.

Source: www.hindustantimes.com

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A research team from Johns Hopkins Kimmel Cancer Center found that the AI blood testing solution was able to detect over 90% of lung cancers in samples from nearly 800 individuals with and without cancer. The research findings have been published in Nature Communications. Known as DELFI (DNA evaluation of fragments for early interception), the test is designed to detect unique patterns in the fragmentation of DNA shed from cancer cells circulating in the bloodstream.

Researchers applied the DELFI technology to blood samples taken from 796 individuals in Denmark, the Netherlands, and the USA. They determined that the DELFI approach accurately distinguished between patients with and without lung cancer. Investigators combined the test with an analysis of clinical risk factors, a protein marker, and computed tomography image. They found that DELFI helped to detect 94% of patients with cancer across stages and subtypes, including 91% of patients with earlier or less invasive stage I/II cancers and 96% of patients with more advanced stage III/IV cancers.

According to the World Health Organization, lung cancer is the biggest killer, causing 1.8 million deaths in 2020. Despite this, however, the researchers explained that many people at risk of lung cancers do not undergo recommended low-dose computed tomography screening. Victor E Velculescu, M.D., Ph.D., Professor of Oncology and Co-director of the Cancer Genetics and Epigenetics Program at the Johns Hopkins Kimmel Cancer Center, said that this could be due to a number of reasons, including concerns of potential harm from investigation, false positive imaging results, radiation exposure, or worries about complications from invasive procedures.

Lead author Dimitrios Mathios, a postdoctoral fellow at the Johns Hopkins Kimmel Cancer Center, said: “It is clear that there is an urgent, unmet clinical need for development of alternative, non-invasive approaches to improve cancer screening for high-risk individuals and, ultimately, the general population. “We believe that a blood test, or ‘liquid biopsy,’ for lung cancer could be a good way to enhance screening efforts because it would be easy to do, broadly accessible, and cost-effective.”

How does it work?

The DELFI technology uses a blood test to indirectly measure the way DNA is packaged inside the nucleus of a cell by studying the size and amount of cell-free DNA present in the circulation from different regions across the genome. Healthy cells package DNA by organising different regions of the genome into various compartments. The nuclei of cancer cells, by contrast, are more disorganised, with items from across the genome thrown in at random. When cancer cells die, they release DNA in a chaotic manner into the bloodstream.

DELFI helps to identify the presence of cancer using machine learning, a type of artificial intelligence, to examine millions of cell-free DNA fragments for abnormal patterns, including the size and amount of DNA in different genomic regions. This approach provides a view of cell-free DNA referred to as the ‘fragmentome’. The DELFI approach only requires low-coverage sequencing of the genome, enabling this technology to be cost-effective in a screening setting, the researchers say.

Working with researchers in Denmark and the Netherlands, the Johns Hopkins investigators first performed genome sequencing of cell-free DNA in blood samples from 365 individuals participating in a seven-year Danish study called LUCAS. The majority of participants were at high risk for lung cancer and had smoking-related symptoms, such as a cough or difficulty breathing. The DELFI testing approach found that patients who were later determined to have cancer had widespread variation in their fragmentome profiles, while patients found not to have cancer had consistent fragmentome profiles. Subsequently, researchers validated the DELFI technology using a different population of 385 individuals without cancer and 46 individuals with cancer. Overall, the approach detected over 90% of patients with lung cancer, including those with early and advanced stages, and with different subtypes.

Potential for a liquid biopsy test

Study author Rob Scharpf, Ph.D., Associate Professor of Oncology at the Johns Hopkins Kimmel Cancer Center, said: “DNA fragmentation patterns provide a remarkable fingerprint for early detection of cancer that we believe could be the basis of a widely available liquid biopsy test for patients with lung cancer.”

A first-of-a-kind national clinical trial called DELFI-L101, sponsored by the Johns Hopkins University spin-out Delfi Diagnostics, is evaluating a test based on the DELFI technology in 1,700 participants in the US, including healthy participants, individuals with lung cancers and individuals with other cancers. The group plans to further study DELFI in other types of cancers.

Source: www.healtheuropa.eu

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Many chronic kidney disease patients who receive hemodialysis experience severe itching afterward. The exact cause of this condition, called pruritus, isn’t known but it can significantly diminish quality of life. Patients now have their first FDA-approved therapy, an injectable drug developed by Cara Therapeutics.

The FDA’s decision clears the way for the drug, difelikefalin, to be used as a treatment for adults undergoing dialysis who experience moderate-to-severe pruritus. Stamford, Connecticut-based Cara will commercialize its new drug under the name “Korsuva.”

According to the National Kidney Foundation, more than 500,000 people in the U.S. receive dialysis to replace kidney function. An estimated 60% of them have pruritus; in 40% of dialysis patients, the condition is moderate to severe, said Eric Vandal, the company’s senior vice president, commercial, speaking on a conference call.

Pruritus has traditionally been managed by steroids, antihistamines, and other drugs that are used off-label. Korsuva is a peptide that targets kappa opioid receptors in the peripheral nervous system and on immune cells. In its regulatory filings, Cara says these receptors regulate the release of substances that cause itching. The drug does not target mu opioid receptors, which trigger the feelings of euphoria that can lead to addiction.

The FDA’s approval of Korsuva was based on the results of two placebo-controlled Phase 3 studies. Combined, the studies evaluated the drug in 424 patients dosed three times weekly compared to 424 subjects given a placebo. The main goal was to measure a change according to a scale used to assess itching severity. In the first trial, a 4-point or greater improvement in itching score was reported in 40% of patients in the treatment group compared to 21% of those given a placebo. In trial 2, the 4-point or greater mark was achieved by 37% of those dosed with the Cara drug compared to 26% of those given a placebo.

Korsuva was well tolerated by patients. The most common adverse reactions included diarrhea, dizziness, nausea, headache, and sleepiness. Though the drug targets a type of opioid receptor, it is not a scheduled substance. According to the prescribing information, Korsuva is administered as an injection into the venous line of a dialysis circuit at the end of each hemodialysis treatment. Cara will commercialize Korsuva under a partnership with Vifor Pharma.

For many years, pruritus was an elusive drug target. That’s starting to change. Last month, Albireo Pharma received the FDA nod for Bylvay, a small molecule that’s the first drug approved for treating pruritus in patients born with progressive familial intrahepatic cholestasis, a rare genetic liver disorder.The Cara pipeline remains oriented around Korsuva. The injectable version is currently under review as a potential treatment for acute post-operative pain and the management of post-operative nausea and vomiting. Meanwhile, the company is also making progress with an oral version of the drug being evaluated in separate Phase 2 studies for chronic kidney disease-associated pruritus; the liver disease primary biliary cholangitis; and notalgia paresthetica, a nerve disorder that causes itchy skin on the upper back.

Not all of Cara’s efforts have been successful. In April, the company reported that oral Korsuva failed a Phase 2 study in pruritus associated with the skin disorder atopic dermatitis.

Source: www.medcitynews.com

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Pfizer has made clear that it’s willing to open its checkbook to support growth opportunities, and on Monday the pharmaceutical giant unveiled its latest such deal: a $2.3 billion agreement to acquire clinical-stage Trillium Therapeutics, a biotech taking a novel approach to cancer immunotherapy.

Trillium is developing drugs that target CD47, a protein that sends out a signal that macrophages, a pathogen-chomping immune cell, reads as “don’t eat me.” Blocking this signal enables macrophages to see cancer cells as targets. Several companies, large and small, are developing drugs that also work in this manner but Andy Schmeltz, oncology global president for Pfizer, said that Trillium’s molecules have the potential to be safer and more effective than others in this emerging class.z

“While we’re not first, from the way it looks today, we are very bullish on the best-in-class opportunity,” he said, speaking on a conference call on Monday, Aug 23,2021.

According to terms of the acquisition agreement, Pfizer will pay $18.50 for each share of Trillium that it doesn’t already own. That’s a more than 200% premium to the stock’s $6.09 closing price last Friday. But that purchase price is still less than the $20.96 per share peak the company has reached in the past year. In the past month, shares of the biotech have been trading much closer to their 52-week low—well below the $10.88 per share price Pfizer paid last year when it made a $25 million equity investment in Trillium.

Trillium, which splits its operations between Mississauga, Ontario, and Cambridge, Massachusetts, has two CD47-targeting drugs in early clinical development. TTI-622 and TTI-621 are both fusion proteins designed to block CD47. But blocking the “don’t eat me” signal is just half the battle. The Trillium molecules also engage a receptor on macrophages that triggers an “eat me” signal. Schmeltz said these drugs have demonstrated early promise in blood cancers, whose cells express CD47 proteins in substantial amounts. He added that these drugs are also showing potential for use in solid tumors, which have been a harder target for immunotherapies.

In April, Trillium reported preliminary data from a 43-patient Phase 1b/2 study testing both of its molecules. In patients whose lymphoma had relapsed or has been resistant to treatment, the overall response rate to TTI-622 was 33%. That response was observed across multiple types of lymphomas. In updated data through late July, the durability and efficacy of the treatment continued with a response rate of 30%. For TTI-621, the first cut of data in April showed that the overall response rate in relapsed or refractory T cell and B cell lymphomas was 18% to 29%. Pfizer did not report updated July data for that molecule.

In addition to efficacy and durability, the Trillium molecules are also hitting key safety measures. One of the challenges for drugs that block CD47 is that this protein is also found on red blood cells, so these oxygen-carrying cells of the blood can also be targeted. When that happens, patients develop anemia. Jeff Settleman, Pfizer’s oncology chief scientific officer, said both TTI-622 and TTI-621 have shown minimal binding to red blood cells. Those results suggest the Trillium molecules could reduce the risk of anemia compared to other CD47-targeting drugs, while improving the therapeutic index—how much of a drug can be used to provide benefit before toxicity gets too high.

“We believe it will be possible to deliver a lower, but still effective, dose of these molecules,” Settleman said.

Settleman added the Trillium molecules hold potential as monotherapies or as part of drug combinations with currently approved Pfizer drugs and candidates still in the pipeline. Other companies have similar ideas. CD47 has become an attractive target as companies look to expand beyond checkpoint inhibitors, a class of immunotherapies that block PD1 or PD-L1.

Gilead Sciences is the furthest along of CD47-targeting companies with magrolimab, an antibody that the company added to its pipeline last year via its $4.9 billion acquisition of Menlo Park, California-based Forty Seven. Magrolimab is currently in late-stage clinical development for myelodysplastic syndrome and acute myeloid leukemia. Others in the chase with CD47-blocking drugs include AbbVie, which is partnered with I-Mab. That Shanghai-based biotech’s drug, also an antibody, is in early clinical development.

Pfizer has been swinging deals to bolster its cancer drug pipeline. A month ago, the New York-based pharma giant announced a $1 billion commitment to clinical-stage Arvinas in an alliance focused on the development and commercialization of that company’s lead drug in breast cancer. Arvinas is developing drugs based on targeted protein degradation, which harnesses a cellular process for disposing of old proteins as a way of getting rid of proteins that cause disease.

The Trillium acquisition will require the approval of two-thirds of that company’s shareholders, as well as regulatory approvals in the U.S. and Canada.

Source: www.medcitynews.com

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The Re/Wire Health Studio will invite emerging health and tech companies to work with GSK’s consumer division on diagnostic solutions with the aim of developing better health experiences. Startups who partner with GSK on the programme will receive guidance and be offered market opportunities and partnerships. The studio will focus on three core areas of health – oral health, women’s health and wellness, and mental resilience.

Nick Tate, vice-president at GSK and head of GSK Next, said: “We’re seeing huge disruption and partnership opportunities in the consumer health space and we’re excited about fusing the trusted science and scale of GSK Consumer Healthcare with brilliant new thinkers and makers across everyday health.”

The studio will select six startups to work with, who will have access to R/GA’s services and strategists, technologists, designers and consultants to help them develop their businesses. Startups must be prepared to launch in the US with a minimum viable product or service in development or in-market.

Source: www.research-live.com

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