India Globalization Capital announced that it has filed a provisional method and composition patent application, or IGC-509, with the U.S. Patent and Trademark Office, or USPTO, for the treatment of fatigue and energy restoration. The filing is for a provisional patent and no assurance can be given as to whether or when a registered patent may be granted by the USPTO in the future. This patent filing made on October 4 is one of a series of steps in the Company’s development and commercialization plan to support the creation of a branded, hemp/CBD sugar-free energy drink, which was previously disclosed by the Company on September 25.
Tuesday, October 9, 2018
Colorectal Cancer Rising in the Obese Young
There has been an “alarming” increase in the incidence of young-onset colorectal and gastric cancers and surgeries for these cancers in recent years, a researcher reported at the annual meeting of the American College of Gastroenterology here.
During the years 2002 to 2013 in national databases, the incidence of colorectal cancer increased in patients younger than age 50 at a rate of 1.5% per year, for an average 15% increase over the study period, according to Hisham Hussan, MD, of the Ohio State University Wexner Medical Center in Columbus.
And in the age group of 18 to 49, there was an annual percentage change of 13.1% in colorectal cancer resection surgeries among obese individuals ages 18 to 49 (P<0.001), he added.
The rates of obesity among U.S. adults are approaching 40%, and sufficient evidence has linked obesity with colorectal, gastric, pancreatic, and esophageal cancers. However, the impact of rising obesity prevalence on the incidence of these obesity-associated gastrointestinal cancers is unknown.
“Our hypothesis was that the incidence of some obesity-related gastrointestinal cancers is rising in certain age groups, and we expect that this corresponds with increasing rates of patients undergoing resections for these cancers,” Hussan said.
He and his colleagues therefore conducted a study to investigate the incidence of obesity-related gastrointestinal cancers stratified into age groups, and to look at the relationships between the incidence of cancers and resections in obese and nonobese patients.
Cancer incidence rates were obtained from the Surveillance, Epidemiology and End Results database, while obesity data and cancer resection rates were obtained from the National Inpatient Sample (NIS).
As with increases in colorectal cancer in younger patients, the rates for gastric cancer rose by 0.7% per year in those ages 18 to 49 (P<0.05), while decreasing incrementally with age in the older groups, the researchers found. The incidence of pancreatic cancer increased across all age groups, with the highest increase seen for patients older than 50. The incidence of esophageal cancer decreased across age groups, with the most pronounced decrease in patients younger than 50.
In the NIS 2002-2013 data, Hussan and colleagues identified 91,116 obese and 1,181,127 nonobese patients who had resection surgeries for these cancers. A total of 93.1% of these were for colorectal cancer and 4.4% were for gastric cancer.
The rate of obese patients undergoing colorectal cancer resection increased over time across all age groups, while the opposite was seen for nonobese patients, where there was a decrease in all age groups. For gastric cancer resections, there also was an increase across all age groups among obese patients, Hussan said.
“The picture was a bit muddier for pancreatic cancer, where there was an increase in resection rates for both obese and nonobese patients. However, the most pronounced increase was in obese patients, who had an increase of more than 25% per year,” he said.
For esophageal cancer, there was an increase exceeding 25% for obese patients ages 65 to 75, the team found.
“These findings strengthen a contributing role of obesity in the etiology and increasing incidence of these cancers and call for more efforts targeting obesity,” Hussan concluded, noting, however, that further research is needed to confirm the findings.
Hussan and co-authors reported having no relevant financial relationships.
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American College of Gastroenterology annual meeting
Pets Need Not Derail Asthma Control in Kids
Parents of kids with uncontrolled asthma may be told they need to re-home a beloved family dog or cat to help their child breathe easier.
But it turns out a much better strategy than saying goodbye to Fluffy or Fido may be to make sure children with asthma receive recommended treatments.
When researchers with Nationwide Children’s Hospital in Columbus, Ohio, examined the impact of environmental exposures, such as living with a dog or cat in the home, on asthma control among children whose asthma was managed according to widely accepted guidelines, the results showed that the exposures had little impact on asthma improvement over time.
Once the treatment guidelines were followed, exposure to pet dander or even secondhand smoke were not found to be significant factors in overall asthma control.
Findings from the study by Shahid Sheikh, MD, and colleagues were presented at CHEST 2018, the annual meeting of the American College of Chest Physicians.
Christopher Carroll, MD, medical director and research director for pediatric critical care at Connecticut Children’s Medical Center in Hartford, who was not involved with the study, told MedPage Today that it is not uncommon for physicians to tell the parents of their pediatric patients that having a dog or cat in the home can exacerbate their child’s condition.
“I think parents may often interpret that as, ‘Get rid of the pet,'” he said. “The message from this study to doctors is if they can convince parents to keep their children on appropriate meds and treatment schedules the pets can probably stay.”
The 3-year prospective study included 395 children referred by primary care physicians with the diagnosis of uncontrolled asthma. All participants were enrolled in the Nationwide Children’s Hospital acute care center for treatment, and all were provided asthma care as instructed by National Asthma Education and Prevention Program guidelines.
At each visit, every 3 to 6 months, asthma control was evaluated and families completed asthma questionnaires that included information about acute care needs, symptom control, and the Asthma Control Test (ACT).
The results were compared between patients with and without exposure to secondhand smoke (cigarette smoking by caretakers), and between patients with and without exposure to dogs or cats living in the home at baseline and over time.
The distribution of scores was measured by mean, standard deviation, median, and interquartile range depending on the normality of the data. Poisson Mixed Effects Modeling was used to evaluate changes in asthma indicators in 3-6 month increments.
The median age of the children included in the study was 6, and the majority had a diagnosis of either mild persistent asthma or moderate persistent asthma.
Exposure to secondhand smoke was documented in 98 children (25%) and exposure to a cat or dog in the home was documented in 215 children (55%). There was no significant difference in demographics among children with or without pet exposure or exposure to secondhand smoke.
In the total cohort, acute care need scores (hospital admissions, emergency department visits, urgent care visits, predicted forced expiratory volume in one second, mean ACT, and number of days with wheezing and night time cough) improved significantly by the follow-up visits at 3-6 months (P<0.001) for all patients, and the improvement persisted for the 3 years of follow-up.
Environmental exposures were not found to have a significant impact on asthma improvement over time when asthma guidelines were followed, the team concluded.
“These researchers showed that adherence to asthma treatment guidelines was more important than pet exposure, in terms of improving asthma symptoms over time,” Carroll said.
He acknowledged that adherence to medications and treatment schedules is a continuing challenge for parents and clinicians, noting that as the parent of a child with asthma, he knows the issue from both sides.
“Remembering to give a medication twice a day is challenging, much less three or four times a day,” he said. “I can personally attest to that as a parent and a doctor.”
The researchers disclosed no relevant financial disclosures related to this study.
Family Physicians to Test New Option for 10-Yr Maintenance of Certification Exam
A new, more flexible alternative to the current 10-year “high stakes” exam for maintenance of certification will soon be available to family physicians, the American Board of Family Medicine (ABFM) announced here on Tuesday.
Jerry Kruse, MD, chair of the ABFM, announced the new pilot program at the American Academy of Family Physicians (AAFP) Congress of Delegates meeting. He anticipates the program, which will use a longitudinal assessment, will be available to test-takers in January 2019.
Kruse, who is the dean and provost of the Southern Illinois University School of Medicine, described the new model as an “efficient and effective way” to support learning and improve practice.
He noted that the traditional 10-year exam will remain an option for those who choose it.
In crafting this new testing model, the ABFM surveyed a random sample of 6,000 family physicians after they had taken the 10-year exam in 2016 and 2017 and discovered their preferences for an alternative to the current exam.
Under the new pilot, participants will receive approximately 25 questions every 3 months, that can be answered “anywhere, any time” Kruse said, over a period of 3 to 4 years. For those who participate, once the exam is completed, the participants will not need to take another test until 2029, he stressed.
The test will be open-book, clinical references may be used, and participants will be given 5 minutes to respond to each question.
Also, no additional payment, beyond the current standard fee will be required, Kruse said.
Another benefit of the pilot is that participants will be able to learn immediately whether a question is correct or not, along with references on the topic.
Throughout the process the ABFM will solicit feedback about how to improve the assessment.
Kruse noted that the ABFM is also committed to a new approach for engaging with physicians focused on “two-way” and “just-in-time” communication.
AAFP members seemed open to the alternative testing strategy.
Robyn Liu, MD, MPH, president of the Oregon chapter of the AAFP, said the current high-stakes exam is “stressful and disruptive” to a physician’s life and practice.
Some of her colleagues often take a week off from work just to study. “This would eliminate that [problem] as far as we know,” Liu continued, but noted that she hadn’t yet seen the details “in writing.”
Alex McDonald, MD, a board member of the California chapter of the AAFP, was also enthusiastic.
“Right now cramming for a big test, for me personally, doesn’t really add value to my knowledge,” McDonald said, in comparison to learning in smaller chunks of continuous “digestible” information.
Another family physician, Ravi Grivois-Shah, MD, of Tucson, said he was “one hundred percent” interested in the new option.
“There’s absolutely no evidence that our current high-stakes exam actually improves our understanding or knowledge, or outcomes for our patients,” Grivois-Shah told MedPage Today.
He likes the idea of a testing process that is open-book and more “representative” of daily practice.
“If I have a question, I don’t just guess, I look it up with the patient in the room with me,” said Grivois-Shah. “I tell him, ‘Hey, give me a second … because we need to get more detail.'”
“That’s how we practice medicine and to take a test that doesn’t reflect that doesn’t make sense,” Grivois-Shah added.
Daniel Derksen, MD, an alternate delegate of the AAFP, told MedPage Today in an email that he’s due to renew his license in 2019 and will likely choose to participate in the pilot. “It sounds like an innovative approach to lifelong learning,” he said.
Novartis bets on next big MS drug, eyes US, EU approvals in ’19
One of Novartis’ top late-stage candidates for multiple sclerosis is now under review on both sides of the Atlantic.
Having stoked enthusiasm for siponimod through a solid Phase III data package, the Swiss drugmaker traded in a priority review voucher at the FDA for an expedited action date around March of next year. The EMA decision, meanwhile, will likely come in late 2019.
If Novartis appears upbeat, it’s for obvious reasons.
A new commercial drug for MS could bolster Novartis’ blockbuster plans in the field, led by a Gilenya franchise that currently brings in $3 billion in revenue. Though the pharma giant has staved off generic entry — originally expected in 2019 — to the next decade, branded drug rivals abound fighting to reach patients with relapsing-remitting multiple sclerosis.
Siponimod, though, taps into secondary progressive multiple sclerosis (SPMS), a condition that develops over time in a majority of the MS patients diagnosed with the relapsing-remitting form of the disease. The drug works by binding to the S1P1 sub-receptor on lymphocytes, which prevents them from penetrating the central nervous system.
“Siponimod is the first investigational medicine to show a significant delay in disability progression in typical SPMS patients,” said Paul Hudson, CEO of Novartis Pharmaceuticals.
As we reported earlier, the drug was shown to reduce the risk of disease progression and hit a series of secondary measurements including rate of brain volume loss, the T2 lesion volume, annual relapse rate and cognitive processing speed.
Novartis’ announcement also comes days after Celgene filed some new trials for ozanimod, triggering fresh concerns that its S1P contender might not overcome the challenges that blunted its first FDA application in time — if at all. With other big players like Roche and Biogen still in the game, though, the MS competition is still heated.
Pfizer’s leukemia drug gets NHS funding in England and Wales
Pfizer’s Mylotarg has been approved by the English and Scottish NHS cost watchdogs as a restricted use treatment for a certain type of acute myeloid leukaemia (AML).
Mylotarg (gemtuzumab ozogamicin) is approved for NHS use in combination with chemotherapy for previously untreated, newly diagnosed, CD33-positive AML.
It was previously only approved to treat patients whose cytogenetics showed the CD-33 mutation, or where they were so far unknown, and could not be used where the presence of the CD-33 mutation was deemed unclear.
The National Institute of Health and Care Excellence (NICE) made its recommendation last week; the Scottish Medicines Consortium (SMC) followed suit this week.
NICE’s Final Appraisasl Determination (FAD) backed the drug to be used for patients aged 15-plus, in combination with daunorubicin and cytarabine for untreated CD33-positive AML.
A phase 3 clinical trial, ALFA-0701, showed that Mylotarg plus chemotherapy gave a statistically significant and meaningful improvement in median event-free survival, versus chemotherapy alone – 17.3 months compared with 9.5 months respectively.
It also demonstrated a statistically significant improvement in relapse-free survival, versus chemotherapy alone: 28.0 months and 11.4 months respectively.
AML is a rare, aggressive blood cancer that affects approximately 2,600 people in the UK each year. It has an average life expectancy of less than 10 months if untreated.
Professor Nigel Russell from the Centre for Clinical Haematology, Nottingham University Hospital Trust, said: “Over the past few decades, there has been little innovation in how we treat AML. Despite slow improvements in outcomes, the prognosis for patients with this type of blood cancer remains poor.
“Gemtuzumab ozogamicin is a targeted therapy that is given with standard chemotherapy and prolongs the time spent in remission compared to standard treatments. It provides a welcome addition to the treatment options for eligible patients with AML and is an important step towards ensuring that some very sick blood cancer patients can access appropriate treatments to achieve a prolonged, complete remission.”
In May, NICE told Pfizer it had to cut the price of the drug to secure funding from the NHS. In draft guidance issued at the time, it said Mylotarg was too pricey for patients with AML unless it was clear that they had the CD-33 mutation.
Mylotarg was first approved in 2000 and was the world’s first antibody-drug conjugate, consisting of a cancer-seeking antibody bound to a cytotoxic compound unleashed when the drug binds to its target.
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