FDA Approves Palsonify (paltusotine) for the Treatment of Acromegaly in Adults

Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that the U.S. Food and Drug Administration (FDA) approved Palsonify (paltusotine) for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Palsonify, a selectively-targeted somatostatin receptor type 2 nonpeptide (SST2) agonist, is now the first once-daily, oral treatment approved for adults with acromegaly.

“With the FDA approval of our lead therapy Palsonify, today marks a new era for those living with acromegaly and also for Crinetics as a company,” said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. “We are very pleased to be fulfilling our commitment to transforming patient lives. This approval is the first to come from our deep pipeline of first-in-class, small molecule drugs. This would not be possible without the help and partnership of people living with acromegaly, their caretakers, our employees, and the clinical researchers and health care professionals who contributed to Palsonify’s successful development program. Thank you to all involved.”

The approval is based on data from the PATHFNDR-1 and PATHFNDR-2 Phase 3 pivotal trials, which evaluated Palsonify’s safety and efficacy in previously treated and medically untreated adults with acromegaly. Across both trials, Palsonify consistently demonstrated rapid onset, reliable biochemical control, and sustained efficacy.

Participants also reported significant reductions in signs and symptoms associated with acromegaly as measured by the Acromegaly Symptom Diary (ASD) — an FDA-aligned patient-reported outcome tool developed to capture the symptoms that matter to people living with acromegaly. Symptoms include headaches, joint pain, sweating, fatigue, weakness, swelling, and/or numbness/tingling. Palsonify was generally well-tolerated, with no serious adverse events reported in the randomized controlled portion of the trial.

Long-term results from the open-label extension (OLE) phases of both trials were presented at this year’s Endocrine Society’s annual meeting, ENDO 2025, providing further evidence of Palsonify’s ability to deliver durable IGF-1 control, sustained improvements in patient symptom burden, and a consistent safety profile. Ninety-one percent of patients from PATHFNDR-1 and 97 percent of completers from PATHFNDR-2 enrolled in the OLE.

“The PATHFNDR clinical development program set a new standard for acromegaly treatment by demonstrating the ability of Palsonify to drive both biochemical and symptom control, regardless of the degree of underlying disease severity,” said Dr. Shlomo Melmed, Executive Vice President of Medicine and Health Sciences and Dean of the Medical Faculty at Cedars-Sinai, “The approval of Palsonify is a significant advancement for our patients, as there is an unmet need for an easy-to-administer and safe therapeutic option with a rapid action and durable response that can consistently manage acromegaly.”

“For people living with acromegaly, treatment once meant burdensome injections, breakthrough symptoms, and lifestyle sacrifices just to stay on track,” said Jill Sisco, President of Acromegaly Community. “What matters most to our community – maintaining consistent control so the disease doesn’t control us – led us to partner with the FDA on Externally Led Patient-Focused Drug Development meetings. This new treatment reflects that our voices have been heard in shaping the next generation of acromegaly care.”

Palsonify is expected to be available in the U.S. in early October. Crinetics is ensuring broad access to Palsonify by working closely with payers, healthcare providers, and patient advocacy organizations to support those who may benefit from this treatment.

As part of this commitment, Crinetics has launched CrinetiCARE®, a comprehensive support program designed to assist people living with acromegaly throughout their treatment journey. CrinetiCARE provides disease and product education, benefit verification, financial assistance resources, and access to dedicated nurse educators who can offer support with treatment onboarding and ongoing adherence.

A Marketing Authorization Application (MAA) for paltusotine in acromegaly is currently under review for use in the European Union, and the current timeline for the Committee for Medicinal Products and Human Use (CHMP) opinion is the first half of 2026. Crinetics is in partnership with Sanwa Kagaku Kenkyuso (SKK) to develop and commercialize paltusotine for acromegaly in Japan.

Paltusotine is also being evaluated for the treatment of carcinoid syndrome in the pivotal Phase 3 CAREFNDR trial. Global enrollment for CAREFNDR is expected throughout 2025.

Palsonify (paltusotine) INDICATION:

Palsonify is a somatostatin receptor agonist indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS:

Cholelithiasis and Its Complications: Cholelithiasis, including related complications such as acute cholecystitis and pancreatitis, have been reported. Monitor patients periodically. Discontinue Palsonify if complications of cholelithiasis occur and treat appropriately.

Hyperglycemia and Hypoglycemia: Hyperglycemia, diabetes mellitus, or hypoglycemia, may occur. Monitor blood glucose levels when Palsonify treatment is initiated or when dosage is altered. Adjust antidiabetic treatment accordingly.

Cardiovascular Abnormalities: Cardiac conduction abnormalities and other ECG changes such as PR interval prolongation, bradycardia, sinus arrest, and atrioventricular block may occur in patients with acromegaly and were reported in Palsonify clinical trials. Dosage adjustments of concomitant drugs that have bradycardic effects may be necessary.

Thyroid Function Abnormalities: Somatostatin analogs may suppress the secretion of thyroid-stimulating hormone, which may result in hypothyroidism. Periodic assessment of thyroid function is recommended.

Steatorrhea and Malabsorption of Dietary Fats: Somatostatin analog treatment may result in malabsorption of dietary fats and subsequent symptoms of steatorrhea, loose stools, abdominal bloating, and weight loss. If new or worsening symptoms are reported with Palsonify, evaluate patients for potential pancreatic exocrine insufficiency and manage accordingly.

Vitamin B12 Deficiency: Vitamin B12 deficiency may occur. Monitor vitamin B12 levels, if clinically indicated.

ADVERSE REACTIONS:

Most common adverse reactions (>5%) are diarrhea, abdominal pain, nausea, decreased appetite, sinus bradycardia, hyperglycemia, palpitations, and gastroenteritis.

FDA Approves Palsonify (paltusotine) for the Treatment of Acromegaly in Adults

Daily Multivitamin May Protect Against Cognitive Decline in Older Adults

In continuation of my update on Vitamin and their importance 

A daily multivitamin may provide cognitive benefits for older adults, according to a study published online Sept. 14 in Alzheimer’s & Dementia.

Laura D. Baker, Ph.D., from the Wake Forest University School of Medicine in Winston-Salem, North Carolina, and colleagues assessed whether daily use of cocoa extract (containing 500 mg/day flavanols) versus placebo and a commercial multivitamin-mineral (MVM) versus placebo improved cognition in 2,262 older women and men (mean age, 73 years).

The researchers found that cocoa extract had no effect on global cognition. However, compared with placebo, daily MVM supplementation resulted in a statistically significant benefit on global cognition, with a more pronounced effect seen in participants with a history of cardiovascular disease. Benefits of MVM were also seen for memory and executive function. There were no significant interactions observed between cocoa extract and MVM for any of the cognitive composites.

"Our study showed that although cocoa extract did not affect cognition, daily multivitamin-mineral supplementation resulted in statistically significant cognitive improvement. This is the first evidence of cognitive benefit in a large longer-term study of multivitamin supplementation in older adults," Baker said in a statement. "It's too early to recommend daily multivitamin supplementation to prevent cognitive decline. While these preliminary findings are promising, additional research is needed in a larger and more diverse group of people."

Ref : Daily Multivitamin May Protect Against Cognitive Decline in Older Adults 

FDA Approves Inrebic (fedratinib) for the Treatment of Patients With Myelofibrosis

Celgene Corporation (NASDAQ: CELG)  announced the U.S. Food and Drug Administration (FDA) approval of  Inrebic (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.1

“The approval of Inrebic is another important milestone for Celgene and underscores our commitment to people living with blood cancers,” said Jay Backstrom, M.D., M.P.H., Chief Medical Officer for Celgene. “We are excited to provide Inrebic as a new treatment option that may be used in patients with myelofibrosis, including patients previously treated with ruxolitinib.”

“Myelofibrosis can cause patients to suffer in many ways, including experiencing debilitating symptoms,” said Ruben Mesa, M.D., FACP, Director of the Mays Cancer Center at UT Health San Antonio Cancer Center MD Anderson. “There has not been a new treatment approved for this disease in nearly a decade. With Inrebic, physicians and patients now have another option available for myelofibrosis.”

The Inrebic development program consisted of multiple studies (including JAKARTA and JAKARTA2) in 608 patients who received more than one dose (ranging from 30 mg to 800 mg),1 of whom 459 had myelofibrosis,1 including 97 previously treated with ruxolitinib.1 The JAKARTA study evaluated the efficacy and safety of once-daily oral doses of Inrebic compared with placebo in patients with intermediate-2 or high-risk, primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis who were previously untreated with a JAK inhibitor, had enlarged spleens (a condition known as splenomegaly), and had a platelet count of ≥50 x 109/L (median baseline platelet count was 214 x 109/L; 16% <100 x 109/L and 84% ≥100 x 109/L).1,2 In the JAKARTA study, spleen volume was reduced by 35% or greater, when assessed from baseline to the end of cycle 6 (week 24), with a 4-week follow-up scan, in 37% (35 of 96) of patients treated with INREBIC 400 mg versus 1% (1 of 96) of patients who received placebo (p<0.0001).1 INREBIC also improved the Total Symptom Score as measured by the modified Myelofibrosis Symptoms Assessment Form (MFSAF) v2.0 diary2 (night sweats, itching, abdominal discomfort, early satiety, pain under ribs on left side, bone or muscle pain) by 50% or greater when assessed from baseline to the end of cycle 6 in 40% of (36 of 89) patients treated with 400 mg, versus 9% (7 of 81) of patients who received placebo (p<0.0001).1

Inrebic has a Boxed Warning for serious and fatal encephalopathy, including Wernicke’s. Serious encephalopathy was reported in 1.3% (8 of 608) of patients treated with Inrebic in clinical trials and 0.16% (1 of 608) of the cases were fatal. Wernicke’s encephalopathy is a neurologic emergency resulting from thiamine (Vitamin B1) deficiency. Thiamine levels should be assessed in all patients prior to starting Inrebic, periodically during treatment, and as clinically indicated.1 Do not start Inrebic in patients with thiamine deficiency; replete thiamine prior to treatment initiation. If encephalopathy is suspected, immediately discontinue Inrebic and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize.

In the JAKARTA study, serious adverse reactions occurred in 21% of patients treated with Inrebic 400 mg once daily (n=96), with the most common (≥2%) being cardiac failure (5%) and anemia (2%).1 Fatal adverse reactions of cardiogenic shock occurred in 1% of patients.1 Permanent discontinuation due to an adverse reaction occurred in 14% of patients. The most frequent reasons for permanent discontinuation in ≥2% of patients receiving Inrebic included cardiac failure (3%), thrombocytopenia, myocardial ischemia, diarrhea, and increased blood creatinine (2% each).1

Dosage interruptions due to an adverse reaction during the randomized treatment period occurred in 21% of patients who received Inrebic. Adverse reactions requiring dosage interruption in >3% of patients who received Inrebic included diarrhea and nausea. Dosage reductions due to an adverse reaction during the randomized treatment period occurred in 19% of patients who received Inrebic. Adverse reactions requiring dosage reduction in >2% of patients who received Inrebic included anemia (6%), diarrhea (3%), vomiting (3%), and thrombocytopenia (2%).

“Inrebic is a much-welcomed new treatment for the myelofibrosis community,” said Ann Brazeau, Chief Executive Officer and Founder, MPN Advocacy and Education International. “This FDA approval marks an important milestone for people living with myelofibrosis as we embark on making greater strides in the diagnosis, understanding and treatment of this disease.”

https://pubchem.ncbi.nlm.nih.gov/compound/Fedratinib

https://en.wikipedia.org/wiki/Fedratinib

Is Green Tea a Fad or a Real Health Boost?

In continuation of my updates on Green tea

Green tea is a popular health trend, with many people sipping in hopes of deriving benefits from the brew.

There's nothing wrong with that, dietitians say -- green tea is a healthy drink loaded with antioxidants. But the jury's still out on many of its purported health benefits.

"Clinical trials related to green tea are still in their early stages," said Nancy Farrell Allen, a registered dietitian nutritionist in Fredericksburg, Va. "I say drink it, enjoy it. It's not going to hurt, and it might have worthy benefits to it. But nutrition is a science, and it takes time for our understanding to evolve."

Green tea's potential health benefits derive from catechins, which are powerful antioxidant compounds known as flavonoids, said Chelsey Schneider, clinical nutrition supervisor at Mount Sinai Beth Israel Cancer Center in New York City.

One catechin in particular, known as EGCG, is found at higher levels in green tea than in either white or black tea, she said.

"This compound can be even stronger than vitamin C and E, which are very, very strong antioxidants," Schneider said. Antioxidants help prevent damage to cells.

Green, black and white tea all come from the same plant, said Allen, who is a spokeswoman for the Academy of Dietetics and Nutrition.

Green tea is made from the leaves of the mature plant, while white tea is made of leaves plucked early in development. Black tea is made from green tea leaves that are laid out and covered with a damp cloth, she said.

"They dry and blacken and ferment a little, giving black tea that darker, richer flavor," Allen said. But this process also reduces levels of catechins in black tea.

Weight loss has been associated with green tea, with experts suggesting that its mixture of caffeine and catechins can enhance a person's metabolism and processing of fat, according to the University of California-Davis Department of Nutrition.

But it appears that folks have to drink a lot of green tea to get substantial weight loss benefits and carefully watch the rest of their diet, UC-Davis says.

Green tea also has been tied to heart health.

For example, green tea was shown to reduce "bad" LDL cholesterol in a 2018 study of more than 80,000 Chinese published in the Journal of the American Heart Association.

Evidence suggests catechins in green tea also could lower risk of heart attacks, help blood vessels relax and reduce inflammation, UC-Davis says.

Green tea even has been associated with a lower risk of some cancers.

The American Cancer Society says studies have linked green tea to a reduction in ovarian cancer risk. And UC-Davis said experimental models have shown that green tea might reduce risk of a variety of other cancers.

But a 2016 evidence review by the Cochrane Library concluded that there is "insufficient and conflicting evidence to give any firm recommendations regarding green tea consumption for cancer prevention."

Schneider said the research is limited. "Some small studies say green tea can maybe be preventative for certain cancers, like breast, ovarian, endometrial, pancreatic and oral cancers, but there aren't so many conclusive human trials that support that," she said.

Green tea also might help keep your brain younger. A 2014 study in the journal PLOS One found that Japanese who drank more green tea had significantly less decline in brain function, although researchers couldn't rule out the possibility that these folks might have other healthy habits that helped keep them mentally sharp.

One caveat with all of this research is that it tends to take place in Asian countries, where people drink much more green tea. There might be significant differences for Americans.

And the way you take your green tea could diminish any potential positive effects, Schneider added.

"A lot of people are adding processed white sugar to their green tea, which really makes something beautiful and healthy into something unhealthy," she said.

Adding milk or cream to your tea also might not be a good idea.

"There are some studies that say having milk in green tea can actually block the effects of you absorbing the antioxidant," Schneider said. "If it was me, I'd drink it straight up."

FDA Approves Sorilux for Adolescent Plaque Psoriasis

In continuation of my update on Sorilux(calcipotriene) 

 

Mayne Pharma Group Limited, announced that the US Food and Drug Administration (FDA) has approved Sorilux(calcipotriene) Foam, 0.005% in adolescents.

Sorilux is now approved for treating plaque psoriasis of the scalp and body in patients aged 12 years and older.

The FDA approved Sorilux in 2010 based on evidence from two 8-week placebo controlled clinical trials in patients with mild to moderate plaque psoriasis of the body and one 8-week placebo controlled clinical trial in patients with moderate plaque psoriasis of the scalp. Further data was obtained in a follow-on open label study in patients aged 12 to 17 years of age with psoriasis.

Sorilux Foam contains calcipotriene, a synthetic vitamin D analog that has a similar receptor binding affinity as natural vitamin D. The exact mechanism of action contributing to the clinical efficacy is unknown.

Psoriasis is a chronic disease of the immune system affecting approximately 7.5 million Americans each year[1]. The most common form, plaque psoriasis affects roughly 80 percent of people who have the condition.

Mayne Pharma's CEO, Mr Scott Richards, said "Sorilux is an elegant foam formulation that is marketed by Mayne Pharma's Specialty Brands sales team alongside recently launched LEXETTE™ (halobetasol propionate) Foam, a potent topical corticosteroid also used to treat plaque psoriasis in adult patients. Topical products are the mainstay of treatment for plaque psoriasis patients and the foam delivery platform has a well-established reputation with dermatologists due to ease of application and lack of greasiness and stickiness, especially in hair-bearing areas and under clothing."

Mayne Pharma directly markets more than 60 products in the US including four branded dermatology products FABIOR® (tazarotene) Foam, Sorilux Foam, DORYX® MPC (doxycycline hyclate) delayed-release tablets and LEXETTE Foam. The Company also markets TOLSURA® (SUBA®-itraconazole) capsules used to treat certain fungal infections which was recently approved and launched this year.

https://en.wikipedia.org/wiki/Calcipotriol

FDA Approves Onpattro (patisiran) Targeted RNA-based Therapy for Polyneuropathy Caused by hATTR

The U.S. Food and Drug Administration today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients. This is the first FDA-approved treatment for patients with polyneuropathy caused by hATTR, a rare, debilitating and often fatal genetic disease characterized by the buildup of abnormal amyloid protein in peripheral nerves, the heart and other organs. It is also the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

“This approval is part of a broader wave of advances that allow us to treat disease by actually targeting the root cause, enabling us to arrest or reverse a condition, rather than only being able to slow its progression or treat its symptoms. In this case, the effects of the disease cause a degeneration of the nerves, which can manifest in pain, weakness and loss of mobility,” said FDA Commissioner Scott Gottlieb, M.D. “New technologies like RNA inhibitors, that alter the genetic drivers of a disease, have the potential to transform medicine, so we can better confront and even cure debilitating illnesses. We’re committed to advancing scientific principles that enable the efficient development and review of safe, effective and groundbreaking treatments that have the potential to change patients’ lives.”

RNA acts as a messenger within the body’s cells, carrying instructions from DNA for controlling the synthesis of proteins. RNA interference is a process that occurs naturally within our cells to block how certain genes are expressed. Since its discovery in 1998, scientists have used RNA interference as a tool to investigate gene function and its involvement in health and disease. Researchers at the National Institutes of Health, for example, have used robotic technologies to introduce siRNAs into human cells to individually turn off nearly 22,000 genes.

This new class of drugs, called siRNAs, work by silencing a portion of RNA involved in causing the disease. More specifically, Onpattro encases the siRNA into a lipid nanoparticle to deliver the drug directly into the liver, in an infusion treatment, to alter or halt the production of disease-causing proteins.

Affecting about 50,000 people worldwide, hATTR is a rare condition. It is characterized by the buildup of abnormal deposits of protein fibers called amyloid in the body's organs and tissues, interfering with their normal functioning. These protein deposits most frequently occur in the peripheral nervous system, which can result in a loss of sensation, pain, or immobility in the arms, legs, hands and feet. Amyloid deposits can also affect the functioning of the heart, kidneys, eyes and gastrointestinal tract. Treatment options have generally focused on symptom management.

Onpattro is designed to interfere with RNA production of an abnormal form of the protein transthyretin (TTR). By preventing the production of TTR, the drug can help reduce the accumulation of amyloid deposits in peripheral nerves, improving symptoms and helping patients better manage the condition.

“There has been a long-standing need for a treatment for hereditary transthyretin-mediated amyloidosis polyneuropathy. This unique targeted therapy offers these patients an innovative treatment for their symptoms that directly affects the underlying basis of this disease,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

The efficacy of Onpattro was shown in a clinical trial involving 225 patients, 148 of whom were randomly assigned to receive an Onpattro infusion once every three weeks for 18 months, and 77 of whom were randomly assigned to receive a placebo infusion at the same frequency. The patients who received Onpattro had better outcomes on measures of polyneuropathy including muscle strength, sensation (pain, temperature, numbness), reflexes and autonomic symptoms (blood pressure, heart rate, digestion) compared to those receiving the placebo infusions. Onpattro-treated patients also scored better on assessments of walking, nutritional status and the ability to perform activities of daily living.

The most common adverse reactions reported by patients treated with Onpattro are infusion-related reactions including flushing, back pain, nausea, abdominal pain, dyspnea (difficulty breathing) and headache. All patients who participated in the clinical trials received premedication with a corticosteroid, acetaminophen, and antihistamines (H1 and H2 blockers) to reduce the occurrence of infusion-related reactions. Patients may also experience vision problems including dry eyes, blurred vision and eye floaters (vitreous floaters). Onpattro leads to a decrease in serum vitamin A levels, so patients should take a daily Vitamin A supplement at the recommended daily allowance.

The FDA granted this application Fast Track, Priority Review and Breakthrough Therapy designations. Onpattro also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

https://en.wikipedia.org/wiki/Patisiran

----------------------------------------------------------------------------------------

FDA Approves Onpattro (patisiran) Targeted RNA-based Therapy for Polyneuropathy Caused by hATTR

Compound prevents neurological damage, shows cognitive benefits in mouse model of Alzheimer’s disease

The supplement nicotinamide riboside (NR) – a form of vitamin B3 – prevented neurological damage and improved cognitive and physical function in a new mouse model of Alzheimer’s disease. The results of the study, conducted by researchers at the National Institute on Aging (NIA) part of the National Institutes of Health, suggest a potential new target for treating Alzheimer’s disease. The findings appear in the Feb. 5, 2018, issue of Proceedings of the National Academy of Sciences.

NR acts on the brain by normalizing levels of nicotinamide adenine dinucleotide (NAD+), a metabolite vital to cellular energy, stem cell self-renewal, resistance to neuronal stress and DNA repair. In Alzheimer’s disease, the brain’s usual DNA repair activity is impaired, leading to mitochondrial dysfunction, lower neuron production, and increased neuronal dysfunction and inflammation.

“The pursuit of interventions to prevent or delay Alzheimer’s and related dementias is an important national priority,” said Richard J. Hodes, M.D., director of the NIA. “We are encouraging the testing of a variety of new approaches, and this study’s positive results suggest one avenue to pursue further.”

The international team of scientists was led by Vilhelm A. Bohr, M.D., Ph.D., senior investigator and chief of the Laboratory of Molecular Gerontology of the NIA’s Intramural Research Program, with Dr. Yujun Hou, a postdoctoral investigator in the laboratory.

Based on their studies in human postmortem brain, they developed a new strain of mice mimicking major features of human Alzheimer’s such as tau pathology, failing synapses, neuronal death and cognitive impairment. Using this animal model, the researchers tested the effects of an NR supplement by adding it to the drinking water of the mice. Over a three-month period, researchers found that mice who received NR showed reduced tau in their brains, but no change in amyloid-beta.

The NR-treated mice also had less DNA damage, higher neuroplasticity (activity and reorganization of brain cells associated with learning or memory), increased production of new neurons from neuronal stem cells, and lower levels of neuronal damage and death. In the hippocampus area of the brain – in which damage and loss of volume is found in people with dementia – NR seemed to either clear existing DNA damage or prevent it from spreading further.

The NR-treated mice also performed better than control mice on multiple behavioral and memory tests, such as water mazes and object recognition. NR mice also showed better muscular and grip strength, higher endurance, and improved gait compared to their control counterparts. The research team believes that these physical and cognitive benefits are due to a rejuvenating effect NR had on stem cells in both muscle and brain tissue.

“We are encouraged by these findings that see an effect in this Alzheimer’s disease model,” said Dr. Bohr. “We are looking forward to further testing of how NR or similar compounds might be pursued for their possible therapeutic benefit for people with dementia.”

Next steps for the research team include further studies on the underlying mechanisms and preparations towards intervention in humans.

The team’s work also included contributions from researchers at the Danish Aging Research Center at the University of Aarhus, and the Center for Healthy Aging at the University of Copenhagen. The Bohr lab has a Cooperative Research and Development Agreement -- which allows NIH investigators to join colleagues from industry and academia to pursue common research goals -- with ChromaDex Corp.

Compound prevents neurological damage, shows cognitive benefits in mouse model of Alzheimer’s disease

High vitamin D levels may help prevent cancer

In continuation of my update on Vitamin D, 

The study reinforces the existing theory that vitamin D helps defend against certain cancers. Exposure to sunlight stimulates the production of vitamin D by our skin. Vitamin D contributes to calcium level maintenance in our bodies, which in turn helps teeth, muscles and bones remain healthy. Aside from established benefits of vitamin D on bone diseases, evidence continues to emerge that vitamin D could be effective for other cancers and chronic diseases.   

Yet more comprehensive research needs to be conducted, as to date, the majority of studies have been conducted throughout American and European populations, and more studies focusing on Asian populations are necessary.
It is vital to determine whether the effects are the same in non-Caucasian populations, since Vitamin D metabolism and concentrations differ dependant on ethnicity.
The study published by the BMJ was carried out to determine if vitamin D was linked to site specific and total cancer.

Data spanning nine public health centres across Japan was analysed, from 33,736 female and male participants between the ages of 40 and 69 years old.
Participants were required to disclose a comprehensive overview of their lifestyle, diet and medical history and have blood samples taken to assess their vitamin D levels. Factors such as seasons affected vitamin D levels; summer and autumn typically produced higher levels compared to spring or winter. Samples were then assigned to one of four groups, based on levels.

Researchers then monitored the study participants for a mean period of 16 years, during which 3,301 new cancer cases were registered.
Once multiple known cancer risk factors had been accounted for, including weight (BMI), physical activity, age, dietary factors, smoking and alcohol intake, researchers discovered that high levels of vitamin D  reduced the overall risk of cancer by 20% in both women and men.

Higher levels were linked to a 30-50% lower relative risk of liver cancer, and more so in men than women. No cancers exhibited a higher risk connected to high vitamin D levels, and there was no evidence of a link to prostate or lung cancer.
Adjustments were made for dietary and other factors to confirm the strength of the findings, but this did little to affect the results. One limitation of the study was an insufficient number of organ specific cancers. In addition, even with the risk factor adjustments, there is no absolute certainty that the results were skewed by unidentified factors.  For this reason, no concrete conclusions about cause and effect can be asserted.

The large sample size for overall cancer, large number of blood samples tested and the extensive follow up period were vital strengths of the study. The result reinforce the theory that vitamin D has a role in defending against the risk of cancer, but the authors emphasize that vitamin D may carry additional health benefits too, that were not measured in this study.  

Further studies are needed to clarify the optimal concentrations (of vitamin D) for cancer prevention."

Further studies are needed to clarify the optimal concentrations (of vitamin D) for cancer prevention."

Ref : https://www.eurekalert.org/pub_releases/2018-03/b-hvd030618.php

High vitamin D levels may help prevent cancer

FDA Approves Ascor (Ascorbic Acid Injection, USP) for the Treatment of Scurvy

McGuff Pharmaceuticals, Inc., a wholly owned subsidiary of McGuffCompany, Inc. announces the United States Food and Drug Administration’s New Drug Approval (NDA) of Ascor (Ascorbic Acid Injection, USP). Ascor is provided in a 50 mL vial labeled as a Pharmacy Bulk Package with a strength of 500mg/mL.

Ascor is vitamin C indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated.

Ascor is the first single moiety ascorbic acid drug approved for the US market and is the result of a multi-year development effort.

Ronald McGuff, CEO said "The FDA approval of Ascor Ascorbic Acid
Injection USP will allow McGuff Pharmaceuticals, Inc. to deliver this
medically necessary drug to US hospitals and pharmacies to improve
patient health. In addition, McGuff Pharmaceuticals, Inc. currently
holds Ascorbic Acid Injection USP approvals in multiple other
countries."

Walnuts could be key to happier state-of-mind in young healthy men

In continuation of my update on walnuts

College can be a stressful time for young adults as they figure out how to manage intense daily routines that include work, study and play. Eat well, exercise and get plenty of sleep is a familiar mantra to alleviate this stress, but now with the results of his latest study, UNM Nutrition Professor Peter Pribis is able to tell college students that walnuts could be a key to a happier state-of-mind. 

In this first intervention study in humans, Pribis measured the effect of walnut consumption on mood.

"In the past, studies on walnuts have shown beneficial effects on many health outcomes like heart disease, diabetes and obesity," said Pribis. "Our study was different because we focused on cognition, and in this controlled randomized trial (CRT) we measured mood outcomes in males and females."

The participants of the study were 64 students between the ages of 18-25. They represented most ethnic groups: Caucasian, African American, Hispanic and Asian.

The participants were asked to eat three slices of banana bread every day for sixteen weeks--eight weeks of banana bread with walnuts and eight weeks of banana bread without walnuts. The nuts were finely ground into the dough so the two banana breads were similar in taste and appearance. While eating banana bread with walnuts the participants consumed half a cup of walnuts daily.

The mood of the students was measured at the end of each eight-week period.

"We used a validated questionnaire called Profiles of Mood States (POMS)," says Pribis. "It is one of the most widely used and accepted mood scales in studies on cognition. The test has six mood domains: tension, depression, anger, fatigue, vigor, confusion and also provides a Total Mood Disturbance score (TMD). The lower the TMD score the better the mood."

In this double-blind, randomized, placebo controlled, cross-over feeding trial with walnuts for eight weeks, Pribis observed a significant improvement in mood in young, healthy males.

"There was a meaningful, 28 percent improvement of mood in young men," said Pribis. "However we did not observe any improvement of mood in females. Why this is we do not know."

There are several nutrients in walnuts that could be responsible for the improved mood like alpha-Linolenic acid, vitamin E, folate, polyphenols or melatonin. However, this was a whole food study, so in the end it was the synergy and interaction of all the nutrients in the walnuts combined.

For Pribis, the lesson learned from this food study is clear, "Eat more walnuts. This is an easy intervention. They're not only good for your mood, but overall health as well. The recommended amount is one handful per day."

With this knowledge in hand--and hopefully walnuts in the other--young men can happily tackle life's daily stress.

Ref: http://news.unm.edu/news/the-key-to-a-better-mood-for-young-men-is-a-nut




Read more at ..

Folinic acid treatment could help improve language and communication skills of children with ASD

In continuation of my update on Folinic acid

Prescription doses of folinic acid, which is a reduced form of a B vitamin known as folate, could help improve the language and communication skills of children with autism spectrum disorder (ASD). These are the preliminary findings from a placebo-controlled trial in which children were randomized to receive either high-dose folinic acid or a placebo, says lead author Richard Frye of Arkansas Children's Research Institute in the US. The study, which is published in Springer Nature's journal Molecular Psychiatry, also identified a specific blood marker that can be used to predict which patients have the best chance to respond to the treatment.

Up to two percent of American children are said to experience symptoms that place them on the autism spectrum. Many of these children have difficulty communicating and interacting with others, especially within a social setting. Researchers do not yet fully understand all the reasons behind the development of ASD and, importantly, there are currently no approved treatments that address the core symptoms of this disorder.

"The only currently approved medications for autism are both antipsychotic medications that address non-core symptoms and can lead to unwanted side effects," says John Slattery, a co-author of the study.

Scientific research has linked this disorder to abnormalities in the metabolism of folate as well as genes that are involved in folate metabolism. Certain studies have also shown that the offspring of women who took folate supplements before conception and during pregnancy had a lower risk of having a child with ASD.

About ten years ago a condition, known as cerebral folate deficiency (CFD), was described in which the concentration of folate is below normal in the central nervous system but not in the blood. Many children with CFD had ASD symptoms and responded well to treatment with high-dose folinic acid.

Previously Frye's team could show that folate receptor autoantibodies were found with a high prevalence in children with ASD. In the current study, these researchers found that participants with folate receptor autoantibodies had a more favourable response to the folinic acid treatment. This leads the way to a test that might be useful for clinicians to determine if high-dose folinic acid might be a treatment for a particular child with ASD. The deleterious effects of folate receptor antibodies on brain development and function are now confirmed in a laboratory rat model.

"Improvement in verbal communication was significantly greater in participants receiving folinic acid as compared with those receiving the placebo," says Frye. He adds that the findings should be considered preliminary until the treatment has been assessed further in larger long-term studies.

The researchers indicated they were very pleased with the positive findings of this study, but caution that more research is needed in order to replicate the findings in a larger population.

Animal studies examine role of raspberry products in weight management and motor function

 

The latest issue of the Journal of Berry Research includes two new animal studies that investigate the effects of raspberry consumption in helping to support healthy weight and motor function (strength, balance and coordination). Future studies are needed to support the results found in these studies.

One-cup of frozen red raspberries has only 80 calories, is an excellent source of vitamin C, and provides nine grams of fiber (more fiber than any other berry). Like most berries, raspberries are a low-glycemic index food. Raspberries contain phytochemicals, such as ellagic acid, quercetin, gallic acid, cyanidins, pelargonidins, catechins, kaempferol and salicylic acid.

Animal and cellular studies examining how phytochemicals may work at the molecular level suggest that certain phytochemicals may help slow age-related declines. Age is the number one risk factor for many chronic diseases. Likewise, obesity is a major risk factor for chronic disease. These latest animal studies examine two important areas of health where raspberry products may play a role in weight management and also support motor function.

OBESITY

An animal study conducted by researchers at Oregon State University found that when added to a high-fat, high-sucrose diet, raspberry products and raspberry phytochemicals were found to significantly decrease weight gain associated with a high-fat, high calorie diet. Raspberry juice and raspberry puree concentrates were provided at 10% of total energy (the equivalent of 200 calories in a 2,000 calorie diet), and a combination of ellagic acid and raspberry ketone were provided at 0.2% weight/weight.

In the study, 76 male mice were divided into the following diets: a low-fat control group (10% calories from fat), a high-fat control group (45% calories from fat) and seven "high-fat treatment" groups that included a high-fat diet plus either raspberry juice concentrate, raspberry puree concentrate, raspberry fruit powder, raspberry seed extract, raspberry ketone and a combination of equal parts of ellagic acid and raspberry ketone.

"The addition of raspberry juice concentrate, raspberry puree concentrate and the combination of ellagic acid plus raspberry ketones to the high fat diet significantly reduced weight gain observed in the high-fat fed mice," said Dr. Neil Shay, Principal Investigator. "In the case of the high-fat and raspberry juice concentrate diet, weight gain was reduced to a level that was statistically equivalent to the weight gain of the low-fat fed mice, despite the fact that all high-fat fed groups consumed the same amount of calories and more energy than the low-fat control group throughout the study."

The researchers concluded that the intake of a reasonable level of some raspberry food products may influence some of the metabolic consequences of consuming a high-fat, high-calorie diet in the development of obesity in male mice.

"We hope that the findings from this study can help guide the design of future clinical trials," said Dr. Shay.

MOTOR FUNCTION

Researchers from the Human Nutrition Research Center on Aging at Tufts University evaluated the effectiveness of a red raspberry-supplemented diet on age-sensitive measures of learning, memory and motor performance in older rats.

In this 10-week study, red raspberry supplementation was found to significantly improve motor skills. Specifically, compared to rats fed a standard well-balanced diet, rats fed a diet supplemented with freeze-dried raspberry extract performed better on tests which measured psychomotor coordination and balance, as well as tests that measure muscle tone, strength, and stamina.

"These results may have important implications for healthy aging," said lead researcher Barbara Shukitt-Hale, PhD. "While further research in humans is necessary, animal model studies are helpful in identifying deficits associated with normal aging."