In the News
Altin Biosciences announces US patent approval for its non-hormonal, oral botanical uterine fibroid drug candidate.
Kyowa Hakko Presents New Findings on Cognizin® Citicoline at ILSI Europe's 5th Symposium on Nutrition for the Ageing Brain
New Study Examining Blood Levels of Omega-6 in Thousands of Subjects Concludes that it Does Not Raise Inflammatory Markers
CBD Might Help Children with Autism, but More Research Needed
Loma Linda University Health study shows vegetarian diets have reduced risk of medium-frequency cancers
Altin Biosciences announces US patent approval for its non-hormonal, oral botanical uterine fibroid drug candidate.
Founder and CEO, Sue McKinney, states, “Altin's fibroid candidate meets the stated ideal for patients and doctors: easy to take, easy to tolerate, preserves fertility, and no hormones. Beyond symptomatic management, we aim to reduce or eliminate the tumors themselves. Altin’s plant-based formula, being developed under the FDA Botanical Drug Guidance, positions Altin for licensing agreements and partnership development for this novel approach to fibroid treatment. We’re pursuing FDA fast track status to meet this urgent need.”
Pre-clinical studies utilizing the combination of natural compounds Crinum latifolium L var. crilae Tram & Khanh (Crila®) and epigallocatechin gallate (EGCG) showed apoptosis (cell death) and synergistic anti-proliferative (suppression of cell growth) effects on human fibroid cells.
Ayman Al Hendy Al-Hendy, M.D., Ph.D., Chair of Altin Biosciences’ Medical Advisory Board, and Vice Chair for Research, Department of Obstetrics and Gynecology at University of Chicago, states: “Altin's drug candidate is a significant advancement to offer fibroid patients non-hormonal treatment options that go beyond merely addressing symptoms, offering a paradigm shift in fibroid treatment. Our study shows these natural compounds may provide a safe and cost-effective alternative to current hormonal fibroid therapies."
“Naturally occurring plant-based chemicals, like the potential drug candidate from Altin Biosciences, Crila + EGCG, is a promising drug candidate for evaluation through clinical trials for its safety and efficacy in treating gynecological conditions like uterine fibroids. Fibroids cause significant negative impact on the quality of life of women suffering from them. An effective non-hormonal intervention that reduces the fibroid size and associated symptoms would potentially alter fibroid management for millions of women in a positive manner.” Bhuchitra Singh, MD, MPH, MS, MBA Singh, MD, MPH. Altin’s Chief Medical Officer and Director of Clinical Research, Department of Gynecology and Obstetrics, Division of Reproductive Sciences and Women’s Health Research, Johns Hopkins University School of Medicine.
Uterine fibroids impact up to 80% of women, disproportionately impacting women of color.[1] These non-cancerous tumors cause debilitating symptoms and increase the risk of infertility, preterm delivery, post-partum hemorrhage, and anemia. Each year in the US alone, 300,000 elective hysterectomies are due to fibroids.[2] The direct and indirect annual costs associated with fibroids in the United States are $42.2 billion.[3]
Altin’s lead drug candidate, backed by 30 years of research, seeks to reduce reliance on hysterectomy and revolutionize the treatment of uterine fibroids, menopause, endometriosis and prostate conditions.
Kyowa Hakko Presents New Findings on Cognizin® Citicoline at ILSI Europe's 5th Symposium on Nutrition for the Ageing Brain
Kyowa Hakko Bio Co., Ltd., a global leader in health ingredients innovation, proudly participated in the 5th Symposium on Nutrition for the Ageing Brain hosted by ILSI Europe. This premier event gathered international experts to explore the latest science behind how diet and nutrients influence cognitive health and aging.
"Cognizin® represents a science-driven solution to support brain health at any age," said Nakazaki. "Our findings reinforce the value of Cognizin® as a nutritional intervention that aligns with the goals of healthy cognitive aging."
During the symposium, Kyowa Hakko presented a scientific session titled "Unlocking Brain Health: Evaluating the Role of Cognizin® Citicoline in Cognitive Function." The presentation spotlighted the extensive clinical research behind Cognizin®, a patented, branded form of citicoline, and its benefits in supporting brain health across age groups, particularly in aging populations.
The presentation, led by Danielle Citrolo, PharmD, Vice President of Scientific & Regulatory Affairs at Kyowa Hakko USA, and Eri Nakazaki, PhD, Manager in the Health Science Department at Kirin Holdings, reviewed key outcomes from randomized controlled trials, neuroimaging studies, and behavioral assessments. A new study presented at ILSI Europe provided confirmatory evidence of Cognizin® Citicoline's effectiveness in supporting attention and focus in healthy middle-aged adults. Specifically, the findings demonstrated improvements in:
· Sustained reaction time
· Sustained cognitive performance, including alertness, processing speed, and cognitive stamina
· Rapid Visual Information Processing (RVIP) reaction time
Citrolo's session also provided insights into citicoline's mechanisms of action, including its role in phospholipid metabolism, neurotransmitter synthesis, and mitochondrial function, all essential for optimal brain performance.
"Cognizin® is backed by decades of clinical and preclinical research," said Citrolo. "We're proud to share our latest findings with the global scientific community and continue contributing to the evidence base for nutrition and cognitive health."
Nakazaki also presented a scientific poster further detailing new clinical findings demonstrating the effectiveness of Cognizin® in supporting sustained attention and information processing in healthy middle-aged adults — key cognitive functions that are clinically relevant for maintaining cognitive health and brain resilience across the lifespan.
"Cognizin® represents a science-driven solution to support brain health at any age," said Nakazaki. "Our findings reinforce the value of Cognizin® as a nutritional intervention that aligns with the goals of healthy cognitive aging. Through both our oral presentation and poster, we aimed to demonstrate how Cognizin® contributes meaningfully to the broader conversation on nutrition for the aging brain."
Kyowa Hakko will also be participating at IFT FIRST in Chicago July 13-16. Attendees interested in learning more about the latest science behind Cognizin® can visit booth #S3037 to speak with members of the team. The Kyowa Hakko booth will also feature its branded glutathione ingredient, Setria®, which has been shown to increase glutathione levels in the blood to support detoxification, immune health, respiratory health, and skin health. As the top-selling, clinically studied form of branded glutathione, Setria® is used in more than 100 commercially available products globally.
At Naturaltech in São Paulo, Brazil, earlier this month, Puravida's Glutationa featuring Setria® received a third-place Food, Beverage, and Supplements Award as a natural and healthy product that best aligns with trends in innovation among 500 products that participated.
About the Speakers
Danielle Citrolo, PharmD, brings nearly 13 years of experience in regulatory affairs and clinical development in the nutraceuticals industry. Based in New York, she guides Kyowa's scientific communication and regulatory compliance strategies across the Americas.
Eri Nakazaki, with a Ph.D. in nutritional neuroscience, has led groundbreaking research on citicoline's neurological benefits and now works to expand the impact of Cognizin® globally through both science and innovation.
About Kyowa Hakko Bio CO., LTD. (Kyowa Hakko Bio)
Kyowa Hakko Bio CO., LTD. is a subsidiary of Kirin Holdings Company, Limited, and a leading company in the research, development, and production of innovative bioactive ingredients. With a strong commitment to scientific excellence and customer satisfaction, Kyowa Hakko Bio specializes in the development and production of amino acids, nucleic acids, and fermentation-derived ingredients, including human milk oligosaccharides. The company's mission is to contribute to the well-being of people around the world by providing high-quality, safe, and effective ingredients for various industries, including healthcare, pharmaceuticals, food, and cosmetics. We strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances of life sciences and technologies. For more information, visit http://www.kyowahakko-bio.co.jp/english/.
About Kyowa Hakko USA (Kyowa)
Kyowa Hakko USA is a subsidiary of Kyowa Hakko Bio Co., Ltd., a global biotechnology company with over 75 years of expertise in fermentation, purification, and modification of bioactive substances. Kyowa Hakko Bio is dedicated to improving the health and well-being of people worldwide by creating innovative solutions with science and nature. With cutting-edge research capabilities, Kyowa Hakko Bio is committed to developing unique ingredients supported by scientific evidence. For more information, visit kyowa-usa.com.
About Cognizin® Citicoline
Cognizin® Citicoline, manufactured by Kyowa Hakko Bio Co., Ltd., is a clinically studied and branded form of citicoline, a natural substance made endogenously in the body and especially vital to brain health. Citicoline is a potent brain-health nutrient. A proprietary form of citicoline, Cognizin® has been clinically studied to support mental energy, focus, and attention. Cognizin® is manufactured through a fermentation process to yield high quality and high purity. Cognizin® is also highly stable, GRAS, ultra-pure, and allergen-free. Cognizin® can be sold as a dietary ingredient for supplements, foods, and beverages in the United States and is approved as a novel food ingredient in the EU for food supplements. For more information on Cognizin®, visit Cognizin.com.
About Setria® Glutathione
Setria® Glutathione, manufactured by Kyowa Hakko Bio Co., Ltd., is a clinically studied and innovative form of glutathione that, when taken orally, has been shown to replenish the body's reserves, which may be depleted because of poor lifestyle choices, stress, or natural aging. Called the "standout antioxidant," glutathione helps protect cells in the body from the damaging effects of oxidative stress and toxins. Setria® Glutathione is manufactured through an innovative fermentation process to yield high purity and high quality, is vegetarian, GRAS, and allergen-free. For more information, visit setriaglutathione.com.
*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
New Study Examining Blood Levels of Omega-6 in Thousands of Subjects Concludes that it Does Not Raise Inflammatory Markers
A new study published in Nutrients offers new insight into omega-6 and whether it is truly the proinflammatory fatty acid many claim it to be.
There is currently a heightened interest in the health effects of seed oils, many of which are rich in linoleic acid (LA), an essential omega-6 fatty acid. Many have claimed that western diets contain “too much” LA and that many diseases of modernity stem from the increased intake of LA over the last century.
This narrative places the blame on excess inflammation presumably caused by higher LA intakes. But are higher intakes – and therefore higher blood levels – really linked with increased inflammation? That was the primary question this new study addressed.
Investigators relied on data from the Framingham Offspring Study, a well-known research cohort from the Boston area. The Framingham Offspring Study is a landmark longitudinal research initiative that follows the children of participants in the original Framingham Heart Study to investigate genetic and lifestyle factors influencing cardiovascular and metabolic health. Launched in 1971, it has provided decades of valuable insights into chronic disease risk and prevention. The cohort’s rigor and continuity make it one of the most trusted sources for understanding long-term health trajectories.
This was a cross-sectional study, meaning that the LA and arachidonic acid (AA) levels were measured in the same blood samples as the 10 inflammation-related biomarkers in 2700 individuals. The relationships between the levels of these two omega-6 fatty acids and 10 separate blood/urine biomarkers of inflammation and oxidative stress were statistically evaluated.
After adjusting (controlling statistically) for multiple other potentially confounding factors (age, race, sex, smoking, blood lipid levels, blood pressure, body weight, etc.), the researchers found that higher LA levels were associated with statistically significantly lower levels of five of the 10 biomarkers, and in no case was higher LA related to higher levels of any biomarker. For AA, higher levels were linked with lower concentrations of four markers, and, like LA, there were no statistically significant associations with higher levels of inflammation/oxidation.
“These new data show clearly that people who have the highest levels of LA (and AA) in their blood are in a less inflammatory state than people with lower levels. This finding is exactly the opposite of what one would expect if omega-6 fatty acids were ‘proinflammatory’ – in fact, they appear to be anti-inflammatory,” explained study investigator William S. Harris, PhD; President Fatty Acid Research Institute; Founder, OmegaQuant Analytics, LLC; and Professor, Department of Internal Medicine, Sanford School of Medicine, University of South Dakota, Sioux Falls, SD.
“In the flurry of news stories about the harms of seed oils – the primary sources of LA in the diet – many voices are calling for reducing Americans’ intakes of LA. This is not a science-based recommendation, and this study – in addition to many more – point in precisely the opposite direction: instead of lowering LA intakes, raising intakes appears to be a healthier recommendation,” Dr. Harris continued. “These findings contradict a narrative, not previous research findings. There are many studies in the medical literature that are consistent with our findings here.”
CBD Might Help Children with Autism, but More Research Needed
In the first controlled clinical trial of CBD in boys with autism, two-thirds of participants showed behavioral improvements with treatment, but there was also a significant placebo effect.
Researchers at the Center for Medicinal Cannabis Research at University of California San Diego School of Medicine have found that cannabidiol (CBD), a non-intoxicating compound found in cannabis, could help reduce problematic behaviors in autistic boys. The results provide valuable insights into the potential benefits and limitations of CBD as a therapeutic intervention for autism.
Autism spectrum disorder is a complex neurodevelopmental condition characterized by social communication difficulties, repetitive behaviors and restricted interests. In more severe cases, these behaviors can also include self-injury or aggression. While existing treatments can help manage these symptoms, there is a pressing need for effective and safe interventions to address the diverse needs of autistic individuals.
Some prior studies have suggested that CBD could help reduce problematic behaviors in children with autism. However, no controlled clinical trials have addressed safety, tolerability and efficacy of this treatment approach until now.
In the trial, autistic boys with severe behavior problems aged 7–14 years were split into two groups. One received eight weeks of daily CBD then eight weeks of placebo, separated by a four-week “washout” period in which no treatment was given. The other group received placebo first, then CBD. Behavioral assessments were completed before and after each treatment phase. A total of 30 participants completed the trial.
The researchers found:
· CBD was safe and well-tolerated in boys with severe autism and behavioral problems – participants were able to take the drug without difficulty and there were no serious adverse events.
· While no significant differences were found between CBD and placebo on broad measures of behavior, clinician impressions suggested that approximately two-thirds of participants showed evidence of clinical improvement with CBD.
· Reductions in aggressive behaviors and hyperactivity were observed most frequently by clinicians, with improvements in communication seen in almost 30% of participants.
· While both groups showed improvements during the study, demonstrating a strong placebo effect, the CBD group generally showed greater improvement than the placebo group.
The study's findings suggest that while CBD may have some benefits in reducing problematic behaviors in autistic children, its effectiveness is not universally established, and more research is needed to fully understand its therapeutic potential. The study's results also underscore the importance of rigorous, controlled trials in evaluating the efficacy of novel treatments for autism.
The study, published in the Journal of Autism and Developmental Disorders, was led by UC San Diego School of Medicine distinguished professors Doris Trauner, M.D., in the Departments of Neurosciences and Pediatrics, and Igor Grant, M.D., in the Department of Psychiatry.
Loma Linda University Health study shows vegetarian diets have reduced risk of medium-frequency cancers
A longitudinal study of various vegetarian diets shows a 12% overall reduced risk of all cancers and strong support for the finding in less-studied, medium-frequency cancers, such as stomach and lymphomas.
This is all relatively unique information and possibly the most robust that's out there concerning cancers such as stomach and lymphoma.
Lead author Gary Fraser, MBCHB, PhD, said this is the first study with strong information and sufficient precision to report on the association between various vegetarian diets and risk of some less common cancers.
Researchers found that a vegetarian diet was associated with even greater risk reduction of stomach cancer, as high as 45%, as well as lymphomas by 25%.
Fraser said the study also offered solid evidence confirming previous studies that vegans have lower risks of the common breast and prostate cancers (by about 25%). Further, vegetarian diets overall also offer major risk reduction of colorectal, and stomach cancers, and this report adds new evidence about their lower risk of lymphomas The risk of colorectal cancer was reduced by approximately 20% with a vegetarian diet, he said.
"This is all relatively unique information and possibly the most robust that's out there concerning cancers such as stomach and lymphoma," Fraser said. "It may also be pointing the finger at several other cancers — such as lung, ovary, and pancreas — where the evidence from this study was suggestive of lower risk in vegetarians, but did not quite reach the necessary standard to say more."
Fraser said other cancers, such as uterine, myeloma, myeloid leukemias, or those of the nervous system, gave no hint of protection from diet.
The study, "Longitudinal Associations Between Vegetarian Dietary Habits and Site-Specific Cancers in the Adventist Health Study-2 North American Cohort" was published this month in the American Journal of Clinical Nutrition.
The study, conducted by Loma Linda University Department of Research Affairs, examined data from tens of thousands of Seventh-day Adventists vegetarians and non-vegetarians. Researchers used data from the Adventist Health Study-2, a cohort of nearly 96,000 people who identify as Seventh-day Adventist and lived in the United States and Canada during the study's baseline recruitment between 2002 and 2007, with follow-up through 2015. Researchers used data from nearly 80,000 people from the study, about half of whom were vegetarian, Fraser said.
The study was funded by Loma Linda University. Funding to establish the original cohort and its data, was provided by the National Cancer Institute and Britain's World Cancer Research Fund.
That original cohort has been the subject of more than 200 published studies on diet, health, disease, and mortality, Fraser said.
Researchers noted that the study involved comparing vegetarian Adventists to non-vegetarian Adventists, which could indicate the findings would be even more substantial when compared to the general population.
Fraser said previous studies, comparing this population to that from a U.S. census general population suggest that non-vegetarian Adventists have about a 25% risk reduction of all cancers when compared to the general population and that vegetarian Adventists have about a 35% reduction.
"Many of those non-vegetarian Adventist people in this study were still very health-conscious people, so in some ways, it's amazing that we found anything at all," Fraser said.
While the new study found overall increased benefits for vegans compared to other vegetarian diets, one exception was that a pescatarian diet was found to have less risk of colorectal cancers compared to other vegetarian diets.