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Blue California completes groundbreaking human clinical trial on ErgoActive® ergothioneine intervention for cognitive function, memory, and sleep

Rancho Santa Margarita, Calif., Feb. 05, 2024 (GLOBE NEWSWIRE) — Blue California, an industry leader in science–driven ingredient development, announced the successful completion of a groundbreaking human clinical trial of ergothioneine. A double–blinded placebo–controlled clinical trial sponsored by Blue California has shown that ErgoActive® ergothioneine supports aspects of cognitive function, memory, and sleep in healthy elderly subjects with subjective memory complaints.

“Blue California is proud to have sponsored such an important human study,” said Linda May–Zhang, Ph.D., VP of Science and Innovation at Blue California. “We are pleased by the results showing improvements of cognitive function and ability to get to sleep in subjects consuming ErgoActive for four months.”

Research has suggested that inadequate levels of ergothioneine are associated with a range of health problems, including cardiovascular disease, frailty, age–related cognitive decline, neurodegenerative diseases such as Parkinson’s disease, and dementias such as Alzheimer’s disease. Mushroom consumption and estimated dietary ergothioneine intake have previously been associated with reduced risk of cognitive decline and potentially longer lifespan.

Despite decades of preclinical research, association studies, and clinical studies conducted with mushrooms, it remained untested whether supplementation with pure ergothioneine can improve cognitive outcomes. Rigorous clinical studies were lacking. Today, Blue California has made a substantial advancement by sponsoring a double–blinded, placebo–controlled clinical study conducted at a national research institution.

Sharing his insights, Robert B. Beelman, Ph.D., Professor Emeritus of Food Science and Director of the Center for Plant and Mushroom Foods for Health at Pennsylvania State University, stated, “The results of this study provide important clinical evidence supporting the idea that ergothioneine is a ‘longevity vitamin’ that can help mitigate cognitive decline and sleep issues commonly associated with aging.”

Blue California is a proud gold sponsor for the National University of Singapore’s Center of Healthy Longevity global conference on Supplements for Healthy Longevity, held Feb. 29 – Mar. 2, 2024.

ErgoActive ergothioneine is made by precision fermentation with FDA–reviewed safety of GRAS. This ingredient is easy to formulate for dietary supplements, functional food and beverages, pet supplements, and cosmetics.

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About Blue California Ingredients

Blue California is a science–driven, nature–inspired ingredient company dedicated to developing innovative solutions for health and well–being. We provide and manufacture clean, natural, and sustainable ingredients used in food, beverage, flavor, fragrance, dietary supplements, personal care, and cosmetic products.

With a commitment to rigorous scientific research, the company aims to address pressing concerns related to aging and healthspan.  For more information, visit https://bluecal–ingredients.com/ergothioneine.

ErgoActive® is a registered trademark of Blue California, Inc.

Ergothioneine is also referred to as L–Ergothioneine, (ET) and (ERG).

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GLOBENEWSWIRE (Distribution ID 9031565)

Entera Bio Reports Key Milestone Relating to Oral PTH (1-34) Peptide (EB613) Phase 3 Program: ASBMR-SABRE Has Submitted to FDA the Full Qualification Plan to Approve BMD as a Surrogate Endpoint for Osteoporosis

JERUSALEM, Nov. 09, 2023 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, reports today that the American Society for Bone and Mineral Research (ASBMR) has announced that the SABRE (Strategy to Advance BMD as a Regulatory Endpoint) project team has submitted to the U.S. Food and Drug Administration (FDA) its full qualification plan to use the treatment–related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti–osteoporosis drugs.

BMD is the first surrogate endpoint undergoing qualification by the FDA under the 21st Century Cures Act which was signed into law on December 13, 2016, to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

"This submission is critical to the future of osteoporosis drug innovation which has been hampered by ethical and cost constraints associated with fracture outcome studies. We would like to sincerely acknowledge and thank the ASBMR–FNIH–SABRE team for its significant contributions and for furthering this key initiative with the FDA," said Miranda Toledano, Chief Executive Officer of Entera. "The last 15 months have been intense for Entera from a regulatory standpoint, and we believe EB613 stands as the first program to potentially avail itself of the ASBMR–SABRE BMD endpoint. We have powered our proposed phase 3 study using the published SABRE quantitative thresholds which statistically correlate to reductions in vertebral, non–vertebral and all site fracture risk. Much like biomarkers and validated surrogates that are routinely used across oncology, cardiovascular and metabolic disorders, we look forward to FDA's potential qualification of BMD for osteoporosis and to promptly advancing EB613 forward using this more ethical approach," said Ms. Toledano.

EB613 (oral PTH (1–34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for osteoporosis. In a phase 2, 6–month, 161–patient, placebo–controlled study EB613 produced rapid dose–proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BMD in postmenopausal women with low mass or osteoporosis and no prior fracture. In October 2022, following a Type C meeting, Entera announced FDA's concurrence that a 2–year, placebo–controlled phase 3 (registrational) study with Total Hip BMD as primary endpoint could support an NDA for EB613.

About ASBMR–FNIH SABREi

Initiated in 2013, the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium Bone Quality Project assembled data from more than 150,000 participants across more than 50 clinical trials of anti–osteoporosis drugs. The project team re–evaluated these existing data to understand which measurements could predict the ability of the treatment to reduce fractures. The study findings identified an increase in bone mineral density, as measured by a low–dose X–ray imaging technique, as a strong predictor of the extent to which treatments reduce fracture risk. A change in bone mineral density could therefore be used in future clinical trials to determine the effectiveness of osteoporosis drugs. Through a partnership with ASBMR, the FNIH extended and continues to support the original study, renamed SABRE, to seek FDA approval for the surrogate biomarker.

About the Cures Act

The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

The law builds on FDA's ongoing work to incorporate the perspectives of patients into the development of drugs, biological products, and devices in FDA's decision–making process. Cures enhances our ability to modernize clinical trial designs, including the use of real–world evidence, and clinical outcome assessments, which will speed the development and review of novel medical products, including medical countermeasures.

It also provides new authority to help FDA improve our ability to recruit and retain scientific, technical, and professional experts and it establishes new expedited product development programs.

About Entera Bio

Entera focuses on significant unmet medical needs where an oral tablet form of a peptide treatment or protein replacement therapy holds the potential to transform the standard of care. The Company's oral PTH (1–34) teriparatide mini tablets have been administered to a total of 240 subjects (153 patients) across Phase 1 and Phase 2 studies, with demonstrated bioavailability and clinical benefit across two distinct diseases. The Company's most advanced product candidate, EB613 (oral PTH (1–34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613. EB612 is being developed as the first tablet peptide replacement therapy for the treatment of hypoparathyroidism. The Company is currently conducting a phase 1 PK study of novel PTH formulations using its proprietary, next generation oral delivery platform with data expected in the second half of 2023. Entera is also developing oral GLP–2 peptide as an injection–free alternative for patients suffering from short bowel syndrome and other severe intestinal and malabsorption metabolic conditions and oral Oxyntomodulin (GLP1/glucagon) peptide for obesity in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are "forward–looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera's forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA's interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera's product candidates; Entera's reliance on third parties to conduct its clinical trials; Entera's expectations regarding licensing, business transactions and strategic collaborations; Entera's operation as a development stage company with limited operating history; Entera's ability to continue as a going concern absent access to sources of liquidity; Entera's ability to obtain and maintain regulatory approval for any of its product candidates; Entera's ability to comply with Nasdaq's minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera's intellectual property position and its ability to protect its intellectual property; and other factors that are described in the "Cautionary Statements Regarding Forward–Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Entera's most recent Annual Report on Form 10–K filed with the SEC, as well as the company's subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

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i https://www.asbmr.org/about/news–release–detail/asbmr–sabre–team–submits–full–qualification–plan–t


GLOBENEWSWIRE (Distribution ID 8976760)

King Faisal Specialist Hospital and Research Centre gibt Start des innovativen klinischen Pharmakogenomik-Dienstes bekannt

RIAD, Saudi–Arabien, Oct. 25, 2023 (GLOBE NEWSWIRE) — The King Faisal Specialist Hospital and Research Centre (KFSH&RC) ist stolz darauf, den Start der ersten Phase seines klinischen Pharmakogenomik–Dienstes innerhalb seines Herzzentrums bekannt zu geben. Dieser bahnbrechende Dienst nutzt die DNA des Patienten, um die Dosierung und Auswahl der Arzneimittel individuell zu gestalten, und lutet damit eine neue ra im Gesundheitswesen ein, in der die personalisierte Behandlung fr jede Person im Vordergrund steht. Dieser bahnbrechende Ansatz ist geeignet, die Behandlungsergebnisse zu verbessern und mgliche Schden zu verringern.

Die Experten des KFSH&RC erklrten, dass diese Analyse den rzten die Mglichkeit gibt, jedem Patienten unter Bercksichtigung seines individuellen Gesundheitszustands und seiner genetischen Merkmale mageschneiderte Medikamente zu verschreiben. Das Ansprechen der Patienten auf Arzneimittel kann je nach ihrem genetischen Profil sehr unterschiedlich sein. Was sich bei einem Patienten als wirksam erweist, kann daher bei einem anderen nur eine minimale Wirkung haben. Es ist erwhnenswert, dass statistisch gesehen 15 % der Krankenhauseinweisungen auf unerwnschte Arzneimittelwirkungen zurckzufhren sind. Dies stellt eine erhebliche finanzielle und personelle Belastung fr die Gesundheitssysteme in aller Welt dar.

Dieser innovative Dienst ist ein gemeinsames Projekt des Centre for Genomic Medicine, von Healthcare Information Technology Affairs und des Pharmaceutical Care Department des KFSH&RC. In der Anfangsphase umfasst dieser Dienst sechs der nach Krankenhausdaten am hufigsten verschriebenen Medikamente, von denen bekannt ist, dass ihre Wirksamkeit durch genetische Variationen beeinflusst wird.

Das KFSH&RC hat deutlich gemacht, dass es sich weiterhin dafr einsetzt, den Umfang dieses Dienstes schrittweise auf alle Krankenhausabteilungen auszuweiten. Diese Ausweitung unterstreicht das unermdliche Engagement des Krankenhauses, jedem Patienten eine individuelle Behandlung zukommen zu lassen, ein Hchstma an Sicherheit zu gewhrleisten und schdliche Wirkungen zu minimieren, whrend gleichzeitig die neuesten, weltweit anerkannten wissenschaftlichen Praktiken eingehalten werden.

Auf der Global Health Exhibition, die vom 29. bis 31. Oktober in Riad stattfindet und bei der das KFSH&RC als strategischer Gesundheitspartner eine wichtige Rolle spielt, wird das Krankenhaus den innovativen Dienst vorstellen, der die Gesundheitsversorgung in der Region zu verbessern verspricht.

Das KFSH&RC erklrte, es wolle den Anwendungsbereich des Dienstes schrittweise auf alle medizinischen Fachrichtungen ausdehnen. Dies sei Teil seines Engagements fr eine personalisierte Gesundheitsversorgung fr jeden Patienten auf hchstem Niveau in Bezug auf Sicherheit und Schadensverhtung und diene der Nutzung der weltweit neuesten wissenschaftlich erprobten Verfahren.

Das King Faisal Specialist Hospital and Research Centre gilt als eines der weltweit fhrenden Zentren fr spezialisierte Gesundheitsversorgung, als Vorreiter in Sachen Innovation und als fortschrittliches medizinisches Forschungs– und Ausbildungszentrum. Darber hinaus ist es bestrebt, in Zusammenarbeit mit fhrenden lokalen, regionalen und internationalen Instituten medizinische Technologien zu entwickeln und die Gesundheitsversorgung weltweit zu verbessern, um erstklassige Dienstleistungen im klinischen Bereich sowie in Forschung und Bildung zu erbringen.

Kontaktinformationen:

[email protected]

Ein Foto zu dieser Mitteilung ist verfgbar unter https://www.globenewswire.com/NewsRoom/AttachmentNg/9e826983–52ae–4fe5–8579–0cbdfcca9d1c


GLOBENEWSWIRE (Distribution ID 8965796)

King Faisal Specialist Hospital and Research Centre Lança Inovadora Farmacogenômica Clínica

RIADE, Arábia Saudita, Oct. 25, 2023 (GLOBE NEWSWIRE) — O King Faisal Specialist Hospital and Research Centre (KFSH&RC) tem o orgulho de anunciar o lanamento da fase inaugural do seu servio de farmacogenmica clnica no Heart Center. Este servio pioneiro que utiliza o DNA do paciente para adaptar as escolhas e dosagens dos medicamentos, estabelece uma nova era na rea da sade que prioriza o tratamento personalizado para cada indivduo. Esta abordagem inovadora est viabiliza o aprimoramento dos resultados do tratamento e a reduo dos danos potenciais.

Os experts da KFSH&RC dizem que esta anlise capacita os mdicos a prescrever medicamentos personalizados para cada paciente, levando em considerao suas condies de sade e caractersticas genticas nicas. As respostas dos pacientes aos produtos farmacuticos podem ser substancialmente diferentes de acordo com seus perfis genticos. Por isso, o que demonstra ser eficaz para um paciente pode ter um impacto mnimo em outro. Vale a pena notar que as estatsticas revelam que 15% das internaes hospitalares decorrem de reaes adversas a medicamentos, que causam nus financeiros e humanos substanciais aos sistemas de sade em todo o mundo.

Este servio inovador um esforo colaborativo entre o Centro de Medicina Genmica, Assuntos de Tecnologia da Informao de Sade e o Departamento de Assistncia Farmacutica do KFSH&RC. Na sua fase inicial, este servio engloba seis dos medicamentos mais frequentemente prescritos, de acordo com dados hospitalares, cuja eficcia sabidamente influenciada pelas variaes genticas.

O KFSH&RC deixou claro que continua empenhado em expandir progressivamente o mbito deste servio, abrangendo todos os departamentos do hospital. Essa expanso demonstra a dedicao inabalvel do hospital em fornecer cuidados de sade personalizados a todos os pacientes, garantindo o nvel mximo de segurana e minimizao de danos, ao mesmo tempo em que adere s mais recentes prticas cientficas adotadas em todo o mundo.

Na Exposio Global de Sade realizada em Riade de 29 a 31 de outubro, onde a KFSH&RC ter um papel vital como parceira estratgica de sade, o hospital ir introduzir o servio inovador que promete acelerar os resultados de sade na regio.

O KFSH&RC disse que est trabalhando para expandir gradualmente o escopo da aplicao do servio para incluir todas as especialidades mdicas, como parte do seu compromisso de fornecer cuidados de sade personalizados para cada paciente no mais alto nvel de segurana e preveno de danos possvel, e utilizar as mais recentes prticas cientificamente comprovadas em todo o mundo.

O King Faisal Specialist Hospital and Research Center considerado um dos mais proeminentes do mundo na prestao de cuidados de sade especializados, um pioneiro em inovao e um centro avanado de pesquisa e educao mdica. O hospital tambm trabalha no desenvolvimento tecnologias mdicas e aprimoramento dos cuidados de sade em todo o mundo em parceria com instituies locais, regionais e internacionais proeminentes. Para o alcance de um servio de classe mundial nos campos clnico, de pesquisa e educacional.

Informaes de Contato:

[email protected]

Foto deste comunicado disponvel em https://www.globenewswire.com/NewsRoom/AttachmentNg/9e826983–52ae–4fe5–8579–0cbdfcca9d1c


GLOBENEWSWIRE (Distribution ID 8965796)

Le King Faisal Specialist Hospital & Research Center annonce le lancement d’un service de pharmacogénomique clinique innovant

RIYADH, Arabie saoudite, 25 oct. 2023 (GLOBE NEWSWIRE) — Le King Faisal Specialist Hospital and Research Centre ( KFSH&RC ) est fier d'annoncer le lancement de la phase inaugurale de son service de pharmacognomique clinique au sein de son ple cardiologie. Ce service pionnier utilise l'ADN du patient pour adapter les dosages et le choix des mdicaments, annonant ainsi une nouvelle re dans les soins de sant, qui donne la priorit un traitement personnalis pour chaque individu. Cette approche novatrice devrait permettre d'amliorer les rsultats thrapeutiques et de rduire les effets indsirables potentiels des mdicaments.

Selon les experts du KFSH&RC, cette analyse permet aux mdecins de prescrire des mdicaments adapts chaque patient, en tenant compte de son tat de sant et de ses caractristiques gntiques. Les ractions des patients aux produits pharmaceutiques peuvent varier considrablement en fonction de leur profil gntique. Par consquent, ce qui s'avre efficace pour un patient peut n'avoir qu'un effet minime pour un autre. Il convient de noter que les statistiques rvlent que 15 % des admissions l'hpital sont dues des effets indsirables des mdicaments, ce qui reprsente une charge financire et humaine considrable pour les systmes de soins de sant du monde entier.

Ce service innovant est le fruit d'une collaboration entre le Centre de mdecine gnomique, le dpartement des technologies de l'information dans le domaine de la sant et le dpartement des soins pharmaceutiques du KFSH&RC. Dans sa phase initiale, ce service englobe six des mdicaments les plus frquemment prescrits, sur la base des donnes hospitalires recueillies, dont l'efficacit est connue pour tre influence par des variations gntiques.

Le KFSH&RC a clairement indiqu qu'il restait dtermin tendre progressivement le champ d'application de ce service tous les services de l'hpital. Cette expansion souligne la volont inbranlable de l'hpital de dispenser des soins de sant personnaliss chaque patient, de garantir le plus haut niveau de scurit et de minimiser les effets indsirables, tout en adhrant aux dernires pratiques scientifiques approuves l'chelle mondiale.

l'occasion du salon Global Health Exhibition, qui se tient Riyad du 29 au 31 octobre, un vnement dans le cadre duquel le KFSH&RC joue un rle essentiel en qualit de partenaire stratgique dans le domaine de la sant, l'hpital s'apprte dvoiler ce service innovant qui promet de faire progresser les rsultats en matire de soins de sant dans la rgion.

Le KFSH&RC a dclar qu'il s'apprtait tendre progressivement le champ d'application du service toutes les spcialits mdicales dans le cadre de son engagement dispenser des soins de sant personnaliss chaque patient moyennant le plus haut niveau de scurit et de prvention des effets indsirables et exploiter les dernires pratiques scientifiquement prouves dans le monde entier.

L'tablissement est considr comme l'un des plus rputs au monde en matire de soins de sant spcialiss, un pionnier en matire d'innovation et un centre de recherche et d'enseignement mdical de pointe. Il cherche galement dvelopper des technologies mdicales et amliorer les soins de sant dans le monde entier, en partenariat avec d'minentes institutions locales, rgionales et internationales. Assurer un service de niveau international dans les domaines clinique, de la recherche et de l'enseignement, telle est la mission qu'il s'est fixe.

Coordonnes :

[email protected]

Une photo accompagnant cette annonce est disponible l'adresse suivante : https://www.globenewswire.com/NewsRoom/AttachmentNg/9e826983–52ae–4fe5–8579–0cbdfcca9d1c


GLOBENEWSWIRE (Distribution ID 8965796)

King Faisal Specialist Hospital and Research Centre Announces Innovative Clinical Pharmacogenomics

RIYADH, Saudi Arabia, Oct. 24, 2023 (GLOBE NEWSWIRE) — The King Faisal Specialist Hospital and Research Centre (KFSH&RC) is proud to announce the launch of the inaugural phase of its clinical pharmacogenomics service within its Heart Center. This pioneering service leverages the patient's DNA to tailor drug dosages and selections, heralding a new era in healthcare that prioritizes personalized treatment for each individual. This groundbreaking approach is poised to enhance treatment outcomes and reduce potential harm.

KFSH&RC's experts have said that this analysis empowers physicians to prescribe medications customized to each patient, factoring in their unique health conditions and genetic traits. Patients' responses to pharmaceuticals can significantly differ based on their genetic profiles. As a result, what proves effective for one patient may have minimal impact in another. It is worth noting that statistics reveal that 15% of hospital admissions stem from adverse drug reactions, imposing substantial financial and human burdens on healthcare systems across the globe.

This innovative service is a collaborative endeavor between the Centre for Genomic Medicine, Healthcare Information Technology Affairs, and the Pharmaceutical Care Department at KFSH&RC. In its initial phase, this service encompasses six of the most frequently prescribed medications, as determined by hospital data, whose efficacy is known to be influenced by genetic variations.

KFSH&RC has made it clear that it remains committed to expanding the scope of this service progressively, encompassing all hospital departments. This expansion underscores the hospital's unwavering dedication to providing personalized healthcare to every patient, ensuring the utmost level of safety, and minimizing harm, while adhering to the latest globally endorsed scientific practices.

At the Global Health Exhibition held in Riyadh from October 29th to 31st, where KFSH&RC plays a vital role as a strategic health partner, the hospital is set to unveil the innovative service that promises to advance healthcare outcomes in the region.

KFSH&RC stated that it is moving to gradually expand the scope of application of the service to include all medical specialties as part of its commitment to providing personalized health care for each patient at the highest level of safety and prevention of harm and to harness the latest scientifically proven practices around the world.

King Faisal Specialist Hospital and Research Center is considered among the most prominent in the world in providing specialized health care, a pioneer in innovation, and an advanced medical research and education center. It also seeks to develop medical technologies and raise health care worldwide in partnership with prominent local, regional and international institutions. To achieve world–class service in the clinical, research, and educational fields.

Contact information:

[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9e826983–52ae–4fe5–8579–0cbdfcca9d1c


GLOBENEWSWIRE (Distribution ID 8964787)

Datacubed Health Launches eClinical Platform App in China, Ensuring Full Compliance and Accessibility

New York, New York, Sept. 26, 2023 (GLOBE NEWSWIRE) — Datacubed Health, a leading global provider of innovative solutions for patient engagement and data collection in clinical trials, is excited to announce the official launch of its eClinical platform app in China. This milestone achievement represents a significant step forward for Datacubed Health's commitment to expanding its presence in the Chinese market.

As part of this strategic move, Datacubed Health has joined forces with AppInChina, a renowned leader in Android App Store publication, ensuring seamless deployment of the eClinical platform app in official Android stores across China and the Apple App Store. This partnership guarantees accessibility to a wide range of devices and ecosystems.

Kyle Hogan, President of Datacubed Health, emphasized the importance of this collaboration: “Our partnership with AppInChina has been instrumental in ensuring the smooth launch of our eClinical platform app in China. This strategic alliance allows us to reach a broader audience while maintaining compliance with local regulations, which is essential for our growth in this market.”

In preparation for this momentous launch, Datacubed Health has established a legal entity within China and acquired all necessary commercial and legal licenses and certificates. These crucial steps are a testament to Datacubed Health's commitment to providing secure and regulated services within the Chinese market.

Brett Kleger, CEO of Datacubed Health, stated, “Our investment in establishing a legal presence and obtaining the requisite licenses underscores our dedication to operating ethically and responsibly in China. We are focused on delivering cutting–edge solutions while adhering to local regulations and standards.”

Moreover, Datacubed Health has undertaken comprehensive efforts to ensure full software compliance with Chinese regulations. The eClinical platform app for China has been meticulously customized to align with local requirements and has undergone rigorous testing by local quality assurance teams. This meticulous approach ensures the seamless functioning of the platform while adhering to Chinese network security requirements and restrictions.

Datacubed Health has also bolstered its presence in China by establishing a fully compliant and fault–tolerant Software as a Service (SaaS) infrastructure. The Datacubed China solution is now hosted in AWS Beijing, ensuring data security and reliability for users in the region.

With these key developments in operational, legal, and software compliance, Datacubed Health is well–prepared to provide unmatched support to clinical research efforts in China. The launch of the eClinical platform app represents a significant stride in bridging the gap between global research initiatives and the Chinese healthcare landscape.

In the words of CEO Brett Kleger: “We are thrilled to introduce Datacubed Health's eClinical platform app to the Chinese market. Our partnership with AppInChina, legal entity establishment, and rigorous compliance efforts demonstrate our dedication to providing world–class services to our Chinese users. We look forward to empowering clinical research initiatives in China with our cutting–edge solutions.”

To learn more, we invite you to join us at Booth #24 at the 11th Annual Outsourcing in Clinical Trials Southern California 2023 from September 26–27 in San Diego, California, or visit our website at www.datacubed.com.

About Datacubed Health:

Datacubed Health is a pioneering eClinical technology company built from the ground up by industry veterans who wanted to create a better clinical trial experience for all stakeholders. Our solutions are all infused with neuroeconomic principles designed to be inclusive, drive compliance, and greatly improve retention. We strive to deliver the best experience for you and your patients through ease of use and flexible technology configurable to your needs. Our offerings include a Decentralized Trials Platform, eCOA/ePRO, Patient Engagement, eConsent, Medication Adherence, Televisits, and Geofencing. Learn more at www.datacubed.com.

Media Contact:
Heather Shea
Catalytic Agency for Datacubed Health
[email protected]


GLOBENEWSWIRE (Distribution ID 8926943)

Purdue researcher awarded $1.3 million for malaria drug trials in Southeast Asia and Africa

WEST LAFAYETTE, Ind., Sept. 15, 2023 (GLOBE NEWSWIRE) — A Purdue researcher is taking a giant leap forward in the fight against drug–resistant strains of malaria in developing countries.

Open Philanthropy has awarded $1.38 million to Philip Low to further validate a drug therapy that he and his colleagues have previously shown to successfully treat the disease. Low (rhymes with "now") is Purdue University's Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry in the College of Science.

For years, experts have been concerned about the rise of drug–resistant malaria variants in Southeast Asia and the prospect that one or more of these strains might travel to Africa. A similar event occurred in the 1980s with the emergence of drug resistance to the then–standard treatment of chloroquine, which resulted in millions of deaths.

But Low is working to save lives on both continents by conducting clinical trials to validate previous results and to test whether the number of days of an anti–malaria treatment can be reduced.

While studying how malaria propagates in human blood, Low and his research team discovered that the cancer drug therapy imatinib is effective in the treatment of drug–resistant malaria. Trials in Southeast Asia showed that imatinib, when combined with the customary malaria therapy, clears all malaria parasites from 90% of patients within 48 hours and 100% of patients within three days. The patients receiving imatinib were also relieved of their fevers in less than half of the time experienced by similar patients treated with the standard therapy.

Open Philanthropy has awarded Low $600,000 for a larger clinical trial in Southeast Asia to validate his previous trials. The organization has also awarded Low $780,000 to determine whether the usual three–day therapy can be reduced to two days or even one. This work will be focused in the African countries of Kenya and Tanzania where malaria is prominent.

"We found that people in Africa must often walk many miles to obtain treatment for malaria. They will receive three pills, walk all the way home, take one or two pills, start to feel better, and then save the third pill for their next malaria infection," Low said. "When they don't finish the course of treatment, only the most drug–resistant strains of the parasite survive and spread. And that's how people build up drug resistance. So we'd like to eventually be able to cure all patients with just one pill. It would prevent these drug–resistant strains from ever proliferating."

Open Philanthropy is a grantmaking organization whose mission is to use its resources to help others as much as it can, according to the funder.

"This is yet another case of an organization recognizing Philip Low's brilliance, scientific vision and mission to help people in all corners of the world," said Brooke Beier, senior vice president of Purdue Innovates. "The Purdue Research Foundation has been a proud partner in supporting his work, protecting and promoting his intellectual property that is changing lives and making our world a better place to live."

Since 1988, Low has been listed on more than 145 invention disclosures to the Purdue Innovates Office of Technology Commercialization. He has been listed on more than 600 patents in nearly two dozen countries around the world from the U.S. Patent and Trademark Office and international patent organizations. During his tenure at Purdue, Low has been awarded 213 research grants for more than $43.5 million. His work also receives support from the Purdue Institute for Cancer Research and the Purdue Institute for Drug Discovery.

Imatinib was originally produced by Novartis for the treatment of chronic myelogenous leukemia and other cancers. It works by blocking specific enzymes involved in the growth of cancers.

"When we discovered the ability of imatinib to block parasite propagation in human blood cultures in petri dishes, we initiated a human clinical trial where we combined imatinib with the standard treatment (piperaquine plus dihydroartemisinin) used to treat malaria in much of the world," Low said.

Malaria infects human red blood cells, where it reproduces and eventually activates a red blood cell enzyme that in turn triggers rupture of the cell and release of a form of the parasite called a merozoite into the bloodstream. Low and his colleagues theorized that by blocking the critical red blood cell enzyme, they could stop the infection. The data from initial drug trials have confirmed that.

"Because we're targeting an enzyme that belongs to the red blood cell, the parasite can't mutate to develop resistance "" it simply can't mutate our proteins in our blood cells," Low said. "This is a novel approach that will hopefully become a therapy that can't be evaded by the parasite in the future. This would constitute an important contribution to human health."

The goal, Low said, is to get this into developing countries to save lives. With this new round of funding, he says they're now closer than they've ever been.

About Purdue University

Purdue University is a public research institution with excellence at scale. Ranked among top 10 public universities and with two colleges in the top 4 in the United States, Purdue discovers and disseminates knowledge with a quality and at a scale second to none. More than 105,000 students study at Purdue across modalities and locations, with 50,000 in person on the West Lafayette campus. Committed to affordability and accessibility, Purdue's main campus has frozen tuition 12 years in a row. See how Purdue never stops in the persistent pursuit of the next giant leap, including its first comprehensive urban campus in Indianapolis, the new Mitchell E. Daniels, Jr. School of Business, and Purdue Computes, at https://www.purdue.edu/president/strategic–initiatives.

About Purdue Innovates

Purdue Innovates is a unified network at Purdue Research Foundation to assist Purdue faculty, staff, students and alumni in either IP commercialization or startup creation. As a conduit to technology commercialization, intellectual property protection and licensing, startup creation and venture capital, Purdue Innovates serves as the front door to translate new ideas into world–changing impact.

For more information on licensing a Purdue innovation, contact the Office of Technology Commercialization at [email protected]. For more information about involvement and investment opportunities in startups based on a Purdue innovation, contact Purdue Innovates at [email protected].

Media contact: Steve Martin, [email protected]

Sources: Philip Low, [email protected]

Brooke Beier, [email protected]

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GLOBENEWSWIRE (Distribution ID 8923129)

A Curia apoia o ensaio clínico de fase 1 da nova vacina de RNA de última geração da Replicate Bioscience

ALBANY, N.Y., Sept. 13, 2023 (GLOBE NEWSWIRE) — A Curia, uma organizao lder em pesquisa, desenvolvimento e fabricao por contrato, anunciou hoje que sua parceira, Replicate Bioscience, recebeu autorizao IND da FDA e dosou o primeiro participante com RBI–4000, uma vacina autorreplicante (de srRNA) contra a raiva, em um estudo clnico de fase 1 utilizando material clnico desenvolvido como parte da colaborao com a Curia.

A Curia liderou o desenvolvimento do processo, o aumento de escala e a fabricao de acordo com as BPFa do frmaco de srRNA RBI–4000. Com aproximadamente 10.000 bases, este srRNA significativamente maior do que um RNAm linear convencional e, historicamente, tem sido difcil fabric–lo nas escalas necessrias para o desenvolvimento clnico. O desenvolvimento do mtodo analtico da Curia e a qualificao dos ensaios tambm foram fundamentais para a liberao dessa molcula de srRNA.

"A Curia se orgulha de ser pioneira na fabricao dessa nova classe de tecnologia de srRNA ao fornecer o frmaco de srRNA RBI–4000 nossa parceira Replicate para apoiar seu ensaio clnico de fase 1", afirmou Christopher Conway, Presidente de Pesquisa e Desenvolvimento da Curia. "Dedicamo–nos a fornecer solues vantajosas, desde o desenvolvimento at a fabricao de acordo com as BPFa para nossos clientes na rea de RNAm."

Essa nova classe de vacinas de srRNA trazem vrias vantagens em relao s vacinas de RNAm existentes, incluindo a necessidade de dosagens mais baixas e maior tolerabilidade. Esse avano abre tambm a porta a mais inovaes em RNA para uso em vacinas e terapias com menos restries em relao ao tamanho das molculas.

"Nossa colaborao com a Curia nos ajudou a fabricar uma nova classe de RNAs autorreplicantes que tm o potencial de fornecer perfis melhorados de bioatividade, tolerabilidade e eficcia em comparao com outras tecnologias de RNA", disse Nathaniel Wang, PhD., fundador e CEO da Replicate. "A Curia ampliou a escala de um processo para RNAs mais longos, que permitiu a produo em larga escala com rendimentos, pureza e potncia suficientes para apoiar o ensaio clnico de fase 1 da Replicate."

A Curia est comprometida em ser uma parceira preferencial desde a descoberta e desenvolvimento at fabricao e comercializao, fornecendo um conjunto completo de servios de suporte a pequenas e grandes molculas, frmacos, enchimento e acabamento assptico de produtos farmacuticos e testes laboratoriais em todas as fases do ciclo de vida do desenvolvimento de medicamentos.

Sobre a Curia
A Curia, antiga AMRI, uma organizao lder em pesquisa, desenvolvimento e fabricao por contrato, que fornece produtos e servios desde a P&D at a fabricao em escala comercial para clientes farmacuticos e biofarmacuticos. Os quase 4.000 funcionrios da Curia em 29 locais nos Estados Unidos, Europa e sia ajudam seus clientes a progredir da curiosidade cura. Saiba mais em CuriaGlobal.com.

Informaes de contato da Curia:
Viana Bhagan
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 8921444)

Curia unterstützt die klinische Studie der Phase 1 von Replicate Bioscience mit einem neuartigen RNA-Impfstoff der nächsten Generation

ALBANY, N.Y., Sept. 13, 2023 (GLOBE NEWSWIRE) — Curia, ein fhrendes Auftragsforschungs–, Entwicklungs– und Produktionsunternehmen, gab heute bekannt, dass sein Partner Replicate Bioscience die IND–Freigabe von der FDA erhalten hat und der erste Teilnehmer mit RBI–4000, einem selbstreplizierenden (srRNA) Tollwut–Impfstoff, in einer klinischen Studie der Phase 1 unter Verwendung von klinischem Material, das im Rahmen der Zusammenarbeit mit Curia entwickelt wurde, geimpft wurde.

Curia fhrte die Prozessentwicklung, das Scale–up und die cGMP–Herstellung des Wirkstoffs srRNA RBI–4000 durch. Mit etwa 10.000 Basen ist diese srRNA deutlich grer als eine herkmmliche lineare mRNA und war in der Vergangenheit nur schwer in dem fr die klinische Entwicklung erforderlichen Umfang herzustellen. Die Entwicklung der analytischen Methode und die Qualifizierung der Assays durch Curia waren ebenfalls entscheidend fr die Freigabe dieses srRNA–Molekls.

"Curia ist stolz darauf, ein Pionier in der Herstellung dieser neuen Klasse von srRNA–Technologie zu sein, indem wir den Wirkstoff RBI–4000 srRNA an unseren Partner Replicate liefern, um ihn bei seiner klinischen Studie der Phase 1 zu untersttzen", sagte Christopher Conway, President, Research & Development, Curia. "Wir sind bestrebt, unseren Kunden im mRNA–Bereich vorteilhafte Lsungen von der Entwicklung bis zur cGMP–Herstellung anzubieten."

Diese neue Klasse von srRNA–Impfstoffen bietet eine Reihe potenzieller Verbesserungen im Vergleich zu den bestehenden mRNA–Impfstoffen, darunter eine geringere Dosierung und bessere Vertrglichkeit. Die Weiterentwicklung erffnet zudem Mglichkeiten fr weitere RNA–Innovationen zur Verwendung in Impfstoffen und Therapeutika mit weniger Beschrnkungen hinsichtlich der Moleklgre.

"Unsere Zusammenarbeit mit Curia half uns bei der Herstellung einer neuen Klasse von selbstreplizierenden RNAs, die das Potenzial haben, im Vergleich zu anderen RNA–Technologien verbesserte Bioaktivitts–, Vertrglichkeits– und Wirksamkeitsprofile zu liefern", so Nathaniel Wang, Ph.D., Grnder und CEO von Replicate. "Curia hat ein Verfahren fr lngere RNAs entwickelt, das eine gro angelegte Produktion mit einer Ausbeute, Reinheit und Wirksamkeit ermglicht, die die klinische Studie der Phase 1 von Replicate untersttzt."

Curia hat sich zum Ziel gesetzt, von der Erforschung und Entwicklung ber die Herstellung bis hin zur Vermarktung ein Partner erster Wahl zu sein, und bietet in jeder Phase des Lebenszyklus der Wirkstoffentwicklung eine umfassende Palette von Dienstleistungen zur Untersttzung von kleinen und groen Moleklen, Wirkstoffen, aseptischem Fill & Finish sowie Labortests.

ber Curia
Curia (ehemals AMRI) ist ein fhrendes Auftragsforschungs–, Entwicklungs– und Produktionsunternehmen. Es bietet Pharma– und Biopharma–Kunden Produkte und Dienstleistungen von der Forschung und Entwicklung bis zur kommerziellen Herstellung. Die fast 4.000 Mitarbeiterinnen und Mitarbeiter von Curia an 29 Standorten in den USA, Europa und Asien untersttzen ihre Kunden dabei, von Kreativitt und Neugier zu Behandlungs– und Heilungsmglichkeiten zu gelangen. Mehr Informationen erhalten Sie unter CuriaGlobal.com.

Curia "" Kontaktinformationen:
Viana Bhagan
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 8921444)