Dual-action therapy shows promise against aggressive oral cancer

A new treatment combining tiny iron particles and nitric oxide gas shows promise in targeting oral cancer cells for destruction.

In a new study, scientists at Shanghai Jiaotong University School of Medicine found a promising new way to treat a type of oral cancer known as oral squamous cell carcinoma. The method specifically targets the cancer cells through a combination of nitric oxide gas therapy and nanocatalytic therapy, killing them more effectively and with fewer side effects. The study was published in Science and Technology of Advanced Materials.

Illustration of nitric oxide-releasing iron atoms being created and used to treat oral squamous cell carcinoma.
Illustration of nitric oxide-releasing iron atoms being created and used to treat oral squamous cell carcinoma.

Oral squamous cell carcinoma is a very aggressive cancer that tends to spread quickly and to reappear after treatment. Traditional treatments, such as surgery, chemotherapy, and radiation, often have serious side effects, including trouble speaking or eating and painful conditions like mouth sores and dry mouth. Researchers are trying to develop better treatments that wouldn’t have such harsh side effects. One approach relies partly on nanocatalysts, tiny particles measuring 1 to 100 nanometers in size which are used to accelerate chemical reactions.

“We created tiny iron particles composed of individual iron atoms, designed to interact with hydrogen peroxide—a substance found in elevated levels inside tumor cells,” explains Professor Ping Xiong, who led the study. “These atoms use a chemical process called the Fenton reaction, where the iron atoms act as catalysts to convert hydrogen peroxide into highly toxic hydroxyl radicals.”

Hydroxyl radicals are extremely reactive and cause intense oxidative stress by damaging cellular components such as DNA and proteins. The iron particles also carried molecules that released nitric oxide gas when activated by near-infrared laser light. The nitric oxide gas amplified the effect of the hydroxyls by triggering apoptosis, a controlled form of cell death crucial for removing damaged cells.

In animal model experiments, a single dose of treatment combined with a laser pulse was found to suppress tumors by around 85.5%, suggesting that the treatment is very effective. “This treatment is highly specific to cancer cells, reducing damage to healthy tissues and minimizing side effects, which makes it both more efficient and better tolerated by the body,” says Yuting Xie, one of the study’s authors.

One major difficulty was ensuring that the infrared laser targeted only the tumor, especially in hard-to-reach areas like the sides and bottom of the tongue. The team is exploring ways to improve the precision of the laser treatment to avoid inadvertent damage to the surrounding healthy tissues, which could result in unwanted side effects. One approach being investigated involves developing nanocatalysts that would be administered through an intravenous injection, which could enhance the targeting by interacting with the laser in a more controlled manner.

The researchers are also working on strategies to prevent the cancer from spreading or returning after treatment. By further refining these technologies, they hope to create a more effective and targeted treatment option for this invasive cancer.

Further information
Ping Xiong
Shanghai Jiaotong University School of Medicine
Email:  xiongp@shsmu.edu.cn

Paper: https://doi.org/10.1080/14686996.2024.2368452

About Science and Technology of Advanced Materials (STAM)
Open access journal STAM publishes outstanding research articles across all aspects of materials science, including functional and structural materials, theoretical analyses, and properties of materials. https://www.tandfonline.com/STAM 

Dr Yasufumi Nakamichi
STAM Publishing Director
Email: NAKAMICHI.Yasufumi@nims.go.jp 

Press release distributed by Asia Research News for Science and Technology of Advanced Materials.

CGFNS International Joins WHO Stakeholder Network to Advance Rehabilitation Care

CGFNS International, a worldwide leader in international credentials evaluation and certification to support health worker careers, has been inducted into the World Rehabilitation Alliance (WRA).

CGFNS International
CGFNS International

The WRA is the World Health Organization’s global network of stakeholders whose mission is to advocate for the implementation of WHO’s Rehabilitation 2030 initiative, which aims to improve rehabilitation management and investment, build a high-quality rehabilitation workforce and services, and enhance data collection on rehabilitation.

“We are delighted to receive this recognition of our extensive work in developing practical solutions to improve rehabilitation care for the more than 2.4 billion people around the world who need it,” said Dr. Peter Preziosi, President and CEO of CGFNS. “We are also determined to further dedicate ourselves to advancing the WRA’s impact in promoting and strengthening health systems worldwide through better and more accessible rehabilitation services.”

Preziosi noted that one of the key calls to action of the WRA is for “developing a strong multidisciplinary rehabilitation workforce that is suitable for country context and promoting rehabilitation concepts across all health workforce education.”

“We believe we have a great deal of knowledge and experience to contribute to advancing critical workforce initiatives in the global rehab community, especially toward achieving the WHO goal of integrating rehab care more firmly into primary healthcare across local settings,” said Dr. Julia To Dutka, Chief of the CGFNS Global Health Workforce Development Institute. “Providing global certifications to recognize knowledge and skills of health workers will help facilitate this integration.”

To that end, for the past five years, CGFNS has been leading a collaboration of key stakeholders to develop exam-based global certifications for nurses and other health workers in rehabilitation settings worldwide. That effort has produced the first-ever global credential for registered nurses working in rehabilitation, habilitation or restorative care – the Certified Global Nurse – Rehabilitation (CGN-R), which was launched last month.

The organization is also developing credentials for other rehabilitation health workers, including physical and occupational therapists, speech-language pathologists, and rehab technicians, using an interprofessional and interdisciplinary approach. These global credentials, Certified Global Health Worker – Rehabilitation (CGHW-R) and Certified Global Health Worker – Rehabilitation Advanced (CGHW-RA), will be available in 2025.

As a newly appointed member of the WRA, CGFNS will participate in four of its workstreams: Workforce, Primary Care, Research, and Emergencies.

About CGFNS International, Inc.
Founded in 1977 and based in Philadelphia, CGFNS International is an immigration-neutral not-for-profit organization proudly serving as the world’s largest credentials evaluation organization for the nursing and allied health professions. CGFNS International is an NGO in Consultative Status with the United Nations Economic and Social Council (ECOSOC) and is a member of the Conference of NGOs in Consultative Relationship with the United Nations (CoNGO).

Contact Information
David St. John
dstjohn@cgfns.org

SOURCE: CGFNS International

Avance Clinical Appoints Asia Regional Director as Part of Global Expansion Program

Avance Clinical, the award-winning CRO for biotechs, is proud to announce the appointment of Jessica Han as Director, Asian Operations based out of Avance Clinical’s Seoul, Korea office.

Jessica Han, Avance Clinical Director, Asian Operations
Jessica Han, Avance Clinical Director, Asian Operations

The formal announcement will be made at BIO Taiwan, in the Australian Pavilion, at the Taipei International Convention Centre (July 26 – 28). Book a meeting with the Avance Clinical team attending BIO Taiwan.

This strategic move underscores Avance Clinical’s commitment to the Asia market, which is an attractive region for biotechs to access patients during their clinical trial development.

Avance Clinical CEO Yvonne Lungershausen said she was extremely pleased to have Jessica Han lead Avance Clinical’s Asia operations.

“With over 17 years of experience in the healthcare and clinical research industry, and a deep understanding of the Asian market, and in particular the Korean market, Jessica Han is set to drive Avance Clinical’s operations and strategic initiatives across Asia,” Lungershausen said.

Han’s career began as a registered nurse in the critical care unit at Samsung Medical Center, where she focused on patient care and clinical research. Transitioning into the clinical trial sector, she has worked in various roles at leading contract research organizations in the region, such as Parexel, PRA Health Sciences (now ICON), and Novotech.

On her decision to join Avance Clinical, Han stated, “I was drawn to Avance Clinical because of its innovative approach to clinical trial management and its commitment to high-quality service delivery”.

“I was particularly impressed by Avance Clinical’s strategic focus on scaling up its operations in the region and its strong reputation for excellence in clinical research. I am eager to contribute to the company’s growth and support its strategy to further expand in this dynamic market, driving successful clinical trials and fostering new business opportunities in Asia,” she said.

“In the region, Avance Clinical is known for its tailored solutions that meet the unique needs of biotech companies and importantly, its commitment to quality that ensures the integrity and reliability of trial outcomes. Avance Clinical’s demonstrated scientific and regulatory expertise streamlines the approval process, reducing timelines and accelerating project delivery. These comprehensive and client-focused services make Avance Clinical a leader in the industry, which aligns perfectly with my passion for advancing clinical research,” Han said.

Lungershausen said, “The decision to establish clinical operations in Seoul reflects the increasing demand from biotechs and CRO partners who seek access to South Korea’s scientific excellence and diverse patient populations. Our new presence in South Korea also offers a strategic advantage for our CRO partners conducting multi-regional or global trials.”

The expansion into South Korea and Asia aligns with Avance Clinical’s GlobalReady drug development solution, which has already garnered significant interest from over 75 Korean biotechs and pharmaceutical companies. “There is a clear need for Korean clinical operations that provide a global pathway,” Lungershausen added.

The Asia expansion enhances Avance Clinical’s capability to offer world-class clinical research services, adding to its seamless coverage across the globe, and high-quality data that meets key standards of major regulatory authorities, including the MFDS and FDA. This move will facilitate Asian biotechs’ access to Avance Clinical’s robust services in Australia and the United States, further accelerating their drug development programs.

“Our teams across Asia, Australia, New Zealand, Europe, and the United States deliver exceptional quality data and operational excellence, positioning our biotech clients for success in their clinical trials,” she said.

Meet Jessica Han, Yvonne Lungershausen and the team at BIO Taiwan, in the Australian Pavilion, at the Taipei International Convention Centre, from July 26 – 28. Book a meeting now to discuss your drug development program or upcoming clinical trial.

Find out more:

  • Learn about the GlobalReady model
  • For more information about the benefits of running your next study with Avance Clinical contact us
  • Request a Proposal here

Media Contact:
Avance Clinical
media@avancecro.com 
Kate Thompson

About Avance Clinical
Avance Clinical is the largest premium full-service Australian, Asian and North American CRO delivering quality clinical trials with globally accepted data for international biotechs. The company’s clients are biotechs completing Phase I to Phase III of their drug development program that requires fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past four years, has been providing CRO services in the region for more than 26 years.

Pre-clinical through to mid to late phase
Avance Clinical offers pre-clinical consulting and regulatory services with their experienced ClinicReady team right from pre-clinical through to Phase III clinical services leveraging significant Australian Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 120 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA, EMA and MFDS review.

Technology
Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners.

www.avancecro.com

Q&M Dental Group Advanced “Treatment Plan” AI-Module Released Today

Mainboard listed Q & M Dental Group (Singapore) Limited (“Q & M” or “the Group” and together with its subsidiaries, the “Group”) is proud to announce the release of the “Treatment Plan” on its Artificial Intelligence (AI)-module developed by its 49%-owned subsidiary, EM2AI, in collaboration with AI Singapore.

The “Treatment Plan” AI-Module leverages state-of-the-art technology including Large Language Models (LLM) to optimise treatment recommendations. It combines the strength of conventional clinical decision support systems, with the advanced processing capabilities of LLM to understand and interpret all data and input effectively.

The tangible benefits for patients are as follows:

  • Early detection of oral health issues with suggested treatment options based on conditions detected and analysed by AI;
  • An iterative platform that learns continuously;
  • Allows patients to be informed of all available treatment options for their individual condition, that is AI-based, resulting in more objective decision-making.

To ensure safety and accuracy, we have implemented thoughtful measures to mitigate potential issues such as inaccurate, over or under-diagnosis to maintain precise control over treatment outcomes. By integrating the latest advancements in LLM, this innovative approach not only enhances the accuracy of treatment options, but also instils confidence in dental professionals by providing reliable insights tailored specifically for each patient.

Furthermore, with the introduction of this “Treatment Plan” Module, the patient journey through advanced AI digital dentistry is now covered from start to end. Starting with the initial consultation and followed by x-ray imaging, the AI swiftly analyses the x-rays for pathologies, auto-generates treatment options and the journey ends with a dental health report that patients can bring back home. This complete and streamlined workflow not only enhances patient satisfaction but also empowers Q & M to deliver superior care to patients with confidence.

Dr Ng Chin Siau, Group Chief Executive Officer of Q & M, said, “This latest release of the AI-Treatment Plan module signifies a significant advancement in our dental clinics’ digital capabilities and enables the Group to offer this enhanced service to patients within its network. Most importantly, our dentists will be able to deliver superior care to our patients, enhancing both clinical outcomes and elevating the overall patient experience. All this, while greatly strengthening our overall value proposition as patients will be provided with holistic analysis with recommendations that will be unbiased and objective. “

“After successfully supporting EM2AI in developing their AI capabilities through the 100E programme in 2018, this new module marks a significant extension of our collaboration under the Short Industry Project (SIP) programme. I am thrilled to see our engineers partnering with EM2AI’s domain experts and AI team to harness large language models (LLMs) for cutting-edge dental treatment planning, ensuring precise, reliable, and patient-centered care. We are committed to continuing our support for local enterprises as they innovate with AI integration, striving to deliver tangible benefits, elevate consumer experiences, and make a positive societal impact,” said Laurence Liew, Director of AI Innovation, AI Singapore.

About Q & M Dental Group (Singapore) Limited (QC7.SI)

Q & M Dental Group (Singapore) Limited (QC7.SI) (“Q & M” or together with its subsidiaries, the “Group”) is a leading private dental healthcare group in Asia.

The Group owns the largest network of private dental outlets in Singapore, operating 105 dental outlets across the country. Underpinned by about 270 experienced dentists and over 350 supporting staff, the Group sees an average of 40,000 patient visits a month in Singapore. The Group also operates 5 medical clinics and a dental supplies and equipment distribution company.

Outside of Singapore, the Group has 44 dental clinics and a dental supplies and equipment distribution company in Malaysia. Q & M is also the substantial shareholder of Aoxin Q & M Dental Group Limited, a dental Group listed on the Catalist board of the Singapore Exchange that operates dental clinics and hospitals primarily in the north-eastern region of the PRC. The Group aims to expand its operations geographically and vertically through the value chain in Malaysia, the PRC and within the ASEAN region.

The Q & M College of Dentistry was established in 2019 to offer postgraduate dental education as part of its commitment to continual education and professional development of dentists. It offers Singapore’s first private postgraduate diploma programme in clinical dentistry.

In 2020, the Group expanded into the medical laboratories and research industry with the strategic investment into Acumen Diagnostics Pte. Ltd. (“Acumen”). Currently, Acumen focuses on developing its range of medical research, tests and solutions to secure viable patents and to achieve successful commercialisation of the medical products in the near future.

The Group was listed on the Mainboard of the Singapore Exchange Securities Trading Limited (“SGX- ST”) on 26 November 2009.

For more information on the Group, please visit www.QandMDental.com.sg

Investor and Media queries, please contact:

Waterbrooks Consultants Pte Ltd
Wayne Koo: wayne.koo@waterbrooks.com.sg (+65) 9338-8166
Derek Yeo: derek@waterbrooks.com.sg (+65) 9791-4707
General: query@waterbrooks.com.sg

Proud Investor Relations partner: https://www.waterbrooks.com.sg/ and https://www.alphainvestholdings.com/

CGFNS International Announces First Global Credential for Rehab Nurses

Exam registration for Certified Global Nurse – Rehabilitation (CGN-R) to open in July, handbook available now

CGFNS International, a worldwide leader in international credentials evaluation to support health worker careers, has launched the first-ever global credential for registered nurses working in rehabilitation, habilitation or restorative care.

CGFNS Certified Global Nurse - Rehabilitation
CGFNS Certified Global Nurse – Rehabilitation

The Certified Global Nurse – Rehabilitation (CGN-R) credential is intended to advance and improve services for the more than two billion people worldwide who need this care. It has been developed specifically for eligible registered nurses worldwide who wish to have their applied experience and competencies in rehab care recognized and verified by passing a certification examination.

The exam was created in collaboration with a global task force of more than 60 rehabilitation nursing experts from 17 countries who contributed their knowledge and guidance to develop a global competency framework for rehabilitation nursing and to create a test blueprint for a competency-based exam. The task force’s framework is aligned with the Rehabilitation Competency Framework established by the World Health Organization.

Accordingly, those who earn the CGN-R credential will be able to show their employers, prospective employers and others that they have been assessed against a global industry standard for rehabilitation care and that their expertise has been benchmarked against other nurses in rehab care worldwide.

Registration for the CGN-R exam will open in July, with testing dates to be scheduled for November. Registered (first-level) nurses with at least two years’ work experience in rehabilitation care are eligible to apply. Further details on eligibility requirements, exam topics and how to apply can be found in the exam handbook, now available at the CGFNS website.

“This will be the first global specialty certification offered anywhere for rehab nursing. It represents a huge shift for our global health workforce, for whom specialty credentials are often out of reach and require migration to the countries that offer them. The CGN-R certification will enable rehabilitation nurses everywhere to demonstrate a validated specialty skillset to their employers, carry the credential with them wherever they want to work in the world, and advance their career opportunities,” said Julia To Dutka, Chief of the CGFNS Global Health Workforce Development Institute, which is leading the initiative to develop this and other global credentials for the rehabilitation workforce.

“Provider certifications enable health systems and hospitals to confidently identify the most well-equipped workforce candidates to meet their burgeoning care needs. At a time when qualified interdisciplinary care teams are critically needed in rehabilitation care, the CGN-R establishes a global standard against which employers can set the bar for provider qualifications within their health systems,” said Terrence Carolan, Managing Director of Medical Rehabilitation and Aging Services of CARF International, an independent, nonprofit organization that accredits more than 66,000 rehabilitation and other health and human service providers on five continents and that has advised CGFNS in developing the CGN-R credential.

Nurses who sit for the initial CGN-R exam in November will receive a discount on exam fees.

CGFNS is also offering an early adopter program for hospitals, health systems or rehabilitation organizations that would like to invest in specialty certification for their rehab nurse workforce. The program includes opportunities to host the CGN-R exam onsite for their rehab nursing teams and earn an early adopter’s badge for organizational recognition.

Information on additional credentials for other health workers in a rehabilitative/habilitative/restorative environment – including physical and occupational therapists, speech-language pathologists and rehab technicians, among others – will be made available in the coming months.

More information on the program can be found at https://www.cgfns.org/services/certification/global-rehabilitation/

About CGFNS International, Inc.
Founded in 1977 and based in Philadelphia, CGFNS International is an immigration-neutral not-for-profit organization proudly serving as the world’s largest credentials evaluation organization for the nursing and allied health professions. CGFNS International is an NGO in Consultative Status with the United Nations Economic and Social Council (ECOSOC) and is a member of the Conference of NGOs in Consultative Relationship with the United Nations (CoNGO).

Contact Information
David St. John
dstjohn@cgfns.org

SOURCE: CGFNS International

HighTide Therapeutics Presents Analyses of a Phase 2 T2DM Study at the ADA Scientific Sessions, Highlighting Glycemic and Cardiometabolic Benefits of Berberine Ursodeoxycholate (HTD1801)

HighTide Therapeutics, Inc. (HKG: 2511), a clinical stage biopharmaceutical company specializing in the development of multi-targeted therapies for chronic liver and metabolic diseases, announced today that it will present at the American Diabetes Association’s (ADA) 84th Scientific Sessions, taking place from June 21-24, 2024 in Orlando, Florida. The presentation is a post-hoc analysis of the Phase 2 clinical study of berberine ursodeoxycholate (HTD1801), a gut-liver anti-inflammatory metabolic modulator, in patients with type 2 diabetes mellitus (T2DM) (NCT06411275).

Based on the successful Phase 2 study, two Phase 3 studies (NCT06350890, NCT06353347) are currently ongoing to further evaluate the efficacy and safety of HTD1801 (as monotherapy and as add-on to metformin) in patients with T2DM and inadequate control. “We look forward to the results of our pivotal T2DM program which we expect to announce in the first half of 2025,” said Dr. Leigh MacConell, Chief Development Officer of HighTide.

“Berberine Ursodeoxycholate (HTD1801) Improves Key Glycemic and Cardiometabolic Parameters Across the T2DM Disease Spectrum” (Abstract 847-P, Poster Presented June 23rd)
About the Abstract:
In a Phase 2, placebo-controlled, double-blind study in patients with T2DM, treatment with HTD1801 for 12 weeks resulted in significant dose-dependent improvements in key glycemic parameters. The objective of this post-hoc analysis was to evaluate the effectiveness of HTD1801 in patients with T2DM across the disease spectrum based on baseline HbA1c, with a particular emphasis on glycemic and lipid metabolism markers, along with indicators of liver injury. These data show that regardless of baseline disease severity, HTD1801 treatment resulted in significant improvements across these key parameters. The magnitude of improvement was greater in those with more severe disease. HTD1801 may offer a unique therapeutic approach for individuals with T2DM and other comorbidities (i.e. MASH and dyslipidemia), as managing these conditions effectively is crucial in controlling T2DM and reducing its associated complications.

About HighTide Therapeutics

HighTide Therapeutics, Inc. (2511.HK) is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional multi-targeted therapies with chronic liver and metabolic diseases with significant unmet medical needs. The company is developing multiple clinical assets, including therapy for metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes (T2DM), severe hypertriglyceridemia (SHTG), primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). Berberine ursodeoxycholate (HTD1801), the company’s lead drug candidate, received Fast Track designation from the U.S. FDA for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project.

Disclaimer
The information contained herein is based solely on events or data available as of the date of this document. Unless required by law, we are under no obligation to update or publicly revise any forward-looking statements or events beyond those anticipated, even if new information, future events, or other circumstances arise after the date of the forward-looking statement. Please review this document carefully and be aware that our actual future performance or results may significantly deviate from expectations. All statements in this document are made as of the publication date and may change considering future developments.

For more information, please visit www.hightidetx.com 
Contact: pr@hightidetx.com 

DC Healthcare’s Approve All Resolutions in AGM

DC Healthcare Holdings Berhad (“DC Healthcare” or the “Group”), an aesthetic medical services provider specialising in the provision of non-invasive and minimally invasive procedures, is pleased to announce the successful completion of its Second Annual General Meeting (“AGM”) held virtually on June 11, 2024. The AGM was conducted through Remote Participation and Voting facilities, allowing shareholders to actively participate and cast their votes on key resolutions.

Dr. Chong Tze Sheng, Managing Director of DC Healthcare
Dr. Chong Tze Sheng, Managing Director of DC Healthcare

During the AGM, shareholders approved all the resolutions including the adoption of the Audited Financial Statements for the year ended December 31, 2023. Key resolutions passed also involved the re-election of directors, ratification of directors’ fees, and the re-appointment of Messrs. Moore Stephens Associates PLT as the Company’s auditors.

Dr. Chong Tze Sheng, Managing Director of DC Healthcare expressed his gratitude to the shareholders, said, “We are incredibly thankful for the continued support and trust our shareholders place in us. This AGM not only reflects our commitment to transparency and robust corporate governance but also sets the path for our strategic initiatives aimed at enhancing service excellence and expanding our market presence. As we move forward, we remain dedicated to leveraging our strengths to drive sustainable growth and deliver value to all our stakeholders.”

Looking ahead, DC Healthcare is dedicated to strengthening its position in the medical aesthetics sector by implementing focused business strategies. These include expanding our clinics across Southern and Northern Malaysia, recruiting highly skilled and experienced staff, and continuously upgrading medical equipment with the latest technology to support growth and improve service quality. The Group remains optimistic about its future, bolstered by competitive advantages that are well-suited to drive sustainable growth in a dynamic market.

DC Healthcare Holdings Berhad https://dchealthcareholdings.com/ 

HighTide Therapeutics Presents Analyses of Phase 2a MASH Study at the 2024 International Liver Congress, Reinforcing and Further Characterizing the Efficacy and Safety of Berberine Ursodeoxcyholate (HTD1801)

HighTide Therapeutics, Inc. (HKG: 2511), a clinical stage biopharmaceutical company specializing in the development of multi-targeted therapies for chronic liver and metabolic diseases, announced that it will make multiple presentations at the European Association for the Study of the Liver (EASL) Congress, taking place from June 5-8, 2024 in Milan, Italy. The presentations include post-hoc analyses of the Phase 2a clinical study of berberine ursodeoxcyholate (HTD1801), a gut-liver anti-inflammatory metabolic modulator, in patients with metabolic dysfunction-associated steatohepatitis (MASH) and comorbid type 2 diabetes mellitus (T2DM) (NCT03656744).

“These data provide additional insight on the potential benefits of HTD1801, a novel, multifunctional therapy being developed for the treatment of patients with MASH and T2DM. The ongoing multi-regional Phase 2b study (CENTRICITY, NCT05623189), now fully enrolled, evaluates the histologic benefit of HTD1801 in this same patient population. We look forward to the results of CENTRICITY which is on track to read out in the first half of 2025,” said Dr. Leigh MacConell, Chief Development Officer of HighTide.

“Efficacy of Berberine Ursodeoxycholate (HTD1801) Compared to Ongoing Use of GLP-1 Receptor Agonists in Patients with MASH and T2DM” (Abstract SAT-227, Poster Presented June 8)

About the Abstract: As GLP-1 Receptor Agonists (GLP-1RAs) are prominently used in patients with T2DM and gaining attention as a potential treatment for MASH, this post-hoc comparative efficacy analysis evaluated ongoing GLP-1RA use compared to newly initiated HTD1801 treatment. This analysis suggests that HTD1801 provides greater benefit across multiple cardiometabolic endpoints compared to ongoing GLP-1RA use. These findings are important as they suggest that patients with MASH and T2DM, on concomitant GLP-1RA treatment, could achieve additional benefit with HTD1801 in terms of further glucose and lipid lowering as well as weight loss.

“Berberine Ursodeoxycholate (HTD1801) Provides a Unique Therapeutic Approach for Patients with Metabolic Liver Disease and Severe Insulin Resistance” (Abstract SAT-225, Poster Presented June 8)

About the Abstract: Insulin resistance is a significant risk factor for T2DM, obesity and MASH. HTD1801 enhances the utilization of glucose and fats through activation of AMP-activated protein kinase (AMPK), thereby improving insulin sensitivity. As HTD1801 is under development as a treatment for patients with MASH and T2DM, the objective of this post-hoc analysis was to evaluate the effects of HTD1801 based on degree of insulin resistance. These data demonstrate that HTD1801 can alleviate the metabolic inhibitory effects caused by hyperinsulinemia, leading to even greater metabolic benefits in patients with MASH and more severe insulin resistance and therefore may offer a unique therapeutic approach for individuals with MASH and T2DM.

“Time Course of Onset, Incidence, and Prevalence of Gastrointestinal Adverse Events with HTD1801 (Berberine Ursodeoxycholate) in Patients with MASH and T2DM” (Abstract SAT-243, Poster Presented June 8)

About the Abstract: The most commonly occurring adverse events (AEs) in studies of HTD1801 across several indications have been mild to moderate gastrointestinal (GI) AEs, primarily diarrhea and nausea. The purpose of this post-hoc analysis was to characterize the time course and severity of GI AEs in patients with MASH and T2DM treated with HTD1801 for 18 weeks. Diarrhea and nausea, the most commonly occurring of GI AEs, followed a trend that was consistent with all reported GI AEs; they showed early onset (within the first 4 weeks), were mild or moderate in severity, and importantly, showed a decreasing incidence and prevalence over the course of treatment. These data demonstrate that with continued treatment with HTD1801, GI tolerability improves supporting its potential for long-term use for the treatment of chronic disease, such as MASH.

About HighTide Therapeutics

HighTide Therapeutics, Inc. (HKEX: 2511) is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional multi-targeted therapies with chronic liver and metabolic diseases with significant unmet medical needs. The company is developing multiple clinical assets, including therapy for metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes (T2DM), severe hypertriglyceridemia (SHTG), primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). Berberine ursodeoxycholate (HTD1801), the company’s lead drug candidate, received Fast Track designation from the U.S. FDA for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project.

Disclaimer
The information contained herein is based solely on events or data available as of the date of this document. Unless required by law, we are under no obligation to update or publicly revise any forward-looking statements or events beyond those anticipated, even if new information, future events, or other circumstances arise after the date of the forward-looking statement. Please review this document carefully and be aware that our actual future performance or results may significantly deviate from expectations. All statements in this document are made as of the publication date and may change considering future developments.

For more information, please visit www.hightidetx.com.

Contact: pr@hightidetx.com 

New Research Launched at BIO24 Finds CROs with In-house Regulatory Affairs Deliver 30% Savings, Halve Timelines and Cut Risk for Biotechs

Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, is sharing new data at BIO 2024 from Frost & Sullivan research showing biotechs save more than 30% in costs and halve start-up times with CROs that have in-house scientific and regulatory affairs.

Meet the team at BIO 2024 Booth #5601

DOWNLOAD THE REPORT HERE

According to the report key benefits for biotechs with CROs that have in-house scientific and regulatory affairs included:

  • Decrease trial startup timelines by up to 50% by supporting sponsors in preparing the study protocols, reviewing essential documents and prepping site for activation. 
  • Reduced compliance risk and achieve zero errors by preparing necessary regulatory documents, compile submission dossiers and manage responses with regulatory authorities 
  • Decreased cost to sponsors by up to 30% by enabling sponsors to leverage benefits of full-service CRO services and avoiding standalone contracts with independent regulatory affairs agency. 

Avance Clinical’s Chief Scientific Officer Gabriel Kremmidiotis said some of the biotech services offered by the Avance Clinical in-house Scientific and Regulatory Affairs team included:

  • Regulatory Strategy Development: We devise regulatory strategies to navigate diverse regulatory landscapes, ensuring timely submissions and approvals. 
  • Liaison with Regulatory Authorities: We serve as the primary liaison between our clients and regulatory authorities, maintaining open lines of communication and addressing inquiries promptly.
  • Surrogate Development: Acting as a surrogate development department, we assist start-up companies in demonstrating safety and preliminary clinical proof of concept of their assets.
  • Streamlined Marketing Application: Our medium-term aim is to offer a streamlined and flexible marketing application experience to our clients through our fully integrated functions within SRMA, harnessing our comprehensive global expertise.
  • Adherence to GCP Standards: We utilize quality systems that uphold adherence to Good Clinical Practice (GCP) standards, safeguarding the integrity and ethical conduct of clinical trials. 

Avance Clinical recent news:

Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to later phase trials.

Avance Clinical CEO, Yvonne Lungershausen said “It’s clear there is a demand for a mid-sized, agile, and responsive CRO with an in-house regulatory affairs team, and a proven track record of swiftly advancing high-quality clinical programs”.

“Our Australian and New Zealand operations have been delivering successful early phase clinical trials for decades, while our European and North American operations as well as our new Asia operations makes us an ideal CRO partner for later phase biotechs that are seeking access to significant patient populations,” she said.

“Our global teams offer our biotech clients world-class quality data and seamless geographic expansions to accelerate their drug development programs and position for success.” 

“Avance Clinical’s study data is accepted by all the main regulatory authorities including the EMA and FDA.” 

“Biotechs are looking for a partner that can start fast with high-quality data that is readily accepted by the US FDA and other regulatory agencies. Backed by our in-house global regulatory affairs team, we can navigate biotechs through regulatory complexities with confidence including FDA, EMA, MFDS and TGA submissions,” she said.

“In addition, our GlobalReady Site Partnership Network of over 2,500 highly qualified sites across the globe ensures maximum efficiency and effectiveness for our biotech clients’ trials.”

Lungershausen said this is our GlobalReady program and we currently have more than 90 biotech clients leveraging this unique, streamlined multi-phase and multi-region process. “With a globalized strategy, we ensure efficiency every step of the way,” she said.

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Find out more:

  • Learn about the GlobalReady model
  • For more information about the benefits of running your next study with Avance Clinical contact us
  • Request a Proposal here

Media Contact:
Avance Clinical
media@avancecro.com 
Kate Thompson

About Avance Clinical

Avance Clinical is the largest premium full-service Australian and North American CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company’s clients are biotechs completing Phase I to Phase III of their drug development program that requires fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past four years, has been providing CRO services in the region for more than 26 years.

Pre-clinical through to mid to late phase
Avance Clinical offers pre-clinical services with their experienced ClinicReady team right from pre-clinical through to Phase III clinical services leveraging significant Australian Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 120 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology
Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners.

www.avancecro.com

Avance Clinical Expands Specialist CNS, Cardiometabolic, and Rare Diseases CRO Services in Europe with Julius Clinical

Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs has signed a Memorandum of Understanding (MOU) with Julius Clinical, a leading CNS, cardiometabolic, and rare diseases specialist CRO with extensive site relationships in the region.

Meet the Avance Clinical team at BIO 2024 – Book a meeting now.

Julius Clinical, established in 2008 and headquartered in Zeist, The Netherlands, specializes in CNS, cardiometabolic, and rare diseases. The non-exclusive MOU between Avance Clinical and Julius Clinical offers a streamlined global solution for biotech clients.

Avance Clinical CEO, Yvonne Lungershausen noted that Avance Clinical has expanded globally establishing operations now in Europe, Australia, New Zealand, Asia and North America.

She emphasized, “Avance Clinical is now a global CRO for biotechs. In addition to our existing operations, our specialist partner CROs work alongside our teams to ensure our biotech clients benefit from the most experienced scientific, regulatory, and clinical operations teams across various therapeutic areas and regions”.

“Julius Clinical are an ideal partner for Avance Clinical because they lead with scientific expertise and can support our biotech clients with specialist CNS, cardiometabolic and rare diseases clinical operations and site relationships in Europe,” Lungershausen said.

She added, “Julius Clinical clients can also leverage Avance Clinical operations in Asia, Australia, New Zealand, and North America for their expanded later phase trials”.

Julius Clinical has supported over 380 clinical trials, enrolling more than 220,000 participants in around 39 countries.

Lungershausen said that Avance Clinical teams across Europe, Australia, New Zealand, Asia, and North America provide world-class data and facilitate seamless geographic expansions to accelerate drug development programs, with study data accepted by regulatory authorities including the EMA and FDA. 

Martijn Wallert, CEO of Julius Clinical, added, “We are excited to be partnering with Avance Clinical. Biotechs seek partners that can start quickly with high-quality data accepted by regulatory agencies like the MHRA, EMA, and US FDA. Together with Avance Clinical, we offer a nimble, flexible, and scientifically robust service, providing a tailored global solution”.

Avance Clinical is committed to accelerating drug development for biotech clients from early to later phase trials, allowing clients to remain with one CRO throughout their clinical development program. “This is our GlobalReady program, currently utilized by more than 90 biotech clients. Our globalized strategy ensures efficiency at every step,” Lungershausen concluded.

Find out more:

  • Learn about the GlobalReady model
  • For more information about the benefits of running your next study with Avance Clinical contact us
  • Request a Proposal here

Media Contact:
Avance Clinical
media@avancecro.com 
Kate Thompson

About Avance Clinical
Avance Clinical is the largest premium full-service Australian and North American CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company’s clients are biotechs completing Phase I to Phase III of their drug development program that requires fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past four years, has been providing CRO services in the region for more than 26 years.

Pre-clinical through to mid to late phase
Avance Clinical offers pre-clinical consulting and regulatory services with their experienced ClinicReady team right from pre-clinical through to Phase III clinical services leveraging significant Australian Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 120 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology
Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners.

www.avancecro.com

About Julius Clinical
Julius Clinical, founded in 2008 and based in Zeist, The Netherlands, is a scientifically focused CRO providing end-to-end clinical trial service to pharmaceutical and biotechnology customers, as well as governments and academia. Julius Clinical’s renowned scientific leaders are at the forefront of their fields, which combine with operational excellence and a global network of research sites to deliver tailor-made solution for customers and their clinical trials. With a focus on the therapeutic areas of CNS, cardio-metabolic, renal, and rare diseases, Julius Clinical has grown to approximately 200 employees and has supported over 380 clinical trials, enrolling more than 220,000 participants in around 39 countries.

www.juliusclinical.com