Avance Clinical, the largest premium Australian Contract Research Organisation (CRO) for international biotechs, has been selected as a finalist for the Best Contract Research Organization in APAC by Informa Pharma Intelligence. Avance Clinical has undergone significant expansion in recent years, including new offices in Sydney and Melbourne to accommodate the growing clinical team in Australia.
The award winner will be announced on 1 September 2022. The finalists are: – Avance Clinical – Calyx – CMIC Group – EPS – ICON – Parexel – Syneos Health
Avance Clinical’s CEO Yvonne Lungershausen said:
“Avance Clinical is extremely pleased to be selected as a finalist for this prestigious award. It is a credit to our amazing customer-focused team for delivering the CRO excellence that has been recognized by the Informa Pharma Intelligence award judges.
“Avance Clinical has a global reputation for agile clinical solutions to support accelerated clinical development for our international biotech clients. We are very proud of our growth and success in APAC in recent years.”
According to Informa Pharma Intelligence:
This Award is to recognize CROs that provide full or specialist services to their clients and which have an office in either in Japan or the Asia region including Australia.
Judging considers the quality of services and relationships built with clients and pays particular attention to the innovative patient recruitment strategies the CRO has brought to the table.
The award is based on achievements in the 2021 calendar year.
Core areas judged include: – The particular capabilities and strengths the CRO offers – How the company has delivered results that exceed sponsor expectations – Innovations in patient recruitment strategy has the CRO brought to its partner – How it has improved its performance, for example, in its quality of data, timelines and transparency – The steps the company is taking towards streamlining data collection and reporting
To find out more please visit: https://pharmaintelligence.informa.com/events/awards/japan-awards-2022/shortlist-2022
Avance Clinical recently secured a significant investment from global private equity firm, The Riverside Company (Riverside), to support further regional and global expansion. The investment values the company in excess of $200m.
“With the support of Riverside and its powerful global footprint and deep healthcare experience, Avance Clinical will execute on its regional and international expansion plans organically and via acquisitions,” said Lungershausen.
Avance Clinical is the Australian-owned CRO that provides global regulatory standard clinical research services across all phases to the local and international biopharma industry.
The company is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) which has allowed it to expand into clinical trials for vaccines and GMO therapies.
“We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biopharma clients require in this fast-moving, competitive and high-stakes sector,” said Lungershausen.
Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.
Find out more: – Learn about the Australian Advantage here https://www.avancecro.com/the-australian-advantage/ – Read more about Avance Clinical’s cell and gene therapy capabilities here www.avancecro.com/avance-clinical-featured-in-endpoints-news-on-cell-gene-therapy-capabilities/ – For more information about the benefits of running your next study with Avance Clinical contact us: enquiries@avancecro.com
About Avance Clinical
Avance Clinical is the largest premium full-service Australian CRO delivering quality clinical trials, with globally accepted data, in Australia and New Zealand for international biotechs. The company’s clients are biotechs in their early phases of drug development that need 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 two years, has been providing CRO services in the region for 24 years.
Pre-clinical through to Phase 1 and 2 Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.
With experience across more than 105 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, and Medrio are just some of the technology partners.
Media Contacts: Avance Clinical Chris Thompson media@avancecro.com
Clinical PURSUIT has leveraged Enterprise Solutions to optimize data integration and flow in their Electronic Data Capture Software (EDC). Enterprise Solutions use privately hosted server environments with redundancy for data storage, making it easier to organize data access and operations management.
By incorporating their advanced enterprise solutions into their EDC software, Clinical PURSUIT has converted its EDC into an EDC-CTMS (Clinical Trial Management Software) hybrid. The reason is that the software can now access trial schedules, drug supply information, treatment plans, etc., match them to data capture, and automatically update fields with relevant information.
These intelligent data transfers and updates allow researchers to generate trial reports and analytics with a single click instead of manually organizing information to achieve the same results.
About Clinical Pursuit
ClinicalPURSUIT (https://clinicalpursuit.com/) has been in the industry for over 20 years and is renowned for its innovative clinical trial data management and patient registry solutions. It has a diverse team of experts who leverage its competencies to develop multi-dimensional technological solutions for clinical trials.
Their clinical trial management solutions have user-friendly interfaces, simplified dashboards, and consolidated data controls, enabling researchers to spend less time on routine tasks. It makes the clinical trial run efficiently and gives researchers more time to consider alternate approaches for developing treatments.
– Rapid Study Development – Streamlined EDC Data Management – Intelligent Electronic Data Capture (EDC) – Electronic Patient-Reported Outcomes (ePro) – Enterprise Clinical Electronic Data Capture – Patient Registry
Significance of Enterprise Clinical Electronic Data Capture
Clinical trials gave three key areas that require data optimization:
– Data Capture – Data Management – Drug Supply Management
Clinical EDC software was initially designed to manage only data capture. However, the Clinical PURSUIT team has used creativity and innovation to make their EDC a hybrid system that contains all three features for clients who need such solutions.
Their Enterprise Clinical Electronic Data Capture connects their data capture software to trial management software, thus optimizing data monitoring. The system automatically updates relevant categories after capturing treatment response data, making it easy for researchers to monitor and manage trial updates from a single dashboard.
This simplified control makes the process significantly efficient and reduces the time it takes researchers to conclude trials.
Company Contact Information
ClinicalPURSUIT offers clinical trial management and data management solutions to organizations involved in clinical research. More information about the business is available on their website (https://clinicalpursuit.com/).Inquiries can also be made by emailing PR@clinicalpursuit.com or calling 877-791-4367.
ClinicalPURSUIT Jim Harris 877-791-4367 https://clinicalpursuit.com
Since February 2020, when Suntrap Life Technologies Ltd established a COVID-19 project for drug discovery, the Suntrap research team has evaluated and prudently predicted the characteristics of COVID-19. Utilizing the proprietary S-CPDD drug design and discovery system and IDDNU(R) (International Drug Design Network Union) platforms in accordance with scientific laws of drug discovery, Suntrap’s research team has tracked and analyzed the pathological characteristics, clinical needs, pathogenesis research and social demands of patients. In terms of the determination of the direction of drug research and development (R&D), COVID-19 drug related targets acquisition, molecular design and screening, and preclinical verification, the new drug R&D in the Suntrap research team is fully guided by clinical values. It will be standard for the Suntrap team to quickly transform biomedical research into industrial products, and ultimately develop new pharmaceutical products that benefit the public, thus realizing the fundamental significance of new drug R&D.
The Suntrap team believes that the prevention and treatment of COVID-19 should focus on the development of multi-targeted and broad-spectrum anti-coronavirus drugs.
In May 2020, the Suntrap research team identified a lead compound “LeSoleil-T” through a series of bioassays, which showed anti-coronavirus activities with multi-targets inhibition effects. Further studies revealed that the multi-targets design properties of LeSoleil-T could meet the demands of broad-spectrum anti-coronavirus.
In view of the inhibitory effects of LeSoleil-T against SARS-CoV-2, the pharmacological mechanisms of LeSoleil-T were explored through a series of experimental assays. The results showed that LeSoleil-T has pharmacological effects in the treatment of SARS-CoV-2 infection as the following: broad-spectrum anti-coronavirus inhibitory effects, anti-inflammatory effects, neuron protections, delay and reversal of tissue fibrosis.
Based on the above results, the Suntrap team has obtained the Chinese invention patent authorization for the broad-spectrum anti-coronavirus in January 2021, and has filed international patent applications through the PCT, and applied for patent protection in many countries and regions.
According to clinical investigations, upon SARS-CoV-2 infection, the levels of the neutrophil count, D-dimer, blood urea and creatinine in patients will increase continuously, while the count of lymphocytes will continue to decline until death. The Suntrap team found that LeSoleil-T could eliminate inflammation induced by SARS-CoV-2 infection. The anti-inflammatory effects of LeSoleil-T are mainly to inhibit proinflammatory factor expression and reduce oxidative stress responses. Firstly, LeSoleil-T can inhibit neutrophil aggregation to reduce the production of 4-HNE (4-hydroxynonenal) by oxidative stress response, which leads to the reduction of the lipid peroxidation end-product formation, and finally, contribute to its anti-inflammatory activity. Secondly, LeSoleil-T directly inhibits the expression of proinflammatory factors (e.g., Tnf-α, IL-1β, IL-6, Mcp-1, Mcp-2, and Mip-1α). Finally, it activates the interactions among PGC-1α (Peroxisome proliferator-activated receptor-γ coactivator), Nrf1 (Nuclear Respiratory Factor 1) and Nrf2 (Nuclear Respiratory Factor 2) to regulate the mitochondrial synthesis, respiration, and various antioxidant enzymes. Meanwhile, the Nrf2/ARE (antioxidant response element) complex scavenges free radicals by regulating the expression of HO-1 (heme oxygenase-1).
Based on the clinical symptoms and pathogenic mechanism of patients infected with SARS-CoV-2, the Suntrap research team optimized and developed different clinical protocols. The basic formulation was completed in November 2020.
The LeSoleil broad-spectrum anti-coronavirus protective and therapeutic spray is portable and easy to use. It effectively prevents healthy people from infection and blocks the spread of SARS-CoV-2 from asymptomatic and mild COVID-19 patients. LeSoleil broad-spectrum anti-coronavirus protective and therapeutic spray can cope with the prevention and treatment of SARS-CoV-2 and variant strains (e.g., Delta and Omicron.). In addition, the preclinical study conducted by the Suntrap team revealed that LeSoleil can also be used for upper respiratory tract infections caused by influenza viruses and mutant strains (e.g., H1N1, H5N1, H7N1, H7N2, H7N3, H7N7, H7N9, H9N2 and H10N8). The new corresponding symptoms still need to be verified by clinical research.
The COVID-19 pandemic has continued for nearly two years. Mutant strains are constantly emerging, and the global incidence rate continues to rise. To date, the Suntrap research team has achieved a certain degree of breakthrough in the design of multi-target anti-coronavirus drugs. It is necessary to accelerate the clinical verification and strengthen cooperation. To further in-depth clinical research of LeSoleil anti-SARS-CoV-2 drugs, and deter COVID-19 as an obstacle for social stability, economic development and human health, Suntrap recruits qualified clinical research institutions around the world to carry out clinical revalidation studies on the efficacy of the LeSoleil broad-spectrum anti-coronavirus drug series against mutant strains of SARS-CoV-2.
Consult www.suntrap.com or search for “IDDNU” and “Suntrap” for related reports.
Eisai Co., Ltd. and Biogen Inc. announced today results of sensitivity analyses evaluating the consistency of lecanemab efficacy results across multiple statistical models in patients with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD). This presentation was made by Eisai at the 2021 Clinical Trials on Alzheimer’s Disease (CTAD) conference, November 9-12, 2021 in Boston, Massachusetts and virtually.
In September 2021, Eisai initiated a rolling submission of a Biologics License Application (BLA) for lecanemab, an investigational anti-amyloid beta protofibril antibody, for the treatment of early AD, to the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway.
Study 201, a multicenter, double-blind, placebo-controlled, Phase 2b trial conducted in 856 patients with early AD, evaluated key efficacy assessments, including clinical change on the Alzheimer’s Disease Composite Score (ADCOMS) at the primary endpoint of 12 months and at select key secondary endpoints, Clinical Dementia Rating-Sum-of-Boxes (CDR-SB) and Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) at 18 months. Six sensitivity analyses across four statistical models (mixed model for repeated measures, disease progression model, natural cubic spline model, and quadratic mixed model) showed consistent positive lecanemab treatment effects for ADCOMS, CDR-SB and ADAS-Cog14 at 18 months.
The primary endpoint was Bayesian analysis of 12-month clinical change on ADCOMS with the goal to identify the most efficacious dose (ED90 dose). Primary analysis was super-superiority over placebo by ≥25%: goal was 80% probability of >/=25% reduction in decline versus placebo. Study achieved the goal of identifying smallest dose that achieved ≥90% of maximum treatment effect (10 mg/kg biweekly), i.e., the ED90 dose. At 12 months, ED90 dose had 64% probability of being super-superior to placebo by 25% reduction. At 12 months, ED90 dose had 98% probability superior to placebo. Consistent treatment effect was observed at 18 months for ADCOMS (29% to 37%), CDR-SB (26.5% to 35%), and ADAS-Cog (47% to 56%), with separation from placebo observed by six months for the top dose (10mg/kg biweekly) across all analyses.
“In Study 201, lecanemab showed robust clearance of brain amyloid and slowing of clinical decline across several clinical and biomarker endpoints. This sensitivity analysis shows lecanemab clinical efficacy results across statistical models are consistent, reliable and further enhances our confidence in the clinical potential of this investigational therapy,” said Michael Irizarry, M.D., Vice President, Deputy Chief Clinical Officer, Neurology Business Group, Eisai Inc. “Through our comprehensive research program, we will continue to advance the understanding of how this anti-amyloid beta protofibril antibody may play a role in the treatment of early and preclinical AD. In March 2021, Eisai completed enrollment of 1,795 patients with early Alzheimer’s disease in our confirmatory Phase 3 Clarity AD clinical study. The Phase 3 clinical study, AHEAD 3-45, is currently exploring lecanemab’s safety and efficacy in individuals with preclinical AD.”
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agent will successfully complete clinical development or gain health authority approval.
For more information, visit https://www.eisai.com/news/2021/news202187.html.
The largest Australian full-service CRO for international biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical today congratulated client Tetherex Pharmaceuticals on first patient dosing for its Phase 1 vaccine clinical trial. Tetherex Pharmaceuticals, Inc. is a privately held, clinical stage biopharmaceutical company focused on development of selectin inhibitor therapeutics for the treatment of a broad range of inflammatory diseases and single-cycle adenovirus vaccines for multiple infectious diseases and cancer indications.
Avance Clinical Chief Scientific Officer Dr Gabriel Kremmidiotis said:
“The exciting aspect of the Tetherex product is the potential to vaccinate using a nasal spray. Administering the vaccine via the same route that the virus uses to get into our bodies, may result in more effective protection compared to the first generation Covid-19 vaccine products currently being administered as injectables. Commencement of dosing with the Tetherex Covid-19 vaccine product constitutes a major achievement for the Avance Clinical team who played a key role in supporting Tetherex in gaining regulatory approval to conduct the First-in-Human trial with their exciting vaccine candidate.”
According to Tetherex Pharmaceutical’s announcement:
Tetherex Pharmaceuticals has executed an exclusive worldwide license with Mayo Clinic for the development and commercialization of a novel single-cycle adenovirus vaccine platform. The platform will be used to target multiple infectious diseases, beginning with a Phase 1 clinical study investigating a vaccine for COVID-19. Dosing of the initial cohort of the Phase 1 study is underway in Australia.
“Current adenovirus vaccines under investigation for COVID-19 and other infectious diseases are highly restricted in the amount of vaccine antigen they can deliver to cells,” said Dr. Russell Rother, President and Chief Operating Officer of Tetherex. “The single-cycle adenovirus platform allows one round of robust vaccine antigen expression to occur without the generation of infectious virus particles which, in preclinical models, translates to a marked improvement in the ensuing immune response.”
About the Single Cycle Adenovirus Vaccine Platform
The single-cycle adenovirus platform was developed to enhance the expression of target antigens, amplifying immune responses to infectious disease targets. Preclinical studies have demonstrated that the single-cycle adenovirus can increase target antigen expression up to 100-fold over currently utilized replication defective adenovirus vaccines. Intranasal administration of single-cycle vaccine elicits both systemic and mucosal immune responses. A mucosal response allows the immune system to encounter respiratory viruses like SARS-CoV-2 at the site of entry while the viral titers are lower. The platform also provides a robust manufacturing and supply chain paradigm relative to other vaccine platforms, such as mRNA.
Tetherex’s Phase 1 open label study, designed to assess safety, reactogenicity and immunogenicity of the single-cycle adenovirus vaccine, is expected to recruit a total of approximately 80 healthy volunteers and includes both a single ascending dose group and a multiple dose group. Subjects will receive the vaccine via either intramuscular or intranasal administration.
The study site is Nucleus Network in Brisbane, and Dr Paul Griffin Nucleus Network’s Principal Investigator said:
“The covid 19 global pandemic continues to impact lives around the world. We are very fortunate to have developed a number of vaccines for Covid-19 already that are safe and highly effective. These vaccines are beginning to give us the capacity to start to reduce the impact of this viral infection, however it’s clear there are certain properties of these vaccines that we would ideally like to improve upon such as having a vaccine that could be given via a route other than needle and syringe and perhaps a vaccine that could further reduce the ability for a vaccinated individual to become infected in the first place, a so called transmission blocking vaccine. A vaccine given intranasally has the potential to achieve some of these objects hence I am very excited to be the principal Investigator on the Tetherex clinical trial.”
“The addition of this novel vaccine platform to the Tetherex portfolio significantly expands our ability to leverage our scientific and clinical development expertise and broadens our overall technology base. This reduces risk to our investors while providing the potential of significant upside,” said Dr. Scott Rollins, Chairman and Chief Executive Officer of Tetherex. “The platform will be utilized to target multiple infectious diseases which allows Tetherex to seek partnerships and alliances for the ever-expanding infectious disease marketplace.”
About Avance Clinical
Avance Clinical is the largest full-service Australian CRO focussed on delivering quality clinical trials in Australia and New Zealand for international biotechs. Avance Clinical has been delivering CRO services in the region for the past 24 years. Avance is accredited by the office of the gene technology regulator (OGTR) and has experience with the level of complexity involved in the granting of licenses from OGTR. This accreditation allows Avance to take responsibility, on behalf of clients, for the execution of trials which involve genetically modified organism products.
The company’s clients are international biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services. Avance Clinical delivers customised solutions designed around specific client needs rather than a one size fits all approach. As a company Avance Clinical has focused on state-of-the-art technology and systems across all functional areas to provide clients with the most effective processes.
Medidata, Oracle, and Medrio are just some of our technology partners. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of candidates who demonstrate passion and expertise in their chosen field. Visit http://www.avancecro.com for more information.
Recent Awards: Excellence in Business Award 2021 Frost & Sullivan Asia-Pacific CRO Market Leadership Award 2020
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