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Asia Pacific Cell & Gene Research: Novotech is Growing 50% Faster than ROW

SYDNEY, AU, Feb 3, 2023 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific focused biotech specialist CRO and recipient of the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence award, said the number of cell & gene therapy trials in the region was growing 50% faster than ROW. The majority of trials are in oncology, specifically for blood cancers, viral infections, and solid tumors.Novotech, which has extensive experience in cell & gene therapy clinical trials, is sponsoring the 6th Annual Cell And Gene Therapy Innovation Summit in Berlin, Germany (15-16 February 2023).The company recently acquired EastHORN, a European CRO with clinical, medical and regulatory expertise in multiple strategically important locations across the continent. The acquisition is part of Novotech's global expansion program in Europe and the US.The acquisition means biotech clients can access Novotech's unique and unparalleled suite of early to late-phase CRO services across Europe and the US, with a specialist focus on Asia Pacific where the company has built a reputation for delivering high-quality expedited clinical trials. The latest data shows Asia Pacific is the fastest-growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies, with China leading in the region.The region already accounts for over a third of cell & gene therapy trial activity and shows a nearly 50% faster growth rate in cell & gene therapy trials compared to ROW between 2016 and 2021. China shows a 15% faster growth rate than the ROW. After oncology, the majority of cell & gene trials are in infectious diseases, CNS, and cardiovascular diseases.In addition, the Asia Pacific is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022.Novotech CEO Dr. John Moller said: "Cell & gene therapy research typically presents another level of complexity and regulatory processes which means an experienced CRO partner is vital. Our deep experience, exceptional site and investigator relationships - which also translates to patent access - our project management approach focused on problem-solving, ownership and flexibility, and our investments in data and technology combine to deliver the service biotechs need in this specialist sector for success."Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs, selected for the Asia-Pacific Contract Research Organization Company of the Year Award, and has signed 45 Leading Site Partnership agreements over the last 3 years.Download our latest data report:Evolution of Clinical Trials in the Asia Pacific Region Compared to the US and the EU5https://novotech-cro.com/whitepapers/evolution-clinical-trials-asia-pacific-region-compared-us-and-eu5About Novotech (Novotech-CRO.com)Novotech is internationally recognized as the leading Asia Pacific centred biotech Contract Research Organization (CRO) with global execution capabilities. Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services and FDA regulatory expertise and has experience in over 3,700 pre-clinical and clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US and Europe. Novotech has over 2,700 staff working across offices in 20 geographies. For more information visit https://novotech-cro.com/contactMedia ContactDavid Jamescommunications@novotech-cro.comAU: +61 2 8218 2144 USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2023 ACN Newswire. All rights reserved. (via SEAPRWire)

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Novotech presented with Cell & Gene Excellence Award 2022 at 6th Cell & Gene Therapy World Asia Conference

SYDNEY, AU, Sep 15, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific biotech specialist CRO, has been awarded the Cell & Gene Therapy Clinical Trials award at the 6th Cell & Gene Therapy World Asia 2022 conference.Novotech has extensive experience in cell & gene therapy clinical trials across Asia Pacific. The Asia Pacific accounts for over a third of cell & gene therapy trial activity with China being the leading location in APAC. In addition, APAC has nearly a 50% faster growth rate in cell & gene therapy trials than ROW. Blood cancers (ALL, NHL, DLBCL, lymphomas), solid tumors, viral infections, liver and gastrointestinal tract cancers are the top indications in China-based cell & gene therapy trials between 2016 and 2021.Watch our recent Endpoints News webinar for more information:EVOLUTION OF CELL & GENE THERAPY IN CHINA: THE CASE FOR UNIVERSAL CAR-Thttps://novotech-cro.com/webinars/evolution-cell-gene-therapy-china-case-universal-car-tThe award was presented to Novotech during the 6th Cell & Gene Therapy World Asia 2022 conference (14th - 15th September) at the Sheraton Towers, Singapore.Novotech CEO Dr. John Moller said, "We are extremely pleased our team has been recognized with this prestigious award at the 6th Cell & Gene Therapy World Asia 2022 conference. Cell & gene therapy is driving recent innovations in biotech and it is an honour to be recognized as the CRO at the forefront in Asia-Pacific supporting this vital clinical research. Cell & gene therapy research typically presents another level of complexity and regulatory processes which means an experienced CRO partner is vital. Our deep experience, exceptional site and investigator relationships - which also translates to patent access - our project management approach focused on problem-solving, ownership and flexibility, and our investments in data and technology combine to deliver the service biotechs need in this specialist sector for success."Novotech has recently also been benchmarked as a top 10 CRO among the world's leading CROs, and has signed 45 Leading Site Partnership agreements over the last 3 years.Download our latest data reports here:EVOLUTION OF CLINICAL TRIALS IN THE ASIA PACIFIC REGION COMPARED TO THE US AND THE EU5https://novotech-cro.com/whitepapers/evolution-clinical-trials-asia-pacific-region-compared-us-and-eu5About Novotech Novotech is the leading Asia-Pacific centered, globally capable, biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contactMedia ContactDavid JamesE: communications@novotech-cro.comAU: +61 2 8218 2144 USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

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Hitachi: Proton Therapy Provider Chosen for UW Health Eastpark Medical Center

MADISON, WI, Jul 27, 2022 - (JCN Newswire via SEAPRWire.com) - UW Health has selected Hitachi, Ltd. (TSE:6501, "Hitachi") to provide the infrastructure to support proton therapy at UW Health Eastpark Medical Center.Proton therapy equipment combined with Hitachi's 360° rotating gantry and Leo's upright systemHitachi will provide equipment and technology to support UW Health's traditional proton therapy room equipped with spot scanning irradiation technology, a 360 degrees rotating gantry with cone-beam CT(1), and Real-time image Gated Proton Therapy (RGPT)(2), as well as the revolutionary upright proton therapy coming to UW Health from Leo Cancer Care, according to Dr. Paul Harari, radiation oncologist, UW Health, and chair of the Department of Human Oncology, University of Wisconsin School of Medicine and Public Health."We're excited to reach this important milestone to offer state-of-the-art proton therapy at UW Health," Harari said. "It's particularly significant in linking together Hitachi, an experienced proton provider, a new technology from Leo Cancer Care and a major academic medical center with a track record of cutting-edge technology development and implementation, all working together on behalf of cancer patients."UW Health worked closely with Proton International, a consulting organization dedicated to connecting hospitals and physicians with proton specialists and developing state- of-the-art proton therapy facilities."The team at Proton International is excited to help UW Health bring this important technology to the people of Wisconsin," said Chris Chandler, CEO, Proton International. "We also believe that the Leo Cancer Care's upright treatment room is an important innovation that will help patients and we look forward to working on the project implementation.""We feel privileged that we were selected by UW Health, one of the top healthcare institutions in the nation," said Hiroyuki Itami, General Manager of the Smart Therapy Division of Hitachi. "We are also thrilled to partner with Leo Cancer Care and Proton International to achieve a new innovative proton therapy solution. Hitachi is committed to supporting people's quality of life through technical advancement."UW Health broke ground on Eastpark Medical Center in May and it is expected to open in 2024.(1) Cone beam CT provides three-dimensional anatomical images of patients, at isocenter immediately prior to being treated. Information on the location of bone is obtained from traditional orthogonal x-rays and the motion of tumors is captured by RGPT. These are then combined with the ability to identify healthy tissue surrounding a tumor, particularly the location and shape of soft tissue, via Cone beam CT.(2) RGPT allows real-time beam irradiation to the tumor while compensating for movement associated with respiration. This technology was collaboratively developed between Hokkaido University and Hitachi and supported by the Funding Program for World-Leading Innovative R&D on Science and Technology (FIRST) of the Japan Society for the Promotion of Science. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

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Shonan Kamakura Advanced Medical Center Begins Treatment with Hitachi’s First Dedicated Compact Proton Therapy System

TOKYO, Feb 2, 2022 - (JCN Newswire via SEAPRWire.com) - Hitachi, Ltd. (TSE: 6501) has announced that "Shonan Kamakura Advanced Medical Center" at Shonan Kamakura General Hospital of Tokushukai Medical Group, where Hitachi's compact proton therapy system (hereafter, "the system") has been installed, has commenced treatment with the system on 31 January 2022. This is the first order for Hitachi's dedicated compact proton therapy system.Proton Therapy SystemShonan Kamakura Advanced Medical Center is a medical facility providing comprehensive cancer treatment, including advanced radiotherapy, built adjacent to the site of Shonan Kamakura General Hospital by Tokushukai Group Medical Corporation, which operates approximately 400 medical facilities and nursing homes throughout Japan. Until now, there have been no proton therapy facilities in Kanagawa Prefecture, where the center is located, but the compact proton therapy system, with its reduced footprint, makes it possible to install a proton therapy facility on a limited site close to the city center.Features of the installed systemIn response to the growing worldwide demand for smaller proton therapy systems, Hitachi has developed the proton therapy system, which is specifically designed for a single treatment room. The system is a compact proton therapy system which, by optimizing the layout of the machine, reduces the installation area to about 70% of that of conventional solutions, making it possible to install the system on a limited site in an urban area and reducing the cost and time involved in its installation. It is equipped with advanced technologies such as spot scanning irradiation technology, which allows the proton beam to be delivered according to the shape of the cancer, a 360degree rotating gantry with cone-beam CT(1) for high-precision positioning, and Real-time image Gated Proton Therapy (RGPT)(2), making it both compact and highly functional.Hitachi is committed to accelerating the global development of particle therapy system and contributing to cancer treatment around the world, as well as to further expanding its healthcare services.(1) Cone beam CT provides three-dimensional anatomical images of patients, at isocenter immediately prior to being treated. Information on the location of bone is obtained from traditional orthogonal x-rays and the motion of tumors is captured by RGPT. These are then combined with the ability to identify healthy tissue surrounding a tumor, particularly the location and shape of soft tissue, via Cone beam CT.(2) RGPT allows real-time beam irradiation to the tumor while compensating for movement associated with respiration. This technology was collaboratively developed between Hokkaido University and Hitachi, and supported by the Funding Program for World-Leading Innovative R&D on Science and Technology (FIRST) of the Japan Society for the Promotion of Science.Overview of Particle TherapyParticle Therapy is an advanced type of cancer radiotherapy. Protons extracted from hydrogen atoms, or carbon ions are accelerated up to 70% of the speed of light. This energy is concentrated directly on the tumor while minimizing radiation dose to surrounding healthy tissue. Particle therapy improves the quality of life for cancer patients since the patient experiences no pain during treatment and the procedure has very few side effects compared to that of traditional radiotherapy. In most cases, patients can continue with their normal daily activities while undergoing treatment.About Hitachi, Ltd.Hitachi, Ltd. (TSE: 6501), headquartered in Tokyo, Japan, contributes to a sustainable society with a higher quality of life by driving innovation through data and technology as the Social Innovation Business. Hitachi is focused on strengthening its contribution to the Environment, the Resilience of business and social infrastructure as well as comprehensive programs to enhance Security & Safety. Hitachi resolves the issues faced by customers and society across six domains: IT, Energy, Mobility, Industry, Smart Life and Automotive Systems through its proprietary Lumada solutions. The company's consolidated revenues for fiscal year 2020 (ended March 31, 2021) totaled 8,729.1 billion yen ($78.6 billion), with 871 consolidated subsidiaries and approximately 350,000 employees worldwide. For more information on Hitachi, please visit the company's website at https://www.hitachi.com. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

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Hitachi Selected by the University of Tsukuba for its Second Proton Therapy System as a PFI Project

TOKYO, Nov 22, 2021 - (JCN Newswire via SEAPRWire.com) - Hitachi, Ltd. (TSE: 6501) announced today that it has been selected by the University of Tsukuba to provide Hitachi's proton therapy solution including its design, manufacturing, construction, maintenance and operation as a PFI (Private Finance Initiative) project*. The parties have signed the contract on September 30, 2021. The new proton therapy center will be equipped with Hitachi's compact design proton therapy system, including a set of one accelerator and two rotating gantry treatment rooms. The new therapy center is expected to start treating patients around the summer of 2025, followed by a 20-year period of operation and maintenance support by Hitachi.Image of New Proton Therapy Center; The new center is on the left of existing siteThe University of Tsukuba has been using Hitachi's proton therapy system since 2001. After 20 years of operation, due to aging facilities, the university has determined to introduce a 2nd unit. Upon completion and opening of the new proton therapy center, the University of Tsukuba will shift its treatment from the existing center to the new center. This is the first time in Japan for a particle therapy system provider to receive a 2nd unit order from an existing facility.*PFI (Private Finance Initiative) project: Method for utilizing private funds, management skills, and technology in order to construct, operate, and maintain public facilities, etc.Background and InsightThe University of Tsukuba has been practicing cancer treatment using a proton accelerator since 1983, as a worldwide pioneer. In 2001, the University of Tsukuba adopted Hitachi's proton therapy system and has provided proton therapy to approximately 6,000 cancer patients to date. Hitachi will establish a new proton therapy facility through a strong partnership with the University of Tsukuba which is aiming to be a base for further development of research, education, and treatment for radiotherapy that represents not only Japan, but also the world. In addition, Hitachi and the University of Tsukuba will carry out a joint research program on treatment technologies for pediatric cancer, and tumors of respiratory moving organs (migratory tumors) such as liver and lung cancer. Through this project, Hitachi will contribute to treatment that is gentle to children and the elderly, as well as the maintenance and improvement of patients' quality of life after treatment.In addition, Hitachi will accelerate the global expansion of particle cancer treatment systems and contribute to the further development of minimally invasive cancer treatments.Overview of Particle TherapyParticle Therapy is an advanced type of cancer radiotherapy. Protons extracted from hydrogen atoms, or carbon ions are accelerated up to 70% of the speed of light. This energy is concentrated directly on the tumor while minimizing radiation dose to surrounding healthy tissue. Particle therapy improves the quality of life for cancer patients since the patient experiences no pain during treatment and the procedure has very few side effects compared to that of traditional radiotherapy. In most cases, patients can continue with their normal daily activities while undergoing treatment.About Hitachi, Ltd.Hitachi, Ltd. (TSE: 6501), headquartered in Tokyo, Japan, contributes to a sustainable society with a higher quality of life by driving innovation through data and technology as the Social Innovation Business. Hitachi is focused on strengthening its contribution to the Environment, the Resilience of business and social infrastructure as well as comprehensive programs to enhance Security & Safety. Hitachi resolves the issues faced by customers and society across six domains: IT, Energy, Mobility, Industry, Smart Life and Automotive Systems through its proprietary Lumada solutions. The company's consolidated revenues for fiscal year 2020 (ended March 31, 2021) totaled 8,729.1 billion yen ($78.6 billion), with 871 consolidated subsidiaries and approximately 350,000 employees worldwide. For more information on Hitachi, please visit the company's website at https://www.hitachi.com. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

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Topelia Australia launches US$25M Series A call for COVID-19 ATT Ziverdox

SYDNEY, Oct 14, 2021 - (ACN Newswire via SEAPRWire.com) - Topelia Australia, a biotech company established to commercialise a novel ATT treatment for Australians in quarantine, has launched an investment program designed to keep the invention Australian owned - while rolling out treatment to the world.Prof Thomas Borody- Topelia announces US$25 mil Series A capital raise to fund manufacture and clinical trials of the COVID-19 Antiviral Triple Therapy (ATT).- Topelia has secured exclusive global patent rights to COVID-19 Antiviral Triple Therapy from Prof Thomas Borody.- Borody's track record includes effective treatment for Peptic Ulcers & Crohn's Disease, recolonisation of bowel microbiome, and 3 FDA approved drugs on the market.- Based on current research, the ATT provides an inexpensive and medically efficacious treatment for the prevention and early treatment of COVID-19.The company is raising USD$25 million from investors in Australia, Asia and USA. The company said: "Topelia proposes to offer the ATT treatment alongside the current vaccination program to treat and vaccinate our way out of this pandemic. As Australia comes out of lockdowns and countries around the world experience spikes in cases, it is vital to fast-track the production of a safe early antiviral medical treatment kit.The novel Antiviral Triple Therapy, to be branded as Ziverdox, comprises TGA-approved medications prescribed for decades with exceptional safety profiles. COVID-19 will be with us for some time so even vaccinated people with breakthrough Covid-19 infections can benefit from ATT to prevent long-COVID associated lung, brain and organ damage."The company says it is pleased the Australian Government is supportive of early at-home treatments. The Government has recently invested in an experimental early antiviral drug candidate which may be available early next year if the safety profile and clinical research allows for TGA approval.Purpose of proposed Series A fundingThe investment will finance:- Preparation of a Literature-Based Submission to the TGA to gain approval;- Clinical trials to prove efficacy of both treatment and prevention regimens;- Sourcing of ATT components and manufacture of compliance enhancing packaging;- Liaison with the TGA for marketing approval including TGA fees, consultant fees, scale-up of manufacturing and distribution costs;- Following TGA approval, product launch costs for the ATT pack called Ziverdox.About Topelia Aust Pty LtdTopelia Australia was founded based on the wealth of experience in commercialising the ground-breaking triple therapy cure for peptic ulcers which has saved over 18 thousand lives in Australia alone. This innovation has also saved the Australian Government more than $10 billion in medical costs associated with peptic ulcer surgery and hospitalisations. Professor Borody has more than 190 patents and applications, 3 FDA-approved drugs on the market, and more than 300 peer-reviewed papers published. Topelia Australia owns the patent rights to the novel Antiviral Triple Therapy. Visit https://TopeliaAustralia.com.Media contact: Info@TopeliaAustralia.comInvestor contact: Investor@TopeliaAustralia.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

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Eisai and Biogen Inc. Announce U.S. FDA Grants Breakthough Therapy Designation for Lecanemab (BAN2401)

TOKYO, Jun 24, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of Alzheimer's disease (AD). Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions. The benefits of a Breakthrough Therapy designation include more intensive guidance on an efficient development program as well as eligibility for rolling review and potentially priority review. The FDA's Breakthrough Therapy designation for lecanemab is based on the recently published results of a Phase 2b clinical trial (Study 201) of 856 patients with mild cognitive impairment (MCI) due to AD and mild AD with confirmed presence of amyloid pathology.1 The proof-of-concept Study 201 explored the impact of treatment with lecanemab on reducing brain amyloid beta (Abeta) and clinical decline. In this study, pre-specified analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses.In March 2021 Eisai and Biogen completed enrollment of 1,795 patients with early AD in the the Phase 3 Clarity AD study. The study's primary endpoint is expected to be completed by the end of September 2022. Additionally, the Phase 3 clinical study, AHEAD 3-45, is currently exploring lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains. Open label extension data from Study 201 confirmed time-dependent reduction of brain Abeta in individuals newly treated with lecanemab and was presented at the 2021 Alzheimer's Disease and Parkinson's Disease Conference. 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 any investigational uses of such product will successfully complete clinical development or gain health authority approval.For more information, visit: https://www.eisai.com/news/2021/news202151.html. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

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