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China Pharma Holdings, Inc. Announced the Completion of Third Party Testing of Dry Eye Disease Therapeutic Device

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HAIKOU, China, Nov. 29, 2023 /PRNewswire/ — China Pharma Holdings, Inc. (NYSE American: CPHI) ("China Pharma", or the "Company"), an NYSE American-listed corporation with a fully-integrated specialty pharmaceuticals subsidiary based in China, today announced that its Dry Eye Disease (DED) therapeutic device has passed third-party testing and is preparing to apply for market launch to the National Medical Products Administration (NMPA) of China.

According to a disclosure by the Shanghai Public Health Clinical Center on June 6, 2023, an epidemiological survey of DED showed that approximately 344 million patients are suffering from DED worldwide, accounting for 30% of the total number of ophthalmic outpatient visits, with an annual increase of 10%. There are about 80 million DED patients in China, ranking second in ophthalmic diseases.

This device has a utility model patent; Epidemiological research shows that the incidence rate of DED for all the  people in China is about 25% to 30%, and about 75% for people over 65-year-old; In the field of DED and visual fatigue, this product is expected to fill in the market gap of medical therapeutic apparatus; and The Company has established sales channels in more than 30 provincial and municipal hospitals, as well as OTC markets in China for more than 20 years. This sales network may strongly support the launch and promotion of this device.

Ms. Li Zhilin, CEO of China Pharma said: " After passing third-party testing, this product has obtained qualifications to apply for market approval from NMPA. We are actively working to try to launch this product in the first half of next year. We are confident that with the patented technological advantages and our sales channels, the launch of this product will bring excellent treatment experience to every DED patient, which will create value for our shareholders."

About China Pharma Holdings, Inc.

China Pharma Holdings, Inc. is a specialty pharmaceutical company that develops, manufactures and markets a diversified portfolio of products, focusing on conditions with high incidence and high mortality rates in China, including cardiovascular, CNS, infectious, and digestive diseases. The Company’s cost-effective business model is driven by market demand and supported by new GMP-certified product lines covering the major dosage forms. In addition, the Company has a broad and expanding nationwide distribution network across all major cities and provinces in China. The Company’s wholly-owned subsidiary, Hainan Helpson Medical & Biotechnology Co., Ltd., is located in Haikou City, Hainan Province. For more information about China Pharma Holdings, Inc., please visit www.chinapharmaholdings.com. The Company routinely posts important information on its website.

Safe Harbor Statement

Certain statements in this press release constitute forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Any statements set forth above that are not historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties may include, but are not limited to: the achievability of financial guidance; success of new product development; unanticipated changes in product demand; increased competition; downturns in the Chinese economy; uncompetitive levels of research and development; and other information detailed from time to time in the Company’s filings and future filings with the United States Securities and Exchange Commission. The forward-looking statements made herein speak only as of the date of this press release and the Company undertakes no duty to update any forward-looking statement to conform the statement to actual results or changes in the Company’s expectations, except as required by applicable law or regulation.

Source : China Pharma Holdings, Inc. Announced the Completion of Third Party Testing of Dry Eye Disease Therapeutic Device

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This content was prepared by our news partner, Cision PR Newswire. The opinions and the content published on this page are the author’s own and do not necessarily reflect the views of Siam News Network

Wondershare Edraw Empowers Users with Major Upgrades for EdrawMax and EdrawMind

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VANCOUVER, BC, Nov. 29, 2023 /PRNewswire/ — Wondershare Edraw, a prominent market leader in the field of mind mapping and diagramming tools, is excited to announce substantial user experience enhancements for both EdrawMax and EdrawMind.

The recent transformation of EdrawMax to V13 brings a new user interface and an extensive collection of over 26,000 vector graphics, along with intelligent AI diagram tools. EdrawMax enables users to create charts and diagrams with improved productivity and a better overall experience.

EdrawMind V11, an advanced mind mapping tool, introduces an industry-first cross-platform integration, allowing users to collaborate seamlessly across multiple devices. This update revolutionizes the collaborative landscape by offering enhanced multi-user functionality and cloud file management. EdrawMind is dedicated to optimizing teamwork, boosting collaboration efficiency, and empowering users with a versatile and dynamic collaborative environment.

Kim, Head of Product for Wondershare Edraw, states, "EdrawMax V13 and EdrawMind V11 embody our commitment to user-centric innovation. The refreshed UI and UX of EdrawMax reflect our dedication to user experience, while the multi-platform integration of EdrawMind redefines collaborative possibilities. We believe these updates will empower our users to achieve more, collaborate seamlessly, and visualize their ideas with greater ease."

With these enhancements, Wondershare Edraw continues its mission to make complex ideas simple and enable users worldwide to unleash their full creative potential.

Compatibility and Price

Wondershare EdrawMax and EdrawMind are compatible with Windows, Mac, Android, and iOS. EdrawMax pricing starts at $69 for a six-month subscription, and EdrawMind pricing starts at $39 for a six-month subscription. For free trials and downloads, please visit our official website or follow us on YouTube, Facebook, Twitter, and Instagram.  

About Wondershare:

Wondershare Technology is a global leader in software development and a pioneer in the field of digital creativity and productivity solutions. Celebrated for its commitment to innovation, Wondershare has earned accolades from The Shorty Awards, G2, and GetApp, distinguishing itself in the tech community. Serving over 100 million users in 150 countries, Wondershare provides a vast portfolio of applications that enhance video editing, PDF editing, and data recovery.

Source : Wondershare Edraw Empowers Users with Major Upgrades for EdrawMax and EdrawMind

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This content was prepared by our news partner, Cision PR Newswire. The opinions and the content published on this page are the author’s own and do not necessarily reflect the views of Siam News Network

7th Edition of Fintech Abu Dhabi Explores Synergy Between Finance and Technology

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ABU DHABI, United Arab Emirates, Nov. 30, 2023 /PRNewswire/ — Building upon the successes of MENA’s biggest Fintech Festival presented by Abu Dhabi Global Market (ADGM), the 7th edition of Fintech Abu Dhabi welcomed an impressive turnout of financial tech leaders and visionaries converging from across the globe today. This included those leading innovation in major financial institutions, startups, innovators, entrepreneurs, venture capitalists, scientists and academics, solidifying Abu Dhabi’s position as a forward-thinking innovation and tech hub.

 

 

ADGM’s flagship event, Fintech Abu Dhabi, conducted in partnership with Huawei continued to be a highlight of Abu Dhabi Finance Week (ADFW) this year, focusing on the central theme of the event – ‘The Convergence of Finance and Technology’. The event kicked off with a lively debate on the financial crime economy and brought together prominent AI institutions in Abu Dhabi to discuss the city’s early commitment to AI. Participants also delved into the maturity of the crypto industry. Dr. Alexander Lipton, Global Head of Research & Development at ADIA provided insights on how social media is reshaping the global banking landscape, while the CEO of Circle outlined strategies for harnessing digital assets to enhance global financial stability. Other interesting sessions today included ‘Decoding a "Skandal" – Inside Wirecard’s Investigation discussed by Financial Times Investigative Reporter – Dan McCrum and Themis Founder and CEO – Dickon Johnston and ‘Finding an Entrepreneurial Mindset with VaynerX Chairman and CEO – Gary Vaynerchuk.

One-of-a-kind forums featured during Fintech Abu Dhabi included Blockchain, AI and Risk & Security. Blockchain Abu Dhabi presented in partnership with Circle discussed topics such as the quest to design stability for digital money, digital currencies of Central Banks improving digital asset infrastructure and the overall impact of blockchain and Web3 on the financial industry. AI Abu Dhabi was conducted in collaboration with Mastercard while Risk 4.0 was conducted in association with the Executive Council for Anti-Money Laundering and Counter Terrorism Financing.

During the event, ADGM – in collaboration with its partners, unveiled initiatives to redefine regulatory practices. The Financial Services Regulatory Authority (FSRA) outlined its "Regulation as a Service" strategy through its Digital Lab, aimed at co-creating innovative solutions for the licensing and supervision of firms. Noteworthy collaborations of the FSRA with the National University of Singapore announced aims to develop an AI-powered assessment tool for virtual asset service providers seeking licensing in ADGM.

In its efforts for continuous improvement, the FSRA announced soliciting feedback on a discussion paper related to information technology (IT) risk management to enhance firms’ operational resilience. Furthermore, fostering innovation in Decentralised Finance (DeFi), the FSRA unveiled a collaboration with Coinbase Asset Management and Neoply and also nudged towards a DeFi consultation paper slated for publication in 2024, alongside enhancements to the existing regulatory framework.

Linda Fitz-Alan Registrar and Chief Executive at ADGM Courts said, "In its staggering 7th edition, Fintech Abu Dhabi started as a pioneer, awakening our imagination, guiding the disruption of our norms and making innovation our constant. This is no longer an annual event; this is a pivotal marker to test the temperature and tap into the thoughts of global leaders in financial technology.  The insightful discussions at Fintech Abu Dhabi do not just shape the future of the fintech landscape, but also create its landscape while opening our minds to the endless possibilities for the future of the financial sector."

Furthermore, major announcements by global companies such as GQG Partners (GQG) an independent asset management firm with more than USD 100 billion in AUM and Offset8, a proprietary asset management firm specialising in the global verified carbon credits (VCC) market announced receiving an In-Principle Approval (IPA) from the Financial Services Regulatory Authority (FSRA) of the ADGM. IOTA, the open public goods infrastructure ushering in digital asset innovation, announced its registration as the first company to be registered under the DLT Foundations Regulations of ADGM.

MEVCA and New York and Singapore headquartered-GPCA announced a partnership that will see GPCA establish a permanent presence in the Middle East, with the support of MEVCA.

The Global Financial Regulators Summit, a closed-door gathering of key global financial regulatory leaders was conducted parallel to Fintech Abu Dhabi and discussed the role regulators play in shaping the sustainable finance landscape of the future. The outcomes of the summit will be announced tomorrow during the R.A.C.E (Regulation, Awareness, Collaboration & Ecosystem) Sustainability Summit.

 

Source : 7th Edition of Fintech Abu Dhabi Explores Synergy Between Finance and Technology

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This content was prepared by our news partner, Cision PR Newswire. The opinions and the content published on this page are the author’s own and do not necessarily reflect the views of Siam News Network

Phase II OPALESCENCE Study of TLX250-CDx in Triple Negative Breast Cancer to be Presented at SABCS

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MELBOURNE, Australia, Nov. 30, 2023 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today advises that the completed Phase II OPALESCENCE investigator-initiated trial (IIT) of its carbonic anhydrase IX (CAIX)-targeting positron emission tomography (PET) imaging candidate, TLX250-CDx (89Zr-DFO-girentuximab), in patients with triple-negative breast cancer (TNBC), will be presented at the 2023 San Antonio Breast Cancer Symposium® (SABCS) taking place from December 5-9, 2023.

Dr. Caroline Rousseau, Principal Investigator for the OPALESCENCE study (ClinicalTrials.gov ID NCT04758780) at the Institut de Cancérologie de l’Ouest (ICO) in St Herblain (France), will deliver top-line results as a poster presentation at 5pm CT on Wednesday December 6.

The primary objective of the OPALESCENCE study was to evaluate how CAIX-targeted imaging with PET can be utilised for the diagnosis and staging of TNBC and to develop a deeper understanding of CAIX as a potential therapeutic target in this patient population with a significant unmet medical need. 

SABCS is the largest and most prestigious scientific gathering on breast cancer research worldwide. Visit http://www.sabcs.org/ for more information on the congress.

About the Institut de Cancérologie de l’Ouest (ICO)

ICO is a 1,400 professional strong not-for-profit center fighting against cancer. It welcomes close to 48,000 patients per year, and conducts the mission and service of a public hospital. Strengthened by its 4 missions – Prevention, Care, Research and Teaching – ICO offers broad, state-of-the-art expertise that is exclusively dedicated to cancerology. 

Advanced medicine at the service of patients: specialising in oncology, ICO professionals provide patients with personalised, innovative and multidisciplinary care at every stage of their treatment. From rapid diagnosis to surgery, chemotherapy and radiotherapy, care also extends to supportive care, which is highly developed at ICO.

The integration of care, research and innovation is integral to ICO. Research activities, which are a specific mission at ICO, are undertaken from concept all the way through to clinical trials. Research is conducted in all disciplines of cancerology: medical oncology, radiotherapy, surgery, anaesthesia, nuclear medicine, medical imagery, support care, and human sciences. Patients who are cared for at ICO receive privileged access to cutting edge clinical trials in cancerology. The mission of the Innovation Unit is to support innovation in oncology by assisting both internal and external project leaders from the initial idea to the operational implementation of the innovation. Through its teaching mission and academic expertise, ICO contributes to the training of tomorrow’s cancer professionals. For more information contact: [email protected]

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn.

TLX250-CDx has not received a marketing authorisation in any jurisdiction. Telix’s lead imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA),[1] by the Australian Therapeutic Goods Administration (TGA),[2] and by Health Canada.[3]

Telix’s SENSEI® ultra-miniaturised robotic gamma probe is registered as a Class 1 device with the FDA, and has attained a Conformité Européenne (CE) Mark for use in the European Economic Area for intra-operative detection of sentinel lymph nodes.[4]

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: [email protected]

Legal Notices

This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments.  Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix’s preclinical and clinical studies, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix’s product candidates, if or when they have been approved; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website.

©2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).

[1] Telix ASX disclosure 20 December 2021.

[2] Telix ASX disclosure 2 November 2021.

[3] Telix ASX disclosure 14 October 2022.

[4] Lightpoint Medical media release 20 January 2021.

 

Source : Phase II OPALESCENCE Study of TLX250-CDx in Triple Negative Breast Cancer to be Presented at SABCS

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This content was prepared by our news partner, Cision PR Newswire. The opinions and the content published on this page are the author’s own and do not necessarily reflect the views of Siam News Network

SI Group Inspires Future Scientists through Event with Sheldon ISD

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Students learned about solving problems through chemistry at company’s Global Innovation Center

THE WOODLANDS, Texas, Nov. 30, 2023 /PRNewswire/ — SI Group, a leading global developer and manufacturer of performance additives, process solutions, pharmaceuticals, and chemical intermediates, welcomed approximately 30 students enrolled in the STEM program at Sheldon Independent School District in Houston, Texas to the company’s Global Innovation Center. The event was held to give students firsthand exposure to the world of chemistry and problem-solving through scientific exploration.

The visit showcased SI Group’s commitment to promoting STEM education and inspiring the next generation of scientists. The students engaged in a day filled with interactive sessions and practical demonstrations that highlighted the impact of chemistry in applications such as safer can coatings, asphaltene dispersion in crude oil production and performance enhancement of car tires. The visit included a guided tour of SI Group’s state-of-the-art research facility including the analytical and application development laboratories.

The unique opportunity to interact with SI Group’s team of experienced scientists gave the students valuable insights into the diverse facets of the chemical industry. Furthermore, SI Group’s scientists participated in a discussion with the students about choosing a career in STEM and job opportunities once joining the workforce.

"Taking our STEM Academy to SI Group was eye-opening for the students. They were able to interact with STEM professionals and see the innovative work in the laboratories that produces many of the items we use every day," said Becky Zalesnik, Executive Director of Innovative Programs at Sheldon ISD. "Events like these help students make life-changing career decisions. The partnership between our school and industry partners such as SI Group provides much more than a lesson, we are building the future workforce together."

"We are thrilled to have hosted these bright young minds from Sheldon ISD as part of our ongoing commitment to STEM education," said Narsi Devanathan, Vice President – Research & Development at SI Group. "By engaging with them in a real-world setting, we hope to inspire a passion for science and to ignite their curiosity about the possibilities within the field of chemistry."

SI Group looks forward to continuing its collaboration with local schools and educational institutions to promote STEM education and develop the next generation of innovators.

About SI Group

SI Group is a global leader in the innovative technology of performance additives, process solutions, active pharmaceutical ingredients, and chemical intermediates. SI Group solutions are essential to enhancing the quality and performance of countless industrial and consumer goods within the plastics, rubber & adhesives, fuels & lubricants, oilfield, and pharmaceutical industries. SI Group’s global manufacturing footprint includes 20 facilities on three continents, serving customers in 80 countries with approximately 2,000 employees worldwide. In 2021, SI Group received a gold award for corporate social responsibility by EcoVadis and is ranked among the top five percent of more than 50,000 worldwide companies. SI Group innovates and drives change to create value with a passion for safety, chemistry, sustainability, and extraordinary results. Learn more at www.siigroup.com.

Media Contact: Joseph Grande 
ph: + 1.413.684.2463
[email protected]

 

Source : SI Group Inspires Future Scientists through Event with Sheldon ISD

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This content was prepared by our news partner, Cision PR Newswire. The opinions and the content published on this page are the author’s own and do not necessarily reflect the views of Siam News Network

Navisite Expands Collaboration with AWS in Asia-Pacific

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Digital transformation leader strengthens regional presence and capabilities with AWS to help organizations successfully migrate Oracle to AWS Cloud

ANDOVER, Mass., Nov. 29, 2023 /PRNewswire/ — Navisite, a global strategic advisory and digital transformation leader, announced today that it has strengthened its presence and collaboration with Amazon Web Services (AWS) in Asia-Pacific to help organizations migrate and modernize Oracle applications and databases on AWS Cloud.

In addition to increased regional investment with consulting and technical resources, Navisite will partner with AWS teams in Singapore and Australia on go-to-market activities such as events, webinars, and other sales and marketing collaborations to educate and support customer migrations of Oracle environments, including Oracle E-Business Suite (EBS), JD Edwards, Hyperion, and PeopleSoft.

"Organizations are concerned with moving business-critical Oracle apps to the cloud, especially in areas like security, performance, and licensing compliance," said Mark Clayman, CEO at Navisite. "We’ve had enormous success helping customers overcome these barriers and reduce management complexity and costs on the cloud. We look forward to what we can accomplish with AWS to extend these capabilities in Asia-Pacific and meet the demand for cloud expertise and services."

Navisite has been helping organizations migrate Oracle workloads to AWS since 2011 and is an AWS Premier Tier Services Partner with specialized AWS Migration and Oracle competencies. Navisite works with customers to develop the optimal migration path for Oracle-based workloads and support their success with end-to-end cloud migration, optimization, and managed services.

For example, Navisite helped Penske Australia & New Zealand reduce its data center footprint and migrate Oracle EBS to AWS. The migration not only delivered significant cost savings but also enabled the company to focus on important IT initiatives that deliver business value, rather than spending time and resources managing a legacy system.

"The migration process was as painless as Navisite portrayed it to be," said Bobby Stojceski, chief security officer at Penske Australia & New Zealand. "And now that AWS is part of our environment, we’re seeing more capabilities that we could use in AWS that we didn’t have available to us before."

"Many organizations don’t realize what options they have for Oracle, so it’s important we bring the right resources and capabilities to support their success," said Andrew Powell, head of SAP and Oracle Partner Network – APJ at AWS. "Navisite’s experience migrating Oracle workloads to AWS is exceptional, and we’re thrilled to expand our collaboration in Asia-Pacific to support one of the fastest-growing markets for AWS."

To learn more about how Navisite helped Penske Australia & New Zealand, read the case study.

About Navisite
Navisite is a trusted digital transformation partner for growing and established global brands. Through our highly specialized teams, industry solutions, business process expertise, and application services, we provide the capabilities and practical guidance customers need to modernize, build, and support more agile, resilient, and expanding businesses. Our strategic advisory and transformation services advance innovation with comprehensive cloud, enterprise application, data management, intelligent automation, and cybersecurity solutions, empowering customers to navigate change and meet new demands at any point in their journey. To learn more, visit navisite.com. 

 

Source : Navisite Expands Collaboration with AWS in Asia-Pacific

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This content was prepared by our news partner, Cision PR Newswire. The opinions and the content published on this page are the author’s own and do not necessarily reflect the views of Siam News Network

Clarity's theranostic prostate cancer trial progresses at the highest dose level cohort

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HIGHLIGHTS

Cohort 3 of the theranostic SECuRE trial investigating 64Cu/67Cu-SAR-bisPSMA in metastatic castrate-resistant prostate cancer (mCRPC) has enrolled and treated 3 participants who received therapy with 67Cu-SAR-bisPSMA at the highest dose level of 12GBq.­ No dose limiting toxicities (DLTs) have been reported to date. Only one participant had one adverse event of Grade 1 reduction in neutrophil count and the participant fully recovered.  The Safety Review Committee (SRC) has recommended that the trial continues with the additional 3 participants as planned in cohort 3. All 3 participants had been heavily pre-treated and failed a number of commercial and investigational therapies prior to treatment in the trial. Despite this, 2 of the 3 participants so far have shown a reduction in Prostate Specific Antigen (PSA) levels within weeks after a single cycle of 12GBq 67Cu-SAR-bisPSMA. Recruitment has opened at clinical sites in the US for the additional 3 participants in cohort 3 for a single cycle of 12GBq of 67Cu-SAR-bisPSMA.

SYDNEY, Nov. 29, 2023 /PRNewswire/ — Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce the successful completion of the first stage of cohort 3 of the Phase I/IIa theranostic trial, SECuRE, evaluating 64Cu/67Cu-SAR-bisPSMA in patients with mCRPC where 3 participants have been treated at the highest dose level of 12GBq of 67Cu-SAR-bisPSMA. No adverse events were reported in relation to 64Cu-SAR-bisPSMA. Only 1 adverse event was reported and related to the 12GBq cycle of 67Cu-SAR-bisPSMA in 1 of the 3 participants, which was a grade 1 decrease in neutrophil count, and the patient has fully recovered. No ongoing adverse events and no DLTs have been reported and the SRC has recommended the trial progresses with the 3 additional participants as planned in cohort 3.

The SECuRE trial (NCT04868604)1 is a Phase I/IIa theranostic trial for identification and treatment of Prostate-Specific Membrane Antigen (PSMA) expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation trial with a cohort expansion involving up to 44 patients in the US. The aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.

Cohort 3 of the trial has a 3+3 study design with the intent to gather and analyse data from the first 3 participants before progressing with an additional 3 participants. The initial data is very encouraging with no DLTs observed at the highest dose of 67Cu-SAR-bisPSMA (12GBq) and the SRC, responsible for assessing safety of participants and overseeing the general progress of the trial, has assessed the data and recommended the trial continues.

Cohort 3 is the last to assess single doses of 67Cu-SAR-bisPSMA and will be followed by a multi-dose cohort, pending safety evaluation. The initial 3 participants in cohort 3 were heavily pre-treated prior to entering the trial, having received multiple lines of therapy including other investigational products, radioligand therapy and chemotherapy. They continue to be monitored by their physicians for safety and treatment response as per the trial protocol. All 3 participants in cohort 3 remain on the trial following their recent administration of 12GBq of 67Cu-SAR-bisPSMA, with 2 demonstrating a PSA reduction within weeks of dosing, one of which is greater than 90% reduction and the second approximately 40% reduction to date.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are excited by the PSA declines seen in almost all patients to date in cohorts 2 and 3 from just a single cycle. This result is also seen in patients that have been heavily pre-treated and have failed many other therapies that are either commercial or investigational. Moreover, the safety profile is very favorable and there have been no DLTs reported to date.

"SAR-bisPSMA was designed to be a best-in-class PSMA product as, unlike all other PSMA products in the market, it has dual targeting. The product was optimised to address the challenges of low uptake and retention in lesions that the first generation of PSMA products suffer from, and in both pre-clinical and clinical development to date we have observed two to three times the uptake of SAR-bisPSMA in lesions, followed by retention in lesions out to at least 96 hours. So far, the higher uptake and retention of product, coupled with the advantageous properties of copper-67, has shown quite impressive responses measured by PSA reductions in patients from single cycles of product to date.

"A number of patients from the SECuRE trial have either received, or will soon receive, additional doses of 67Cu-SAR-bisPSMA under the US Food and Drug Administration’s (FDA) Expanded Access Program (EAP). This demonstrates the initial clinical benefit observed in such patients after the administration of a single cycle of the product during the trial.

"As we have seen PSA reductions in the majority of patients after a single cycle of 67Cu-SAR-bisPSMA across all dose levels, which is known to be an independent prognostic indicator of improved overall survival following radio-ligand therapy2,3, we hope to achieve long-term and durable responses once we progress to the multi-dose cohorts of the trial. Furthermore, with commercial quantities of the 67Cu radioisotope now being routinely produced domestically in the US, we see a clear path to commercialisation as we can resolve the supply and manufacturing issues which have plagued the commercial launch of first-generation products. We look forward to sharing more data along with any further updates from patients who may receive single or multiple cycles of 67Cu-SAR-bisPSMA in our programs and bringing this product to the greater prostate cancer patient population," said Dr Taylor.

About SAR-bisPSMA

SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a TCT that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.­

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA are unregistered products. Individual results may not represent the overall safety and efficacy of the products. The data outlined in this announcement has not been assessed by health authorities such as the US Food and Drug Administration (FDA). A clinical development program is currently underway to assess the efficacy and safety of these products. There is no guarantee that these products will become commercially available.

About Prostate Cancer

Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide4. The American Cancer Institute estimates in 2023 there will be 288,300 new cases of prostate cancer in the US and around 34,700 deaths from the disease5.

About Clarity Pharmaceuticals

Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious disease. The Company is a leader in innovative radiopharmaceuticals, developing targeted copper theranostics based on its SAR Technology Platform for the treatment of cancer in children and adults.

www.claritypharmaceuticals.com

References

ClinicalTrials.gov Identifier: NCT04868604, https://clinicaltrials.gov/ct2/show/NCT04868604 Rahbar K et al. PSMA targeted radioligandtherapy in metastatic castration resistant prostate cancer after chemotherapy, abiraterone and/or enzalutamide. A retrospective analysis of overall survival. Eur J Nucl Med Mol Imaging, 2018. Ahmadzadehfar H et al. Overall survival and response pattern of castration-resistant metastatic prostate cancer to multiple cycles of radioligand therapy using [177Lu]Lu-PSMA-617. Eur J Nucl Med Mol Imaging, 2017. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21660 American Cancer Society: Key Statistics for Prostate Cancer, https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html

For more information, please contact:

Clarity Pharmaceuticals

Dr Alan Taylor

Catherine Strong

Executive Chairman

Investor/Media Relations

[email protected]

[email protected]

+61 406 759 268

This announcement has been authorised for release by the Executive Chairperson.

Source : Clarity's theranostic prostate cancer trial progresses at the highest dose level cohort

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This content was prepared by our news partner, Cision PR Newswire. The opinions and the content published on this page are the author’s own and do not necessarily reflect the views of Siam News Network

MultiMetaVerse Announces Updates of the Taomee Acqusition and Termination of Prior Acquisition Agreement

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NEW YORK and SHANGHAI, Nov. 29, 2023 /PRNewswire/ — MultiMetaVerse Holdings Limited ("MMV" or the "Company"), an animation and entertainment company for young consumers in China, announced today that it has received a letter of termination with respect to MMV’s contemplated acquisition of Taomee (the "Letter of Termination"). On September 15, 2023, MMV announced that it had entered into an acquisition agreement (the "Agreement") to acquire 100% equity in Shanghai Shengran Information Technology Co., Ltd. and associated interests pertaining to all of its consolidated variable interest entities (collectively, the "Target Group," or "Taomee"). The closing of the Agreement was conditioned upon, among others, MMV’s payment of the transaction consideration in installments within a fixed period of time. MMV received the Letter of Termination from Dongzheng Ruibo (Shanghai) Investment Center (Limited Partnership) and Orient TM Ruibo Limited (each a "Seller", and collectively, the "Sellers") terminating the Agreement citing MMV’s inability to pay the consideration within the agreed timeline pursuant to the Agreement.

MMV believes that the Target Group is a valuable asset with synergy to the Company, and intends to further pursue the transaction contemplated under the Agreement. MMV continues to engage the Sellers in negotiation regarding the acquisition of Taomee and is optimistic of the possibility of resuming the transaction when MMV secures sufficient funding for closing. In furtherance of this effort, MMV is actively seeking financing opportunities with institutions and private investors. In particular, MMV has entered into a share subscription agreement with Eagle Creek LP with a total proceed of US$15,000,000. MMV’s management is committed to raising additional funds in an effort to close the transaction.

About MultiMetaVerse Holdings Limited

MultiMetaVerse Holdings Limited (NASDAQ: MMV) is an animation and entertainment company dedicated to providing a high-quality, immersive entertainment experience through original, user-generated, and professional user-generated content. MMV commenced animation production in 2015 under its signature Aotu World brand, which has attracted a broad following with its inspiring storyline and unique graphic style, particularly among younger audiences in China. By leveraging the company’s established user base, MMV has built a diverse product portfolio, including animated content, comic books, short videos, collectibles, stationery, consumer products, and mobile games across the Aotu World brand. It has also developed and augmented new brands, stories, and characters, such as Neko Album.

For more information, please visit https://www.multi-metaverse.com/.

For investor and media inquiries, please contact:

MultiMetaVerse Holdings Limited
Investor Relations
E-mail: [email protected]

Safe Harbor Statement

This press release contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements generally are identified by the words "believe," "project," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Without limiting the generality of the foregoing, the forward-looking statements in this press release include descriptions of the Company’s future commercial operations. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, such as the Company’s inability to implement its business plans, identify and realize additional opportunities, or meet or exceed its financial projections and changes in the regulatory or competitive environment in which the Company operates. You should carefully consider the foregoing factors and the other risks and uncertainties described in the Company’s Annual Report on Form 20-F and other documents filed or to be filed by the Company with the SEC from time to time, which could cause actual events and results to differ materially from those contained in the forward-looking statements. All information provided herein is as of the date of this press release, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law.

Source : MultiMetaVerse Announces Updates of the Taomee Acqusition and Termination of Prior Acquisition Agreement

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