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BioXcel Therapeutics Announces First Patient Enrolled in Phase 1b/2 RELEASE Trial of BXCL501 for the Treatment of Opioid Withdrawal Symptoms

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NEW HAVEN, Conn., June 11, 2020 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced that the first patient has been enrolled in the Phase 1b/2 RELEASE trial of BXCL501, the Company’s proprietary sublingual thin-film formulation of dexmedetomidine (“Dex”), for the treatment of opioid withdrawal symptoms.
“The initiation of the RELEASE trial is a major milestone for our neuroscience program, as we believe it not only showcases BXCL501’s promise across multiple indications, but also supports this candidate’s potential as a sub-chronic treatment,” commented Vimal Mehta, Ph.D., Chief Executive Officer of BTI. “As the leading cause of death in the U.S. for individuals under the age of 50 years old, opioid abuse is a widespread problem that has been heightened by the COVID-19 pandemic. In order to avoid the painful symptoms associated with opioid withdrawal, individuals often continue to abuse these drugs or relapse, highlighting the need for better treatments to halt the cycle of addiction. After witnessing promising results with intravenous Dex, we believe BXCL501 may offer advantages over the current standard of care, as well as provide patients with a non-opioid therapy to alleviate the physiological symptoms of withdrawal. We look forward to reporting topline results from the study in the first quarter of 2021.”The RELEASE trial is a multicenter, randomized, double-blind, placebo-controlled, ascending-dose Phase 1b/2 study designed to evaluate the safety, pharmacokinetics, tolerability and efficacy of BXCL501 in patients experiencing symptoms of opioid withdrawal. This study will enroll approximately 125 subjects with opioid use disorder who are physically dependent on opioids. During the 7-day treatment phase, BXCL501 will be evaluated in sequential, ascending dose cohorts of 30ug, 60ug, 90ug, 120ug, and 180ug, administered twice daily (BID), approximately 12 hours apart. The study will assess opioid withdrawal symptoms using both the Clinical Opiate Withdrawal Scale (COWS) and Short Opiate Withdrawal Scale of Gossop (SOWS-GOSSOP) over a 10-day period.About BXCL501BXCL501 is a potential first-in-class, proprietary sublingual thin film of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of acute agitation. BTI believes that BXCL501 directly targets a causal agitation mechanism and the Company has observed anti-agitation effects in clinical studies across multiple neuropsychiatric indications. BXCL501 has also been granted Fast Track Designation by the U.S. Food and Drug Administration for the acute treatment of mild to moderate agitation in schizophrenia, bipolar disorder, and dementia.A Phase 1b safety and efficacy study of BXCL501 yielded positive dose-response data. BXCL501 is being evaluated in the SERENITY program, consisting of two Phase 3 studies for the acute treatment of agitation in patients with schizophrenia (SERENITY I) and bipolar disorder (SERENITY II). BXCL501 is also being evaluated in the Phase 1b/2 TRANQUILITY trial for the treatment of agitation associated with dementia, as well as the Phase 1b/2 RELEASE trial for the treatment of opioid withdrawal symptoms.About Opioid Drug Withdrawal:According to the Centers for Disease Control and Prevention (“CDC”), the misuse of and addiction to opioids is a serious national crisis and is the leading cause of death in the U.S. for those under 50 years old. Between 1999-2017, almost 400,000 people died from an overdose involving an opioid, with greater than 47,000 deaths occurring in 2017 alone. The CDC estimates the total “economic burden” of prescription opioid misuse alone in the U.S. is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment and criminal justice involvement. Opioid withdrawal is a condition characterized by symptoms such as anxiety, agitation, sleep problems, muscle aches, runny nose, sweating, nausea, vomiting, diarrhea and drug craving — that occur after stopping or reducing the use of opioids in anyone with physical dependence on opioids.About BioXcel Therapeutics, Inc.:BioXcel Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on drug development that utilizes artificial intelligence to identify improved therapies in neuroscience and immuno-oncology. BTI’s drug re-innovation approach leverages existing approved drugs and/or clinically evaluated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BTI’s two most advanced clinical development programs are BXCL501, an investigational sublingual thin film formulation in development for acute treatment of agitation resulting from neuropsychiatric disorders, and BXCL701, an investigational orally administered systemic innate immunity activator in development for treatment of a rare form of prostate cancer and for treatment of pancreatic cancer in combination with other immuno-oncology agents. For more information, please visit www.bioxceltherapeutics.com.Forward-Looking StatementsThis press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to the timing and data from clinical development initiatives and trials for BXCL501 and the potential for BXCL501 to be used as a sub-chronic treatment. When used herein, words including “anticipate,” “being,” “will,” “plan,” “may,” “continue,” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon BTI’s current expectations and various assumptions. BTI believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain.BTI may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; its limited experience in drug discovery and drug development; its dependence on the success and commercialization of BXCL501 and BXCL701 and other product candidates; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by BTI’s product candidates; its approach to the discovery and development of product candidates based on EvolverAI is novel and unproven; its exposure to patent infringement lawsuits; its ability to comply with the extensive regulations applicable to it; impacts from the COVID-19 pandemic; its ability to commercialize its product candidates; and the other important factors discussed under the caption “Risk Factors” in its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and Investors sections of our website at www.bioxceltherapeutics.com.These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While BTI may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing BTI’s views as of any date subsequent to the date of this press release.Contact Information:
BioXcel Therapeutics, Inc.
www.bioxceltherapeutics.com
Investor Relations:
John Graziano
[email protected]
1.646.378.2942
Media:
Julia Deutsch
[email protected]
1.646.378.2967

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Artificial Intelligence

iSHANG and 3Business Collaborate on Web3 Coupon Enterprise Solution under Cyberport Web3 Proof-of-Concept Subsidy Scheme

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HONG KONG, Oct. 13, 2024 /PRNewswire/ — iSHANG Technology Limited (“iSHANG”), a leading technology company specializing in Web3 enterprise solutions, is delighted to announce its collaboration with 3Business, the corporate brand of Hutchison Telecommunications (Hong Kong) Limited, under the Cyberport Web3 Proof-of-Concept Subsidy Scheme to implement the Web3 Coupon Enterprise Solution (Web3-Coupon) leveraging 5G.  This new collaboration represents a major leap forward in enhancing customer engagement and rewards. For more information, please visit – https://ishang.com/web3-coupon-enterprise-solution/

The Web3 Coupon Enterprise solution enables customers to earn unique high-valuable rewards through the Web3 Coupon platform. By introducing personalized, exclusive rewards, it has the potential to transform customer acquisition and reward programs.
The solution will also add a new dimension to 3Business current mobile advertising services for enterprises by revolutionizing the way businesses manage customer engagement and loyalty campaigns. Leveraging Web3 technologies, the solution can ensure secure and traceable transactions, instilling trust and confidence in customers.  
By integrating 5G, artificial intelligence (AI), blockchain technologies and smart contracts, iSHANG Web3-Coupon provides an innovative, secure and transparent platform to simplify coupon management processes such as creation, distribution, redemption and tracking. This streamlines operations and enhances overall efficiency. It addresses the limitations of traditional mass promotion messages by offering a comprehensive solution for merchants to manage and analyze promotion results, conversion rates, and customer consumption data.
The transparency and immutability of the Web3 Coupon System, powered by blockchain technology, establish a trustworthy environment for customers. They can easily verify the authenticity and validity of coupons.
“Web3 seeks to transform various aspects of our digital lives, including how businesses incentivize and reward customers,” said Samson Lee, Co-founder and CEO of iSHANG. “We are thrilled to collaborate with 3Business in implementing the Web3-Coupon. This collaboration represents a significant step towards revolutionizing the customer incentives and loyalty programs. Leveraging the power of Web3 technologies, 5G and the support from the Cyberport Web3 Proof-of-Concept Subsidy Scheme, the solution will provide business customers with a secure, transparent, and efficient coupon system that drives customer engagement and enhances their overall experience.”
The Cyberport Web3 Proof-of-Concept Subsidy Scheme plays a vital role in fostering innovation and adoption of Web3 technologies across various industries. By providing financial support, the scheme empowers businesses to explore the potential of emerging technologies and accelerate the commercial adoption of Web3 in different industry sectors.
Blockchain technology ensures the transparency and security of commercial transactions and enhances the trust of merchants and consumers. Web3-Coupon revolutionizes traditional coupons by introducing an element of uniqueness and exclusivity. The model shifts from general points accumulation to earning unique digital assets, potentially transforming customer loyalty. It adds a layer of personalization and value, enhancing customer engagement and fostering a deeper connection with the brand. Web3-Coupon represents a major leap forward in customer engagement and loyalty programs, providing customers with a more dynamic, engaging and rewarding experience.
About iSHANG Technology Limited (iSHANG)
iSHANG operates a “Web3-as-a-Service” (W3aaS) platform that provides the infrastructure and a gateway for brands & enterprises to enter into the Web3 market. iSHANG W3aaS platform developed 10 x Web3 Solutions that are built on Ethereum and Polygon blockchain using IPFS (Inter Planetary Filing System) decentralized storage system. In addition, iSHANG provides Campaign Driven Launchpad & Marketplace, designed for brands & enterprises to launch their web3 marketing campaigns & facilitates the promotion, customer acquisition, retention programs and also secondary exchange of NFTs. Ultimately, iSHANG also offers one-stop consulting campaign management which develop tailor-made Web3 marketing campaigns empowering brands and enterprises to transform their businesses in various use-cases to capitalize new market opportunities.
For more information about iSHANG, please visit – https://ishang.com/
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GITEX GLOBAL and Expand North Star set to accelerate world’s AI economy with market projected to reach $2.7 trillion by 2032

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•  Event billed as a catalyst for redefining the world’s digital economy and AI ecosystem under this year’s ‘Global Collaboration to Forge a Future AI Economy’ theme
DUBAI, UAE, Oct. 12, 2024 /PRNewswire/ — GITEX GLOBAL, the world’s largest tech and startup event, takes centre stage in the UAE next week with this year’s 44th edition destined to redefine the world’s digital economy and AI ecosystem.

Held at Dubai World Trade Centre (DWTC) from 14-18 October, the incomparable international showpiece will be more influential than ever this time around – presenting an expanded events programme that transforms the UAE into an AI universe epicentre.
Under the theme “Global Collaboration to Forge a Future AI Economy”, GITEX GLOBAL 2024 welcomes the world’s largest technology enterprises alongside governments, investors, experts, startups, academia, and researchers.  
Expand North Star, the world’s largest startup and investment show, runs concurrently at Dubai Harbour from 13-16 October – hosted by Dubai Chamber of Digital Economy and organised by DWTC.
With over 6,500 exhibiting companies, 1,800 startups, and 1,200 investors from more than 180 countries participating across 38 halls of innovation and business opportunities, these blockbuster events will see the UAE “strategically propel the next generation of AI-driven technologies”.
Trixie LohMirmand, Executive Vice President of DWTC, the organiser of GITEX GLOBAL and Expand North Star, said: “At GITEX GLOBAL in Dubai, we shall close the year with significant manoeuvres from our tech community by doubling down on global collaborations and intensive engagements amongst all involved. Through these efforts, we shall forge competitive advantages in the race towards regional and international digital supremacy.
“With international participation in GITEX GLOBAL 2024 rocketing by almost 40 per cent, it’s a barometer of the unstoppable ambitions of many young rising digital nations who are now confidently forging their ways into the future global AI economy through GITEX. As the world’s most global tech event brand with events in Germany, Singapore, Morocco, and Nigeria alongside Expand North Star, we are committed to strategically propelling the next generation of AI-driven technologies via startups, scale-ups and unicorns.”
A global agenda for tomorrow’s AI economy
According to Fortune Business Insights, the global AI market is projected to reach $621 billion in 2024 and soar to $2.7 trillion by 2032. Given its influence and impact now and in the future, the technology takes centre stage at GITEX GLOBAL 2024 with over 3,500 enterprises presenting the latest breakthrough innovations in AI, IoT, data, and the cloud.
Amongst them is TECOM Group PJSC, which celebrates its 25th successive year at GITEX GLOBAL next week. Ahead of the event, Ammar Al Malik, Executive Vice President of Commercial at TECOM Group PJSC and Managing Director of Dubai Internet City, said: “Dubai’s pro-innovation frameworks are the bedrock of tech advancements that serve a greater purpose. GITEX GLOBAL is a springboard to unlock this potential, and as the region’s leading tech hub, Dubai Internet City has been a proud partner for decades in its mission towards a brighter future. Our community is pleased to connect innovators from more than 3,500 companies across fields like artificial intelligence (AI), Web3, digital transformation, and beyond to realise this vision.”
Abu Dhabi’s most influential companies and organisations, including the Advanced Technology Research Council (ATRC) and G42 Group with its leading enterprises Presight and Khazna, will reinforce the Emirate’s position as an emerging global AI nexus. Other tech giants participating are Adobe, Alibaba Cloud, AWS, Builder Ai, Dell, Google, Honeywell, Huawei, IBM, Lenovo, Microsoft, Nvidia, Oracle, Salesforce, SAS, solutions by STC, and Tech Destination Pakistan.
Presenting the year’s largest AI event, GITEX GLOBAL will deliver 120-plus hours of AI and deep tech-focused content across various topics, facilitating discussions on the implications of AI in Future Health, Digital Finance, and EdTech. Following the wildfire pace of AI adoption and the unprecedented growth in data storage demand, the event is also launching the region’s largest Data Centre Symposium in 2024, featuring the industry leaders Datalec, Kerno, Khazna, Legrand, NTT Data, Schneider Electric, Vertiv, among many others.
The programme will build anticipation ahead of the all-new AI Everything Global 2025. This event – taking place in Abu Dhabi (4 February) and Dubai (5-6 February) will gather some of the world’s most visionary AI tech companies to construct an innovative, fair, and responsible AI industry of the future.
Fast-tracking the next generation of startups
The world’s largest startup and investment event, Expand North Star will foster the next frontier of tech and innovation. In another record-breaking edition, the event will connect the most innovative global founders with new markets, enterprise customers, and an influential pool of investors and venture capitalists with over $1.2 trillion in Assets Under Management (AUM). These include SOSV, Bessemer Ventures, Lightrock, Sinovation Ventures, and the European Innovation Fund.
Additionally, Expand North Star will seek to redefine the future of money, blockchain, and creativity through leading co-located events GITEX Impact, Fintech Surge, Future Blockchain Summit, and Marketing Mania. Accelerating the next generation of scaleups, the world’s largest start-up pitch competition, Supernova Challenge 2.0, also graces GITEX GLOBAL with the winners claiming a share of the $200,000 prize pool.
Historic international involvement
GITEX GLOBAL 2024 will welcome the highest international attendance in its history, welcoming over 400 government and digital development agencies from around the world. Alongside GITEX GLOBAL regulars, the new nations debuting this year will showcase their latest groundbreaking tech innovations.
Next week marks the largest European participation at GITEX GLOBAL with over 35 European countries exhibiting alongside 1,000-plus SMEs and 450-plus startups from debuting countries, including Austria, Bosnia and Herzegovina, Ireland, Latvia, Lithuania, Portugal, Serbia, and Slovenia.
Many rising digital nations from Latin America are also behind the record-breaking international involvement, as are those from Central and Southeast Asia. Joining long-time GITEX GLOBAL participants such as China, Japan, South Korea, and India are several debutants – Singapore, Malaysia, Kazakhstan, and Kyrgyzstan amongst them.
While promoting international business development, entrepreneurship, and investment engagements to benefit enterprises, organisations, and SMEs alike, GITEX GLOBAL welcomes the European Innovation Council for the first time, Europe’s biggest deep-tech investor.
It will also see significant collaborations with global organisations from all continents, such as the European Innovation Council, Tech Destination Pakistan, IE University, University College London (UCL), Johns Hopkins University, the Massachusetts Institute of Technology (MIT), and key corporate ventures from leading tech enterprises such as Sony, Honda, Standard Chartered, QIC, and many more.
An action-packed agenda
Throughout its six-day duration, GITEX GLOBAL will become a microcosm of the world, launching industry-defining programmes such as GITEX Editions, an exclusive platform for late-stage advanced tech companies and a premier hub for unicorns, soonicorns and rhinos. In 2024, the event will connect 59 top global unicorns, such as Axelera, DeepL, Insilico Medicine, and Synthesis AI.
The World Future Economy Digital Leaders Summit is another must-attend show with global innovators and influential leaders set to address critical priorities shaping the future of technology. Additionally, GITEX Cyber Valley is this year’s most anticipated cybersecurity showcase – hosted by the UAE Cyber Security Council. With specialists forecasting that damage costs could reach $10.5 trillion annually by 2025, the show will present a power-packed conference agenda as the world’s most influential CISOs, CIOs, and GRC leaders to discuss the risks of global cybercrime.  
Leo Chen, Corporate Senior Vice President & President of Enterprise Sales at Huawei, which will be present with a flagship stand at the event, commented on the possibilities unlocked at the event for the industry: “GITEX GLOBAL offers a unique platform for us to engage in meaningful dialogues with industry peers about the trends and perspectives on industrial intelligence. We look forward to sharing our insights and learning from others to explore the endless possibilities of industrial digital and intelligent transformation.”
For more information on GITEX GLOBAL 2024 and to secure your passes, please visit www.gitex.com.
Follow GITEX Global on social media: Facebook  |Instagram  |X  |LinkedIn  |Youtube
Hashtag: #GITEXGLOBAL
About GITEX GLOBAL
GITEX GLOBAL, the world’s largest tech event, is returning for its 44th edition at Dubai World Trade Centre from 14-18 October 2024. The 2024 edition will feature 6,500 exhibitors, and welcome 200,000 tech executives from 180 countries, converging the best minds, future-focused government leaders, and the most visionary enterprises and start-ups to scrutinise, challenge, define, and empower the digital agendas of the world. Independently rated globally as the world’s best tech show, GITEX GLOBAL’s continued expansion is amplified by the launch of GITEX EUROPE Berlin, GITEX ASIA Singapore, and GITEX NIGERIA in 2025, as well as the growth of GITEX AFRICA Morocco leading up to its third record-breaking edition. More information: www.gitex.com
About Dubai World Trade Centre
A global business facilitator since 1979, Dubai World Trade Centre (DWTC) is home to the region’s leading purpose-built convention and exhibition centre. DWTC provides a platform for connecting people, products, innovation and ideas from around the world through a dynamic calendar of international trade exhibitions and its own roster of sector leading mega events. As a designated free zone, complemented by award-winning commercial real estate, DWTC plays an integral role in Dubai and the region’s growth story. Since its inauguration, DWTC has hosted over 6,000 events, with an estimated economic output of AED 248 billion, attracting over 38 million business visitors to Dubai.
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Huawei Showcases Intelligent Technologies at InnoTrans 2024

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BERLIN, Oct. 12, 2024 /PRNewswire/ — The 14th InnoTrans took place in Berlin, Germany from September 24 to 27. The theme of the event is “The future of mobility”. At this trade fair, with a focus on digital and intelligent transformation trends in rail transportation, Huawei showcased innovative applications of FRMCS(Future Railway Mobile Communication System), AI, cloud computing, IoT, and other cutting-edge technologies in the rail industry.

Railway, as a complex and huge system that always puts safety first, needs a unified digital and intelligent foundation alongside an industry ecosystem that consists of partners specializing in diverse domains to go digital and intelligent.
Jacky Wang, Vice President of Smart Transportation BU, Huawei, said that the global rail transportation industry is striding toward an era of broadband, cloud, and intelligence. “Aligning with this trend, Huawei has launched a One Cloud, One Network, Multi-Hub Solution to help the railway industry address challenges in network bandwidth, information system integration, and digital and intelligent transformation.”
Leveraging large models, AI, big data, and intelligent algorithms, this solution promotes intelligent upgrades across a wide range of professional domains, including train operation, locomotive, rolling stock. The goal is to help customers build safe, efficient, and green integrated transportation hubs, improving overall railway transportation quality and efficiency.
Jacky Wang emphasized that the reliable FRMCS features high bandwidth, wide coverage, and low latency, and is crucial for implementing broadband across rail transportation. He went on to explain that migrating services to the cloud is becoming increasingly popular as it allows for centralized use of IT resources and unified O&M, which can reduce investment costs.
“Big data and AI technologies tailored to specific scenarios will enhance the value of data, bolster service security, and increase efficiency in production management,” said Jacky Wang.
Currently, the solution has been deployed in various service scenarios like intelligent freight train inspection, intelligent scheduling in EMU depots, and smart railway perimeter detection, resulting in substantial benefits. Huawei’s scenario-specific solutions and partners are going global, too. They are continuously addressing the challenges faced by railway customers and generating value for the industry.
Up to now, Huawei has served more than 300 urban rail lines across 70 cities and more than 180,000 km of railways worldwide.

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