Artificial Intelligence
BioXcel Therapeutics Receives FDA Breakthrough Therapy Designation for BXCL501 for the Acute Treatment of Agitation Associated with Dementia
NEW HAVEN, Conn., March 15, 2021 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that BXCL501, the Company’s investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine (“Dex”), has been granted Breakthrough Therapy designation from the U.S. Food and Drug Administration (“FDA”) for the acute treatment of agitation associated with dementia. The Breakthrough Therapy designation is intended to expedite the development and review of certain product candidates designed to treat serious or life-threatening diseases or conditions, and the designation includes increased interaction and guidance from the FDA.
“Managing dementia related agitation, specifically in elderly patients, represents a significant challenge for physicians and caregivers, as there are currently no FDA-approved therapies and off-label drugs come with black box warnings,” stated Vimal Mehta, Chief Executive Officer of BioXcel. “The FDA’s decision to grant Breakthrough Therapy designation further underscores the significant unmet need for a new treatment for this underserved patient population, as well as highlights BXCL501’s potential in becoming the first therapeutic option, if approved, to address this debilitating medical condition. We look forward to working closely with the FDA to advance BXCL501 into a pivotal dementia program, in hopes of quickly bringing this therapy to the millions of patients across treatment settings that lack alternative options.”
The Breakthrough Therapy designation for BXCL501 was supported by the positive topline data from the Phase 1b/2 TRANQUILITY study for the acute treatment of agitation associated with dementia, including Alzheimer’s disease. BXCL501 demonstrated statistically significant reductions in agitation measures at 2 hours post-dose with both the 30 and 60 mcg doses as measured by multiple scales. The dose dependent response observed has the potential to support the Company’s plans to evaluate BXCL501 for use across the full range of dementia care settings.
About FDA Breakthrough Therapy Designation
Breakthrough Therapy designation is an FDA program intended to expedite the development and regulatory review of investigational therapies that are designed to address serious or life-threatening conditions. The criteria for Breakthrough Therapy designation requires preliminary clinical evidence that indicates that the candidate may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. This designation provides the Company with more intensive FDA guidance on an efficient drug development program, and eligibility for other actions to expedite the FDA review, such as a rolling review of a New Drug Application (“NDA”), where the FDA may review sections of the NDA before the complete application is submitted. An NDA for a product candidate receiving breakthrough designation may also be eligible for priority review if the relevant criteria are met. Breakthrough Therapy designation does not change the standards for approval. For more information, please visit the FDA website at www.fda.gov. About Dementia Related Agitation
Dementia is a neurocognitive condition caused by damage to brain cells that leads to a decline in cognitive abilities and independent function. It affects approximately 6 million individuals in the United States, with Alzheimer’s disease accounting for up to 80% of these cases. During the course of the disease, patients with dementia often suffer from psychological and behavioral symptoms, such as agitation, which has been reported in up to 70% of patients. Agitation associated with dementia can negatively affect both the patient and caregiver’s quality of life. Caregiver burden can contribute significantly to burnout, which can result in premature institutionalization of the patient. Treating agitation associated with dementia has been a challenge for providers as there are currently no FDA-approved therapies for the treatment of dementia-related agitation, and off-label therapies have black box warnings associated with their use.
About BXCL501
BXCL501 is an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of agitation and opioid withdrawal symptoms. BioXcel believes that BXCL501 potentially targets a causal agitation mechanism, and the Company has observed anti-agitation results in multiple clinical studies across several neuropsychiatric disorders. BXCL501 has been granted Fast Track Designation by the U.S. Food and Drug Administration for the acute treatment of agitation in patients with schizophrenia, bipolar disorders, and dementia. BXCL501 has been studied in two Phase 3 trials (SERENITY I and II) for the acute treatment of schizophrenia related agitation and bipolar disorder related agitation, respectively, and in a Phase 1b/2 trial (TRANQUILITY) for the acute treatment of dementia related agitation. This product candidate is also currently being evaluated in a Phase 1b/2 trial (RELEASE) for the treatment of opioid withdrawal symptoms and in a Phase 2 trial (PLACIDITY) for the treatment of delirium related agitation.
BioXcel Therapeutics, Inc. BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. BioXcel’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BioXcel’s two most advanced clinical development programs are BXCL501, an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation and opioid withdrawal symptoms, and BXCL701, an investigational, orally administered, systemic innate immunity activator in development for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. For more information, please visit www.bioxceltherapeutics.com.
Forward-Looking Statements
This 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 potential for BXCL501 to treat dementia-related agitation and the timing of the planned pivotal Phase 3 trial of BXCL501 in dementia-related agitation. 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 BioXcel’s current expectations and various assumptions. BioXcel believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain.
BioXcel 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 BioXcel’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 Annual Report on Form 10-K for the year ended December 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 the Investors section 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 BioXcel 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 BioXcel’s views as of any date subsequent to the date of this press release. Contact Information:
BioXcel Therapeutics, Inc. Investor Relations: John Graziano Media:
www.bioxceltherapeutics.com
Mary Coleman
BioXcel Therapeutics, VP of Investment Relations
[email protected]
1.475.238.6837
Solebury Trout
[email protected]
1.646.378.2942
Julia Deutsch
Solebury Trout
[email protected]
1.646.378.2967
Artificial Intelligence
Xinhua Silk Road: E China’s Changzhou City unveils investment opportunities in sectors of new productive forces for global investors
BEIJING, Sept. 29, 2024 /PRNewswire/ — Changzhou City, an leading international smart manufacturing base located in east China’s Jiangsu Province, has released a bunch of investment investment opportunities to global investors in various sectors of new productive forces at the the 2024 New Energy Industry Development Conference & Invest in Changzhou Conference held in the city on September 19.
The investment opportunities covers nine areas including synthetic biology, low-altitude economy, intelligent connected new energy vehicles, solid-state batteries, hydrogen energy, third-generation semiconductors, and artificial intelligence, manifesting the confidence of Changzhou in further opening development.
Changzhou, seated in the axis of the Yangtze River Delta, has become an important base for advanced manufacturing in China.
In recent years, thanks to intensified efforts in developing new energy industry and fostering new quality productive forces, Changzhou has expanded the added value of its industrial sector to more than two trillion yuan, with manufacturing added value accounting for about 43 percent, both ranking among the top three in Jiangsu Province.
In the Hurun China New Energy Cities 2024, a list released by the Hurun Research Institute at the conference, Changzhou ranked first among other cities in the country for three consecutive years in terms of investment attractiveness and concentration.
Changzhou has accumulated a total of 10.59 billion US dollars (nearly 74.25 billion yuan) in terms of actually utilized foreign capital since 2020. Major projects such as soft magnetism of ArcelorMittal and medical device of BIOS, a Hong Kong-based company, have been launched during the conference.
In addition, Changzhou has released a multilingual guide for foreign nationals in Changzhou at the conference, which includes practical service items in stay and residence, work, convenient payment options, among others, turning the city into a more open and international place.
Original link: https://en.imsilkroad.com/p/342380.html
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View original content:https://www.prnewswire.co.uk/news-releases/xinhua-silk-road-e-chinas-changzhou-city-unveils-investment-opportunities-in-sectors-of-new-productive-forces-for-global-investors-302261868.html
Artificial Intelligence
CGTN: China honors individuals with highest awards in celebration of 75th National Day
BEIJING, Sept. 29, 2024 /PRNewswire/ — Huang Zongde enlisted in the Chinese People’s Liberation Army at the age of 17, beginning a nearly four-decade-long military career where his bravery, valor and devotion earned him countless awards and honors.
The heavily decorated 93-year-old received the highest state honor on Sunday when Chinese President Xi Jinping conferred him with the Medal of the Republic at a ceremony in the Great Hall of the People in Beijing.
China awarded national medals and national honorary titles to 15 individuals, including Huang, in recognition of their contribution and achievement as it celebrates the 75th anniversary of the founding of the People’s Republic of China, which falls on October 1.
Chinese heroes and role models
In addition to Huang, three others were awarded the Medal of the Republic. Wang Yongzhi, a missile and rocket expert and a pioneer of China’s manned space program, was honored posthumously. Wang Zhenyi, a medical scientist known for breakthroughs in leukemia treatment, and Li Zhensheng, an expert in wheat breeding, are also among the honorees.
The national honorary titles went to 10 people, including scientists, a border patrolman, an artist, a craftsman, educators, a health worker, an economist and an athlete.
Addressing Sunday’s awarding ceremony, President Xi, also general secretary of the Communist Party of China Central Committee and chairman of the Central Military Commission, called on the Chinese people to learn from heroes and role models to form a mighty force to build a strong China.
China is in a crucial period for building a great modern socialist country in all respects and achieving national rejuvenation through Chinese modernization, he said.
Encouraging the Chinese people to strive for extraordinary achievements at ordinary job posts, Xi urged them to contribute to resolving challenges to development and reform and safeguarding social harmony and stability.
China’s old friends and good friends
As its highest state honor for foreigners, China awarded the Friendship Medal to Dilma Rousseff, president of the New Development Bank and former Brazilian president, for her commitment to the friendship between China and Brazil, and development of relationship between China and the Community of Latin American and Caribbean States, and cooperation among BRICS countries, a group of major emerging economies.
Accepting the honor at the ceremony, Rousseff said the medal symbolizes the strong bonds between Brazil and China and pledged to continue her unremitting efforts to promote the friendship.
China’s achievements over the decades, including economic transformation, technological innovation and remarkable social development, have made it a beacon and a source of inspiration for the world, she said.
Xi lauded Rousseff as an outstanding representative of China’s old friends and good friends who have shared the same aspirations and stood together with the Chinese people over the past 75 years and vowed that China will never forget such international friends.
The Chinese people are ready to join hands with people from all over the world to safeguard world peace, promote common development and advance the building of a community with a shared future for mankind to create a better future for humanity, he said.
https://news.cgtn.com/news/2024-09-29/China-honors-individuals-with-highest-awards-ahead-of-National-Day-1xhS1SaZeZa/p.html
View original content:https://www.prnewswire.co.uk/news-releases/cgtn-china-honors-individuals-with-highest-awards-in-celebration-of-75th-national-day-302261867.html
Artificial Intelligence
Kazakhstan Government Delegation Visited SUPCON
HANGZHOU, China, Sept. 29, 2024 /PRNewswire/ — On September 26, a delegation from the Ministry of Digital Development, Innovations and Aerospace Industry of the Republic of Kazakhstan, led by Minister Madiyev Zhaslan, visited SUPCON. SUPCON’s Chairman and President, Mr.Cui Shan, warmly welcomed the delegation.
The Kazakhstan government representatives expressed their appreciation and recognition of SUPCON’s expertise and innovation in intelligent manufacturing, digital transformation, and industrial AI.
Madiyev Zhaslan expressed a strong interest in industrial AI technologies of SUPCON, particularly their applications in intelligent and low-carbon facilities. He looks forward to exploring extensive collaboration with SUPCON across various sectors in Kazakhstan.
Cui Shan emphasized that as a leading industrial AI company with a global presence, SUPCON will leverage its technological advantages to meet Kazakhstan’s industry development requirements and trends, injecting new momentum into the country’s industrial digitalization.
In 2023, SUPCON established a subsidiary in Kazakhstan as its Central Asia regional headquarters and set up a localized operational system. SUPCON will continue to invest in the long-term development of the Central Asia region, contributing further wisdom and strength to the industrial digital transformation in Kazakhstan and beyond.
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View original content:https://www.prnewswire.co.uk/news-releases/kazakhstan-government-delegation-visited-supcon-302261857.html
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