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Associated Press
2 days ago
- Business
- Associated Press
Vitalgen's Gene Therapy Drug VGN-R09b for Primary Parkinson's Disease Receives FDA Fast Track Designation
SHANGHAI, CHINA, June 30, 2025 / / -- Shanghai Vitalgen BioPharma Co., Ltd. ('Vitalgen') announced that its gene therapy drug, VGN-R09b, for the treatment of Primary Parkinson's Disease (PD), has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA). VGN-R09b received IND approvals in China and the US in 2024, as a first-in-class recombinant adeno-associated virus (rAAV) gene therapy that targets two key pathways for the treatment of Parkinson's Disease (PD). The Phase I/II clinical trials have been ongoing in China since September, 2024, with all six patients dosed in the Phase I dose-escalation study. Safety data shows that the product is well-tolerated with no findings of VGN-R09b-related adverse events. Preliminary efficacy readouts show that VGN-R09b has a rapid onset of action, with significant gait improvements within two weeks post-treatment. The MDS-UPDRS Part III OFF scores decreased significantly after one month, with an average of 25-point improvements (approximately 50% improvements from the baseline) at six months. Overall, the Hoehn-Yahr (H-Y) scores progressively decreased, along with a reduction in oral medication dosages. The FTD indicates FDA's recognition of the clinical potential of VGN-R09b, marking an important milestone for Vitalgen's expansion into the chronic disease area, and it also represents a global breakthrough for a Chinese gene therapy company in the neurodegenerative field. Together with its FDA IND approval in July 2024, this FTD further validates VGN-R09b's global development potential and will provide expedited support for its future US clinical trials and regulatory filings. About Fast Track Designation (FTD) FTD is an FDA program designed to accelerate the development and approval of drugs that treat serious or life-threatening conditions and have the potential to address unmet medical needs. According to the performance report from the FDA's Center for Biologics Evaluation and Research (CBER), over 800 products have applied for FTD, with a success rate of approximately 68%. After receiving FTD, applicants are given the opportunity for frequent discussions with the FDA regarding their drug development plans, thereby increasing development efficiency. If the product meets certain criteria, it can qualify for accelerated approval, priority review, and rolling reviews, which can further accelerate development and market approval processes. About Parkinson's Disease (PD) Parkinson's Disease (PD) is the second most common neurodegenerative disease, with fast-growing incidences. It is projected that the global PD patient numbers will increase to more than 25 million by 2050. Current PD treatments are primarily small-molecule drugs for symptom relief. As the disease progresses, patients gradually lose response to oral medication, and significant motor complications persist despite fine-tuning the treatment regimens. There is currently no available treatment to delay disease progression or improve long-term outcomes. a: Projections for prevalence of Parkinson's disease and its driving factors in 195 countries and territories to 2050: modeling study of Global Burden of Disease Study 2021. BMJ. 2025;388:e080952. doi:10.1136/bmj-2024-080952. About Vitalgen Vitalgen was founded in March 2020 as a cell and gene therapy (CGT) company based in Shanghai, China, dedicated to translating cutting-edge CGT technologies into clinically accessible treatments for patients worldwide. With proprietary intellectual property rights covering three core CGT platforms: ViVec® (AAV manufacturing platform), ViCas® (CRISPR gene-editing platform) and ViLNP® (Lipid nanoparticle delivery platform), Vitalgen has developed a diversified portfolio of innovative CGTs targeting CNS diseases, ophthalmic conditions, metabolic and hematologic disorders, and oncology, including multiple potential First-in-Class (FIC) products. Up-to-date, Vitalgen has received multiple rounds of investment from renowned venture funds and has established CGT R&D labs and operational centers in the Zhangjiang High-tech Park and a GMP commercial production facility in the Waigaoqiao Free Trade Zone, Shanghai, China. David Wu Vitalgen BioPharma email us here Legal Disclaimer: EIN Presswire provides this news content 'as is' without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
Perth Now
23-06-2025
- Entertainment
- Perth Now
Bruce Willis's daughter Tallulah shares intimate moments with father amid dementia fight
Bruce Willis' daughter Tallulah has shared intimate moments with her father amid his ongoing battle with frontotemporal dementia and aphasia. The 70-year-old Die Hard star has faced a difficult couple of years, with his wife Emma Heming Willis, 46, revealing publicly in 2023 he was living with FTD, a progressive neurological disorder affecting behaviour and language, after first announcing his frontotemporal aphasia diagnosis in 2022. His 31-year-old fashion designer daughter is among his family members who have been caring for him, and has now posted snaps of her time with him, including one of her giving him a hug. She captioned the image, posted to her Instagram Stories: 'Sunday funday at Grams! Grateful (white dove emoji.)' Tallulah's older sister Rumer, 36, also shared a heartfelt update in a Father's Day post, reflecting on the challenges her father now faces. She wrote: 'Today is hard, I feel a deep ache in my chest to talk to you and tell you everything I'm doing and what's going on in my life. To hug you and ask you about life and your stories and struggles and successes.' The House Bunny star made reference to Bruce's struggles with speech and memory, admitting, 'I wish I asked you more questions while you could still tell me about it all.' She expressed gratitude for the moments she still shares with her father, adding: 'I know you wouldn't want me to be sad today so I'll try to just be grateful reminding myself how lucky I am that you're my dad and that you're still with me and I can still hold you and hug you and kiss your cheek and rub your head I can tell you stories.' Rumer also posted a touching photograph of Bruce with her two-year-old daughter, Louetta, noting: 'I can watch the way your eyes light up when you see Louetta I will be grateful for every moment I have with you. I love you so much dad happy Father's Day.' Emma Heming paid tribute to her husband on Instagram, writing: 'Happy Father's Day to all the dads living with disability or disease, showing up in the ways they can and to the children who show up for them.'
Metro
23-06-2025
- Entertainment
- Metro
Tallulah Willis calls out critics after posting recent pictures of dad Bruce
Tallulah Willis, the 31-year-old daughter of legendary Hollywood actor Bruce, has hit back at critics after providing a new update on her dad. In 2023, the Die Hard actor's family sadly announced that 70-year-old Bruce had been diagnosed with frontotemporal dementia (FTD), a year after he retired from acting. In the two years since, his loved ones – including ex-wife Demi Moore and their three daughters – have shared ongoing updates about his condition in a bid to raise awareness of FTD. Brand new intimate photographs, shared by Tallulah on social media, showed dad and daughter in a loving and tender moment as they held hands. Other photos showed the pair hugging, while more pictures from the gallery showed Bruce looking well and standing next to Tallulah's fiancé, Justin Acee. However, the images were deemed inappropriate by some users who criticised Tallulah for sharing images of her father while he is unable to consent to the images being shared. One comment read, 'I don't think you should expose your dad to the public! He is vulnerable! And some things should be kept private! You don't have his permission to post it!' To this critic, Tallulah responded: 'Hi. I hear that. As a family we use our discretion when posting. Today was a great day filled with smiles. She added: 'I made the judgment call to show that to the world, because I know what he means to everyone.' Her pictures of Bruce were met with mixed reviews, with some criticising the star and others celebrating Tallulah for sharing positive updates about him. JanMoore828 commented: 'Thank you for sharing bits of happiness of your dad, our hero. I respect your privacy, but so happy to see you and dad smile. That's what it is all about. Hold him close. We hold you all close in our hearts.' Bruce has a huge support network with his blended family sticking together through tough times – that network includes wife Emma, 46, who gives occasional updates on the Hollywood legend's health. Former model Emma and Bruce tied the knot 16 years ago and share two young children- 10-year-old daughter Evelyn and 12-year-old daughter Mabel. From his 13-year marriage to Demi Moore, which lasted between 1987 and 2000, Bruce also has three grown-up daughters – Tallulah, as well as 36-year-old Rumer and 33-year-old Scout. While Ghost actress and Bruce divorced 25 years ago, they have still remained close friends since, with Demi recently saying there is 'life after divorce'. 'We will always be a family, just in a different form. For me, there was never a question. I show up because that's what you do for the people you love.' More Trending Commonly abbreviated to FTD, the disease Bruce was diagnosed with in 2023 is the most common form of dementia for people under the age of 60. It currently has no treatment or cure. Last week, Bruce's eldest daughter Rumer admitted she feels a 'deep ache in her chest' during an emotional statement posted to her own Instagram page. ''Today is hard, I feel a deep ache in my chest to talk to you and tell you everything I'm doing and what's going on in my life. To hug you and ask you about life and your stories and struggles and successes. 'I wish I asked you more questions while you could still tell me about it all. But I know you wouldn't want me to be sad today so I'll try to just be grateful reminding myself how lucky I am that you're my dad and that you're still with me.' Got a story? If you've got a celebrity story, video or pictures get in touch with the entertainment team by emailing us celebtips@ calling 020 3615 2145 or by visiting our Submit Stuff page – we'd love to hear from you. MORE: Country music legend, 75, rushed to hospital after slurring words mid-concert MORE: Brad Pitt reveals he 'needed rebooting' in AA after bitter Angelina Jolie split MORE: Justin Timberlake fans gutted after Isle of Wight performance 'not allowed' on TV
The Star
16-06-2025
- Automotive
- The Star
FT Dept, JPJ ordered to address abandoned vehicles in KL, Putrajaya
KUALA LUMPUR: The Federal Territories Department (FTD) has been directed to hold discussions with the Road Transport Department (JPJ) to examine the loopholes in existing legislation relating to the disposal of abandoned vehicles in the federal capital and Putrajaya, says Datuk Seri Dr Zaliha Mustafa. The Minister in the Prime Minister's Department (Federal Territories) said the action needed to be expedited following the high number of public complaints regarding abandoned vehicles in urban areas. "In Kuala Lumpur alone, public complaints regarding abandoned vehicles reach over 2,500 cases every year. This is not a small number and should not be allowed to continue. "However, we are faced with several legal constraints, including abandoned vehicles on private premises that cannot be towed to the local authority depot as well as vehicles that have been at the depot for a long time but have not yet been disposed of due to legal obstacles," she said in a Facebook post Monday (June 16). Earlier, she visited Car Medic Sdn Bhd, a licensed automotive treatment centre that carries out the disposal of vehicles that have been declared written-off, to personally observe the implementation of a faster, more orderly and sustainable disposal process. Dr Zaliha stressed that abandoned vehicles cannot continue to mar the city, hence a comprehensive solution needs to be jointly formulated by the relevant agencies. She also encouraged owners who want to dispose of their vehicles voluntarily to visit a licensed automotive treatment centre. "The process is simple and the owner will receive cash payment based on the condition of the vehicle," she said. - Bernama
New Straits Times
16-06-2025
- Automotive
- New Straits Times
FT Dept, RTD ordered to handle abandoned vehicles in KL, Putrajaya
KUALA LUMPUR: The Federal Territories Department (FTD) has been directed to hold discussions with the Road Transport Department (RTD) to examine the loopholes in existing legislation relating to the disposal of abandoned vehicles in the federal capital and Putrajaya. Minister in the Prime Minister's Department (Federal Territories) Datuk Seri Dr Zaliha Mustafa said the action needed to be expedited following the high number of public complaints regarding abandoned vehicles in urban areas. "In Kuala Lumpur alone, public complaints regarding abandoned vehicles reach over 2,500 cases every year. "This is not a small number and should not be allowed to continue. "However, we are faced with several legal constraints, including abandoned vehicles on private premises that cannot be towed to the local authority depot as well as vehicles that have been at the depot for a long time but have not yet been disposed of due to legal obstacles," she said in a Facebook post today. Earlier, she visited Car Medic Sdn Bhd, a licensed automotive treatment centre that carries out the disposal of vehicles that have been declared written-off, to personally observe the implementation of a faster, more orderly and sustainable disposal process. Dr Zaliha said abandoned vehicles cannot continue to mar the city, hence a comprehensive solution needs to be jointly formulated by the relevant agencies. She also encouraged owners who want to dispose of their vehicles voluntarily to visit a licensed automotive treatment centre. "The process is simple and the owner will receive cash payment based on the condition of the vehicle," she said. – Bernama
