Latest news with #osteosarcoma
ABC News
a day ago
- Health
- ABC News
Woman feels abandoned by WA health system amid year-long chronic pain battle
Jayde Guest spends most evenings in extreme pain. For almost a year, the mother of two from Esperance, 700 kilometres south-east of Perth, has barely been able to work or socialise. She feels as though her life has been stripped of all its best parts. "I'm at the end of my tether right now. "Day-to-day life is a real challenge." While she has turned to Western Australia's health system numerous times for help, she said the process had only compounded her suffering. The pain, which "feels like her chest wall is caving in", arrived out of the blue on a normal winter's morning. It has returned each day since, intensifying the more active she is and often becoming unbearable by night. Her doctor's first suspicion was cancer, as she had been in remission from an aggressive form called osteosarcoma for about 20 years. But the medical system was at a loss when tests ruled out cancer. She made the journey to Perth, seeing five different specialists on separate occasions, none of whom could produce the answers she sought. Ms Guest said she was then twice rejected from the WA Health Department's central referral service — designed to triage and allocate cases — and the hospital stopped calling her back. "I [was] in the too-hard basket," she said. Ms Guest said she turned to support groups on social media and sought out experts in London, America, Melbourne and Sydney. Finally, she found someone who might have an answer to her pain. During her previous bone cancer battle, she had five ribs removed and replaced with a Gore-Tex mesh. A doctor in Sydney believes the 20-year-old mesh is now shrinking and pulling against her chest wall. The doctor, who specialises in mesh removal, told Ms Guest they were confident of being able to remove hers but is still working out how to rebuild her chest wall. Ms Guest is relieved to have a way forward, but the wait continues as they work on a solution. She said the uncertainty of her experience felt harder than the 16 rounds of chemotherapy she endured in her 20s. "The lack of communication from the medical system has been really disappointing," she said. "And I think that's what makes people feel really alone. Clare Mullen, executive director at WA's Health Consumers Council, said experiences like Ms Guest's happened "too often". But Ms Mullen said cases involving regional patients and chronic pain could be particularly difficult. She said this was due to the disconnect between country GPs and metropolitan health professionals and the scepticism that could follow chronic pain. "Unfortunately, it's one of the areas where we see a lot of people having to convince the clinicians … that their pain is real." Ms Mullen said anyone feeling like their case was not progressing or who had been rejected from the service should contact the GP who made their first referral. "It's not ideal, particularly in a case like this [where] someone is living with chronic pain," she said. "It's a time-consuming process." Ms Mullen said if they still had no luck, they should contact the Health Consumers Council. Monika Boogs, chief executive of Pain Australia, said the number of Australians suffering chronic pain was about 3.7 million and growing. But Ms Boogs said there were only about 200 pain specialists in the country, with access proving particularly difficult for regional residents. She said a national action plan for pain management was done six years ago, but many programs were still unfunded. "Pain is like mental health was 20 years ago. It's something that's growing. It's impacting so many people," she said. WA Health Minister Meredith Hammat said the health system aimed to provide world-class care to all West Australians. "We will never stop working to advance the care our health system provides," she said. A WA Health spokesperson said initiatives were in progress to improve access to public specialist outpatient services. To help others, Ms Guest started blogging about her experience. She said she was a big believer in documenting experiences and helping others to advocate within the medical system. "By me sharing it, I've had people open up to me and hopefully I've helped them to see that they're not alone. "And Facebook groups, as much as they can be a little bit negative sometimes, I've found some great people and great friends going through similar things to me. "And that's definitely helped." Ms Guest said it also kept her sane, as the wait for a cure continued. "I think it's hard for people to understand because I look kind of normal, I don't walk around going, 'Oh, my gosh, I'm in so much pain.' "I just have to carry on."
Yahoo
5 days ago
- Business
- Yahoo
OS Therapies Receives Positive FDA Meeting Feedback on Regulatory Pathway for Accelerated Approval of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pediatric Lung Metastatic Osteosarcoma
Company has requested End of Phase 2 Meeting and Breakthrough Therapy Designation (BTD) based upon the positive FDA Meeting feedback NEW YORK, June 24, 2025--(BUSINESS WIRE)--OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that it received positive written feedback from the US Food & Drug Administration ("FDA") Type D Meeting that occurred in mid-June 2025 regarding endpoints required to support an Accelerated Approval Program marketing application for its Phase 2b trial of OST-HER2 in the prevention or delay of recurrence in fully resected, pediatric lung metastatic osteosarcoma. The Company reiterates that additional data from its Phase 2b trial will be presented at the major osteosarcoma conference MIB Factor in Salt Lake City on Saturday June 28, 2025 at 3:30pm MDT. Concurrent with this announcement, the Company announced that it has submitted End of Phase 2 Meeting and Breakthrough Therapy Designation (BTD) requests to FDA based on the positive Type D Meeting feedback. The End of Phase 2 Meeting is expected to occur in the third quarter of 2025. This is in alignment with the company's overall regulatory strategy and timelines. "We are pleased with the feedback we received from the FDA regarding the use of external control comparators in settings where placebo-controlled randomization trials are not feasible – particularly in rare pediatric diseases such as the indication treated by OST-HER2 ," said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. "Moreover, we received additional collaborative input regarding suggested statistical methods as we seek to compare OST-HER2 active treatment with external control arm(s) to support a Biologics Licensing Application (BLA) via the Accelerated Approval Program. Taken together, the feedback gives us insight on the FDA's current position and allows us to be fully prepared for the End of Phase 2 Meeting." OST-HER2 has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to immediately sell. The most recent PRV sale occurred in June 2025, valued at $160 million. The osteosarcoma treatment market was estimated at $1.2 billion in 2022 according to Data Bridge Market Research. Approximately 50% of patients are diagnosed with a lung metastasis at some point following surgical resection and chemotherapy. 3-year survival rates in patients who were not diagnosed with a metastasis are 59%. 3-year survival rates in patients who were diagnosed with pulmonary metastasis were 30%. The Company believes the market opportunity for OST-HER2 in the prevention of lung metastases is over $500 million. OST-HER2, an immunotherapy for osteosarcoma that uses a HER2-bioengineered form of the bacterium Listeria monocytogenes to trigger a strong immune response against HER2-expressing cancer cells, is featured in the movie Shelter Me: The Cancer Pioneers. The movie offers a look into canine comparative oncology, a field that compares treatment of cancers in dogs to those in people and covers developing treatments for rare forms of cancer. The movie is available via streaming on PBS' website. About OS Therapies OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the US Food & Drug Administration and Fast-Track and Orphan Drug designations from the US FDA and European Medicines Agency. The Company positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a Biologics Licensing Application (BLA) to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma. In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as "anticipate," "expect," "intend," "may," "will," "should" or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the US FDA and other risks and uncertainties described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's most recent Annual Report on Form 10-K and other subsequent documents the Company files with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. View source version on Contacts OS Therapies Contact Information: Jack Doll410-297-7793Irpr@ Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Malay Mail
11-06-2025
- Health
- Malay Mail
Vinmec performs its first total femoral replacement for world's youngest cancer patient
Vinmec successfully performs world's youngest pediatric total femur replacement surgery using 3D printing technology. HANOI, VIETNAM - Media OutReach Newswire - 11 June 2025 -In October 2022, after a minor fall, Tran Minh Duc (a boy from Ho Chi Minh City) hurt his left thigh. Believing it to be just a simple injury, his family was shocked to hear the bad news from the doctor: The boy was diagnosed with osteosarcoma - a malignant bone cancer with a tumor that had invaded his entire femur. It is typically seen in adolescents, but rare and haphazard in younger the severe prognosis, most medical facilities recommended amputation to ensure his survival or bone grafting (a conventional method). Both methods carry a high risk of rejection and infection, especially for younger children in the development flash of hope appeared when she met Prof. Dr. Tran Trung Dung - Director of the Orthopedic Council, Vinmec Healthcare System. An unprecedented approach was proposed to apply to such a young patient:According to Prof. Dr. Tran Trung Dung, the entire femur of Duc has been invaded by the tumor. To ensure his life, Duc's leg had to be amputated. However, different types of artificial joints available on the market are not compatible with young various interdisciplinary case conferences including Orthopedics, Oncology, Diagnostic Imaging, Pathology, Clinical Pharmacy, etc., the Vinmec experts reached a consensus on the optimal approach - a two-phase surgery. Phase 1 (January 2024): Removing the tumor and temporarily grafting a cement bone. Phase 2 (May 2025): Replacing the entire femur with a "customized" bone made of 3D-printed January 29, 2024, Duc underwent his first surgery - removing the entire tumor and temporarily grafting a cement bone. In May 2025 when his conditions had stabilized, Duc's entire femur was replaced with a "customized" bone made of 3D-printed metal. For the first time, 3D printing was applied to the youngest patient in the world with the collaboration between Vinmec medical professionals and VinUni's engineers. The bone's design is modular, enabling future extensions based on the child's physical to MSc. Dr. Tran Duc Thanh, who was directly engaged in the surgery:Prof. Dr. Tran Trung Dung added: "The 4-hour surgery was a success. Duc recovered quickly without any complications, now he is able to walk with the support of physical therapy. The surgery represented a breakthrough in complex techniques and the evidence for sound collaboration in the multidisciplinary medical team. Both the life and limb of the child were kept intact."Once at risk of amputation and life-long dependence, Minh Duc is now able to walk on his own feet, supported by physical therapy without any complications of infection or transplant rejection. Every step Duc takes is a testament to precision medicine, advanced technologies, and the unwavering love of his mother.- Ms. Hoang said in Dr. Tran Trung Dung also shared his emotions:Vinmec is the first Vietnamese healthcare system that applies personalized 3D printing in the treatment of musculoskeletal conditions. Instead of using standardized equipment, Vinmec uses CT and MRI data in the design of artificial joints and bones tailored to each patient to optimize motor functions, enhance precision, and reduce the recovery date, Vinmec has achieved successes in many difficult and rare cases, e.g. liver transplantation for an 8-month-old patient from a brain-dead donor, the first in Southeast Asia to reproduce 3D-printed titanium chest wall, and the first in the world to replace the pelvis and femur at the same time with 3D-printed its series of breakthroughs and pioneering achievements in high-tech healthcare and precision medicine, Vinmec further affirms the aspiration to elevate the position of Vietnam in the global medical - A Place of Healing and Reimagining the #Vinmec The issuer is solely responsible for the content of this announcement. About Vinmec Healthcare System Vinmec is Vietnam's leading private healthcare system, with a network of 9 hospitals nationwide, developed to international standards with a focus on comprehensive, personalized, and specialty care. Its proud achievements include: A strategic partnership with Cleveland Clinic , one of the world's top healthcare systems, enabling global clinical collaboration and access to world-class medical standards. , one of the world's top healthcare systems, enabling global clinical collaboration and access to world-class medical standards. No.1 Healthcare Services for Foreigners in Vietnam , trusted by international residents for its high-quality care, globally trained physicians, and international-standard facilities. , trusted by international residents for its high-quality care, globally trained physicians, and international-standard facilities. The only healthcare system in Asia honored at the Healthcare Asia Awards 2025 , receiving two prestigious accolades: Hospital Group of the Year and Technology Innovation of the Year , reinforcing its leadership in the region. , receiving two prestigious accolades: and , reinforcing its leadership in the region. JCI-accredited , meeting the world's most rigorous standards for patient safety and healthcare quality. , meeting the world's most rigorous standards for patient safety and healthcare quality. The first and only healthcare system in Vietnam to establish Centers of Excellence (CoEs) across four key specialties: Cardiology, Oncology, Orthopedics & Sports Medicine, and Clinical Immunology – Allergy.
BBC News
09-06-2025
- Health
- BBC News
Biggleswade Blue Badge holder dubs process 'bureaucracy gone mad'
A man who has had a prosthetic leg for half a century has described a request for more medical information to renew his Blue Badge as "bureaucracy gone mad".Raymond Dingwall,72, from Biggleswade, Bedfordshire, lost his leg to bone cancer in 1976, and said he had never experienced a problem renewing his disabled parking permit said that after he applied, he received an email asking for more details, including letters of diagnosis, consultant letters - and proof of care requirements.A spokesperson for Central Bedfordshire Council said "all applications are treated as new applications, and we require supporting evidence to ensure fairness and consistency for all applicants". "The information they require I cannot give them as the surgeon who looked after me when I was very poorly has died," said Mr Dingwall."I have not kept documentation of all the illnesses I have and I have never had a letter from a hospital consultant." Mr Dingwall, who used to play semi-professional football for Stevenage FC, had to have his right leg amputated in 1976 because he had bone cancer, and he needed it removed to prevent the spread of had long running chemotherapy and after 12 months he was told the cancer had spread to his lung. He then had part of his left lung said he now struggled to get about mainly due to his secondary "complaints" - he has chronic heart failure, an arthritic left knee, kidney stones, skin cancer on his head and has undergone radiotherapy for prostate says he needs the Blue Badge, which expires in August, as "if the weather was bad I need to park near the shops as I would be like Bambi"."People with conditions that are never going to change and only deteriorate are effectively put through the process as if you have applied from day one, which seems ludicrous," Mr Dingwall said.A spokesperson for the council said he had been contacted by telephone to explain what he needed to do, and he had agreed to provide the information required to process his application. They added: "Our procedures and practices align with national guidance as set out by the Department for Transport and are followed by other local authorities." Follow Beds, Herts and Bucks news on BBC Sounds, Facebook, Instagram and X.
BBC News
02-06-2025
- Health
- BBC News
Peterborough parents determined to give football-loving daughter happy life
A family have launched a fundraising campaign to help pay for a specialist leg and future treatment for their 11-year-old was a talented footballer but was diagnosed with osteosarcoma - a form of bone cancer - last Gordon and Gemma Blair, both Cambridgeshire Police officers from Peterborough, have described the gruelling cycle of chemotherapy and their determination to give her the life she left leg had to be amputated above the knee as part of her treatment. Gordon said it was one of the "darkest moments" and called it "soul-destroying". Millie was a talented horse rider and a promising footballer who played for Oundle Town girls and Peterborough United aspired to play for Chelsea women's team and was generally healthy before her diagnosis, her family far, Millie has had seven operations, blood transfusions, and spent more than 100 nights in hospital."She was diagnosed on her 11th birthday. A present nobody wanted," Gordon said the family "knew something was wrong" when she took a knock to her left leg playing football last year."Finding out your kid has cancer is the worst feeling imaginable, your whole world implodes in an instant."Suddenly, we were thrust into this scary world of unknowns, spending our days in hospitals with tubes and machines and procedures. It's an awful place to be."It is soul destroying."He said Millie had been "phenomenal" throughout the cancer journey and had helped them stay strong. Fundraising efforts The cost of a specialist leg and rehabilitation is more than £130,000, and the family said they had been told there was no rehabilitation centre specifically for children."She's determined to play for England women's amputee football team and even compete in the Paralympics. We don't mind what she does, we just want her to be happy and to be able to get back to running around with her friends."To do that, she'll need the right support."The NHS can provide prosthetics, but many aren't suitable for someone as active as Millie, and it's likely she will need new parts for her leg as she grows – all of which cost a considerable sum." On 4 July, Gordon will be joining a team of 30 people on an 88-mile walk (142km) from Peterborough United's ground in London Road, to Stamford Bridge in west London, the home of Chelsea Football clubs hold a special place in Millie's walk, which could take up to three days to complete, has been organised by Gemma's boss, Det Sgt Adam McCluskey."If anyone can join us at any point it will be a real morale boost," said Gordon."It will make all the difference. Adam has been amazing in organising it all, I'm just turning up and hoping to get through it."This isn't about luxuries or experiences, we don't need those and we don't want anyone to pay for them, we just want to give Millie the power to dream again and to give our family some normality." Follow Peterborough news on BBC Sounds, Facebook, Instagram and X.
