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National Post
6 hours ago
- National Post
Satellos Reports Second Quarter 2025 Results and Highlights Upcoming Clinical Milestones
Article content Reported positive Phase 1b data in five adults with Duchenne muscular dystrophy (DMD) after 28 days of treatment Demonstrated safety, tolerability and an approximate doubling in grip strength On track to initiate a follow-up of the Phase 1b study in adults with DMD in Q3 2025 Expected to report 3-month interim data this year Preparing submissions to enable initiation of a global Phase 2 randomized, placebo-controlled clinical trial in children with DMD Appointed Dr. Wildon Farwell as chief medical officer (CMO) Ended the second quarter of 2025 with cash balance of $52.1 million ($38.2 million in $U.S.) Article content TORONTO — Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) ('Satellos' or the 'Company'), a clinical-stage biotechnology company developing life-improving medicines to treat degenerative muscle diseases, today announced its financial results and corporate highlights for the second quarter ended June 30, 2025. Article content 'We are excited by the clean safety profile and promising functional improvements with SAT-3247 in our Phase 1a/1b study,' said Satellos Co-Founder and Chief Executive Officer Frank Gleeson. 'The consistency between our clinical and preclinical findings continues to point to the transformative potential of SAT-3247 as a novel treatment for degenerative muscle conditions broadly. In Duchenne, current therapies are making important progress in slowing disease progression and preserving muscle. We designed SAT-3247 to do something different — help rebuild muscle and improve strength. We look forward to our imminent Phase 1b long-term follow-up trial in adults and planned Phase 2 study with children, where we aim to demonstrate how SAT-3247 may contribute to that most important goal of improving functional outcomes for people living with Duchenne through a potentially safe, disease modifying, oral treatment.' Article content On May 22, 2025, Satellos announced positive Phase 1b results from a 28-day open-label study in five adult male patients with DMD (ages 20–27). SAT-3247 was safe and well tolerated in all participants Grip strength, measured using the standardized MyoGrip device, showed an approximate doubling across the 5 participants from ~ 2 kg to 4 kg. In addition, patients demonstrated an approximate average increase in force-vital capacity of 5%. Study participants appeared to remain stable in other exploratory measurement areas. The expected pharmacokinetic of SAT-3247 was met — an important result with these patients who were all on steroids. Building on these positive outcomes, Satellos received approval and plans to initiate SAT-3247-LT-001 in Q3 2025. This will offer an additional 11 months of treatment for adult participants from the initial 28-day Phase 1b trial. The study will assess the durability of functional responses, longer-term safety, and changes in muscle composition as measured by MRI. Interim 3-month results are expected prior to year-end. Satellos also plans to expand the protocol to include additional patients. Global Phase 2 trial for pediatric patients with DMD: Satellos is on track to submit an IND application to the FDA and CTAs in other countries in Q3 2025 to enable initiation — subject to regulatory approval — of a global Phase 2 randomized, placebo-controlled, proof-of-concept trial in pediatric patients with DMD. The planned trial is designed to assess safety, pediatric pharmacokinetics, optimal dose, biologic effects, and measures of functional efficacy. Article content FINANCIAL RESULTS (in $U.S.) Article content Satellos had cash and cash equivalents and short-term investments of $38.2 million as of June 30, 2025, compared with $48.5 million at Dec. 31, 2024. The decrease in funds available is due to the net loss in the current year period, as well as increased deposits related to the planned Phase 2 clinical trial. Article content For the three-months ended June 30, 2025, Satellos reported a net loss of $5.6 million ($0.03 loss per share), compared to a net loss of $4.4 million ($0.04 loss per share) for the three-months ended June 30, 2024. The increase in net loss for the three-months ended June 30, 2025, compared with the same period in 2024, was a result of increased research and development (R&D) expenses, as well as increased general and administrative (G&A) expenses. Article content R&D expenses increased to $4.4 million for the three-months ended June 30, 2025, compared to $3.6 million for the three-months ended June 30, 2024. The increase in R&D expenses was the result of increased clinical costs associated with ongoing and planned clinical trials, partially offset by decreased CMC activities related to the process development and manufacturing of SAT-3247 for clinical use in the prior year period and preclinical costs due to IND enabling studies conducted to support the clinical regulatory filings for SAT-3247 as we prepared to initiate Phase 1 clinical development in Q3 2024. Article content G&A expenses increased to $1.9 million for the three-months ended June 30, 2025, as compared to $1.3 million for the three-months ended June 30, 2024. The increase in general and administrative expenses in the current year period is primarily the result of increased salary and professional fees related to changes in headcount to support expanded operations and non-cash stock-based compensation expense due to new grants issued in the current period. Article content The Satellos consolidated interim financial statements for the three- and six-months ended June 30, 2025, and the related management discussion and analysis will be available on SEDAR+ at Article content ABOUT SAT-3247 Article content SAT-3247 is a proprietary, oral, small molecule drug being developed by Satellos as a novel treatment to regenerate skeletal muscle that is lost in Duchenne muscular dystrophy and other degenerative or injury conditions. Satellos is advancing SAT-3247 as a potential treatment for DMD, independent of dystrophin and regardless of exon mutation status. Article content ABOUT SATELLOS BIOSCIENCE INC. Article content Satellos is a clinical-stage drug development company focused on restoring natural muscle repair and regeneration in degenerative muscle diseases. Through its research, Satellos has developed SAT-3247, a first-of-its-kind, orally administered small molecule drug designed to address deficits in muscle repair and regeneration. SAT-3247 targets AAK1, a key protein that Satellos has identified as capable of replacing the signal normally provided by dystrophin in muscle stem cells to effect repair and regeneration. By restoring this missing dystrophin signal in DMD, SAT-3247 enables muscle stem cells to divide properly and more efficiently, promoting natural muscle repair and regeneration. SAT-3247 is currently in clinical development as a potential disease-modifying treatment initially for DMD. Satellos also is leveraging its proprietary discovery platform MyoReGenX™ to identify additional muscle diseases or injury conditions where restoring muscle repair and regeneration may have therapeutic benefit and represent future clinical development opportunities. For more information, visit Article content This press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding Satellos and its business, which may include, but are not limited to, expected timing for Phase 2 regulatory filings, the timing of initiating the Phase 1b long term follow up study and when three month interim data will be available, estimated runway based on cash on hand; statements regarding the potential for SAT-3247 to represent a disease modifying approach to the therapeutic treatment of people living with Duchenne; anticipated benefits to patients from a small molecule treatment for Duchenne; the advancement SAT-3247 through clinical trials; the pharmacodynamic properties and mechanism-of-action of SAT-3247; the potential of our approach in other degenerative muscle diseases; its/their prospective impact on Duchenne patients, patients with other degenerative muscle disease or muscle injury or trauma, and on muscle regeneration generally; and Satellos' technologies and drug development plans. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, occurrences or developments, are 'forward-looking information or statements.' Often but not always, forward-looking information or statements can be identified by the use of words such as 'shall', 'intends', 'believe', 'plan', 'expect', 'intend', 'estimate', 'anticipate', 'potential', 'prospective' , 'assert' or any variations (including negative or plural variations) of such words and phrases, or state that certain actions, events or results 'may', 'might', 'can', 'could', 'would' or 'will' be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, risks relating to the pharmaceutical and bioscience industry (including the risks associated with preclinical and clinical trials and regulatory approvals), and the research and development of therapeutics, the results of preclinical and clinical trials, general market conditions and equity markets, economic factors and management's ability to manage and to operate the business of the Company generally, including inflation and the costs of operating a biopharma business, and those risks listed in the 'Risk Factors' section of Satellos' Annual Information Form dated March 26, 2025 (which is located on Satellos' profile at Although Satellos has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Satellos does not undertake any obligation to publicly update or revise any forward-looking statement, whether resulting from new information, future events, or otherwise. Article content Article content Article content Article content Article content Contacts Article content Investors: Article content Liz Williams, CFO, Article content ir@ Article content Article content Media: Article content Emily Williams, Senior Director of Communications, Article content Article content
CBC
10 hours ago
- CBC
How doctors are using AI in the exam room — and why it could become the norm
The Quebec government says it's launching a pilot project involving artificial intelligence transcription tools for health-care professionals, with an increasing number saying they cut down the time they spend filling paperwork.
CBC
10 hours ago
- CBC
Doctors are turning to AI scribes to take medical notes. Quebec wants to test it out
Social Sharing Frustrated by overwhelming paperwork that eats into their time with patients, some doctors in Quebec have been turning to artificial intelligence tools to streamline the transcription of their medical notes during consultations. Now, Santé Québec, the Crown corporation that oversees the province's health-care network, is planning to launch a pilot project to look into these technologies with the goal of expanding their use in the health-care system. Dr. Felix Lê-Phat-Hô, a family physician based in Montreal, has been using one of the tools for a year and says it's reduced his mental load and improved his quality of service. "It has a huge impact in my clinical practice," he said of the tool Plume AI. Lê-Phat-Hô says the tool saves him from doing two to three hours of paperwork daily, allowing him to see up to three more patients a day. Right now, only applications that have obtained official certification from Santé Québec, guaranteeing data protection, can be used. Plume AI, which was created by a group of Quebec doctors, is one of these approved platforms. Its co-founder, emergency room physician Dr. James Tu, says 10 per cent of doctors in Quebec already use his application — about 2,000 doctors. For Lê-Phat-Hô, the benefits speak for themselves. "You get to focus your attention solely on the patient, and the patients really appreciate it because they can feel that they have their doctor's full attention." "So it's really like a win-win situation for both the patient and me." WATCH | How AI tools are helping doctors: How doctors are using AI in the exam room — and why it could become the norm 4 minutes ago The Quebec government says it's launching a pilot project involving artificial intelligence transcription tools for health-care professionals, with an increasing number saying they cut down the time they spend filling paperwork. How does it work? Plume AI is an application that doctors can download on their phones or their computers. At the beginning of the consultation, they explain to the patient what the application does and ask for consent before recording the exchange. If the patient accepts, the doctor starts the recording, and the consultation goes on like it normally would: the patient explains their problem, the doctor asks questions, talks about diagnosis and the treatment plan. "It doesn't matter what the flow of the discussion was, what the interview was, what the language was, what the patient's accent was," said Tu. "Thanks to artificial intelligence, it's able to grasp the context of each discussion." Once the consultation ends, the doctor stops the transcription, and Plume AI generates a structured medical note based on the discussion. This way, doctors don't need to take detailed notes during the consultations, or write up the medical note during it or at the end of their day, which Tu says can take an "enormous" amount of time. Instead, they can focus on the patient in front of them. He says he's able to see up to six more patients a day in the emergency room thanks to the technology. "That's what I studied for," he said "To talk to the patient, not to fill out paperwork." Canada now has a minister of artificial intelligence. What will he do? Cybersecurity concerns Lê-Phat-Hô says he was initially skeptical about using AI in his practice, worried about the risks to his patients' privacy. Éric Parent, a cybersecurity expert, shares this concern. He says the data would need to be stored as locally as possible and within a controlled environment to avoid risks, and that there should be a protocol to establish who is legally responsible for the data. He also hopes that startup companies leveraging this technology invest in strong security measures. "When you cut corners with cybersecurity… we're creating a dependency on this technology, so if the system, for example, becomes unavailable, then what would happen?" he said. "And so these systems have to be built to be at the security level or the resiliency level, the quality level that we actually need." Plume AI stores its data locally in Quebec, and new data gets erased automatically after 24 to 48 hours, measures that reassured Lê-Phat-Hô. Tu, the tool's co-founder, is hoping to collaborate with more health-care professionals that could benefit from the technology, such as nurses, social workers, physiotherapists and dentists. He's looking forward to potentially collaborating with Santé Quebec for the pilot project to study the impacts of this technology on the medical field. "I think that the entry of artificial intelligence into the world of health is inevitable. It must be regulated, must be well supervised, must have guidelines in place," he said. "But for once, we are able to have access to technology in the health system that is not so behind the times."
