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  • 64Cu-SAR-bisPSMA Bests SOC 68Ga-PSMA-11 PET/CT in Detecting PSMA-Positive Prostate Cancer Lesions

    64Cu-SAR-bisPSMA Bests SOC 68Ga-PSMA-11 PET/CT in Detecting PSMA-Positive Prostate Cancer Lesions

    The phase 2 Co-PSMA trial (NCT06907641) has achieved its primary end point, displaying a significantly higher proportion of prostate-specific membrane antigen (PSMA)–positive prostate cancer lesions detected using 64Cu-SAR-bisPSMA compared with standard-of-care (SOC) 68Ga-PSMA-11 PET/CT in patients with low prostate-specific antigen (PSA) levels.1

    The topline findings support the hypothesis that SAR-bisPSMA, a targeted copper theranostic that can be used with isotopes of copper-64 for imaging and copper-67 for therapy, can improve early detection of prostate cancer recurrence and staging in patients with low PSA levels who are candidates for curative salvage therapy. A complete analysis of the full data generated in Co-PSMA is ongoing and further findings from the trial will be presented at an upcoming international medical conference.

    64Cu-SAR-bisPSMA for PSMA-Positive Prostate Cancer Lesion Detection: Key Takeaways

    • SAR-bisPSMA is a targeted copper theranostic that can be used with isotopes of copper-64 for imaging and copper-67 for therapy.
    • The phase 2 Co-PSMA trial (NCT06907641) met its primary end point by demonstrating that 64Cu-SAR-bisPSMA produced a higher detection rate of prostate-specific membrane antigen (PSMA)–positive prostate cancer lesions vs 68Ga-PSMA-11 PET/CT in patients with low prostate-specific antigen (PSA) levels.
    • The FDA has granted 2 fast track designations to 64Cu-SAR-bisPSMA: for the PET evaluation of patients with PSMA-positive prostate cancer lesions with suspected metastasis who are candidates for initial definitive therapy and for the PET evaluation of patients with PSMA-positive prostate cancer lesions with biochemical recurrence of prostate cancer after definitive therapy.

    “Achieving the primary end point in the Co-PSMA trial, which was a head-to-head trial against a SOC competing product, is yet another important step in the development of 64Cu-SAR-bisPSMA as we look to further validate this agent as best-in-class through two registrational trials with 2 fast track designations under our belt for diagnostic applications and a strong focus on commercialization,” Alan Taylor, PhD, the executive chairperson of Clarity Pharmaceuticals, stated in a news release.

    In August 2024, 64Cu-SAR-bisPSMA received fast track designation from the FDA for the PET evaluation of patients with PSMA-positive prostate cancer lesions with suspected metastasis who are candidates for initial definitive therapy.2 In January 2025, the theranostic received fast track designation from the FDA for the PET evaluation of patients with PSMA-positive prostate cancer lesions with biochemical recurrence of prostate cancer after definitive therapy.3

    What Prior Data Have Been Reported With 64Cu-SAR-bisPSMA?

    64Cu-SAR-bisPSMA was also evaluated in the phase 1/2 COBRA study (NCT05249127), which examined the theranostic in patients with prostate cancer who experienced biochemical recurrence after definitive therapy.4 Findings from the trial revealed that 64Cu-SAR-bisPSMA led to a change in intended treatment plan in 48% of efficacy evaluable patients (n = 32). Moreover, the approach was found to be safe with only 1 adverse effect being related to 64Cu-SAR-bisPSMA, which was a grade 2 instance of worsening of type 2 diabetes that resolved.

    What Was the Design of the Co-PSMA Trial?

    Co-PSMA enrolled male patients who were at least 18 years old who underwent radical prostatectomy for confirmed adenocarcinoma.5 Eligible patients also needed to have rising PSA levels (0.20 ng/mL to 0.75 ng/mL) following radical prostatectomy with no prior salvage radiotherapy and have received 68Ga PSMA-11 PET/CT within the past 4 weeks for prostate cancer biochemical recurrence. All patients received a single administration of 64Cu-SAR-bisPSMA at 200 MBq.

    “We look forward to [releasing] the full Co-PSMA trial data at world-leading congresses as we continue to adhere to the highest standards of clinical research in our aspirations to bring a best-in-class diagnostic option to men with prostate cancer with clear evidence of superiority,” Taylor added in the news release.1

    The primary end point was the detection rate of lesions per participants between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT in patients with biochemical recurrence following radical prostatectomy who are being considered for curative salvage radiotherapy.5 Secondary end points included comparing 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT in terms of the number of lesions outside of the prostatic fossa per patient, diagnostic accuracy, the magnitude of clinical management change, and the number of total lesions at the 1-to-4, and 24-hour imaging timepoints.

    “We have already seen in the first-in-human PROPELLER trial [NCT04839367] an improved diagnostic performance of 64Cu-SAR-bisPSMA compared [with] 68Ga-PSMA-11 on same-day imaging, including a higher number of lesions identified and 2 [to] 3 times higher tumor uptake and tumor-to-background ratio,” Taylor said.1 “We then showed in the COBRA trial that approximately twice the amount of lesions was identified on 64Cu-SAR-bisPSMA PET on next-day vs same-day imaging, and vs SOC PSMA PET. 64Cu-SAR-bisPSMA also allowed for the identification of lesions in the 2-mm range, something that SOC PSMA PET agents often fail to achieve. This improvement was driven by a substantially increased tumor-to-background ratio and lesion uptake over time with next-day imaging.”

    References

    1. Co-PSMA trial achieves primary endpoint. News release. Clarity Pharmaceuticals. October 14, 2025. Accessed October 14, 2025. https://www.claritypharmaceuticals.com/news/co-psma-endpoint/
    2. Clarity receives FDA fast track designation for 64Cu-SAR-bisPSMA. News release. Clarity Pharmaceuticals. October 14, 2025. Accessed October 14, 2025. https://www.claritypharmaceuticals.com/news/fast-track/
    3. Clarity receives U.S. FDA fast track designation for Cu-64 SAR-bisPSMA in biochemical recurrence of prostate cancer. News release. Clarity Pharmaceuticals. January 24, 2025. Accessed October 14, 2025. https://www.claritypharmaceuticals.com/news/ftd-2/
    4. Nordquist L, Lengyelova E, Saltzstein D, et al. COBRA: assessment of safety and efficacy of 64Cu-SAR-bisPSMA in patients with biochemical recurrence of prostate cancer following definitive therapy. J Nucl Med. 2024;65(suppl 2):242291.
    5. Comparative performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy (Co-PSMA). ClinicalTrials.gov. Updated April 2, 2025. Accessed October 14, 2025. https://clinicaltrials.gov/study/NCT06907641

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  • Mom’s voice boosts language-center development in preemies’ brains, study finds

    Note to reporters: An embargoed video explaining the research is available for preview at https://youtu.be/E5hDhWSmeoY. The mother featured in the video is available for media interviews.

    Hearing the…

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  • Evaluating the link between sound quality, speech recognition and cochlear implant-related quality of life outcomes

    Evaluating the link between sound quality, speech recognition and cochlear implant-related quality of life outcomes

    More than a million people around the world rely on cochlear implants (CIs) to hear. CI effectiveness is generally evaluated through speech recognition tests, and despite how widespread they are, CI sound quality is typically not…

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  • UK faces highest inflation in G7 this year and next, IMF warns | Inflation

    UK faces highest inflation in G7 this year and next, IMF warns | Inflation

    Consumers in the UK are expected to suffer the highest inflation in the G7 group of leading economies this year and next, the International Monetary Fund has warned.

    As policymakers gathered in Washington for its annual meetings, the IMF said prices would rise in Britain at a faster pace in 2025 and 2026 than it had originally forecast at its last update in July.

    According to the fund’s latest World Economic Outlook (WEO), published on Tuesday, UK inflation is on course to average 3.4% this year, up from its previous estimate of 3.2%, and then slow slightly to 2.5% next year, up from its old prediction of 2.3%.

    As Rachel Reeves prepares to fly into the US capital in the run-up to her crunch budget next month, the IMF’s experts cited “sticky” inflation as one reason yields, or interest rates, on UK government bonds have been rising.

    The chancellor intends to use tax rises and spending cuts in the budget to build up a larger financial buffer against her fiscal rules, in part to insulate the government from bond market instability.

    Asked about market pressures on the UK at a press conference in Washington, the IMF’s deputy director for monetary and capital markets, Athanasios Vamvakidis, said: “Clearly markets are concerned about the UK economy, and we have seen more volatility in the UK compared to other advanced economies.”

    Pointing to above-target inflation and weak productivity, he added: “The market is asking for more details on the fiscal plans in the UK: so yields, as a result, are higher in the UK compared to other advanced economies.”

    The IMF modestly increased its forecast for economic growth in the UK for this year, from 1.2% to 1.3%, and slightly downgraded it for 2026, also to 1.3%, amid concerns over the labour market.

    Over the year as a whole, the economic body expects the UK to be the second fastest-growing economy in the G7, behind a 2% expansion of gross domestic product (GDP) in the US.

    IMF graphic

    The IMF’s chief economist, Pierre-Olivier Gourinchas, said many of the drivers of UK inflation were “temporary factors,” such as water bills and rail price rises.

    “So we expect this will moderate going forward but there are risks,” he said, citing higher than expected wage growth, and households and companies becoming less certain that inflation will come down.

    “The path forward for the Bank of England should be very cautious in its easing trajectory and make sure that inflation is on the right track,” Gourinchas added, implying that policymakers should not cut interest rates too quickly.

    The WEO figures highlight the challenge the Bank’s nine-member monetary policy committee faces in getting headline inflation back to its 2% target. According to the latest official figures, UK consumer price index inflation was 3.8% in August, and in September the Bank forecast CPI would peak that month at 4%.

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    The IMF also upgraded its forecast for global GDP growth this year to 3.2%, from 3% at its July forecast. It said the world economy has shown “unexpected resilience” in the face of Donald Trump’s tariffs, but the full impact was yet to be felt and the outlook remains “dim”.

    It said the tariffs imposed were less extreme than initially feared after Trump’s “liberation day” announcements in April and their impact masked by households and companies bringing forward consumption to beat their introduction.

    However, the report pointed to a series of concerns about the global outlook, including the risk to US growth from Washington’s immigration crackdown; “stretched valuations” in stock markets; and the fact the full effects of the tariffs are only now beginning to show.

    Echoing a speech by the IMF managing director, Kristalina Georgieva, last week, the WEO report warned of the risks of a “correction,” in share prices – and a downturn investment – if markets reassess the likely gains from generative AI.

    The fund made a similar warning in its global financial stability report, arguing that US stock markets, which have rallied during the artificial intelligence boom, are “complacent” about the risk of a “sudden, sharp correction”.

    Responding to the improved forecast for UK growth this year, the chancellor, Reeves, said: “This is the second consecutive upgrade to this year’s growth forecast from the IMF. It’s no surprise, Britain led the G7 in growth in the first half of this year, and average disposable income is up £800 since the election.”

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  • Targeting the glycocalyx may offer a new approach to reduce frailty in older adults

    Targeting the glycocalyx may offer a new approach to reduce frailty in older adults

    A new research paper was published in Volume 17, Issue 9 of Aging-US on August 30, 2025, titled, “Glycocalyx-targeted therapy prevents age-related muscle loss and declines in maximal exercise capacity.”

    In this study, led by…

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  • High measles antibody levels indicate strong vaccine coverage in BC’s Lower Mainland

    High measles antibody levels indicate strong vaccine coverage in BC’s Lower Mainland

    In British Columbia’s Lower Mainland, 90% of people have detectable antibodies against measles, indicating high vaccine coverage and population protection, according to a new study published in CMAJ (Canadian Medical Association…

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  • Royal couple meet young firefighters in NI

    Royal couple meet young firefighters in NI

    Mark SimpsonCommunities correspondent, BBC News NI

    Chris Jackson/PA Wire Catherine, Princess of Wales and her husband Prince William smile and laugh during a rope training exercise at the Northern Ireland Fire and Rescue Service (NIFRS) Learning and Development College in County Tyrone. Cathering is wearing a dark olive green coat fastened to the neck and Prince William is wearing a brown blazer, a light coloured shirt and a dark tie. Chris Jackson/PA Wire

    The royal couple smiled and laughed as the princess took part in a rope-throwing exercise organised by firefighters

    The Prince and Princess of Wales have met recently-qualified…

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  • Antibiotic unlocks fungi’s ability to make new molecules

    Antibiotic unlocks fungi’s ability to make new molecules

     

    …

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  • Vision Innovation Summit by EssilorLuxottica, a visionary showcase for the future of connected healthcare

    Paris, France (14 October 2025) – EssilorLuxottica announced today the launch of SWITCH: Vision Innovation Summit by EssilorLuxottica, a new industry wide event that will explore the driving forces behind the industry’s rapid transformation. SWITCH will provide a captivating 3-day experience for eyecare professionals that will spark meaningful conversation around everything from AI wearables to med-tech to myopia innovation, capturing the true potential beyond frames and lenses to shape the future of vision care.

    The new event will be held March 9-11, 2026 in Orlando for partners from the Americas, leading immediately into Vision Expo, and in Monte-Carlo on April 13-15, 2026 for customers in EMEA and Asia, allowing the Company to present a global and unified vision for the future.

    As EssilorLuxottica continues to push the boundaries of patient care through advanced vision care, AI eyewear and med-tech solutions, SWITCH will be an ideal platform for provocative dialogue among industry professionals around advancements in areas such as AI and data science.

    “The world we play and practice in tomorrow will be more predictive, more personalized, more powerful through AI, data and other developments, and it’s essential that eyecare professionals are in the driver’s seat. In creating SWITCH, we will provide an ideal environment for the kind of elevated conversation, discovery and relationships needed to succeed in a much more connected world. We look forward to delivering an experience that truly reflects the inspiring times we’re living in,” said Francesco Milleri, Chairman and CEO, and Paul du Saillant, Deputy CEO at EssilorLuxottica.

    More details on the event will be shared in the coming weeks and months. For customers in the Americas, please visit the following link for more information and to register to the event: CLICK HERE

    DOWNLOAD THE PRESS RELEASE

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  • Just a moment…

    Just a moment…

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