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Business Recorder
10 hours ago
- Business
- Business Recorder
The cost of irrational energy levies
The federal government's decision to impose a petroleum levy of Rs 77 per litre on furnace oil (HFO), supplemented by a carbon tax of Rs 2.50 per litre, adds Rs 84,742 per ton in taxes to a fuel that otherwise costs approximately Rs 130,000 per ton. For export-oriented textile manufacturers, many of whom depend on HFO-based captive power for uninterrupted production, this will severely undermine their viability. Under current market conditions, HFO-fired captive generation costs roughly Rs 33 per kWh, broadly equivalent to prevailing grid tariffs. Once the new levies are applied, generation costs surge to nearly Rs 51 per kWh, by over 50%. At this level, HFO-based power generation ceases to be economically viable, forcing textile firms into an untenable dilemma: continue operating at a severe loss or switch to an unreliable and, ultimately, more expensive grid supply. For most mills, switching to grid-supplied power is not a viable alternative, as HFO-fired captive generation is principally used by units lacking reliable DISCO connections. Across Pakistan—and particularly in urban industrial hubs such as Lahore and Karachi—DISCOs routinely decline new industrial hookups due to constrained infrastructure and transformer capacity. Where connections are technically offered, firms are presented with demand notices running into the tens of billions of rupees merely to secure a feeder line, with no guarantee of timely service: lead times for actual energization often extend to two or three years. Under these conditions, pursuing a formal grid connection is neither commercially nor operationally feasible, aside from enduring the frequent voltage sags and load-shedding that characterize grid supply. This punitive taxation of HFO follows the so-called 'grid transition levy' on gas consumption by captive-power users—a tax that the government itself concedes is incorrectly calculated yet refuses to rectify. Officially, the transition levy is intended to align the cost of captive power with grid tariffs. In practice, however, the levy calculation is based on peak-hour grid rates that apply for only four hours each day, it relies on an eight-year-old Nepra determination of captive O&M costs, a figure that has since doubled or tripled due to inflation and currency depreciation, and incorporates a series of arbitrary errors that artificially inflate the final rate, coercing efficient captive generators onto an unprepared grid. Over the past month alone, two major textile production units served by HESCO reported repeated outages, voltage fluctuations, and sudden trippings. These disturbances burned out feeders and control panels, inflicted heavy machinery damage, and disrupted tightly scheduled production lines. Similar incidents are occurring across multiple DISCOs, underscoring that Pakistan's electricity grid lacks both the capacity and reliability to absorb additional industrial loads. Rather than addressing these structural weaknesses through targeted grid investments, modernization of aging infrastructure, and expansion of generation capacity, the government has opted for a shortcut: tax all alternative energy sources until the grid becomes the sole available option. First gas, now HFO and even solar panels. On one hand, political rhetoric extols market-driven strategy and competitive pricing; on the other, regressive taxes are being wielded to coerce industrial users onto a system that is demonstrably incapable of meeting their needs. The economic repercussions extend far beyond individual factory bills. Pakistan's textile industry accounts for over 50% of export revenues, sustains millions of direct and indirect jobs, and underpins rural livelihoods through cotton cultivation. A unilateral surge in energy costs will erode global competitiveness, and potentially trigger plant closures or relocation of production to more stable energy markets. Already, the poorly designed levy on gas-fired captive generation has slashed captive gas demand by 90%, creating a 400 MMCFD RLNG surplus that the government cannot absorb and which worsens circular debt. The same error is now being applied to furnace oil—despite domestic oversupply, demand will collapse once the levy is imposed, forcing HFO to be exported at under Rs 100,000 per ton rather than sold locally at Rs 130,000. As a result, industry will rely on a grid powered largely by imported coal and RLNG, while domestic HFO is sold abroad at a loss. With demand destroyed, the levy will generate no revenue, import costs will rise, and domestic value addition in exports—through the use of local fuels—will decline. To reverse this trajectory, the government must take three immediate steps. First, suspend the new petroleum and carbon levies on HFO until a comprehensive impact assessment is completed, involving industry stakeholders, DISCO representatives, and energy experts. Such an assessment should quantify the cost differential between captive and grid power under current conditions, and model the long-term effects on export revenue, employment, and foreign exchange earnings. And even then, any levy should be imposed gradually to allow sufficient time for consumers to adjust. Second, the calculation of the grid transition levy must be corrected to reflect actual grid power tariffs and captive generation costs and eliminate arbitrary inflation. Finally, commit to a multi-year grid-modernization plan that addresses transmission bottlenecks, reduces line losses, and provides reliable power at a regionally competitive rate of 9 cents per kWh or below. Without these corrective actions, the government risks imposing a de facto production tax on Pakistan's most vital export sector—one that it can ill afford. Coercive levies may fill the treasury in the short term, but they undermine industrial resilience, drive up unemployment, and weaken foreign-exchange reserves through the hollowing-out of export capacity. In effect, policy is being used not to bolster markets, but to strangle them—and in the process, torpedo the very growth narrative that it purports to champion. A reversal of these levies, accompanied by a clear roadmap for grid improvement, will restore confidence among exporters, stabilize power costs, and ensure that Pakistan's textile sector remains a global competitor rather than a declining casualty of misguided energy policy. Copyright Business Recorder, 2025
Business Recorder
3 days ago
- Business
- Business Recorder
Karachi
Karachi appears to be Pakistan's orphaned child. Once the country's capital, it now holds the dubious distinction of being among the most unliveable cities in the world. Despite contributing over 20% to Pakistan's GDP and hosting around 10% of the nation's population, Karachi struggles significantly to complete critical projects like the BRT and K-4 water supply schemes. Videos highlighting its crumbling infrastructure became memes during the recent India-Pakistan clash, which speaks volumes. For decades, Karachi has absorbed a continuous influx of migrants from various regions of Pakistan, expanding rapidly and without adequate planning, thus becoming a hub for crime and unrest. Despite these challenges, the city has remained Pakistan's economic backbone, functioning as the nation's industrial centre and sole significant link to the global supply chain for seven decades. In short, Karachi has the potential to pull Pakistan out of its financial difficulties with minimal effort—provided it receives proper attention and prioritization. Instead, it consistently receives minimal support. Political parties routinely stage protests against the federal government for neglecting Karachi, yet minor changes. Consider the energy sector, for instance. Karachi hosts the country's only privatized power utility, K-Electric (KE). According to recent communications, KE has become the most improved DISCO since 2009 regarding transmission and distribution losses, reducing its aggregated technical and commercial losses from a staggering 43.2% to approximately 20.3% by 2024. Within Karachi alone, the exempted feeder network increased dramatically from a mere 6.6% to 70%. These achievements, supported by a complete management turnaround, have gained global recognition, including a Harvard Business School case study and positive World Bank reports. However, despite these notable improvements, KE faced significant setbacks, such as delays in the Multi-Year Tariff determination, hindering its financial planning. The private utility, intended as a model for other DISCO privatizations, was inexplicably left in limbo, ultimately punishing Karachi residents more than the company itself. Another example is the denial of Fuel Cost Adjustment (FCA) relief—a substantial amount of Rs4.69 per unit—to KE's customers in a recent NEPRA hearing. The justification given was to maintain a uniform tariff across the country, exemplifying bureaucratic rigidity and the shortsighted decisions of temporary ministers. Karachi is also burdened with inefficiencies from other DISCOs. For nearly two years, Karachi's consumers have borne the Power Holding Limited (PHL) surcharge—debt repayment they did not contribute to or benefit from. Now, due to a new banking agreement, this surcharge is extended for another six years, meaning 72 more months of inflated electricity bills for Karachi residents. Even if the government manages to find buyers for its other DISCOs—a considerable challenge—the current treatment of KE sends a negative message. Potential buyers witnessing such hurdles and neglect may reconsider their interest, fearing similar treatment. Karachi deserves better.
Business Wire
16-06-2025
- Business
- Business Wire
DISCO Brings Gen-AI-Powered Auto Review to the EU, UK
AUSTIN, Texas--(BUSINESS WIRE)-- DISCO (NYSE: LAW), a creator of industry-leading litigation technology, today announced the launch of its generative AI automated review tool in the European Union and the United Kingdom, bringing the powerful eDiscovery technology to tens of thousands of law firms and corporations across Europe. DISCO Auto Review combines unprecedented speeds with accuracy metrics that substantially surpass typical human review. The solution is capable of reviewing 32,000 documents per hour on average – the equivalent of a 640-person review team working at industry-standard speeds – with precision and recall metrics exceeding 90 percent in many cases, better than the industry standard of 75 percent for human review. DISCO Auto Review is the latest tool the company has brought to the EU/U.K. markets, following the 2024 launch of its Cecilia suite of gen AI tools, including Cecilia Q&A and Cecilia document summaries. Additional Cecilia capabilities are expected to launch in these markets later this year. 'There is a growing appetite for generative AI legal tools in the EU and U.K., and our Auto Review technology is the one of the most-requested DISCO capabilities among leading law firms and corporations because of its ability to dramatically reduce the time and resources involved in the early stages of litigation without sacrificing accuracy or relevance,' said CEO Eric Friedrichsen. 'DISCO Auto Review can help significantly reduce costs and improve results on the largest, most complex matters lawyers face today.' The EU/U.K. launch of DISCO Auto Review follows a successful debut in the United States that has seen adoption from Am Law 50 firms, prominent litigation boutiques and large, multinational corporations. Hueston Hennigan, LLP, one of the leading litigation firms in the U.S. used DISCO Auto Review on a recent breach of contract matter and found the technology to be a key support for a lean team working against tight deadlines. 'Document production in high-stakes litigation, particularly on tight timelines, requires speed and accuracy. DISCO Auto Review gave us outstanding results -- 95 percent recall and 91 percent precision – in a fraction of the time of manual, human review,' said Emily Michael Munson at Hueston Hennigan. 'By streamlining first-pass review, my team is able to focus our time on strategic higher-value work and quality control." In addition to launching DISCO Auto Review for the EU and U.K., the company also announced new, highly competitive Auto Review pricing to help encourage law firms and corporations to add Auto Review to their suite of eDiscovery tools as a faster, more cost-effective alternative to manual, human review. 'As the value, accuracy, and speed of our generative AI products consistently impresses DISCO customers, we want to make them available to even more customers– especially for something like first pass review where the cost savings over fully human-based review can be tremendous," Friedrichsen said. 'Providing significantly more value at a lower cost is one more way we are with our customers in every case.' The new DISCO Auto Review pricing is available immediately to customers in the U.S., EU and U.K. Forward-Looking Statements This press release contains forward-looking statements, including, among other things, statements regarding the benefits of DISCO's Auto Review product and the launch of additional capabilities in the EU and UK markets later in 2025. Words such as 'may,' 'should,' 'will,' 'believe,' 'expect,' 'anticipate,' 'target,' 'continue,' 'potential,' 'build,' 'extend' and similar phrases that denote future expectation or intent regarding DISCO's business are intended to identify forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are subject to a variety of risks, uncertainties, and factors, including those more fully described in our filings with the Securities and Exchange Commission ('SEC'), including our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, filed with the SEC on May 7, 2025. Further information on potential risks that could affect actual results will be included in the subsequent periodic and current reports and other filings that we make with the SEC from time to time. Forward-looking statements represent DISCO's management's beliefs and assumptions only as of the date such statements are made. We undertake no obligation to update any forward-looking statements made in this press release to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law. About DISCO DISCO (NYSE: LAW) provides comprehensive, innovative solutions for modern litigation. We create and service an intuitive, cloud-native platform at the forefront of litigation technology, backed by the partnership of expert professional services and support. Leveraging the latest in AI to help law firms and corporations achieve smarter outcomes faster, our scalable products and tools allow customers to simplify everyday tasks and tackle complex matters at every stage of litigation. Learn more at
Yahoo
13-06-2025
- Health
- Yahoo
DISCO topline results: 64Cu-SARTATE is highly effective in detecting tumours in NET patients compared to SOC imaging. Phase III planning underway.
HIGHLIGHTS Topline data from Clarity's diagnostic Phase II trial, DISCO, confirms that 64Cu-SARTATE is safe and highly effective compared to standard-of-care (SOC) imaging at detecting lesions in patients with neuroendocrine tumours (NETs). DISCO compared the diagnostic performance of 64Cu-SARTATE at an average of 4 hours (between 3 to 5 hours) and 20 hours post-administration (same-day and next-day imaging, respectively) to 68Ga-DOTATATE. 64Cu-SARTATE lesion detection substantially outperformed that of 68Ga-DOTATATE. 64Cu-SARTATE detected 393 to 488 lesions, and 68Ga-DOTATATE identified 186 to 265 lesions among 45 study participants across the readers. Out of all the lesions identified by the readers, 230-251 were deemed to be discordant (i.e. only present on one of the scans, 68Ga-DOTATATE or 64Cu-SARTATE positron emission tomography [PET] / computed tomography [CT]). Of these lesions, 93.5% (average across readers) were only detected on the 64Cu-SARTATE PET/CT scans. The number of discordant lesions detected by 64Cu-SARTATE on the same-day and next-day scans was comparable. Approximately half of all the discordant lesions had an available standard-of-truth (SOT), such as histopathology or conventional imaging. The identified discordant lesions yielded a lesion-level sensitivity of 93.4% to 95.6% (95% confidence interval [CI]: 65.1, 99.5) for 64Cu-SARTATE (across both timepoints) and only 4.4% to 6.6% (95%CI: 0.5, 34.9) for 68Ga-DOTATATE across both readers. 64Cu-SARTATE was deemed safe and well tolerated. Only 7 (15.6%) participants experienced 64Cu-SARTATE-related adverse events (AEs). No serious treatment-emergent AEs were observed in the study. Based on the exciting preliminary results of the DISCO trial, Clarity will commence next steps to conduct a registrational Phase III study of 64Cu-SARTATE in NETs with the US Food and Drug Administration's (FDA) guidance. SYDNEY, June 5, 2025 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce positive results from the diagnostic Phase II DISCO trial (NCT04438304)[1] with 64Cu-SARTATE in patients with known or suspected NETs. DISCO trial design DISCO is a "Diagnostic Imaging Study of 64COpper-SARTATE Using PET on Patients with Known or Suspected Neuroendocrine Tumours". It assessed the performance of Clarity's SARTATE imaging product as a potential new method to diagnose and manage NETs. The trial aimed to build on earlier clinical experience with 64Cu-SARTATE in patients with NETs, which demonstrated that the diagnostic has excellent imaging characteristics and suggested that 64Cu-SARTATE PET/CT provides comparable or superior lesion detection to 68Ga-DOTATATE PET/CT in all patients, especially in the liver[2]. DISCO recruited participants with Gastroenteropancreatic NETs (GEP-NETs) across 4 sites in Australia, comparing the diagnostic performance of 64Cu-SARTATE PET at an average of 4 hours (between 3 and 5 hours) and approximately 20 hours post-administration (same-day and next-day imaging, respectively) to the current SOC, 68Ga-DOTATATE PET. Participants were required to have undergone a pre-study 68Ga-DOTATATE PET/CT scan within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SARTATE as part of their routine clinical care. The trial was initially designed to enrol up to 63 patients, based on the anticipated lesion-level discordance rate between 64Cu-SARTATE and 68Ga-DOTATATE PET. Following a pre-planned early analysis of the data collected during the study, the sample size was adjusted to 45 patients, allowing for an earlier enrolment completion. Study participants were dosed with 200 MBq of 64Cu-SARTATE. Both the 64Cu-SARTATE and 68Ga-DOTATATE PET/CT scans were reviewed by 2 blinded central readers. Participants were followed for up to 12 months to complete additional investigations (e.g. biopsy and conventional imaging) and obtain the SOT used to verify discordant findings between the scan pairs. The verification of discordant findings against the SOT evidence (as true- or false-positive findings) was completed by an independent central assessor, distinct from the central readers evaluating the 64Cu-SARTATE and 68Ga-DOTATATE scans. Lesion-level sensitivity was calculated for the discordant lesions between the scan pairs, with each true-positive discordant lesion on one scan considered a false-negative lesion on the other scan, and each false-positive discordant lesion on one scan considered a true-negative lesion on the other scan. Topline results The results indicate that lesion detection by 64Cu-SARTATE (regardless of imaging timepoint) substantially outperformed that of 68Ga-DOTATATE. 64Cu-SARTATE detected 393 to 488 lesions, and 68Ga-DOTATATE identified 186 to 265 lesions among 45 participants across the readers (Figure 1). Out of all lesions identified by the readers, 230-251 were deemed to be discordant between 64Cu-SARTATE and 68Ga-DOTATATE PET/CT, with 93.5% (average across readers and imaging days) of these discordant lesions detected on the 64Cu-SARTATE scans only. A previously completed Phase I study demonstrated a 1.7 fold increase (median of 6.70 vs. 3.92, p=0.002) in contrast (i.e. lesion-to-background ratio) for 64Cu-SARTATE PET/CT performed at 4 hours post-administration compared to 68Ga-DOTATATE PET/CT2. This improvement in contrast may explain the detection of additional lesions observed in the DISCO trial. The average SUVmax, representing the highest concentration of 64Cu-SARTATE uptake in lesions, was notably high, ranging from 37.42 to 43.90 across both imaging days in the DISCO trial. Approximately half of all discordant lesions had an available SOT, which yielded a lesion-level sensitivity of 93.4% to 95.6% (95%CI: 65.1, 99.5) for 64Cu-SARTATE, including both timepoints, and only 4.4% to 6.6% (95%CI: 0.5, 34.9) for 68Ga-DOTATATE. 64Cu-SARTATE was deemed safe and well tolerated. Only 7 (15.6%) trial participants experienced 64Cu-SARTATE-related AEs, the majority of which were mild (Grade 1) gastrointestinal events, commonly observed in NET patients, and typically resolved within 2 days of onset. No serious treatment-emergent AEs were observed in the study. Based on the findings of the DISCO trial to date, Clarity will commence the next steps to conduct a registrational Phase III study of 64Cu-SARTATE in NETs with the US FDA's guidance. Clarity's Executive Chairperson, Dr Alan Taylor, commented, "We are very excited about the initial topline data from the DISCO trial as 64Cu-SARTATE was confirmed to be safe and very effective in detecting NET lesions in patients with known or suspected disease. The DISCO trial demonstrates a significant advantage of our diagnostic over 68Ga-DOTATATE. 64Cu-SARTATE detected almost double the number of lesions compared to the SOC, and, where SOT was available, a very high lesion-level sensitivity of 93.4% - 95.6% in comparison to just 4.4% - 6.6% for 68Ga-DOTATATE for these discordant findings. In addition to identifying more lesions with our product, lesions detected by 64Cu-SARTATE also exhibited high uptake with low background on the PET scans, making it easier to identify those lesions by readers. Excellent lesion visualisation was also supported by substantial clearance from the liver. The favourable biodistribution of 64Cu-SARTATE PET enabled high-contrast diagnostic imaging for up to approximately 24 hours post-injection (Figure 1), offering greater flexibility in the scheduling of PET/CT scans. "In the DISCO trial, we continue to observe the substantial limitations of the current-generation of short half-life isotope products, what we call isotope-centric medicine. This is clearly illustrated by 68Ga-DOTATATE with imaging timepoints solely dictated by the very short isotope half-life (approximately 1 hour for gallium-68) as opposed to good science and medicine. In contrast, 64Cu-SARTATE highlights the extraordinary benefits of next-generation patient-centric medicine, where imaging is guided by the optimal timepoint to scan and detect lesions, focusing on the needs of the patients and their treating professionals. "We believe that the flexibility of imaging with 64Cu-SARTATE, in comparison to approximately 1 hour with 68Ga-DOTATATE, plays an important role in the detection benefits seen in the DISCO study. We have known this for many years and have demonstrated these advantages of optimal timepoint imaging with different products in our Targeted Copper Theranostic (TCT) platform, including SARTATE. We have seen first-hand in a number of clinical trials that once radiopharmaceutical products are administered, they take time to find the lesion whilst also needing to clear from non-target organs, providing greater contrast. This is known as signal-to-noise ratio or, in our case, tumour-to-background ratio. Having greater contrast is especially important to identify smaller or more difficult to find cancers. "The longer half-life of copper-64, combined with Clarity's proprietary SAR Technology, sets up a strong foundation for next-generation diagnostics, which could be unmatched in the radiopharmaceutical sector. In addition to clinical benefits, the opportunity for high-volume centralised manufacturing and broad, on-demand distribution of ready-to-use diagnostics translates into flexibility and reliability for patients and their treating staff, meaning that every patient with access to PET imaging, including those in underserved and broad geographic areas, may access improved cancer diagnostics. "Patients with NETs are often misdiagnosed and experience delays in receiving the correct diagnosis, which may lead to disease progression and identification of their cancer at later stages. Visualising NET lesions earlier and more accurately may have a significant impact on patient outcomes as it equips clinicians with crucial information on disease burden, helping to determine an optimal treatment plan. As such, the SSTR2 imaging market is an important focus for Clarity. We estimate the NET diagnostic market in the US alone to be around 100,000 scans per year, growing to approximately 120,000 scans per year by 2029. "Importantly, the positive results of the DISCO trial open broader opportunities for the development of 64Cu-SARTATE in additional SSTR2-expressing malignancies beyond NETs, such as certain types of breast and lung cancers, where unmet clinical needs remain high. We believe the SSTR2 market is set to grow substantially with a number of therapies in development for this target, which include large indications such as breast and lung cancers. Subject to the successful completion of these studies, we believe that the imaging market for 64Cu-SARTATE could be as large, if not larger, than the very lucrative prostate cancer imaging market where radiopharmaceuticals currently dominate the diagnostic paradigm. "We look forward to sharing additional data readouts from the trial and presenting the results at future international medical conferences. We plan to rapidly progress discussions with the FDA to initiate a diagnostic registrational Phase III study, as a first key step in expanding SARTATE into the theranostic field of NETs, as well as other SSTR2-expressing cancers, with the copper-64/copper-67 pair. If the findings from the DISCO trial are substantiated in a registrational Phase III study and lead to regulatory approval by the US FDA, 64Cu-SARTATE may play an important role in improving diagnostic accuracy, lesion detection and staging of patients with NETs. These factors could improve clinical decision-making and treatment outcomes, potentially positioning 64Cu-SARTATE as a best-in-class agent for the diagnosis of NETs." About SARTATE SARTATE is a next generation, highly targeted theranostic radiopharmaceutical. It is being developed for diagnosing, staging and subsequently treating cancers that express SSTR2, such as NETs. Like all Clarity products, the SARTATE product can be used with copper-64 (64Cu) for imaging (64Cu-SARTATE) or copper-67 (67Cu) for therapy (67Cu-SARTATE). Disclaimer 64Cu-SARTATE is an unregistered product. The safety and efficacy of 64Cu-SARTATE has not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that this product will become commercially available. About NETs NETs, also known as well-differentiated neuroendocrine neoplasms or carcinoids, represent a heterogeneous group of malignant transformations of cells of the diffuse neuroendocrine system[3]. They most commonly occur in the gastrointestinal tract (48%), lung (25%), and pancreas (9%), but may also originate in other areas, including the breast, prostate, thymus and skin[4]. NETs can either be benign or malignant, as well as non-functional and functional[5]. NETs traditionally have been considered uncommon; however, the incidence has been increasing as a worldwide phenomenon[6]. Overall, it is estimated that more than 20,000 people in the United States are diagnosed with a NET each year[7], and approximately 190,000 people are living with this diagnosis[8]. Patients with NETs present with subtle clinical symptoms, which can lead to a delay in diagnosis of more than 4 years[9]. As such, about 30-75% of NET patients have distant metastases at the time of diagnosis[10]. A 10-year relative survival rate for patients with metastatic GEP-NETs is 3–36%[11]. About Clarity Pharmaceuticals Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancers. For more information, please contact: Clarity Pharmaceuticals Dr Alan Taylor Lisa SadetskayaExecutive Chairperson Director, Corporate Communicationsataylor@ lisa@ References [1] Identifier: NCT04438304 [2] Hicks R et al. First-in-human trial of 64Cu-SARTATE PET imaging of patients with neuroendocrine tumours demonstrates high tumor uptake and retention, potentially allowing prospective dosimetry for peptide receptor radionuclide therapy. The Journal of Nuclear Medicine. 2019. [3] Cheung VTF, Khan MS. A guide to midgut neuroendocrine tumours (NETs) and carcinoid syndrome. Frontline gastroenterology. 2015;6(4):264-269. [4] Hallet J, Law CH, Cukier M, Saskin R, Liu N, Singh S. Exploring the rising incidence of neuroendocrine tumors: a population-based analysis of epidemiology, metastatic presentation, and outcomes. Cancer. 2015;121(4):589-597. [5] Yau H, Kinaan M, Quinn SL, Moraitis AG. Octreotide long-acting repeatable in the treatment of neuroendocrine tumors: patient selection and perspectives. Biologics : targets & therapy. 2017;11:115-122. [6] Leoncini E, Boffetta P, Shafir M, Aleksovska K, Boccia S, Rindi G. Increased incidence trend of low-grade and high-grade neuroendocrine neoplasms. Endocrine. 2017 Nov;58(2):368-379. doi: 10.1007/s12020-017 1273-x. Epub 2017 Mar 16. PMID: 28303513; PMCID: PMC5671554. [7] Wu C, Song Z, Balachandra S, Dream S, Chen H, Rose JB, Bhatia S, Gillis A. Charting the Course: Insights into Neuroendocrine Tumor Dynamics in the United States. Ann Surg. 2025 Jun 1;281(6):968-975. doi: 10.1097/SLA.0000000000006331. Epub 2024 May 6. PMID: 38708616; PMCID: PMC11538379. [8] Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589. PMID: 28448665; PMCID: PMC5824320. [9] Basuroy R, Bouvier C, Ramage JK, Sissons M, Srirajaskanthan R. Delays and routes to diagnosis of neuroendocrine tumours. BMC Cancer. 2018 Nov 16;18(1):1122. doi: 10.1186/s12885-018-5057-3. PMID: 30445941; PMCID: PMC6240263. [10] Aluri V. and Dillion, J.S. 2017, "Biochemical Testing in Neuroendocrine Tumors", Endocrinology & Metabolism Clinics of North America, [11] Polee, I.N. et al. 2022, "Long-term survival in patients with gastroenteropancreatic neuroendocrine neoplasms: A population-based study", European Journal of Cancer, Volume 172, 2022, Pages 252-263, ISSN 0959-8049, • Krasnovskaya et al. Recent Advances in 64Cu/67Cu-Based Radiopharmaceuticals. Int J Mol Sci. 2023 May 23;24(11):9154. doi: 10.3390/ijms24119154. This announcement has been authorised for release by the Executive Chairperson. View original content to download multimedia: SOURCE Clarity Pharmaceuticals
Yahoo
05-06-2025
- Health
- Yahoo
DISCO topline results: 64Cu-SARTATE is highly effective in detecting tumours in NET patients compared to SOC imaging. Phase III planning underway.
HIGHLIGHTS Topline data from Clarity's diagnostic Phase II trial, DISCO, confirms that 64Cu-SARTATE is safe and highly effective compared to standard-of-care (SOC) imaging at detecting lesions in patients with neuroendocrine tumours (NETs). DISCO compared the diagnostic performance of 64Cu-SARTATE at an average of 4 hours (between 3 to 5 hours) and 20 hours post-administration (same-day and next-day imaging, respectively) to 68Ga-DOTATATE. 64Cu-SARTATE lesion detection substantially outperformed that of 68Ga-DOTATATE. 64Cu-SARTATE detected 393 to 488 lesions, and 68Ga-DOTATATE identified 186 to 265 lesions among 45 study participants across the readers. Out of all the lesions identified by the readers, 230-251 were deemed to be discordant (i.e. only present on one of the scans, 68Ga-DOTATATE or 64Cu-SARTATE positron emission tomography [PET] / computed tomography [CT]). Of these lesions, 93.5% (average across readers) were only detected on the 64Cu-SARTATE PET/CT scans. The number of discordant lesions detected by 64Cu-SARTATE on the same-day and next-day scans was comparable. Approximately half of all the discordant lesions had an available standard-of-truth (SOT), such as histopathology or conventional imaging. The identified discordant lesions yielded a lesion-level sensitivity of 93.4% to 95.6% (95% confidence interval [CI]: 65.1, 99.5) for 64Cu-SARTATE (across both timepoints) and only 4.4% to 6.6% (95%CI: 0.5, 34.9) for 68Ga-DOTATATE across both readers. 64Cu-SARTATE was deemed safe and well tolerated. Only 7 (15.6%) participants experienced 64Cu-SARTATE-related adverse events (AEs). No serious treatment-emergent AEs were observed in the study. Based on the exciting preliminary results of the DISCO trial, Clarity will commence next steps to conduct a registrational Phase III study of 64Cu-SARTATE in NETs with the US Food and Drug Administration's (FDA) guidance. SYDNEY, June 5, 2025 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce positive results from the diagnostic Phase II DISCO trial (NCT04438304)[1] with 64Cu-SARTATE in patients with known or suspected NETs. DISCO trial design DISCO is a "Diagnostic Imaging Study of 64COpper-SARTATE Using PET on Patients with Known or Suspected Neuroendocrine Tumours". It assessed the performance of Clarity's SARTATE imaging product as a potential new method to diagnose and manage NETs. The trial aimed to build on earlier clinical experience with 64Cu-SARTATE in patients with NETs, which demonstrated that the diagnostic has excellent imaging characteristics and suggested that 64Cu-SARTATE PET/CT provides comparable or superior lesion detection to 68Ga-DOTATATE PET/CT in all patients, especially in the liver[2]. DISCO recruited participants with Gastroenteropancreatic NETs (GEP-NETs) across 4 sites in Australia, comparing the diagnostic performance of 64Cu-SARTATE PET at an average of 4 hours (between 3 and 5 hours) and approximately 20 hours post-administration (same-day and next-day imaging, respectively) to the current SOC, 68Ga-DOTATATE PET. Participants were required to have undergone a pre-study 68Ga-DOTATATE PET/CT scan within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SARTATE as part of their routine clinical care. The trial was initially designed to enrol up to 63 patients, based on the anticipated lesion-level discordance rate between 64Cu-SARTATE and 68Ga-DOTATATE PET. Following a pre-planned early analysis of the data collected during the study, the sample size was adjusted to 45 patients, allowing for an earlier enrolment completion. Study participants were dosed with 200 MBq of 64Cu-SARTATE. Both the 64Cu-SARTATE and 68Ga-DOTATATE PET/CT scans were reviewed by 2 blinded central readers. Participants were followed for up to 12 months to complete additional investigations (e.g. biopsy and conventional imaging) and obtain the SOT used to verify discordant findings between the scan pairs. The verification of discordant findings against the SOT evidence (as true- or false-positive findings) was completed by an independent central assessor, distinct from the central readers evaluating the 64Cu-SARTATE and 68Ga-DOTATATE scans. Lesion-level sensitivity was calculated for the discordant lesions between the scan pairs, with each true-positive discordant lesion on one scan considered a false-negative lesion on the other scan, and each false-positive discordant lesion on one scan considered a true-negative lesion on the other scan. Topline results The results indicate that lesion detection by 64Cu-SARTATE (regardless of imaging timepoint) substantially outperformed that of 68Ga-DOTATATE. 64Cu-SARTATE detected 393 to 488 lesions, and 68Ga-DOTATATE identified 186 to 265 lesions among 45 participants across the readers (Figure 1). Out of all lesions identified by the readers, 230-251 were deemed to be discordant between 64Cu-SARTATE and 68Ga-DOTATATE PET/CT, with 93.5% (average across readers and imaging days) of these discordant lesions detected on the 64Cu-SARTATE scans only. A previously completed Phase I study demonstrated a 1.7 fold increase (median of 6.70 vs. 3.92, p=0.002) in contrast (i.e. lesion-to-background ratio) for 64Cu-SARTATE PET/CT performed at 4 hours post-administration compared to 68Ga-DOTATATE PET/CT2. This improvement in contrast may explain the detection of additional lesions observed in the DISCO trial. The average SUVmax, representing the highest concentration of 64Cu-SARTATE uptake in lesions, was notably high, ranging from 37.42 to 43.90 across both imaging days in the DISCO trial. Approximately half of all discordant lesions had an available SOT, which yielded a lesion-level sensitivity of 93.4% to 95.6% (95%CI: 65.1, 99.5) for 64Cu-SARTATE, including both timepoints, and only 4.4% to 6.6% (95%CI: 0.5, 34.9) for 68Ga-DOTATATE. 64Cu-SARTATE was deemed safe and well tolerated. Only 7 (15.6%) trial participants experienced 64Cu-SARTATE-related AEs, the majority of which were mild (Grade 1) gastrointestinal events, commonly observed in NET patients, and typically resolved within 2 days of onset. No serious treatment-emergent AEs were observed in the study. Based on the findings of the DISCO trial to date, Clarity will commence the next steps to conduct a registrational Phase III study of 64Cu-SARTATE in NETs with the US FDA's guidance. Clarity's Executive Chairperson, Dr Alan Taylor, commented, "We are very excited about the initial topline data from the DISCO trial as 64Cu-SARTATE was confirmed to be safe and very effective in detecting NET lesions in patients with known or suspected disease. The DISCO trial demonstrates a significant advantage of our diagnostic over 68Ga-DOTATATE. 64Cu-SARTATE detected almost double the number of lesions compared to the SOC, and, where SOT was available, a very high lesion-level sensitivity of 93.4% - 95.6% in comparison to just 4.4% - 6.6% for 68Ga-DOTATATE for these discordant findings. In addition to identifying more lesions with our product, lesions detected by 64Cu-SARTATE also exhibited high uptake with low background on the PET scans, making it easier to identify those lesions by readers. Excellent lesion visualisation was also supported by substantial clearance from the liver. The favourable biodistribution of 64Cu-SARTATE PET enabled high-contrast diagnostic imaging for up to approximately 24 hours post-injection (Figure 1), offering greater flexibility in the scheduling of PET/CT scans. "In the DISCO trial, we continue to observe the substantial limitations of the current-generation of short half-life isotope products, what we call isotope-centric medicine. This is clearly illustrated by 68Ga-DOTATATE with imaging timepoints solely dictated by the very short isotope half-life (approximately 1 hour for gallium-68) as opposed to good science and medicine. In contrast, 64Cu-SARTATE highlights the extraordinary benefits of next-generation patient-centric medicine, where imaging is guided by the optimal timepoint to scan and detect lesions, focusing on the needs of the patients and their treating professionals. "We believe that the flexibility of imaging with 64Cu-SARTATE, in comparison to approximately 1 hour with 68Ga-DOTATATE, plays an important role in the detection benefits seen in the DISCO study. We have known this for many years and have demonstrated these advantages of optimal timepoint imaging with different products in our Targeted Copper Theranostic (TCT) platform, including SARTATE. We have seen first-hand in a number of clinical trials that once radiopharmaceutical products are administered, they take time to find the lesion whilst also needing to clear from non-target organs, providing greater contrast. This is known as signal-to-noise ratio or, in our case, tumour-to-background ratio. Having greater contrast is especially important to identify smaller or more difficult to find cancers. "The longer half-life of copper-64, combined with Clarity's proprietary SAR Technology, sets up a strong foundation for next-generation diagnostics, which could be unmatched in the radiopharmaceutical sector. In addition to clinical benefits, the opportunity for high-volume centralised manufacturing and broad, on-demand distribution of ready-to-use diagnostics translates into flexibility and reliability for patients and their treating staff, meaning that every patient with access to PET imaging, including those in underserved and broad geographic areas, may access improved cancer diagnostics. "Patients with NETs are often misdiagnosed and experience delays in receiving the correct diagnosis, which may lead to disease progression and identification of their cancer at later stages. Visualising NET lesions earlier and more accurately may have a significant impact on patient outcomes as it equips clinicians with crucial information on disease burden, helping to determine an optimal treatment plan. As such, the SSTR2 imaging market is an important focus for Clarity. We estimate the NET diagnostic market in the US alone to be around 100,000 scans per year, growing to approximately 120,000 scans per year by 2029. "Importantly, the positive results of the DISCO trial open broader opportunities for the development of 64Cu-SARTATE in additional SSTR2-expressing malignancies beyond NETs, such as certain types of breast and lung cancers, where unmet clinical needs remain high. We believe the SSTR2 market is set to grow substantially with a number of therapies in development for this target, which include large indications such as breast and lung cancers. Subject to the successful completion of these studies, we believe that the imaging market for 64Cu-SARTATE could be as large, if not larger, than the very lucrative prostate cancer imaging market where radiopharmaceuticals currently dominate the diagnostic paradigm. "We look forward to sharing additional data readouts from the trial and presenting the results at future international medical conferences. We plan to rapidly progress discussions with the FDA to initiate a diagnostic registrational Phase III study, as a first key step in expanding SARTATE into the theranostic field of NETs, as well as other SSTR2-expressing cancers, with the copper-64/copper-67 pair. If the findings from the DISCO trial are substantiated in a registrational Phase III study and lead to regulatory approval by the US FDA, 64Cu-SARTATE may play an important role in improving diagnostic accuracy, lesion detection and staging of patients with NETs. These factors could improve clinical decision-making and treatment outcomes, potentially positioning 64Cu-SARTATE as a best-in-class agent for the diagnosis of NETs." About SARTATE SARTATE is a next generation, highly targeted theranostic radiopharmaceutical. It is being developed for diagnosing, staging and subsequently treating cancers that express SSTR2, such as NETs. Like all Clarity products, the SARTATE product can be used with copper-64 (64Cu) for imaging (64Cu-SARTATE) or copper-67 (67Cu) for therapy (67Cu-SARTATE). Disclaimer 64Cu-SARTATE is an unregistered product. The safety and efficacy of 64Cu-SARTATE has not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that this product will become commercially available. About NETs NETs, also known as well-differentiated neuroendocrine neoplasms or carcinoids, represent a heterogeneous group of malignant transformations of cells of the diffuse neuroendocrine system[3]. They most commonly occur in the gastrointestinal tract (48%), lung (25%), and pancreas (9%), but may also originate in other areas, including the breast, prostate, thymus and skin[4]. NETs can either be benign or malignant, as well as non-functional and functional[5]. NETs traditionally have been considered uncommon; however, the incidence has been increasing as a worldwide phenomenon[6]. Overall, it is estimated that more than 20,000 people in the United States are diagnosed with a NET each year[7], and approximately 190,000 people are living with this diagnosis[8]. Patients with NETs present with subtle clinical symptoms, which can lead to a delay in diagnosis of more than 4 years[9]. As such, about 30-75% of NET patients have distant metastases at the time of diagnosis[10]. A 10-year relative survival rate for patients with metastatic GEP-NETs is 3–36%[11]. About Clarity Pharmaceuticals Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancers. For more information, please contact: Clarity Pharmaceuticals Dr Alan Taylor Lisa SadetskayaExecutive Chairperson Director, Corporate Communicationsataylor@ lisa@ References [1] Identifier: NCT04438304 [2] Hicks R et al. First-in-human trial of 64Cu-SARTATE PET imaging of patients with neuroendocrine tumours demonstrates high tumor uptake and retention, potentially allowing prospective dosimetry for peptide receptor radionuclide therapy. The Journal of Nuclear Medicine. 2019. [3] Cheung VTF, Khan MS. A guide to midgut neuroendocrine tumours (NETs) and carcinoid syndrome. Frontline gastroenterology. 2015;6(4):264-269. [4] Hallet J, Law CH, Cukier M, Saskin R, Liu N, Singh S. Exploring the rising incidence of neuroendocrine tumors: a population-based analysis of epidemiology, metastatic presentation, and outcomes. Cancer. 2015;121(4):589-597. [5] Yau H, Kinaan M, Quinn SL, Moraitis AG. Octreotide long-acting repeatable in the treatment of neuroendocrine tumors: patient selection and perspectives. Biologics : targets & therapy. 2017;11:115-122. [6] Leoncini E, Boffetta P, Shafir M, Aleksovska K, Boccia S, Rindi G. Increased incidence trend of low-grade and high-grade neuroendocrine neoplasms. Endocrine. 2017 Nov;58(2):368-379. doi: 10.1007/s12020-017 1273-x. Epub 2017 Mar 16. PMID: 28303513; PMCID: PMC5671554. [7] Wu C, Song Z, Balachandra S, Dream S, Chen H, Rose JB, Bhatia S, Gillis A. Charting the Course: Insights into Neuroendocrine Tumor Dynamics in the United States. Ann Surg. 2025 Jun 1;281(6):968-975. doi: 10.1097/SLA.0000000000006331. Epub 2024 May 6. PMID: 38708616; PMCID: PMC11538379. [8] Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589. PMID: 28448665; PMCID: PMC5824320. [9] Basuroy R, Bouvier C, Ramage JK, Sissons M, Srirajaskanthan R. Delays and routes to diagnosis of neuroendocrine tumours. BMC Cancer. 2018 Nov 16;18(1):1122. doi: 10.1186/s12885-018-5057-3. PMID: 30445941; PMCID: PMC6240263. [10] Aluri V. and Dillion, J.S. 2017, "Biochemical Testing in Neuroendocrine Tumors", Endocrinology & Metabolism Clinics of North America, [11] Polee, I.N. et al. 2022, "Long-term survival in patients with gastroenteropancreatic neuroendocrine neoplasms: A population-based study", European Journal of Cancer, Volume 172, 2022, Pages 252-263, ISSN 0959-8049, • Krasnovskaya et al. Recent Advances in 64Cu/67Cu-Based Radiopharmaceuticals. Int J Mol Sci. 2023 May 23;24(11):9154. doi: 10.3390/ijms24119154. This announcement has been authorised for release by the Executive Chairperson. View original content to download multimedia: SOURCE Clarity Pharmaceuticals Sign in to access your portfolio
