Sydney, Australia 16 February 2023
Clarity Pharmaceuticals (ASX: CU6) (“Clarity”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce its Phase II diagnostic 64Cu SARTATE trial (DISCO NCT044383041) for patients with known or suspected neuroendocrine tumours (NETs) has reached the fifty percent recruitment milestone, with 32 out of 63 participants enrolled and imaged.
DISCO, which derives from “Diagnostic Imaging Study of 64Copper-SARTATE™ Using PET on Patients With Known or Suspected Neuroendocrine Tumours”, is assessing the performance of Clarity’s SARTATE™ imaging product as a potential new way to help diagnose and manage NETs. It is a Phase II study in up to 63 patients with Gastroenteropancreatic NETs (GEP-NETs) across four sites in Australia, comparing the diagnostic performance of 64Cu SARTATE™ at 4 and 20 hours post-administration to the current standard of care, 68Ga DOTATATE, at one hour. The trial aims to build on earlier studies with SARTATE™ (Hicks, R. et al)2 which demonstrated that imaging at later time points, enabled by a longer half-life of 64Cu isotope in comparison to 68Ga, may lead to better identification of disease.
Clarity’s Executive Chairman, Dr Alan Taylor, commented, “We are pleased with the progress of our SARTATE product. There is a clear unmet need in the NET indication with misdiagnosis and delay in diagnosis remaining very common. The vast majority of patients have the cancer spread to distant parts of the body by the time of diagnosis, which significantly affects treatment outcomes for people with NETs. Clarity continues to build on the promising first-in-human data, indicating the safety and potential effectiveness of the product as a new way to detect NETs. Combined with the logistical and supply benefits of central manufacturing enabled by the use of Targeted Copper Theranostics, SARTATE holds promise of delivering timely and crucial diagnostic scans to patients and their treating staff, bringing us closer to our ultimate goal of improving treatment outcomes for children and adults with cancer.”
About SARTATE
SARTATE™ is a next generation, highly targeted theranostic radiopharmaceutical. It is being developed for diagnosing, staging and subsequently treating cancers that express somatostatin receptor 2 (SSTR2), including neuroblastoma and neuroendocrine tumours (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™).
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 system3. 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 skin4. NETs can either be benign or malignant, as well as non-functional and functional5. NETs traditionally have been considered uncommon; however, the incidence has been increasing as a worldwide phenomenon6. This increase is thought to be mostly related to improvements in the way NETs are diagnosed, including better imaging tests and endoscopy, and increased awareness of these tumours7.
Overall, it is estimated that more than 12,000 people in the United States are diagnosed with a NET each year, and approximately 175,000 people are living with this diagnosis7. Patients with GEP-NETs present with subtle clinical symptoms, which can lead to a delay in diagnosis of up to 5–7 years, or result in inappropriate management8. As such, about 30-75% of NET patients have distant metastases at the time of diagnosis9. A 10-year relative survival rate for patients with metastatic GEP-NETs is 3–36%10.
About Clarity
Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious disease. The Company is a leader in innovative radiopharmaceuticals, developing targeted copper theranostics based on its SAR Technology Platform for the treatment of cancer in children and adults.
www.claritypharmaceuticals.com
References
- Clinicaltrials.gov Identifier: NCT04438304 https://clinicaltrials.gov/ct2/show/NCT04438304
- 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. 2018.
- Cheung VTF, Khan MS. A guide to midgut neuroendocrine tumours (NETs) and carcinoid syndrome. Frontline gastroenterology. 2015;6(4):264-269.
- 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. 2015;121(4):589-597.
- 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.
- 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.
- Neuroendocrine Tumors: Statistics, Cancer.Net, ASCO, https://www.cancer.net/cancer-types/neuroendocrine-tumors/statistics
- Modlin, E. et al. 2010, “Gastrointestinal neuroendocrine (carcinoid) tumours: current diagnosis and management”, The Medical Journal of Australia, https://www.mja.com.au/journal/2010/193/1/gastrointestinal-neuroendocrine-carcinoid-tumours-current-diagnosis-and
- Aluri V. and Dillion, J.S. 2017, “Biochemical Testing in Neuroendocrine Tumors”, Endocrinology & Metabolism Clinics of North America, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5777173/
- Polee, I.N. et al. 2022, “Long-term survival in patients with gastroenteropancreatic neuroendocrine neoplasms: A population-based study”, European Journal of Cancer, https://www.sciencedirect.com/science/article/pii/S0959804922003409
Clarity Pharmaceuticals
Dr Alan Taylor
Executive Chairman
+61 (0)413 871 165
ataylor@claritypharm.com
Citadel-MAGNUS
Catherine Strong
Investor/Media Relations
+61 (0)406 759 268
cstrong@citadelmagnus.com
This announcement has been authorised for release by the Executive Chairman.
