Serac Healthcare Limited, a clinical radiopharmaceutical company developing an innovative molecular imaging agent, 99mTc-maraciclatide, and the Nuffield Department of Women’s & Reproductive Health at the University of Oxford announce the journal publication of Phase 2 data from the “Detecting Endometriosis expressed inTegrins using teChneTium-99m” (DETECT) imaging study.
The paper, published open access online in The Lancet Obstetrics, Gynaecology & Women’s Health highlights that 99mTc-maraciclatide has potential as:
• A novel, non-invasive diagnostic test, particularly for superficial peritoneal endometriosis (SPE), which cannot be reliably detected by conventional imaging techniques and currently requires laparoscopic surgery for definitive diagnosis
• A tool to enable disease monitoring, eliminating uncertainty around disease recurrence
• A marker of treatment response, empowering the development of novel therapies
99mTc-maraciclatide is a gamma-emitting radiotracer that binds to αvβ3 integrin, which is upregulated during angiogenesis (new blood vessel formation), a cardinal feature of inflammatory diseases. The DETECT study describes, for the first time, the use of 99mTc-maraciclatide as a potential tool for the visualisation and diagnosis of endometriosis.
Key findings:
• The DETECT study demonstrated a high correlation between locations of maraciclatide uptake and laparoscopy across all types of endometriotic lesions, including superficial peritoneal endometriosis (SPE). SPE is the earliest stage of endometriosis, which is found in 80 per cent of all laparoscopically diagnosed disease
• Imaging with 99mTc-maraciclatide visualised endometriosis, detecting disease missed by conventional imaging methods
• Imaging results were concordant with the surgical presence or absence of endometriosis in 16/19 cases, with endometriosis imaged in 14/17 surgically positive participants, including two cases of thoracic endometriosis
• No false positives were reported in this study
• 99mTc-maraciclatide imaging was able to detect lesions across all endometriosis subtypes supporting the applicability of the scan to various patient groups
• 99mTc-maraciclatide was well tolerated and patient acceptability was high
David Hail, CEO of Serac Healthcare, said: “The completion and publication of this clinical study is a major milestone for Serac Healthcare. These data, from a representative patient population, including women receiving hormone therapy, provide evidence of maraciclatide’s anticipated real-world performance.
“With FDA Fast Track Designation and agreed Phase 3 study designs, we are now advancing to validate these findings in larger trials and progress to regulatory submission.”
