The study starts are in line with Curasight's expanded strategy to pursue therapy as well as diagnostics within head & neck cancer and neurodocrine tumors (NET), as announced in February this year. The decision to expand into new therapeutic areas is based on the published positive results from investigator-initiated phase-II studies with diagnostic uTRACE[®] in both indications. 

"We are very pleased to be able to announce the start of preclinical studies in two additional indications with limited treatment options. Based on the findings in the phase II trials using uTRACE[®] to precisely detect both Head & Neck and neuroendocrine tumors, we believe our uTREAT[®] platform could have an important role to play in the treatment landscape of these two cancers," said Curasight CEO Ulrich Krasilnikoff. "Today's news also emphasizes the potential strength of our uPAR Theranostic platform to combine the detection of tumors with the ability to provide more targeted and gentle treatment of the cancer."

About head and neck cancer

Head and neck squamous cell carcinoma is the 6[th] most common cancer worldwide with 890,000 new cases and 450,000 deaths in 2018. The incidence is anticipated to increase over the coming years. The main finding from the Phase II study using uTRACE[®] was that patients with high uptake on uPAR-PET compared to those with a low uptake had an 8.5-fold poorer prognosis regarding relapse-free survival. Also, when compared with commonly used prognostic markers (FDG-PET, TNM stage and p16 status) in a multivariate analysis, only uPAR-PET remained significant. The conclusion from the trial was that uPAR-PET could potentially become valuable regarding planning of therapy and follow-up in head and neck cancer patients. In addition, the presence of uPAR in head and neck cancer patients and in particular, in those with the most aggressive disease, also formed the basis for pursuing uPAR-targeted radionuclide therapy (uTREAT) in this cancer type.

About neuroendocrine tumors (NET)

Neuroendocrine tumors are a rare form of cancer that occurs in glandular cells most frequently in the lining of the gastrointestinal tract or in the lungs, but the disease can in principle occur in all organs of the body. Each year approximately 35,000 new cases are diagnosed in the US and EU. Due to the long survival of these patients, more than 400,000 patients are living with the disease in the US and EU. The main findings from the phase II study were that uPAR-positive lesions were seen in most NET patients and that uPAR PET was prognostic, and that uPAR may be a promising target for therapy in NET patients.

About uTREAT[®]

Curasight will pursue uPAR targeted radionuclide therapy using the Company's uTRACE[®] ligand but modified and "armed" with short-range radiation therapy (uTREAT[®]). By combining anti-cancer radiotherapy uTREAT[®] (therapy) with uTRACE[®] (diagnostics), the technology jointly known as Theranostics, is expected to detect and treat cancer and metastases in a more gentle and efficient way than today's method of external radiation therapy.