Us humans are in the near constant pursuit of ever increasing efficaciousness, especially in the field of medicine. How can we harness the best possible patient outcome in the least amount of time?
Theranostics is a field of medicine combining both therapeutics and diagnostic measures to tackle the most complex medical burdens of today.
Since their IPO last year, Clarity Pharmaceuticals (ASX: CU6) has made significant inroads with their oncology focused theranostics.
The clinical stage radiopharmaceutical company is focussed on developing their SAR technology which uses radioisotopes to provide diagnostic information about the functioning of organs with superior imaging capabilities, and the ability to provide targeted therapy.
Their flagship clinical product SARTATE is currently in Phase 1/2a clinical trials in paedeatric patients with high-risk neuroblastoma, with the first patient in the second cohort having just been dosed.
Results garnered from treatment in the first cohort showed no dose limiting toxicities, allowing higher dosing of the next cohort to commence. The trial will span over five clinical sites in the US and treat 34 patients.
Neuroblastoma is an aggressive childhood cancer most commonly found in the adrenal glands, above the kidneys and most commonly affects children under 5 years of age. It is the most common type of cancer diagnosed within the first year of life, accounting for 15% of paedeatric cancer mortality. High risk neuroblastoma incurs a low 5 year survival rate of 40-50%.
“We are very excited to dose the first patent in cohort 2 in our neuroblastoma therapy trial in the US, having successfully completed cohort 1 in January 2022,” said Dr Alan Taylor, Clarity’s Executive Chairman.
“The increase in administered activity between cohorts 1 and 2 is significant in radiation-sensitive disease, such as neuroblastoma, and cohort 2 will see administered activities more than double in comparison to cohort 1. We look forward to continuing recruitment in cohort 2 at all five clinical sites in the US, building upon the encouraging initial data from cohort 1 and further gathering evidence of diagnostic and therapeutic benefits of the SARTATE product for the treatment of children with neuroblastoma.”
Positioning them to break into the USD $80.4 billion theranostics market, Clarity gained two Orphan Drug Designations and two Rare Paediatric Disease Designations for SARTATE from the FDA in 2020.
As at 31 December 2021, the Company is well funded to progress with SARTATE and other clinical programs with $96.7 million in cash as well as numerous manufacturing and licensing agreements to ensure continued revenue.