Cyclopharm (ASX:CYC) has completed recruitment and imaging of the first 40 patients in its phase 3 clinical trial required to gain FDA approval to market and sell Technegas in the US market.
The Technegas technology is a structured ultra-fine dispersion of radioactive labelled carbon, produced by using dried Technetium-99m in a carbon crucible, micro furnaced at around 2,700o C. The resultant gas like substance is inhaled by the patient (lung ventilation) via a breathing apparatus, which then allows multiple views and tomography imaging under a gamma or single photon emission computed tomography (SPECT) camera for evaluating functional ventilation imaging.
According to Cyclopharm managing director, Mr James McBrayer, “Achievement of this significant milestone, in line with our previously announced timeline, demonstrates that we remain on track to submit our first 40 patient interim study to the USFDA in the current half year.
“This first 40 patient interim study was agreed to by the USFDA to establish the trial’s effectiveness. It will also provide Cyclopharm the opportunity to engage with the USFDA to review, refine and improve the trial’s protocol which may accelerate the overall rate of recruitment.”
The trial is a non-inferiority, structural indication comparing Technegas with Xenon-133 in a total of 240 patients. It is expected to be conducted at between ten and fifteen locations.
“The results from the first 40 patient interim study will form an important contribution in our New Drug Application for Technegas and provide valuable clinical feedback. Based on the progress to date, including advancing the CDER and CDHR matters, we remain on track to receive the anticipated approvals to commence marketing and sales of Technegas in the US market in 2019,” added Mr McBrayer.