Cyclopharm Limited (ASX:CYC) has completed recruitment and imaging of the first 40 patients in its phase III clinical trial required to gain Food and Drug Administration (FDA) approval to market and sell Technegas in the US.
The company’s Technegas generators produce a gas which is inhaled by patients before taking scans, to assist in the detection of respiratory diseases.
Cyclopharm managing director James McBrayer said: “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.”
Regulatory approval expected in the first half of 2019
Cyclopharm’s trial will compare Technegas with Xenon-133 (another gas used for imaging the lungs) in a total of 240 patients.
The study will be funded from existing cash reserves with regulatory approval expected to be received in the first half of 2019.
Concurrently, Cyclopharm is accelerating programs that relate to satisfying the FDA Center for Drug Evaluation and Research by providing a paediatric plan for Technegas.
Establishing the trial’s effectiveness
Cyclopharm is undertaking a development program to ensure its quality systems and manufacturing processes are FDA compliant.
McBrayer added: “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.”
Potential for use in multiple respiratory diseases
Technegas is inhaled by the patient via a breathing apparatus, which then allows multiple views and tomography imaging.
Historically used in the diagnosis of pulmonary embolism, Technegas, together with advancements in complementary technology to multimodality imaging and analytical software, is being used in other diseases.
These include chronic obstructive pulmonary disease (COPD), asthma, pulmonary hypertension and certain interventional applications to include lobectomies in lung cancer and lung volume reduction surgery.