The Cyclopharm Limited (ASX: CYC) share price continues to bask in the glory of its clinical trial announcement released earlier this week.
Shares in the diagnostic imaging technology developer surged 28.2% to a record high of $2.50 in the last hour of trade, taking its total gain to 78.6% in three days.
In contrast, the All Ordinaries (Index:^AORD) (ASX:XAO) and the S&P/ASX 200 Index (Index:^AXJO) have lost more than 1% each at the time of writing.
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Successful trial triggers Cyclopharma share price surge
Cyclopharma announced on Tuesday that the Independent Data Monitoring Efficacy Committee (DEMC) has unanimously recommended that the company's Technegas Phase 3 trial (CYC-009) be stopped as it was a success.
This means Cyclopharma can suspend the trial. Following consultation with the US Food and Drug Administration (USFDA), the CYC‐009 study will be terminated with orderly formal site close out and notification to reviewing Investigational Review Boards.
"Given over three decades of clinical use, hundreds of clinical papers and references in practice guidelines featuring the benefits of Technegas, we were always confident of a positive outcome," said the company's chief executive James McBrayer.
"The recommendation handed down by the DEMC overnight Australian time validates our confidence in our Technegas technology and further de‐risks our pathway to USFDA approval to sell Technegas in the USA market in 2021."
Poised to join prestigious ASX club
If Cyclopharma gains final USFDA approval for its lung test, which looks likely, it will join the league of other successful ASX medical device companies.
These include the Nanosonics Ltd. (ASX: NAN) share price, RESMED/IDR UNRESTR (ASX: RMD) share price and Cochlear Limited (ASX: COH) share price.
What Cyclopharma's technology does
Cyclopharma's Technegas technology uses very fine radioactive carbon, which is inhaled by a patient. This allows detailed images to be taken by a gamma or single photon emission computed tomography (SPECT) camera.
The technology can be used to diagnose COPD, asthma, pulmonary hypertension and certain interventional applications to include lobectomies in lung cancer and lung volume reduction surgery.
Shareholders breathing easy
The CYC‐009 clinical trial is a prospective, 240‐patient, non‐inferiority comparison against Xe‐133. The Phase 3 trial design was approved under a Special Protocol Assessment granted on 4 October 2016.
The impact of COVID-19 slowed patient recruitment and only 204 patients (or 85% of the targets number) were imaged. This prompted the USFDA to call in an independent committee to review the efficacy data.
The positive recommendation from the DEMC does not guarantee that the USFDA will give CYC-009 its final tick of approval, but this is likely as federal regulators are often guided by independent panel of experts.
