Health Check: No ‘burnt toast’ excuses as Optiscan trial runs ahead of schedule | Stockhead
Unlike London's rail system, Optiscan doesn't need any lame excuses for tardiness because a key trial is ahead of schedule. Pic: Getty Images. Optiscan’s key cancer imaging study has had a. . .
Unlike London's rail system, Optiscan doesn't need any lame excuses for tardiness because a key trial is ahead of schedule. Pic: Getty Images. Optiscan’s key cancer imaging study has had a “quicker-than-expected progression”AFT Pharma wins FDA skin drug approvalNasdaq-listed biotech’s sacked chief medical officer is an alleged fugitiveLike London’s Tube at peak hour, clinical trial delays are de rigeur. Excuses are myriad: leaves on the track, the lack of qualified operating personnel or burnt toastYou read that correctly: charred bread in staff tea rooms reportedly trigger smoke alarms – and chaos – at busy stations. Biotech development can be the same. So, it’s refreshing to see that one of imaging houseOptiscan’s (ASX:OIL)key trials is running ahead of schedule. Optiscan is furthering confocal laser endomicroscopy, CLE. CLE eliminates the age-old and unreliable method of analysing tissue samples under a traditional microscope. CLE involves a single optical fibre in a probe projecting laser light on to live tissue treated with fluorescent dye. This creates real-time digital microscopic images, magnified 1000 times that of computed tomography or magnetic resonance imaging scanning. This train has left the platformThe company today said stage two of its first-in-human head and neck cancer imaging study had started ahead of time. The trial is being done at Perth’s St John of God Murdoch Hospital, withAustralian Clinical Labs (ASX:ACL)analysing the samples. The study tests InVue in real time surgery and InForm for the after-the-fact pathology. The hospital’s ethics committee approved the trial’s progression from stage one of ex-vivo imaging, “based on the rate, quality and variety of tissues imaged to date”. Stage two will obtain in-vivo images during surgery using InVue, supplemented by ex-vivo imaging with InForm. “The quicker-than-expected progression to stage two will result in both time and cost efficiency benefits,” the company said. In early June, Optiscan said it had reached the halfway recruitment mark in a separate Royal Melbourne Hospital trial, imaging breast cancer samples with both InVue and InForm. The study has imaged 25 of the 50 patients targeted, with the trial expanded to a second site (Frances Perry House). Fostering incisions with precisionThe studies seek to validate how real-time microscopic imaging can help surgeons find the tumour ‘margins’ in complex surgeries. This should obviate the need for follow-up surgery to clean up remnant malignant tissue. Optiscan CEO Dr Camile Farah said the study looks to deliver more than clinical benefits. “It is also helping advance our broader intent to validate the Optiscan platform across multiple tissue types, procedures and healthcare settings,” he said. The data should support other activities such as AI development, future US clinical activities and “regulatory pathways. ”Speaking of which, Optiscan does not yet have a device approved for human use. But the data will support Optiscan’s planned marketing entreaty to the US Food and Drug Administration (FDA). The company expects to lodge the paperwork for both devices in the current half. In the US, Optiscan has just launched a veterinary equivalent called InSpecta, under a less arduous clearance pathway. Optiscan showcased InSpecta to the American Veterinary Medical Association’s annual powwow in Anaheim, California last week. Random stuff we learned todayGenetic diseases specialistPYC Therapeutics (ASX:PYC)reports promising progress in the human and animal (primate) legs of its autosomal dominant optic atrophy (ADOA) study. In the phase I/II animal leg, patients treated with the company’s PYC-001 showed “both sustained improvement in visual acuity and decreased retinal stress”. The ape study supports extending dosing beyond once every four months. ADOA is a rare, inherited condition that slowly damages the optic nerve, causing blindness. If the human study succeeds, PYC intends to carry out phase II study in the more common glaucoma. Diversified Trans-Tasman drug houseAFT Pharmaceuticals (ASX:AFP)said the FDA had “tentatively” approved its treatment for facial angiofibromas in tuberous sclerosis. We hadn’t heard of that one either, but it affects between 15,000 and 30,000 Americans. Given that, AFT is angling for ‘orphan’ drug designation and the concomitant attractive pricing. However, the company is “disappointed” the launch has been delayed until March 2029. When it comes to issuing their quarterly reports, companies need a dose of cod liver oil to get things moving. Most of them leave it to the last allowable days, which means the end of this month for June quarter disclosures. But radiopharmaceutical developerTelix Pharmaceuticals (ASX:TLX)has reported June quarter revenue of US$247 million, 7% higher than the March quarter and 21% better year on year. Management said revenue for the full year to June 2026 should be at the upper end of the guided US$950-970 million. Having pivoted from anti-infectives to an acquired next-gen anaesthesia program,Biotron (ASX:BIT)reports quarterly cash burn of $222,000 and a $1. 55 million June-end cash balance. Clinuvel breaks a leg on ‘Broadway’ opening nightClinuvel Pharmaceuticals (ASX:CUV)shares have made a solid debut on the Nasdaq overnight, with the shares closing slightly higher in a broadly weaker market. The skin diseases specialist upgraded its ‘off Broadway’, over-the-counter level I American Depositary Shares (ADS) to a level II Nasdaq listing. The company remains listed primarily on the ASX. The company planned the initiative last year, but the Great US Government Shutdown (repeat screening) intervened. Clinuvel has lodged the paperwork to lift the listing to level I status. The company says the Nasdaq presence will enable greater visibility among US investors. Clinuvel sells its rare-disease drug Scenesse, mainly in the Kingdom of His Excellence the Orange One. “The [Nasdaq upgrade] upgrade marks an important step for Clinuvel’s visibility in US capital markets, as well as reflecting a broader shift of our business towards North America,” Clinuvel chair Jeffrey Rosenfeld says. “In the context of all our activities, the gradual shift to the US makes much sense as the company is maturing. ”In having a Nasdaq presence, Clinuvel joins peers such asMesoblast (ASX:MSB), Telix,Avita Medical (ASX:AVH),Anteris Technologies (ASX:AVR),Immutep (ASX:IMM)andResMed (ASX:RMD). But Nasdaq migrations rarely bolster a company’s valuation overnight. For the record, Clinuvel’s Nasdaq shares closed 5 US cents (0. 68%) to the good at US$7. 40, having traded between US$7. 06 and US$8. 18. Volume amounted to a modest 18,813 units. Yesterday on the ASX, Clinuvel shares gained 32 cents (3%) to $10. 24. One Nasdaq Clinuvel ADS is worth one ASX share. Police arrest US biotech execSpeaking of the Nasdaq, shares in Immix Biopharma Inc fell 13% overnight, on news that police had arrested its chief medical officer. The problem? The exec, 70-year-old Ronald Fischer appears to have been a fugitive going under the false identity of Richard Graydon. According to industry newsletter STAT, federal and Rhode Island authorities detained Fischer on a 56-foot yacht off the coast of New Jersey. Fischer, a former anaesthesiologist, disappeared in 2005 while on trial for first-degree sexual assault. Immix said it had terminated Graydon, hired in March, “for reasons unrelated to his activities at the company”. Given Graydon’s/Fischer’s short tenure, management said the business had not been affected. But America being America, the attorneys are circling: Philadelphia’s Kehoe Law Firm is investigating “potential securities fraud claims on behalf of investors. ”At Stockhead, we tell it as it is. While Optiscan is a Stockhead advertiser, the company did not sponsor this article.