In addition to our amyloid reactive PET/CT agent, 124I-evuzamitide, we have recently developed a novel technetium-99m labeled variant of the pan-amyloid reactive peptide p5+14. Although we anticipate limitations associated with the use of Tc-99m for the detection of, notably, renal amyloidosis, this reagent is an easily produced variant that could be used in the community cardiology setting as a rapid screen for amyloid cardiomyopathy. Here, we present preliminary data from the first-in-human study (NCT05951816) on the biodistribution of 99mTc-p5+14 in healthy volunteers and patients with recently diagnosed ATTR and AL amyloidosis using planar gamma scintigraphic and SPECT/CT imaging.

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Cashell was named Sky Tavern's CEO in February after the retirement of executive director Bill Henderson last fall after 23 years with the resort.

Introduction: Systemic amyloidosis is an incurable disease, and about 20% of patients with cardiac involvement experience early deaths. Recent progress in the treatment of light chain (AL) and transthyretin (ATTR) amyloidosis has greatly improved patient prognosis; however, median survival remains low at approximately five years. Moreover, ATTR amyloidosis, recently referred to as "the Alzheimer’s disease of the heart" is emerging as a significant underlying cause of heart failure with preserved ejection fraction (HFpEF). Therapies for ATTR amyloidosis that slow the progression of amyloid deposition have been developed; however, they are not effective in patients with late-stage disease. Therefore, the ability to detect amyloid cardiomyopathy early is a clinically important unmet need, which may improve the prognosis of these patients. However, there are no FDA-approved imaging agents that specifically detect cardiac amyloid in all patients with amyloidosis.

“Nighttime training is a game-changer for our local high school and UNR’s ski teams,” Cashell said in a news release. “Unlike football or basketball athletes, ski racing athletes can’t train after school and into the evening. They have to leave school early, missing classes, in order to train in the daylight. If they can train after school like all other athletes, that will help keep them on their academic track while they are in training.”

Methods: This is a Phase 1, four (4) part, single-center, open-label study. A total of n=35 subjects (age >18 years) will be recruited, five (n=5) of which will be healthy volunteers and n=30 will be newly diagnosed patients with systemic AL or ATTR amyloidosis. 99mTc-p5+14 is synthesized in the University of Tennessee Graduate School of Medicine radiopharmacy. After assessing release criteria, subjects were administered ≤22 mCi of radiotracer intravenously. At 1 h and 3 h post-injection, subjects were imaged using standard planar gamma scintigraphy and SPECT/CT imaging over the thorax. Blood was collected to assess serum biomarkers, and a transthoracic echocardiogram was performed. Standard 99mTc-pyrophosphate imaging was performed on most patients at 72 h after 99mTc-p5+14 image acquisition.

"Further compounding our concerns, homeowner and ski industry expert Chris Minnes has forecasted a challenging future for the night skiing initiative," theMRPOWC release reads. "Minnes points to the economic vulnerabilities of the project and the heightened risk of potentially fatal accidents, especially among participating children, predicting the program's failure within a short span of three years."

The MRPOWC quoted John Williams, an area resident and Incline Village General Improvement District city infrastructure expert, saying, "The ambient light pollution from this operation will not only disrupt the natural beauty of our night skies but will fundamentally alter the character of our mountain landscape."

In 2019, Reno City Council unanimously approved a 30-year lease for the Sky Tavern Junior Ski program despite objections from operators of Mt. Rose Ski Tahoe, which is 1.5 miles up the hill from Sky Tavern. Mt. Rose development company president Kurt Buser said at the time he was concerned Sky Tavern's non-profit business model was unrealistic. Since the lease was approved, Sky Tavern has moved forward trying to add lights for nighttime skiing. NearbyMt. Rose does not have lights at its resort.

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Sky Tavern CEO Pat Cashell said installing the lights on a portion of the mountain is an important development for skiers who attend class during the day and would be able to train at night in the future.

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Below is the press release announcing the Sky Tavern lighting approval and the response fromMount Rose Property Owners Water Company.

The MRPOWC said a single test light does not provide "arealistic understanding of the impact of 73 lights planned for installation," adding the "proposed night skiing operations blatantly disregard the Mount Rose Scenic Byway Corridor Management Plan and the Washoe County General Plan." The group claims the light installation would threaten the scenic integrity of Mount Rose; the introduction ofsnowmaking equipment would create noise pollution; and the lightning would potentially cause safety and economic issues.

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The seemingly innocuous push to add lights to Sky Tavern, the youthski and snowboard learning center, has become a majorbrouhaha.

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"The community must weigh the economic ambitions of this project against the irrevocable loss of our night sky's natural beauty and the unacceptable risk it poses to our children," Minnes is quoted in the MRPOWC release.

“We thank the Board for understanding the opportunities that our community will gain with the installation of lights,” Cashell said in a news release. “We have lit stadiums all around Reno that allow for night training and night games for all kinds of outdoor sports. Adding lights at Sky Tavern will help our student-athletes and also expand our ability to better serve our community by offering ski lessons midweek for families who cannot participate on the weekends.”

The MRPOWC said it applauds Sky Tavern's efforts in fostering outdoor sports among Reno's youth with its junior ski programs. But the group said it has "grave concerns over environmental impact, economic feasibility, community disruption and increased safety risks."

Conclusions: 99mTc-p5+14 is a promising new reagent for the facile detection of amyloid cardiomyopathy of any type using gamma scintigraphic imaging. This technique might be a useful screening tool for the early detection of amyloidosis by community cardiologists.

Results: The planar and SPECT/CT images generated using 99mTc-p5+14 were of high quality and readily interpretable at both 1 h and 3 h post-injection. No cardiac uptake was observed in healthy subjects. Physiologic distribution of radioactivity was associated with renal and hepatobiliary clearance of the radiotracer. In contrast, patients with amyloid cardiomyopathy had significant uptake of 99mTc-p5+14 in the heart evidenced in planar and SPECT/CT images, where the ventricular walls and interventricular septum were readily imaged (see figure). Preliminary assessment of the myocardium-to-blood ratio at 1 h post-injection in patients was more than 3.5:1. Pulmonary lesions, seen in the CT of patients, were also shown to bind 99mTc-p5+14.

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Sky Tavern opened in 1944 with theReno Junior Ski Program beginning in 1948. Some of the world's top skiers learned to ski on the mountain, includingU.S. Ski & Snowboard Hall of Famers Steve and Tamara McKinney; Sandra Poulsen; two-time Olympic medalist Lane Spina; and three-time Olympic medalist David Wise,whose father helped launch the Sky Kids program. Sky Tavern is a non-profit that has taught more than 100,000 kids to ski and snowboard and recently became a year-round location for mountain biking, camps and the summer music series.

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"The proposed lighting for the night skiing operation, equivalent in scale to eight Walmart parking lots, is set to cast an intense glow over the area," theMRPOWC wrote in a news release. "This artificial brightness will reflect off the snow-covered landscape, causing Mount Rose to emanate a glow akin to downtown Reno."

Last week, the Washoe County Board of Adjustment approved a special use permit for Sky Tavern, granting the organization the right to install lights and snowmaking equipment to accommodate night skiing.

The Washoe County Board of Adjustment members said the lights would be limited to the wintertime with a mandatory shutoff at 9 p.m. to reduce the impact on the region's night skies.Sky Tavern said it was moving forward with final design and permitting for the lights' installation, water storage and snowmaking following last week'sapproval byWashoe County.

The seven-figure project, aimed to increase accessibility to the mountain for afterschool hours, has met resistance fromthe Mount Rose Property Owners Water Company (MRPOWC), which released a nearly 1,000-word statement Monday in opposition of the plan.

AddedNathan Robison, the principal engineer who introduced and defended the use permit to the board: "We are grateful for the attention that Washoe County Planning, Engineering and other departments provided for this complicated but invaluable step towards Sky Tavern's future."