Target $165
Tuesday, September 6, 2022
Point Bio: Presentation at ESMO on Efficacy & Safety Data from Lead-In Cohort of Phase 3
Patients will be subject to follow-up for up to 5 years from their first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival. Key secondary endpoints include overall response rate, overall survival, and pharmacokinetics.
Eiger: Peginterferon Lambda COVID-19 Emergency Use Authorization Application Delayed
Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) and other serious diseases, today provided an update on the status of its planned request for emergency use authorization (EUA) of peginterferon lambda for the treatment of patients with mild-to-moderate COVID-19 based on its most recent communications with the U.S. Food and Drug Administration (FDA).
Following a cooperative and extensive pre-EUA information exchange with FDA regarding the Phase 3 TOGETHER study of peginterferon lambda for COVID-19, the agency has indicated that it is not yet able to determine whether the criteria for the submission of an application and issuance of an EUA are likely to be met. FDA has indicated that it will consider any new information and data from the TOGETHER study to support an EUA as well as the company's plans for the further development of peginterferon lambda for COVID-19. Eiger remains in active dialogue with FDA and will provide additional information to the agency that the company believes could be supportive of an EUA.
https://finance.yahoo.com/news/eiger-biopharmaceuticals-provides-status-planned-120000831.html
Iveric: Encouraging Geographic Atrophy Trial Data
IVERIC bio Inc (NASDAQ: ISEE) announced positive data from the second Phase 3 trial of Zimura (avacincaptad pegol) for geographic atrophy (GA).
GATHER2 met its prespecified primary endpoint of mean growth rate (slope) in GA area at 12 months with statistical significance and a favorable safety profile.
Zimura showed a 14.3% reduction in the mean growth rate (slope) in GA area over 12 months using square root transformation and a 17.7% reduction using the observed GA area.
Post-hoc Analysis of U.S. Patients showed a 25.5% reduction and 32.0%, respectively.
In GATHER2, there were no events of endophthalmitis, no intraocular inflammation events, and ischemic optic neuropathy events. The most frequently reported ocular adverse events were related to the injection procedure.
Zimura 2 mg reduced all analyzed subgroups' mean growth rate (slope) in the GA area.
For best corrected visual acuity, a favorable trend for Zimura 2 mg was observed consistent with GATHER1. A favorable trend was not observed for low luminance best corrected visual acuity.
The company plans to submit a marketing application to the FDA by the end of Q1 2023.
https://finance.yahoo.com/news/iveric-bio-stock-soars-encouraging-115127252.html
Monday, September 5, 2022
'Toxic' Dust Storm Hits Burning Man, Causing Total Whiteout
The final weekend of Burning Man nearly ended earlier as visibility deteriorated to zero during a massive dust storm.
On Saturday, Burning Man's official Twitter account tweeted the gates into the festival in Nevada's Black Rock Desert were closed "due to whiteout conditions." Event staff requested festivalgoers:
"Do not drive. Vehicles are becoming stranded and lost on the playa."
From a distance, the National Weather Service of Reno's stationary cameras captured the moment when dust rolled across the festival area, severely impacting visibility for the tens of thousands of people.
A passenger on a commercial flight captured a clearer view of the dust storm affecting the festival.
The dust storm was so big that a weather satellite spotted it.
On the ground, festivalgoers looked miserable on the last weekend of the nine-day event. The San Francisco Standard pointed out that the dust in the area is full of "alkaline" and is "quite toxic."
San Francisco Chronicle said the dust storm nearly "ruined the annual torching of a giant wooden effigy." But by late Saturday evening, the gates reopened, and around 2200 local time, the statue went up in flames.
Toxic dust wasn't the only thing festivalgoers had to worry about -- daytime highs hit triple digits, sending some people home early.
https://www.zerohedge.com/markets/toxic-dust-storm-hits-burning-man-causing-total-whiteout
A Light at the End of the Tunnel for Low-Risk Prostate Cancer?
At the American Urological Association (AUA) meeting in New Orleans in May, there was seemingly a "light at the end of the tunnel" moment.
Matthew Cooperberg, MD, MPH, a leading advocate for active surveillance (AS) from the University of California San Francisco, announced that the AUA's own data from its AQUA registry showed that, for the first time, the majority of patients with low-risk prostate cancer (just under 60%) opted for AS rather than a rush into the OR or the radiotherapy suite. AS had finally broken out of academic practices and become mainstream.
Victory in our time? Not yet. Not really. A not insignificant 40% of U.S. candidates for AS still opt for radiation or surgery.
The AUA's committee called for greater adoption of AS, with a goal of 80% within some vague timeframe.
Then, someone at the meeting spoke up, a voice from Michigan, which turns out to be a hotbed for urological reform, especially for AS for low-risk prostate cancer. Kevin Ginsburg, MD, a urologic oncologist from Wayne State University in Detroit, stepped up to the mic and said 80% simply was not good enough as a goal and called for a more aggressive migration to AS.
Ginsburg is one of the leaders in MUSIC (Michigan Urological Surgery Improvement Collaborative), an innovative physician-led quality improvement collaborative founded in 2012, comprising a consortium of 46 urology practices in the state of Michigan and supported through Blue Cross Blue Shield of Michigan.
He told the assembly: "I'm Kevin Ginsburg and I work with MUSIC. At MUSIC we've been able to get our rates even higher, up to above 90% in 2021. Why shoot for 80%? In my mind, the only reason to treat someone upfront with Grade Group 1 (GG1) prostate cancer is that they will be harmed and develop metastasis or death from prostate cancer by delaying treatment of their disease with AS. I'm not sure 20% of men with GG1 disease fall into that category."
Of course, that isn't the case with this lazy kind of cancer.
Ginsburg said one of MUSIC's first goals was to step up AS throughout the Mitten State, including academic practices but also large private practices and small practices. Virtually all practices in Michigan are part of MUSIC's efforts to combine and share data to drive improvements in patient care and reductions in cost.
"This isn't just the academic ships, such as Wayne State and the University of Michigan, saying, 'Hey, let's use active surveillance.' This is everyone buying in and saying we can absolutely use more active surveillance for men with low-risk prostate cancer," Ginsburg said.
Michigan has become the Sweden of AS in America, largely due to the efforts of MUSIC. MUSIC helps physicians monitor their own practices and encourages the adoption of AS. Through concerted quality improvement efforts, the state has achieved a rate of more than 90% of low-risk patients going on AS, rivaling AS rates in Sweden.
According to the American Cancer Society, more than 268,000 American men will be diagnosed with prostate cancer in 2022. Of these men, 35% (approximately 94,000) will have low-risk or very-low-risk Gleason scores. Among these low- or very-low-risk men, approximately 60% (56,400) will opt for AS in the U.S.
As an advocate for AS, this is MUSIC to my ears. There will never be 100% uptake of AS, Cooperberg and Ginsburg noted. AS isn't for everybody because of anxiety and other factors, but MUSIC shows there is the possibility of a much higher AS acceptance rate.
MUSIC is showing the way with a model that should be adopted throughout the U.S. It's more than voluntary monitoring to improve rates through medical peer support. MUSIC has studied what could be changed in practice to improve outcomes in multiple areas of prostate cancer care. MUSIC's collaborative model also produces a report card for each practitioner and overall.
"Everyone knows their own and the data of MUSIC as a whole, but they don't know everyone else's individual data. Otherwise, it's too easy to speak in generalities and think you are doing the right thing (like using a lot of AS) without knowing if you are doing the right thing. Knowing your data is the first step in improvement," Ginsburg said.
"One of the founding principles of MUSIC was that as a group we would be 'collegial and non-competitive.' Although it sounds cliche, we have a strong mentality of 'a rising tide lifts all boats.' I wouldn't say we have had to use peer pressure, as urologists in MUSIC are there voluntarily. MUSIC is a coalition of the willing. Urologists participate in MUSIC because they want to deliver the best possible care to their patients," he continued.
In addition to report cards, MUSIC convenes three times per year to discuss quality improvement topics pertaining to prostate cancer care, kidney cancer care, and kidney stone care.
This brings us to "the swish" -- a biopsy disinfectant technique.
Ginsburg said MUSIC examined ways of improving the 1% rate for sepsis in biopsies that lead to hospitalization.
"We got together and asked what are some things we could do to make it safer? We actually found lower rates of sepsis in urologists that swish the biopsy needle directly in formalin -- it decontaminates the needle -- and then they swish in some saline or water and then take the next biopsy. We found that those people had the lowest incidence of infection," he explained.
The docs with higher sepsis rates among patients just rubbed needles on gauze, which would be used to transfer the tissue to the container sent to the pathologist. MUSIC published its findings in BJU International. After adjusting for confounders, the study findings weren't statistically significant.
"It was one of these variation things in medicine. Do you tie your shoe starting with your left foot or your right foot? It's something no one ever thought about. We thought it was inconsequential. But really, you're able to take a deep dive into this and determine that this is one of the techniques that we found to help reduce the incidence of infection after prostate biopsy," he said.
"Although the swishing study didn't meet statistical significance, I still find it valuable. To me, decreasing infectious hospitalizations by 0.3% or 0.5% with a simple maneuver, even if that change is not statistically significant, I still find it clinically significant," he added.
Ginsburg said the success with swishing led to other priorities within MUSIC, such as encouraging transperineal (TP) biopsies. According to MUSIC data that have not yet been published, the rate of hospitalizations for infections is 0.6% following transrectal ultrasound (TRUS) and 0.3% following TP.
"I am a swisher. I mostly do TP biopsy now but when I do TRUS, I swish," Ginsburg noted.
MUSIC currently is exploring more appropriate use of imaging, improving the quality of MRI, fusion imaging, and also several factors to improve prostatectomies.
What's missing?
In my view, MUSIC and other researchers need to look at the psychology of AS, how anxiety and depression impact the decision-making process, what can be done to improve those uptake rates, and how to keep more patients on AS longer. MUSIC needs to generate data on race and ethnicity, especially within the Black population, which is hard hit by prostate cancer but is too often steered away from AS.
Could the MUSIC model spread throughout the U.S. to try to improve the quality of life in patients with low-risk cancers and prevent the damage of overtreatment of prostate cancer and even to switch to safer TP procedures?
"We are currently, and very selectively, investigating how we could expand the MUSIC model outside of Michigan," said Ginsburg.
https://www.medpagetoday.com/special-reports/apatientsjourney/100530
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