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Thursday, January 4, 2024

Why Dermata Therapeutics Stock Took Off

 Dermata Therapeutics, Inc. 

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 shares are trading higher in Thursday's after-hours session after the company announced the issuance of a new patent in Japan for its DMT410 program for the treatment of hyperhidrosis.

What To Know: The announcement of the patent was made Thursday after market close, making it Dermata's first patent issued for DMT410.

The program leverages the company's Spongilla technology to topically deliver botulinum toxin in treating the condition.

It was also noted there are talks of partnership prospects that would further the development of DMT410.

"We believe this patent issuance further validates DMT410's novel concept to easily deliver botulinum toxin topically instead of requiring patients to receive multiple injections," said Gerry Proehl, Dermata's chairman, president and CEO.

"We are excited about the opportunities the DMT410 program can bring to patients, not only for the treatment of axillary hyperhidrosis as we have seen in our proof-of-concept study, but potentially for palmer and plantar hyperhidrosis which has no currently approved products," he added.

https://www.benzinga.com/general/biotech/24/01/36502190/why-dermata-therapeutics-stock-took-off-after-hours

Atai Life Sciences Shows Positive Results In Phase 1 Clinical Study For PTSD

 Atai Life Sciences 

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 shared positive results from a Phase 1 clinical study on MDMA R-enantiomer, EMP-01, under development for the potential treatment of PTSD.

Assessing EMP-01's safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD,) the study enrolled 32 healthy participants who, divided in four cohorts, received one dose of 75mg, 125mg, 175mg or 225mg of EMP-01 or placebo in a 6+2 design.

As reported by Atai: 

  • The compound was well-tolerated and treatment-related adverse events were all expected, none severe and generally dose-dependent. 

  • Non-clinically significant increases in blood pressure and heart rate were observed, yet changes showed limited dose dependency. Peak body temperatures observed were within the normal range, and bruxism was observed in 1 of 24 participants who received the psychedelic.

  • EMP-01’s PK profile was dose-proportional. Exploratory PD measures included subjective reports and blood-based biomarkers, several of them showing “significant, consistent and dose-dependent” changes. 

  • Administration showed a “differentiated” subjective experience compared to racemic MDMA on standard psychedelic experience questionnaires; and dose-dependent changes on measures of emotional breakthrough -one believed “key” mediator of the long-term psychological changes associated with psychedelics- were noted.

Atai CEO and co-founder Florian Brand highlighted EMP-01’s “unique characteristics” within the context of decades of research into MDMA as a potential treatment for mental health disorders, and said the team is set to explore the implications for further clinical development.

Why It Matters

Phase 1 studies are range-assessment trials, aiming to define the highest dose at which the new therapeutic can be provided safely, without causing serious side effects.

The study’s results ultimately met the primary objective, with EMP-01’s administration demonstrating great tolerability, and all treatment-related adverse events (none severe) being anticipated. Further, there were no trial discontinuations.

According to CSO Srinivas Rao, MDMA’s two enantiomers (S- and R-) show “markedly different and rich” pharmacology, and atai’s Phase 1 study -“one of the first specifically focused on assessing the PK and PD of R-MDMA-” showed differences in the subjective experience of R-MDMA as compared to published reports on racemic MDMA. 

If confirmed, Rao says these differences would suggest R-MDMA's potential applicability "in a broad array of mental conditions.”

Atai will present further clinical data from the study at an upcoming medical meeting.

https://www.benzinga.com/general/biotech/24/01/36483373/atai-life-sciences-shows-positive-results-in-phase-1-clinical-study-for-ptsd-treatment

Bayer Study On Parkinson's Disease Gene Therapy Succeeds In Early-Stage Trial

 Bayer AG 

  and Asklepios BioPharmaceutical Inc completed an 18-month data collection in the Phase Ib trial for AB-1005 (AAV2-GDNF), an investigational gene therapy for treating patients with Parkinson's disease (PD).

The study met its primary objective, which was to evaluate the safety of a one-time bilateral delivery of AB-1005 directly to the putamen. 

Eleven patients were enrolled into two cohorts, Mild stage PD (six patients) and Moderate stage PD (5 patients), based upon the timing from a PD diagnosis and the severity of their PD symptoms at screening.

Neurosurgical delivery of AB-1005 was well tolerated by all patients with target putamen coverage of 63% ± 2%, exceeding the goal of greater than 50% coverage with AB-1005. 

No serious adverse events have been attributed to AB-1005, with continued clinical follow-up for up to 5 years post-administration ongoing.

Krystof Bankiewicz, Scientific Chair, Parkinson's and MSA at AskBio is “encouraged by these early data.”

AskBio is planning to present the 18-month study data, including secondary endpoints, at a scientific meeting in Q2 2024. Planning is currently underway for a Phase 2 trial.

The study is expected to begin screening patients soon.

In November, Bayer stopped the OCEANIC-AF Phase 3 study investigating asundexian compared to apixaban (a direct oral anticoagulant) in patients with atrial fibrillation at risk for stroke.

https://www.benzinga.com/general/biotech/24/01/36493163/bayer-study-on-parkinsons-disease-gene-therapy-succeeds-in-early-stage-trial

"System Is Not Going To Let Trump Win" - Dems' Real Puppet Isn't Gavin, It's Nikki: Tucker And Vivek

 With establishment favorite Nikki Haley overtaking long-time runner-up Ron DeSantis in the latest polls, the mainstream media is going wild about the chances of the woman-warmonger toppling Trump somehow.

For context...

However, Trump's massive lead is not stopping the deep state from doing everything it can to promote Haley, and that prompted Vivek Ramaswamy and Tucker Carlson to expose some reality behind her sudden success.

Tucker starts by pointing out the dilemma Democratic megadonors face with Joe Biden's declining popularity and Kamala Harris's unpopularity, suggesting that these donors might be attempting to subvert the Republican Party by backing a candidate like Nikki Haley.

“Strip away all the outward characteristics, and Nikki Haley is identical in her priorities to Joe Biden and the people who back Joe Biden,” Carlson said.

Haley, whose campaign raised $24 million between October and December, has received recent major endorsements from New Hampshire Gov. Chris Sununu and Americans for Prosperity Action, which is backed by billionaire Charles Koch.

Mr. Carlson then shared a video of Ms. Haley during a town hall in Davenport, Iowa, in October.

During the campaign event, the former South Carolina governor claimed that Russian President Vladimir Putin was behind the Hamas incursion of Israel on Oct. 7 and that Russian intelligence had helped aid the attack, which had simultaneously taken attention off the ongoing Russia–Ukraine conflict.

Tech entrepreneur Ramaswamy then weighed in on Tucker's claims, concurring with the former Fox host that Ms. Haley is a “puppet” for the Democratic Party, and branding her a “Trojan horse.”

“I think the true puppet masters, the thing about them, is they’re fundamentally nonpartisan in nature,” the businessman said.

“There are a few things they care about: Keeping the foreign war machine humming is high on the list. Keeping the administrative state’s control of the United States is also high on the list. They found a much more convenient puppet within the Republican Party itself.

"They have their core objectives, and Nikki makes for a far better Trojan horse to actually accomplish that objective than anybody else."

Mr. Ramaswamy concluded that it is now “crystal clear” that the “bipartisan system” wants to narrow the GOP presidential race down to just two candidates: former President Trump and Ms. Haley.

“It’s not Biden, and it’s not even Gavin Newsom. It’s Nikki Haley within the Republican Party itself,” he continued.

“And I think that that makes for a very convenient front man because then they actually have absolved themselves from any allegations of partisanship or Democratic partisanship against [former President] Donald Trump.”

Finally, Vivek notes:

"The system is not going to let Trump win, they have their chosen alternative, ready to trot out."

Watch the abbreviated interview below:

Watch the full discussion between Tucker and Vivek here at TCN.

https://www.zerohedge.com/political/system-not-going-let-trump-win-dems-real-puppet-isnt-gavin-its-nikki-tucker-and-vivek

US Admits "No Signs Of Abating" As Houthis Escalate Red Sea Attacks, Deploy Suicide Drone Boat

 The Houthis have decided to respond to fresh warnings and threats from the US and Western allies by sending an unmanned boat packed with explosives to disrupt international shipping lanes in the Red Sea. Clearly, Biden's "warnings" are doing nothing to deter anything.

The Thursday incident marks the first time the Houthis have deployed a drone boat since its attacks started in the wake of Oct.7. Drones and ballistic missiles from Yemen have wreaked havoc thus far. A US Navy official said, however, that the drone boat exploded before it was able to strike any vessels.

"We all watched as it exploded," Vice Admiral Brad Cooper, the head of US Navy operations in the Middle East said in a press briefing. He described that the "one-way attack" was inbound toward shipping lanes "clearly with the intent to do harm" - and that the boat is a "new capability". He indicated it came within a couple miles of foreign ships.

"Fortunately, there were no casualties and no ships were hit, but the introduction of a one-way attack USV is a concern," he added.

Already major shipping companies have diverted their tanker and cargo ships to avoid the Red Sea region entirely. But ironically on the very day the Houthis unveiled their drone boat capability, the Pentagon tried to put a positive spin on its Operation Prosperity Guardian, meant to thwart Red Sea attacks. Adm. Cooper cited that some 1,500 commercial were able to transit the waters safely since the allied operation was launched on December 18.

Still, Adm. Cooper admitted that "There are no signs the Houthis' irresponsible behavior is abating." The US Navy has tallied that the total number of Houthi attacks since Nov. 18 is now at 25.

Meanwhile, also on Thursday there's been a fresh piracy incident off Somalia. A Liberian-flagged vessel bound for Bahrain was boarded by armed men while it traversed to the south-east of Eyl, Somali.

"Five to six unauthorized armed persons have boarded a merchant vessel…in the vicinity of Eyl," the United Kingdom Maritime Trade Operations (UKMTO) said in an advisory. "Crew are mustered in citadel."

Somali militants have long threatened these waters, but given the bulk of diverted Red Sea traffic must travel via the Cape of Good Hope instead, the fear is that the resulting increased traffic off the Somali coast will lead to more 'opportunity' and ample targets for pirates. 

On Wednesday, the White House warned that this ongoing Red Sea turmoil could hit the US economy in a briefing:

The White House has warned that the potential for higher shipping costs to affect the U.S. economy amid diversion of ships from the Red Sea will depend on how long Houthi rebels sustain their attacks on commercial vessels.

“If we weren’t concerned, we wouldn’t have stood up an operation in the Red Sea, now consisting of more than 20 nations, to try to protect that commerce,” White House spokesman John Kirby said at a White House press conference on Wednesday, referring to the U.S.-led military force Operation Prosperity Guardian.

“The Red Sea is a vital waterway, and a significant amount of global trade flows through it. By forcing nations to go around the Cape of Good Hope, you’re adding weeks and weeks onto voyages, and untold resources and expenses have to be applied in order to do that. So obviously there’s a concern about the impact on global trade.”

Interestingly, Kirby was then asked by a reporter whether the spiraling situation would become “pocketbook” issue for Americans.

Kirby responded by saying "It would depend on how long this threat goes and on how much more energetic the Houthis think they might become." He added: "Right now we haven’t seen an uptick or a specific effect on the U.S. economy. But make no mistake. This is a key international waterway. Countries more and more are becoming aware of this increasing threat to the free flow of commerce." Thus he fully acknowledged this is a distinct possibility that's fast approaching.

One thing is clear - the Western coalition statement filled with warnings aimed at the Houthis and released with great fanfare clearly didn't have the intended effect...

Futile Immunotherapy for Cancer Grows More Common

 Providing immunotherapy for patients with metastatic cancer that proves quickly terminal is increasing, with more than 1 in 14 immunotherapy treatments in 2019 initiated within 1 month of death, according to a large retrospective cohort study.

Proportions of patients with metastatic disease who started immunotherapy within 1 month of death rose over the study periods (the time of FDA approval until 2019) from 0.8% to 4.3% for melanoma, 0.9% to 3.2% for non-small cell lung cancer (NSCLC), and 0.5% to 2.6% for kidney cell carcinoma.

By 2019, these end-of-life–initiated treatments represented 7.3% of all immunotherapy treatments, reported Sajid A. Khan, MD, of the Yale School of Medicine in New Haven, Connecticut, and colleagues.

Moreover, the study showed that this practice is more common at non-academic and lower-volume health care centers, and that these types of facilities have worse survival rates.

"The rate of end-of-life–initiated immunotherapy is increasing," Khan and colleagues wrote in JAMA Oncologyopens in a new tab or window. "More research on the benefit and value of these therapies in patients with advanced-stage disease is needed."

Their study covered 242,371 patients from the National Cancer Database: 20,415 with melanoma, 197,331 patients with NSCLC, and 24,625 patients with kidney cell carcinoma, all at stage IV.

Patients' mean age was 67.9, with 42.5% older than 70; 56.0% were men, and 29.3% received immunotherapy

Study periods for each cancer type started the year immediately following FDA approval of the first immune checkpoint inhibitor for the treatment of stage IV disease for that particular indication (2012 for melanoma, and 2016 for NSCLC and kidney cell carcinoma).

Khan's group found that, when stratifying by facility type and volume, fewer patients treated at academic and high-volume facilities started immunotherapy at the end of life for all three cancer types. And survival on immunotherapy at these institutions was significantly better: odds of death within 1 month of starting immunotherapy were lower by 31% at an academic or high-volume center (OR 0.69, 95% CI 0.65-0.74, P<0.001) versus a non-academic facility, and by 30% (OR 0.70, 95% CI 0.65-0.76, P<0.001) relative to very low-volume centers.

Across all three cancer types, those patients with three or more organs involved in metastatic disease were 3.8-fold more likely (95% CI 3.1-4.7, P<0.001) to die within 1 month of immunotherapy initiation than those with lymph node involvement only.

Khan and colleagues also found that patients with advanced disease treated at high-volume and academic facilities had longer survival compared with those treated at very low-volume or non-academic centers, regardless of whether or not they received immunotherapy, with overall risk-adjusted mortality rates lower by 10%-33%.

In an editorial accompanying the studyopens in a new tab or window, Michael Hoerger, PhD, of Tulane University in New Orleans, and two colleagues highlighted the study's finding that treatment with immunotherapy was associated with a 5%-18% absolute increase in 5-year survival across the three cancer types. But academic centers had 5%-9% better absolute 5-year survival than non-academic centers, and high-volume health care centers had 4%-13% better absolute survival than very low-volume centers.

Furthermore, Hoerger and colleagues suggested that since "academic and high-volume centers may be referred more complex cases," these figures may underestimate the survival gap.

"These health care center associations with survival are profound," the editorialists wrote. "These differences in immunotherapy use and patient survival can be understood through a systemic health care disparities lens. Patients who are experiencing health care disparities may be undertreated early in the disease course due to barriers to access and utilization and may also receive interventions less likely to offer benefit near death. [The findings in this study] fit that pattern."

Disclosures

Khan reported grants from National Institutes of Health Career Development Award during the conduct of the study.

Several co-authors reported relationships with industry.

The editorialists had no disclosures.

Primary Source

JAMA Oncology

Source Reference: opens in a new tab or windowKerekes D, et al "Immunotherapy initiation at the end of life in patients with metastatic cancer in the US" JAMA Oncol 2024; DOI: 10.1001/jamaoncol.2023.6025.

Secondary Source

JAMA Oncology

Source Reference: opens in a new tab or windowHoerger M, et al "Initiating immunotherapy in the treatment of stage IV cancers in the month before death -- a health care disparities lens" JAMA Oncol 2024; DOI: 10.1001/jamaoncol.2023.5932.


https://www.medpagetoday.com/hematologyoncology/othercancers/108123

How To Make An Economy Better In Election Year

 by Law Ka-chung via The Epoch Times,

In 2024, presidential and congressional elections will take place in many countries.

There has been speculation for a long time that existing ruling regimes try their best to make the economy prosperous and market bullish in the run-up to an election. The underlying belief of this is that government policies, whether fiscal or monetary, are effective and efficient. The latter is crucial because this requires a policy launched in the election year to have an imminent impact on the economy or market.

If the pleasing actions by the existing ruling regime are more oral than practical, then soon after, people would find no improvements in the situation and see through such manipulation tricks.

Accordingly, whether actions are deeds more than words or words more than deeds does not really matter, because what matters is policies done previously if policies are to be effective.

What policies have been in place so far?

Clearly, there has been a series of monetary tightening over the past two years, which are supposed to generate the expected cooling impact in 2024.

Because of such a long lag in policy effects (if any), the election year might not exhibit prosperity as expected.

The accompanying chart counts the number of years having various real GDP (year-over-year) growth ranges by years (n) before an election. Here, n = 0 means election year, n = 1 means one year before election, and so on. The counts are presented as a histogram against real GDP growth. A distribution leaning towards the right means better real GDP growth. The data used are the official ones dated earliest from 1930, giving an almost a century’s record.

U.S. Real GDP Growth n Year Before Elections (1930–2022). (Courtesy of Law Ka-chung)

The chart shows the election year (blue line) having slightly better economic performance (leaning somewhat more to the right than other colors).

However, the central tendencies of these distributions might not differ statistically, although the dispersions might look a bit different.

Since there are only slightly more than twenty counts for each year, the small sample (< 30) properties do not allow too much statistical inference from these results.

What can be concluded is that the election year effect looks more like a slogan than anything statistical.

On a specific case level, there are many election years with bad economic performance, namely, 2020 with the COVID-19 lockdown, 2008 with a financial tsunami, and 2000 with the tech bubble burst.

As explained above, such belief relies deeply on the policy impact.

For 2024, the market expects the Federal Reserve to begin rate cuts as early as March.

Nevertheless, experience suggests monetary policy typically has a time lag of 1 to 2 years.

This means if the U.S. economy turns bad within this year, there is not enough time for any policy changes to put off the fire.

[ZH: The timing of Powell's sudden pivot  - which sparked stocks to soar and soft-survey data to improve as rate-cut expectations spiked - happens to have coincided with the rapid decline in President Biden's approval rating...]

This might explain why n = 3 (red line) is also a good year because if a series of easings is made in an election year (n = 0), then the effect will be seen in the year (n = 3).

Will such history repeat this time? We must wait and see.

https://www.zerohedge.com/political/how-make-economy-better-election-year