Completed enrollment of the LEAD Phase 1/2 clinical trial of LX1001 for the treatment of APOE4-associated Alzheimer’s disease
Received clearance of LX2006 Clinical Trial Application (CTA) in Canada for the treatment of FA cardiomyopathy; activated first clinical trial site outside of the United States
Presented additional preclinical data on LX2020 for the treatment of PKP2-ACM at the 2023 American Heart Association Scientific Sessions
Completed initial public offering (IPO) of common stock in November 2023, raising $111.5 million in gross proceeds and supporting operational runway into Q4 2025
All 15 ibezapolstat-treated patients in Phase 2b who achieved Clinical Cure (CC) at end of treatment (EOT) remained free of C. difficile Infection (CDI) recurrence through one month after EOT, for a Sustained Clinical Cure (SCC) rate of 100%
2 of 14 patients treated with standard of care, oral vancomycin, experienced recurrent infection within one month after EOT for a SCC of 86%
100% of the 25 ibezapolstat-treated patients in Phase 2 (Phase 2a and 2b) who had CC at EOT remained cured through one month after EOT
Further analyses will be forthcoming Q1 2024, as data become available, regarding other endpoints, from the Phase 2b trial, including Extended Clinical Cure (ECC) data up to 94 days and comparative effects vs vancomycin on the gut microbiome
Preparation underway for meetings with FDA, European Medicines Agency and other global regulatory agencies and advancement to international Phase 3 clinical trials
Alzamend’s recently completed Phase IIA study of AL001 in Alzheimer’s patients and healthy subjects showed a benign safety profile and identified a candidate dose that is unlikely to require therapeutic drug monitoring
Safety aspects of AL001 development may qualify for a 505(b)(2) NDA pathway for FDA approval
The Biden administration made two virtue-signaling proclamations at last week’sCOP28 conferencein Dubai that it says will help save the planet from climate change.
The policies aren’t likely to change the planet’s temperature by even one-tenth of a degree, but they might just destroy the 21st-century American industrial economy as we know it.
This comes on the heels of President Biden’s Environmental Protection Agency saying this year it would impose new power plant emission regulations that are virtually impossible for coal plants to comply with.
The bottom line: No more coal. Period.
But the White House was just getting started.
Vice President Kamala Harris trumpeted the next day new rules to “sharply reduce methane from the oil and natural gas industry.”
The administration calls methane a “super-pollutant” that it wants to eliminate because it’s “many times more potent than carbon dioxide.”
But methane is effectively a hydrocarbon that comes from natural gas.
John Kerry, the Biden administration’s special presidential envoy for climate, on stage at the COP28 Climate Conference in Dubai on Dec. 6, 2023.Photo by Sean Gallup/Getty Images
Eliminating methane is a de facto ban on natural gas power plants.
Here is the most sinister part of this story that no one in the Biden administration is telling you: Eradicating coal and natural gas plants will ravage America’s electric power capacity.
These regulations will cause rolling blackouts and brownouts across the country, much like we’ve already seen in California — America’s forerunner of radical anti-fossil fuel policies.
The lights will go out intermittently, and home heating in the winter and air conditioning in the summer will have to be turned off or rationed.
Without gas and coal plants, hospitals, schools, the internet, construction projects and factories will be routinely shut down when unreliable alternative energy sources like wind and solar power aren’t delivering enough juice.
Upward of 60% of America’s electric power generation will go away — and soon.
Coal still provides roughly 20% of our electric power; natural gas supplies around 40%.
What will make up for this lost power, especially given that our demands on the power grid are only going to multiply over the coming years as the greens want the entire network of cars, trucks and vans to be powered by charging up on the electric grid?
The Biden administration, in other words, wants to nearly double the demands on the electric grid network at the same time it wants to shut down more than half of the nation’s power generation — and the most reliable sources at that.
Something must give.
The climate-change groups that crammed into Dubai last week, echoed by head-in-the-sand politicians like John Kerry, piously advise that Americans will have to stop taking so many plane trips — especially overseas — and become less reliant on cars, switching to mass transit or bicycles instead.
Some people may believe these mandatory sacrifices and rationing of modern-age conveniences are justified to stave off “catastrophic climate change.”
Except the shutdown of our coal and natural gas power plants won’t move the needle a millimeter on greenhouse gas emissions — and may make global CO2emissions worse, not better.
That’s because by far the biggest producer of greenhouse gas emissions — China — isn’t playing in this climate-change sandbox.
(President Xi Jinping didn’t even attend the conference, and the Chinese who did were adamant that climate-change concerns aren’t going to interfere with Beijing’s grandiose economic expansion plans.)
The coal plants and mines we shut down in places like Pennsylvania, West Virginia and Wyoming are being replaced two or three times over by newly built coal-fired plants in India and China.
We shut down one plant; they bring on line two or three new ones.
This math doesn’t add up — especially since we have cleaner coal plants than China does.
Biden is playing a dangerous game of unilateral energy disarmament.
If he has his way, we will jump off the cliff first in the naïve hope that China, India, Russia and Europe are right behind us.
Whether intentional or not, this radical green agenda will cripple our global economic leadership, cost our economy millions of jobs and make Americans colder in their homes in the winter and hotter in the summer.
Does that seem like a smart way to protect ourselves from the dangers of a changing climate — real or imagined?
Stephen Moore is a senior fellow at the Heritage Foundation and chief economist with FreedomWorks.
Yemen’s Houthi rebels claimed they prevented a ship from sailing to Israel, as the Iranian-backed group escalates its attacks on vessels in the Red Sea in response to the war in the Gaza Strip.
The navy “forced a ship sailing towards occupied Palestine to change its direction and sail back,” Hussein al-Ezzi, the Houthi’s deputy foreign minister, said in a statement on X. His account couldn’t immediately be verified.
The U.S. Food and Drug Administration could not provide information on a confirmed side effect of the Pfizer COVID-19 vaccine, according to a newly disclosed document.
FDA staffers said in the document, from 2021, that one of the agency's top surveillance systems was unable to provide details on heart inflammation after Pfizer vaccination.
The FDA's Sentinel program was described in the document as "NOT sufficient to identify the outcomes of myocarditis and pericarditis due to reasons identified." Pericarditis is inflammation of the pericardium, or the membrane around the heart.
There weren't enough people in the program to assess the risk for 12- to 30-year-olds, the population discovered to be most at-risk from post-vaccination myocarditis, or heart inflammation, FDA staffers said. Assessing whether people who suffered from the condition had recovered, and following them long-term, was also not feasible because the program's data sources "do not have sufficient longitudinal data on patients," they said.
Studying subclinical myocarditis, or heart inflammation without clinical symptoms, was also not able to be done with the data "because of the absence of a definition of subclinical myocarditis and unknown background incidence of troponin abnormalities," the document stated.
Months before the document was prepared, U.S. authorities had learned of a large number of myocarditis cases following Pfizer vaccination in Israel, a fact they hid from Americans. The U.S. military also recorded cases just weeks after the vaccines were rolled out in late 2020. And additional cases were reported to the Vaccine Adverse Event Reporting System (VAERS), which is managed by the FDA and another agency.
"It is shameful that the Sentinel Program electronic database that FDA officials use to monitor reported vaccine side effects appears to have failed to adequately assess the magnitude of risk of heart inflammation (myocarditis and pericarditis) in children and adults aged 12 to 30 that occurred after receipt of Pfizer COVID shots. It also looks like heart inflammation cases were not appropriately followed up to find out how many people suffered permanent heart damage," Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times in an email.
The FDA declined to comment.
The document also said that information on post-vaccination myocarditis, pericarditis, and subclinical myocarditis would be coming from studies that Pfizer was conducting, in lieu of FDA surveillance.
Several of those studies have been completed, but the FDA and Pfizer are refusing to release the results to the public. The FDA and U.S. Centers for Disease Control and Prevention (CDC) have confirmed the Pfizer, Moderna, and Novavax vaccines cause myocarditis and pericarditis. Outside research has found myocarditis and pericarditis happen primarily in young males, while a recent study indicated subclinical myocarditis is more prevalent than previously thought.
The document was sent to the Public Health and Medical Professionals for Transparency (PHMPT), which sued the FDA after it refused to release documents relating to its authorization of Pfizer's vaccine. It was part of the final tranche from the FDA, which the agency was required to produce by a federal court.
Monitoring Systems
The CDC and the FDA have repeatedly claimed the COVID-19 vaccines are closely monitored. The CDC on its website, for instance, says that the vaccines were subject to "the most intense safety monitoring in U.S. history."
But the failure of Sentinel to provide data on a known risk is just one piece of data that undercuts that claim, according to Elizabeth Brehm, a partner at Siri & Glimstad LLP, which represents PHMPT.
VAERS, for instance, is repeatedly described by officials as being unable to provide vaccines cause any conditions. V-safe, another surveillance system, "doesn't directly monitor specific adverse events," Dr. Tom Shimabukuro, a top CDC vaccine safety official, wrote in one email that has been made public. The Vaccine Safety Datalink, run by the CDC, is a closed system, which outside researchers cannot access without approval. A fourth system only has CDC officials and researchers funded by the agency consulting on individual cases. They often encourage patients to receive additional vaccines even if they have experienced an adverse event.
"Without a diagnosis, these types of consultations can be very unfulfilling for the provider and patient; the assessment of causality is typically ‘indeterminate’ as to whether a vaccine caused or contributed to an adverse event," a CDC official wrote in another email about that system.
"When you really look at the 'system' collectively and what they say about it themselves, the question remains: what is an adequate safety surveillance system used by our authorities that provides reliable data to FDA and CDC concerning vaccines?" Ms. Brehm told The Epoch Times via email.
The CDC has said government systems have been useful, including helping detect the problem of thrombosis with thrombocytopenia syndrome after Johnson & Johnson vaccination and providing information on myocarditis after Pfizer and Moderna vaccination.
Additional documents are still forthcoming in a separate legal case brought against the FDA over documents relating to its authorization of Moderna's COVID-19 vaccine.
