AIM ImmunoTech Submits Pre-IND Application for Phase 2 Covid Therapy Trial

 AIM ImmunoTech Inc. (NYSE American: AIM) today announced that is has submitted a Pre-Investigational New Drug application (Pre-IND) to the U.S. Food and Drug Administration (FDA) for two separate Phase 2 clinical studies to study the potential of Ampligen as both an infusion and an intranasal therapy for early-onset COVID-19, the disease caused by SARS-CoV-2.

The two clinical trials will be Phase 2, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of Ampligen as an:

Intravenous therapy — 200 mg of Ampligen or placebo, with five doses over a treatment period of 17 days; and anIntranasal therapy — 1,250 μg spray (625 μg per nostril), with seven doses over a treatment period of 15 days.

In addition to studying efficacy and safety, the new Phase 2 protocols include exploratory endpoints that the company believes could support its recently filed provisional patent application.

AIM CEO Thomas K. Equels stated: “With Ampligen’s recently established intranasal safety profile, and the preliminary results from these trials, we may be able to show that Ampligen not only has an early-onset therapeutic effect against a broad spectrum of respiratory viruses, but also may provide a boost to post-infection immunity that will confer cross-protection against viral variants. We believe the clearly defined exploratory endpoints for the upcoming trials will substantially validate the significant potential of Ampligen. Moreover, as the principal architect of AIM’s developing portfolio of COVID-19-related inventions, I personally believe our most recent provisional patent application for Ampligen, as an early-onset intranasal therapy, stands out as an extremely important development in the progression of our patent portfolio.”

AIM believes that it is critical to test the potential of Ampligen as both an intravenous and an intranasal therapy for early-onset COVID-19, as there is science to support the potential of both approaches.

Ampligen has demonstrated clear activity in prior SARS-CoV-1 virus animal experiments. With a SARS-CoV-1 virus mouse models, Ampligen demonstrated 100% protective survival benefit compared to 100% mortality in a saline control group. Ampligen also reduced SARS-CoV-1 lung titers to below the level of detection.Based on the SARS-CoV-1 data, AIM pursued a successful in   vitro  testing model at the Institute for Antiviral Research at Utah State University, with results showing that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.Additionally, in June 2021 AIM announced that all subjects have completed treatment in a Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as a potential intranasal therapy. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. The study reported no Severe Adverse Events at any dosage level.Intranasal Ampligen conferred a boost to homologous reactivity when used as an influenza vaccine adjuvant. Further, the TLR-3 agonist — when administered intranasally — induced epitope spreading and clear cross-reactivity against heterologous viral variants.

https://baytownsun.com/coronavirus/article_bd4fc964-1760-5569-9e8e-3f1bf1c751c6.html

Altimmune: 'Positive Results in 12-week Phase 1 Obesity Trial'

 

• Mean weight loss of 10.3% achieved in subjects receiving 1.8 mg dose

• Pemvidutide was well-tolerated without the need for dose titration

• No discontinuations due to treatment-emergent adverse events

• NASH IND has cleared FDA review; 12-week NAFLD study to begin in the near future

• Altimmune to host a conference call today at 8:30 am EST

Conference Call Information
Altimmune management will host a conference call and webcast with a slide presentation beginning at 8:30 am E.T. Following the conclusion of the call, the webcast will be available for replay on the Investor Relations page of the Company’s website at www.altimmune.com. The company has used, and intends to continue to use, the IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

Date:		Tuesday, September 28
Time:		8:30 am Eastern Time
Domestic Dial-in:		(844) 615-6509
International Dial-in:		(918) 922-3148
Conference ID:		3792068
Webcast: https://finance.yahoo.com/news/altimmune-announces-positive-results-12-110100084.html		https://edge.media-server.com/mmc/p/ojyxaxpp

Sonoma Pharma Launches 1st OTC Products in U.S. on Amazon

 Sonoma Pharmaceuticals, Inc. (Nasdaq: SNOA), a global healthcare leader developing and producing stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye care, nasal care, oral care, and dermatological conditions, today announced the over-the-counter ("OTC") consumer launch of Regenacyn® Advanced Scar Gel and Ocucyn® Eyelid & Eyelash Cleanser on Amazon.com, and MucoClyns™ on Amazon sites in Europe. All three products are based on Sonoma’s patented Microcyn® technology and are immediately available for customer orders.

Sonoma is pleased to offer its superior, safe and effective hypochlorous acid products directly to consumers. For years, Sonoma has offered its products as prescription or office dispense products available only from physicians. The OTC launch creates an additional line of Sonoma products marketed directly to consumers and provides a direct channel that makes its proven Microcyn® technology widely available for all.

Regenacyn Advanced Scar Gel is clinically proven to improve the overall appearance of scars while reducing pain, itch, redness and inflammation. Regenacyn Advanced Scar Gel protects and moisturizes wound and scar sites to promote lighter, flatter and less prominent scarring. Regenacyn Advanced Scar Gel is non-toxic, non-irritating and non-sensitizing.

Ocucyn Eyelid & Eyelash Cleanser, designed for everyday use, is a safe, gentle & effective solution for good eyelid & eyelash hygiene. Ocucyn Eyelid & Eyelash Cleanser helps clean dirty and crusty irritated eyelids. Ocucyn Eyelid & Eyelash Cleanser is steroid free, non-irritating, non-cytotoxic, non-sensitizing and requires no special handling.

MucoClyns is a personal decontamination solution for the face and skin. MucoClyns is safe to use on mucous membranes, cuts, abrasions, burns and body surfaces to clean and treat immediately after unexpected exposure to infection risk. MucoClyns is biocompatible for its indicated use and safe and non-irritating to human skin.

https://finance.yahoo.com/news/sonoma-pharmaceuticals-launches-first-over-110000236.html

Arrowhead Earns $10 Million Phase 1 Milestone Payment

 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it earned a $10 million milestone payment from Janssen Pharmaceuticals, Inc., (Janssen) part of the Janssen Pharmaceutical Companies of Johnson & Johnson. The milestone payment was earned after Janssen dosed the fifth patient in a Phase 1 clinical study of ARO-JNJ1, an investigational RNAi therapeutic candidate which utilizes Arrowhead’s proprietary Targeted RNAi Molecule (TRiM™) platform.

Arrowhead entered into a license and collaboration agreement, and into a research collaboration and option agreement, with Janssen in October 2018. Arrowhead is eligible for additional payments when future milestones are met and is also eligible for royalties on commercial sales of ARO-JNJ1.

https://www.businesswire.com/news/home/20210928005113/en/Arrowhead-Earns-10-Million-Phase-1-Milestone-Payment

Stealth Bio: Positive Data in Pediatric Cardiology at International Society for Heart Research

 Elamipretide data demonstrated improvement in mitochondrial function in pediatric cardiomyopathy

Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced today the presentation of positive elamipretide data showing improvements in mitochondrial respiration and heart muscle function in tissue from failing human hearts at the International Society for Heart Research North American Section Meeting 2021.

Problems in energy production are well-characterized in pediatric and adult heart failure and postulated to be centrally involved in impaired cardiac function in these patients. In this study, mitochondria and muscle fibers from the explanted failing left ventricle were isolated from adult and pediatric patients undergoing cardiac transplant, post organ transplantation. The effects of elamipretide on mitochondrial respiration and muscle function were determined in the laboratory. Mitochondrial respiration was decreased in heart tissue from patients with pediatric cardiomyopathy compared to explanted tissue from non-failing hearts. Study findings showed that these impairments in respiration were significantly improved with elamipretide treatment in the pediatric hearts. The study also demonstrated that elamipretide treatment improved both contraction and relaxation in muscle fibers isolated from failing hearts of patients with dilated cardiomyopathy.

"This study builds upon our previously published findings that elamipretide improves mitochondrial and muscle fiber function in heart tissue isolated from the failing human heart. The observation of improved mitochondrial function from pediatric cardiomyopathy is very encouraging as there are currently no therapies that target mitochondrial dysfunction in this patient population. These data are consistent with our observed effects of elamipretide across other types of heart failure including idiopathic cardiomyopathy and metabolic (muscular dystrophy) cardiomyopathy" said Dr. Brian Stauffer, Chief of Cardiology at Denver Health Medical Center and Professor of Medicine/Cardiology at the University of Colorado Anschutz Medical Campus, who was the lead author on the study.

https://finance.yahoo.com/news/stealth-biotherapeutics-presents-positive-elamipretide-113000762.html

Lawyers, Scientists Build Case for Natural Immunity to Be Treated Same As Vaccination

 Now that at least one employer in the health-care field - Michigan's Spectrum Health - has decided to accept proof of natural immunity from prior infection as reason to waive its vaccination mandate for all employees, legal expert (and the reporters who love to quote them) are wondering: will the legality of proving natural immunity potentially win out in court?

The answer to that question, they say, will depend - as all things COVID-related do - on "the science", that nebulous and frequently shifting concept of how prior infection impacts immunity to new variants (and whether vaccine's do as well).

According to a report in Yahoo Finance, the notion that natural immunity is superior is already gaining support in the legal world. Presently, a handful of studies from different countries offer a conflicting view of whether natural immunity actually is superior to vaccinated immunity, or a combination of prior infection and vaccination

Since it's likely the federal government's aim to roll out vaccine mandates that cover practically every US worker (they're not too far off already), the issue of natural vs. vaccine immunity and whether some individuals should receive exemptions based on their antibody levels almost certainly be adjudicated in the federal courts.

At least one attorney quoted by Yahoo agrees:

"I think that a judge might reject a rule that's been issued by a body, like the U.S. Department of Labor or by a state, that has not been sufficiently thought through as it relates to the science," Erik Eisenmann, a labor and employment attorney with Husch Blackwell, told Yahoo Finance.

As we reported when it was first published, a report out of Israel suggests that natural immunity could be many times more effective than the Pfizer vaccine at preventing infection with the delta variant. That study has yet to be peer-reviewed, however, and the world is anxiously awaiting the results.

However, another peer-reviewed study cited by the CDC looks at dozens of cases in the US where certain people who tested positive for COVID never ended up generating the antibodies, which, science dictates, are necessary to fend off future infection.

The CDC also published a study of 246 Kentucky residents, concluding that vaccination offers higher protection than a previous COVID infection. The CDC said the study went through a "rigorous multi-level clearance process" before submission, but now some are concerned it's slightly out of date since it pre-dates the rise of delta.

But as far as supporting natural vs. vaccinated immunity goes, this study is another big one: A C A June study by the Cleveland Clinic and Washington University tracked 52,238 Cleveland Clinic employees found that within 1,359 previously infected and unvaccinated people, none contracted a subsequent COVID-19 infection over the five-month study. The findings led authors to conclude that prior infection makes a person "unlikely to benefit from COVID-19 vaccination."

Then there's this:

In a smaller study conducted by Washington University School of Medicine and published in Nature, senior author Ali Ellebedy, PhD, an associate professor of medicine and of molecular microbiology, found antibody-producing cells in the bone marrow of 15 of 19 study subjects 11 months after their first COVID-19 symptoms. "These cells will live and produce antibodies for the rest of people’s lives. That’s strong evidence for long-lasting immunity,” Ellebedy said.

The legal and scientific standards are intertwined here, but as more data develops that appears to validate the argument that natural immunity is at least as effective as vaccinated immunity, it's more likely that lawyers will succeed in convincing judges that the standard should be "immunity by any means."

https://www.zerohedge.com/covid-19/lawyers-scientists-are-building-case-why-natural-immunity-should-be-treated-same

NY Gov Confirms National Guard Will Fill In For Fired Healthcare Workers Who Refuse Vax

 As New York braces for a flood of unemployed front-line healthcare workers who refuse to get the Covid-19 vaccine (regardless of whether they have 'natural immunity' from a previous infection), Governor Kathy Hochul (D) made it official on Monday - that the National Guard will be deployed to fill vacancies after hundreds of hospital workers are set to be fired effective this evening.

The move comes after Hochul previously threatened to replace unvaccinated hospital workers with 'foreign workers'.

Once heralded as heroes for treating Covid patients before the vaccine, front-line healthcare workers who refuse to take the jab are in good company with teachers, police, NBA players, and other professionals whose unions have opposed vaccine mandates.

According to CDC irector Rochelle Walensky, the loss of unvaccinated healthcare workers is a 'challenge.'

As Jack Phillips of the Epoch Times writes:

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky said COVID-19 vaccine mandates for healthcare workers will likely create staff shortages around the United States, coming as some hospital CEOs have issued warnings.

“We have seen that these vaccine mandates get more people vaccinated,” Walensky said during a “Good Morning America” appearance on Monday. “It absolutely creates a challenge. What I would say is [we need] to do some work … to understand where their hesitancy is so we can get them vaccinated and get them back to work,” she said.

In New York, Gov. Kathy Hochul said in a Saturday statement that she may direct the state’s National Guard to replace healthcare workers who resign or are terminated due to the state’s vaccine mandate. The governor also floated the idea of using out-of-state nurses, accredited healthcare workers from other countries, or tapping retired nurses who were vaccinated to replace them.

During her interview Monday, Walensky acknowledged that staff shortages “absolutely” create “a challenge” and didn’t offer a definitive plan to address the potential shortfall of healthcare workers.

“What I would say is [we need] to do some work, to educate these healthcare workers,” she added, “to meet them where they are, to understand where their hesitancy is so we can get them vaccinated and get them back to work.”

The deadline for New York state’s healthcare workers to receive the Covid vaccine is Monday, Sept. 27. According to the governor’s office, about 16 percent of the state’s medical workers have not received the vaccine.

Earlier this month, Lewis County Health System Chief Executive Officer Gerald Cayer said the Lewis County General Hospital in Lowville will not have the capacity to deliver babies in the near future after six employees at the firm’s maternity ward resigned instead of taking the vaccine.

“If we can pause the service and now focus on recruiting nurses who are vaccinated, we will be able to reengage in delivering babies here in Lewis County,” Cayer said at a news conference on Sept. 10.

A federal judge on Sept. 14 temporarily suspended the statewide vaccination mandate for healthcare workers after a group of healthcare workers filed a lawsuit against the state, arguing that their Constitutional rights were violated because religious exemptions were not allowed.

Last week, 10 individual state hospital security officers filed a lawsuit against Hochul, Heath Commissioner Howard Zucker, and the New York State Health Department and are seeking to partake in regular COVID-19 testing instead of being forced to receive the vaccine.

https://www.zerohedge.com/covid-19/ny-gov-confirms-national-guard-will-fill-unvaxxed-healthcare-workers