Medicine is always looking for novel ways to treat diseases and conditions, whether it be through agents, devices or some other unique modality. And this certainly applies to COVID-19. Aethlon Medical has developed its Hemopurifier, which is a therapeutic device designed for the single use depletion of circulating viruses and exosomes from the blood.

The San Diego, Calif.,-based medical technology company has been focusing on developing products to diagnose and treat life and organ threatening diseases. Specifically, when it comes to COVID-19, the company performed an in vitro study with its Hemopurifier, that was published in 

In their study, known concentrations of seven clinically relevant SARS-CoV-2 variants were passed 3 times over columns containing 1 gram of Galanthus nivalis Agglutinin (GNA) affinity resin. The percent decrease in viral titer was compared with a control sample. Viral capture efficiency with the GNA affinity resin ranged from 53% to 89% for all variants tested. Extrapolation of these data would indicate that the binding capacity of the Hemopurifier for viral loads observed in adult patients with severe COVID-19 infection would be more than sufficient.

The Hemopurifier holds a Food and Drug Administration (FDA) breakthrough device designation related to life-threatening viruses that are not addressed with approved therapies. In June 2020, the FDA approved an amendment to Aethlon's existing open IDE for the Hemopurifier in life threatening viral infections, to allow for the treatment of patients with COVID-19 infection. This will allow for up to 40 of these patients to be treated under a new Early Feasibility Study protocol at up to 20 clinical sites in the United States.

 recently spoke to Aethlon CEO Charles Fisher, Jr., MD, and Aethlon CMO Steven LaRosa, MD, who were the study’s lead author and coauthor respectively. They provided an overview of the company, how the device works, and the study’s findings.

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Aethlon Medical’s proprietary Hemopurifier is being studied to treat COVID-19, and they recently reported results.  

A Novel Device With COVID-19 Treatment Potential  

Today marks the start of National Men’s Health Week (June 13-19). With it comes the public health awareness campaign for men to be more proactive in getting regular screenings and seeking out medical professional health more often.

One of the biggest health issues for men is screening. They simply don’t get screened as much as women for the various cancer screenings or testing for infectious diseases such as HIV. According to the CDC, women are 33 percent more likely to visit the doctor than men, and women are 100 percent better at maintaining screening and preventive care.

“In general, men are very reticent to go out and ever seek screenings; and we don’t know the reasons,” Michael Lutz, MD, partner at The Michigan Institute of Urology (MIU) Men’s Health Foundation, said. Lutz says it could be the way boys are conditioned at a very young age, and they are told that “big boys don’t cry.” And, he says when they grow-up, men are not equipped to seek medical counsel.

Another overall health disparity between men and women is public health messaging. For example, in looking at breast and prostate cancer, health awareness delivered by the media has seen a greater proliferation of the former cancer compared to the latter. “In a study exploring newspaper cancer stories, it was found that mammography was mentioned significantly higher than PSA or colorectal screenings in mainstream and in ethnic newspapers,” investigators wrote.

Throughout the year, there are various breast cancer events including the Mother’s Day walk. The annual awareness campaign culminates in October, which is breast cancer awareness month. In perhaps a bit of irony, and an example of the differences in messaging, many professional NFL players wear flashes of pink on their uniforms, gloves, and cleats to raise awareness around breast cancer.

In thinking about infectious disease and HIV screening, years ago and even today to some extent, there has been a stigma around it and delays in testing can lead to less-than-optimal outcomes. “A negative HIV test result can lead to prevention options like pre-exposure prophylaxis (PrEP),” the Centers for Disease Control and Prevention (CDC) stated on its site. “A positive result should lead that person to care and treatment, ideally on the day the diagnosis is made. This protects their health and is key to preventing new infections.”

With National Men’s Health Week, providers and various health organizations are working to turn the tide in favor of more men being proactive in their health.

“We use every hook that we can to try and engage men into health care services, whether it be through our foundation, or any services that are available through the community,” Lutz said.

His Detroit, Michigan-based organization hosts events around screening awareness and doing actual tests during National Men’s Health Week. The foundation also has its Blue Monday (today) to begin Men’s Health Week by promoting men’s health engagement.

And in thinking about HIV/AIDS, The Men’s Health Foundation has partnered with a local organization, Gospel Against AIDS, to raise awareness on men’s health disparities as it relates to HIV.

“We do 2 things: educational sessions and HIV testing,” Rosalind Andrews-Worthy

executive director at Gospel Against AIDS, explained. “Our goal is to empower and equip religious leaders in their houses of worship to effectively operate in the HIV continuum of care by providing services of care for those at risk of HIV infection.”

“HIV screening and HIV screening opportunities are the things we talk about a lot,” Lutz stated. “And thankfully because of Rosalind and our partnership through our Men’s Health Foundation, we are able to offer these screenings. There’s nothing that’s become more valuable at our Men’s Health Event than to stand there and see men openly standing in line waiting for their HIV screening.”

Gospel Against AIDS is funded by the CDC, Michigan Department of Health, and Ryan White HIV/AIDS Foundation, and is celebrating its 25th anniversary.



 spoke to Andrews-Worthy and Lutz about men’s health disparities as it relates to HIV screenings and care, and how clinicians and community leaders can engage men in discussing their sexual health and looking at prevention measures such as PrEP.

To learn more about the foundation’s events this week, go to their 

1. Brett KM, Burt CW. Utilization of ambulatory medical care by women: United States, 1997-98. 

. 2001;(149):1-46. doi:10.1037/e309022005-001

2. Stryker JE, Emmons KM, Viswanath K. Uncovering differences across the cancer control continuum: a comparison of ethnic and mainstream cancer newspaper stories. 

. 2007;44(1):20-25. doi:10.1016/j.ypmed.2006.07.012

The start of Men’s Health Week offers an opportunity for men to get screened for a variety of health issues and be proactive with their health including those who might be at risk of HIV and may benefit from PrEP.

Getting Men Screened and Being Proactive About Their Health


As of Thursday, the Centers for Disease Control and Prevention (CDC) reported there was a total of 45 confirmed monkeypox/orthopoxvirus cases in the United States.

And although there are no specific FDA approved treatments available for monkeypox infection, monkeypox outbreaks can be controlled with vaccines. On Friday, Bavarian Nordic announced the US Biomedical Advanced Research and Development Authority (BARDA) ordered an additional 500,000 doses of liquid-frozen JYNNEOS, a non-replicating smallpox vaccine and the only FDA-approved vaccine against monkeypox, for delivery in 2022. As monkeypox and smallpox stem from the same orthopoxvirus family, it's believed that some smallpox vaccines and therapies have efficacy in preventing and treating monkeypox.

The antiviral therapy, tecovirimat (Tpoxx), manufactured by SIGA Technologies, is approved for smallpox and is being studied for monkeypox treatment. The agent can be administered orally or through IV formulation for smallpox treatment. Back in May, the Food and Drug Administration (FDA) approved the intravenous (IV) formulation for smallpox and is another option for those who are unable to swallow the tecovirimat oral capsules.

“We are grateful to the FDA for their work leading to approval of IV TPOXX, which will provide access to a broader patient population,” Dennis Hruby, PhD, CSO of SIGA said at the time.

Studies using a variety of animal species have shown that tecovirimat is effective in treating disease caused by orthopoxviruses. Clinical trials in people showed the therapy was safe and had only minor side effects. In addition, tecovirimat was given to 

 The patient received 600 mg of the therapy twice a day for 2 weeks and experienced a shorter duration of illness and viral shedding.

Although more studies need to be done to confirm the result, the lead investigator in the study believes the agent has potential treatment benefits.

"The single biggest takeaway is the excellent clinical and virological response to the oral antiviral tecovirimat in one patient with monkeypox who received this agent,” lead author Hugh Adler, PhD, of Liverpool University Hospitals NHS Foundation Trust told 

in an interview. “We definitely need well-powered, prospective studies to validate this finding, but it is a strong signal, and may be of use to clinicians managing patients with monkeypox in the current outbreak in the Western Hemisphere.”

Hruby says the therapy is being utilized for compassionate use indications at the moment.

Tecovirimat is also maintained in the US Strategic National Stockpile for smallpox. And the use of tecovirimat for monkeypox and other non-variola orthopoxvirus infections is under an expanded access 

SIGA is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness.



 spoke to Hruby who provided an overview about the therapy including its safety and efficacy profile, dosing regimen, its contract with BARDA, and information on some of its ongoing studies.

Tecovirimat (Tpoxx) is an antiviral agent that is already indicated for another orthopoxvirus, smallpox. And studies are ongoing to see if it has potential efficacy in treating monkeypox. 

A Potential Monkeypox Therapy? 


The human papillomavirus (HPV) causes more than 30,000 cancers annually. Although many people typically associate HPV with cervical cancer, the most common HPV-associated cancer is actually head and neck.

According to the Centers for Disease Control and Prevention’s (CDC) most recent data, there are 2200 women and 11,800 men diagnosed with oropharyngeal (back of the throat) cancers annually in the United States. And HPV is thought to cause 70% of oropharyngeal cancers in the United States, according to CDC.

The CDC reports that HPV vaccination can prevent over 90% of cancers caused by HPV, as well as anal, vaginal, cervical, and vulvar precancers. More than 4 out of every 10 cases of cancer caused by HPV occur among men. Over 14,000 men get cancers caused by HPV in the US annually, so the HPV vaccine is also recommended for boys and young men.

Beomjune Kim, DMD, MD, FACS, who is a Head and Neck and Microvascular reconstructive surgeon at the Cancer Treatment Centers of America in Atlanta says that a new study demonstrated that vaccination can reduce oral HPV infection by 88%.

Typically, the recommendation has been to administer the vaccine at ages 11 or 12 years, before contact with the HPV virus. However, the CDC says the vaccine can be also be administered to teens and young adults through the age 26. And some adults ages 27 through 45 may elect to get the vaccine although there is less benefit as exposure to HPV has likely happened.

The vaccine series is 2 shots for children before the age of 15, and administered 6 to 12 months apart. The HPV vaccines can be given starting at age 9. For those who begin their HPV vaccine series on or after the age of 15, they will need 3 doses, given over 6 months.

Still, there is a subgroup of people who may have started the series of HPV vaccines, but for whatever reason didn’t complete them. They are eligible to get a catch-up series to be considered fully vaccinated.

“You start from where you left off,” Kim explained about the catch-up series vaccines. “For example, if you received the first dose and then 5 years later you want to catch up, you start from second dose.” He explains that patients will need 2 shots and patients go by the recommended interval protocol of at least 12 weeks between the second dose and third dose. After administration of the third dose, patients are considered fully vaccinated.



 spoke to Kim who offered insights into the HPV vaccine’s efficacy and safety profile, the challenges of low vaccination rates, and strategies to begin a conversation with families and patients about getting the HPV vaccine.

Although underutilized, this highly efficacious vaccine can help prevent numerous cancers including the most prevalent—head and neck and cervical cancers.

HPV Vaccination: A Prevention Measure Against Numerous Cancers

At more than 2 years into the COVID-19 pandemic, there have been significant advances in treatment and prevention options. COVID-19 mRNA vaccination is highly effective against severe disease and death, but highly infectious variants like Omicron BA.1 and BA.2 are causing breakthrough infections, leading cases to rise once again.

To prevent older or otherwise immunocompromised people from severe or fatal infection, 

, an inhalable COVID-19 treatment for hospitalized persons.

Dr. Phillip Monk, the Chief Scientific Officer at Synairgen, joined 

 to discuss the SNG001 trial data Synairgen presented at the American Thoracic Society 2022 International Conference, held in San Francisco last month.

SNG001 is a formulation of Interferon-beta (IFN-β), a naturally occurring protein that catalyzes the body’s antiviral response. SARS-CoV-2 suppresses this protein, so the inhalable IFN-β directly targets the lungs, the primary site of the COVID-19 viral reservoir.

SNG001 may retain some efficacy against the Omicron variant. As a host-directed antiviral, Monk says, SNG001 has “broad spectrum antiviral potential.” “We have in the lab actually shown the antiviral activity of IFN-β against Omicron as we have against other variants”

The phase 3 SPRINTER trial (SG018; NCT04732949) was a global, randomized, placebo-controlled, double-blind clinical study. The trial evaluated inhaled SNG001 to treat adults hospitalized with COVID-19 who required supplemental oxygen. SPRINTER included 624 participants, randomly assigned to either SNG001 (n = 309) or placebo (n = 314) in addition to standard of care.

In February 2022, Synairgen announced that SPRINTER did not meet its primary endpoints of hospital discharge and illness recovery. Monk says that this can be partially attributed to the standard-of-care COVID-19 treatments improving so much that SNG001 had to demonstrate a greater significance of disease reduction. “Because patients are doing so much better, it’s much more difficult to show treatment effect on things like hospital discharge,” Mock explained.

Despite the efficacy of vaccines and other antivirals, there are still COVID-19 mortalities. Monk says over 2000 patients are being hospitalized in the US each day, and about 200 people a day are dying of COVID-19.

Among the trial participants given SNG001, there was a signal in reduction in the relative risk of progression to severe disease or death within 35 days. Monk said that the greatest treatment benefits were observed in older patients, patients with comorbidities, and especially in people who had poor respiratory function at baseline.

“These are people who are having to breathe faster or have low oxygen saturation despite being on oxygen,” Monk said, noting that this treatment population saw a relative risk reduction of 70% for severe disease.

Synairgen's inhalable Interferon-beta treatment, SNG001, may be a treatment option for hospitalized and immunocompromised COVID-19 patients.

SNG001: Synairgen's COVID-19 Antiviral for the Immunocompromised

The COVID-19 pandemic has brought to the forefront the important work of public health officials. Public health departments had a significant role in helping people understand health and safety issues around COVID-19, including avoidance strategies and vaccination.

Although public health took on a more open role in the pandemic, it has been quietly carrying on its work for decades to ensure Americans are aware of health safety.

One public health organization, The National Association of County and City Health Officials (NACCHO), serves 3000 local health departments, and provides professional resources and programs, and supports local public health practices and systems.

 is dedicated to everything from the pandemic public health and safety to infectious disease issues to other more nuanced issues such as addressing health equity and looking at social determinants associated with it.

The organization receives funding from the Centers for Disease Control and Prevention (CDC) and in turn NACCHO provides awards towards city and county health departments for public health initiatives. For example, NACCHO recently announced awards for $2.3 million in funding to prevent outbreaks of infectious diseases in healthcare settings.

NACCHO Chief Executive Officer Lori Tremmel Freeman says the funding for this initiative will go towards 24 health departments across the country to help build up programs around antimicrobial resistance, and prevent healthcare-associated infections in prisons, dialysis centers, and other at-risk facilities. The project expands upon the first year of the BLOC COVID-19 Demonstration Site project by allowing local health departments to go beyond COVID-19 response and address other healthcare-associated infections and antimicrobial resistant pathogens.

Another infectious disease area NACCHO is involved in is STI prevention. And much like the rest of the medical and health fields, COVID-19 greatly diminished their ability to carry out some of its programs, education, etc. NACCHO’s 2020 Report from the Field showed the pandemic wreaked havoc on STI prevention and care across the country—with STI clinics closed or operating at limited capacity, while partner notification had to be conducted virtually, and mobile outreach for testing significantly limited, if not stopped all together. Additionally, staff were redirected to the COVID-19 response that continues to significantly challenge the capacity of local health department STD programs.

Public health departments had to find a way to continue their efforts despite dealing with staffing shortages. Tremmel Freeman says that going into the pandemic, they had lost approximately 21% of their workforce over the previous decade for a variety of reasons.

“We were facing a situation where we had to redeploy people in health departments away from their typical public health work, including their work that they do to prevent other infectious diseases such as sexually transmitted diseases, HIV/AIDS, tuberculosis and measles—it really was not an ideal situation,” explained Tremmel Freeman.

spoke to Tremmel Freeman who provided some insights about the organization, discussed some of their infectious disease initiatives, and the challenges associated with public health staffing and funding.

The organization is behind community-based funding and educational programs to propel a healthier society at a grassroots level. 

NACCHO: Addressing Public Health’s Vital Work

(CDI) bear repeating. It is the number 1 healthcare associated infection (HAI) with over 500,000 cases and 12,000 deaths in the United States annually. With this infection, is the very real possibility of reoccurrence, which can happen at a rate of 15–35% of all CDI cases. Some data suggest that second and subsequent recurrences are common among patients who experience a recurrent episode.

Kevin Garey, PharmD, MS, chair of the Department of Pharmacy Practice and Translational Research and professor of pharmacy practice at the University of Houston in Houston, Texas, says therapy protocols are developed around trying to prevent recurrence.

“Nowadays with C diff infection, your therapies are based on what can I do to make it go away and not come back.”

Although the aforementioned numbers are daunting, there are a number of therapies and modalities that are in development and there is a lot of hope in the potential treatment of this infection.

Garey presentated his program, “Treatment and Diagnostic Stewardship of CDI Infections,” at the 

24th Annual Making a Difference in Infectious Disease (MAD-ID) Meeting 2022

 spoke to Garey during the meeting who provided insights on his presentation and the possibility of new therapies and modalities being added to the armamentarium.

1.Singh T, Bedi P, Bumrah K, Singh J, Rai M, Seelam S. Updates in treatment of recurrent Clostridium difficile infection. 

A clinician discusses the disease burden of reoccurring CDI, but sees a silver lining in the new investigational therapies potentially changing the treatment paradigm for the better. 

The Patient Impact of CDI, Preventing Reoccurrence

The time from clinical evaluation to testing to diagnosis to treatment can be a laborious process that does not always equate to optimal therapy in an efficient manner. Steps along the way can be fraught with delays and uncertainties.

Whereas, the traditional administration of diagnostic tests and the protocols associated with them can be lengthy, the advent of newer technologies such as rapid tests can speed up the process, but also get to optimal antimicrobial therapy prescribing practices more efficiently. These capabilities are part of a new novel concept titled diagnostic stewardship.

Kim Claeys, PharmD, associate professor, University of Maryland, is advocating for bringing diagnostic stewardship into institutions as part of their antimicrobial stewardship programs. “Antimicrobial stewardship and diagnostic stewardship are very intrinsically linked,” Claeys said. “They are synergistic in their actions and there’s a lot of activities that antimicrobial stewardship programs can bring back to their hospitals and talk to their infection prevention and clinical micro [teams] and really work to make their own diagnostic stewardship teams to look at doing these interventions that will improve diagnosis—as well as downstream antimicrobial prescribing.”

She presented her program, “These are Exciting Times: Implementing Diagnostic Stewardship into Traditional Antimicrobial Stewardship Programs,” at the 

 spoke to Claeys at the MAD-ID meeting who provided further insights into her presentation including a deeper understanding of how diagnostic stewardship can be incorporated into antimicrobial stewardship and the exciting possibility that new data from single center studies may lead to best practice guidelines on a larger scale.

A clinician is advocating for incorporating diagnostic stewardship practices within antimicrobial stewardship programs, which could someday lead to best practice guidelines on a larger scale.

The Next Big Thing in Stewardship? 

Diagnostic stewardship is a newer concept in medicine. It has been defined as the appropriate use of laboratory testing to guide patient management, including treatment, in order to optimize clinical outcomes and limit the spread of antimicrobial resistance.

One of the outgoing challenges in hospital medicine is the hours it can take to get from examination to diagnosis to optimal therapy. For example, when looking at blood samples, Saint Francis Hospital, Tulsa, Oklahoma had previously required a growth from a sub-culture of a positive blood culture prior to placing it on the Matrix-Assisted Laser Desorption Ionization Time-of-Flight Mass Spectrometry (MALDI-TOF). In May of last year, the hospital incorporated the Sepsityper in-vitro diagnostic kit (IVD), which is designed to rapidly identify microorganisms directly.

As such, a team of investigators from St. Francis wanted to see if in using this rapid diagnostic technology, they could reduce time to optimal therapy. They performed a study with primary outcomes being time to appropriate (TTAT) and optimal antimicrobial therapy (TTOT). Their secondary outcomes included mortality, antimicrobial stewardship interventions, and hospital length of stay. The time to organism identification was also evaluated.

They included patients 18 years of age or older, who were admitted to Saint Francis Hospital and diagnosed with bacteremia.

“The time to organism identification was significantly shorter in the post-implementation phase at 32 hours compared to 46 hours in the pre-implementation phase (p< 0.01),” the investigators wrote. “Although our study found a significant reduction in time to organism identification by direct from specimen MALDI-TOF MS, this did not translate to clinically significant antimicrobial adjustments. Additional clinical resources, implementation of real-time positive blood culture alerts, and utilization of rapid diagnostic testing with resistance gene identification may result in more significant outcomes.”

The study, “Impact of a Rapid Diagnostic Test on Time to Acceptable and Optimal Antimicrobial Therapy,” was presented at the 

 spoke to lead author Alexander Aucoin, PharmD, BCPS, Saint Francis Hospital, at the MAD-ID meeting who provided further insights into the concept of diagnostic stewardship and his study’s findings.

1. Patel R, Fang FC. Diagnostic Stewardship: Opportunity for a Laboratory-Infectious Diseases Partnership. 

 2018 Aug 16;67(5):799-801. doi: 10.1093/cid/ciy077. PMID: 29547995; PMCID: PMC6093996.

Utilizing a newer technology, investigators wanted to see if a reduction in time led to clinically significant antimicrobial adjustments.

Rapid Diagnostic Testing’s Impact on Timing to Optimal Therapy 

Nontuberculous mycobacterial infections are often accompanied by high levels of drug resistance. Often, combination therapy approaches are needed to combat the opportunistic pathogen associated with these infections.

 is a novel aminomethylcycline antibiotic that is currently FDA approved for both acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia.

A large team of investigators wanted to measure how effective this novel antibiotic might be against nontuberculous mycobacterial infections. As such, they performed multicenter, retrospective, observational study conducted from January 2020 to March 30, 2022. They included patients 18 years of age or older that received omadacycline for nontuberculous mycobacteria infections within 72 hours of diagnosis. In terms of primary outcomes, they were looking at clinical failure, defined as all-cause mortality, persistence or re-emergence of infection during or after therapy, and escalation or alteration of omadacycline therapy.

“Clinical success was observed in 88% of patients, with most receiving active antibiotic treatment prior to OMC (83%), including combination therapy with either clofazimine (44%), or azithromycin (42%),” the investigators wrote. 

The investigators concluded that omadacycline showed effectiveness and a good safety profile and could be another potential option in the treatment of nontuberculous mycobacterial infections.

The study, “Real-world, Multicenter Assessment of Omadacycline Use in patients with Nontuberculous Mycobacterial Infections,” was presented at the 

 spoke to lead author Amer El Ghali, PharmD, Infectious Diseases PK/PD and Health Outcomes Research fellow at Anti-Infective Research Lab, Wayne State University, at the MAD-ID meeting who provided further insights into the study’s findings as well as omadacycline’s safety profile.

A multicenter study looked at treating these infections with omadacycline. 

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