Texas A&M College of Veterinary Medicine and Biomedical Sciences (VMBS) and the Center for Systems Neuroscience in Hannover, Germany, shared findings from a joint study that showed fecal microbiota transplants (FMT) can have a positive impact on canines suffering from epilepsy. The researchers discovered that FMT can reduce negative mental health symptoms in these patients, especially those who have a type of epilepsy that is resistant to drug treatment.

“If you think of the microbiome like a garden, FMT is like putting in a whole new ecosystem. You’re adding in all kinds of bacteria and other organisms to see if something changes. What’s most interesting is that our research team measured the seizure frequency in the patients after the treatment, and that improvement was not very strong. The behavior change was much more pronounced,” explained Jan Suchodolski, MedVet, DrVetMed, PhD, AGAF, DACVM, the associate director of research and head of microbiome sciences at the Texas A&M Gastrointestinal Laboratory.

FMT has recently gained traction within the human medicine space in the last 20 years due to an increased understanding of the microbiome. Although investigated here for its benefits with epilepsy, the microbiome has been discovered to influence other parts of the body, including what is called the gut-brain axis. According to the release,

 there are currently some veterinary experts starting to study that relationship in regards to animal health.

The researchers in the study treated 9 canines that were drug-resistant epilepsy, a type of epilepsy that affects two-thirds of dogs with epilepsy. According to the study,

 the researchers shared that the drug-resistant epilepsy typically has more anxiety and ADHD type symptoms when compared to dogs that have epilepsy that is not drug-resistant.

“Each patient in the study received FMT 3 times over a period of several weeks, and was monitored during follow-up appointments. After treatment, each of the 9 dogs showed significant improvements to their mental health, including a reduction of anxiety-like behavior and improved quality of life,” said Suchodolski.

“While we don’t yet understand the mechanism causing these behavioral improvements, we hope to continue developing new ways to help patients with drug-resistant diseases using microbiome science. Research in this field is highly translational, meaning it is helpful to both human and veterinary medicine,” he continued.

Price C. Fecal Transplants Reduce ADHD, Anxiety Symptoms In Dogs With Epilepsy, Texas A&M Researchers Find. Texas A&M Today. Published September 24, 2024. Accessed September 25, 2024. 

https://today.tamu.edu/2024/09/24/fecal-transplants-reduce-adhd-anxiety-in-dogs/

Watanangura A, Meller S, Farhat N, et al. Behavioral comorbidities treatment by fecal microbiota transplantation in canine epilepsy: a pilot study of a novel therapeutic approach. 

. 2024;11. doi:https://doi.org/10.3389/fvets.2024.1385469

Articles

Study findings showed a positive impact on the negative mental health symptoms 

Researchers discover fecal transplants can benefit canines with epilepsy

The FDA’s Center for Veterinary Medicine has announced Baxter Healthcare Corporation’s updates to the instructions for use of Automated Compounding Device Inlets (disposable inlets) used with the ExactaMix and ExactaMix Pro.

 The updates come in response to increased reports of particulate matter found within the inlet primary packaging inlet components, including in the sterile fluid path tubing, prior to use.

 The issue only affects the disposable inlets, and not the ExactaMix or ExactaMix Pro compounder devices. The FDA identified this recall as the most serious type, with the potential to cause serious injury or death with continued use without consideration for the updated instructions.

The recall recommends the inspection of disposable inlets prior to use, including inlet primary packaging, tubing, connectors, and spikes. If particulate matter is noted during inspection, the inlet should not be used. The compounding devices can continue to be used with inlets when no particulate matter is found.

Specific Automated Compounding Device Inlets affected by the recall:

Non-vented, high-volume inlet (for bags or vented bottles); Product code: H938173

Vented, high-volume inlet (for non-vented bottles); Product Code: H938174

Micro-volume inlet (for small bottles); Product Code: H938175

Micro-volume syringe inlet with luer lock end; Product Code: H938176

On August 20, 2024, Baxter Healthcare Corporation sent Urgent Medical Device Correction letters to all affected customers.

 In the letters, affected pharmacy and clinical staff were advised to complete thorough inspections of the inlets. Staff could still use inlets when no particulate matter was observed. They should prime inlets prior to use according to the instructions provided in the device’s operator’s manual, simultaneously screening for the presence of any particulate matter, stopping the process when it is observed.

In the instance that particulate matter is observed during inspection, staff are advised to contact Baxter Corporate Product Surveillance to report the complaint and arrange for the safe return of the product. Staff should be prepared with the product code and lot number (both of which can be found on the product pouch and carton), in addition to the Baxter 8-digit ship-to account number, and quantity of items to be returned when contacting Baxter.

The letter further recommended the visual inspection of the finished solution in patient bags for precipitates and particulates after compounding by more than 1 health care professional, refraining from use if particulate matter is observed, as directed in the operator’s manual. Additionally, a minimum of 1.2 micron in-line filter should be used during administration of total nutrient admixtures (TNAs), dextrose-amino acid admixtures, and lipid injectable emulsion, as recommended by the American Society for Parenteral and Enteral Nutrition (ASPEN). The minimum of 1.2 micron in-line filter applies to the administration of any solution involving the use of the compounding device inlets, which could include total parenteral nutrition (TPN), cardioplegia, continuous renal replacement therapy, epidural, and basic solutions.

The letter advises that clients share information regarding the updated instructions with anyone who may interact with ExactaMix and ExactaMix Pro compounders. Continued use of the products without consideration for updated instructions may result in pulmonary embolism, stroke, damage to small blood vessels and organs, other serious injuries, and death.

Recall of Certain Compounding Device Inlets Potentially Used in Veterinary Settings. US Food and Drug Administration. September 24, 2024. Accessed September 25, 2024. 

https://content.govdelivery.com/accounts/USFDA/bulletins/3b7db1d

Compounding Device Inlet Correction: Baxter Healthcare Corporation Updates Use Instructions for Exactamix Automated Compounding Device Inlets due to Risk for Particulate Matter in Device Components. US Food and Drug Administration. September 24, 2024. Accessed September 25, 2024. 

https://www.fda.gov/medical-devices/medical-device-recalls/compounding-device-inlet-correction-baxter-healthcare-corporation-updates-use-instructions-exactamix?utm_medium=email&utm_source=govdelivery

Urgent Medical Device Correction. Baxter Healthcare Corporation. August 20, 2024. Accessed September 25, 2024.

The recall involves updating instructions for use, rather than removing devices from where they are used and sold

FDA recall: Updated instructions for compounding device inlets 

Rachel Allbaugh explains her procedure for diagnosing squamous cell carcinoma in horses.

Video interview with Rachel Allbaugh, DVM, MS, DACVO

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During an interview with dvm360 at the Fetch dvm360 Conference in Kansas City, Missouri, Rachel Allbaugh, DVM, MS, DACVO, a professor of ophthalmology at Iowa State University, shared her typical procedure for diagnosing patients with squamous cell carcinoma. Allbaugh explained that, although the clincal signs are often enough to diagnose, there are cases where further tests are required. 

So, with presumed squamous cell carcinoma, many times the clinical sign of what I'm seeing is diagnostic enough, to be honest with you. But, if you're not quite sure, then I think taking a biopsy sample is very much indicated. So, you can take a little punch biopsy or a snip biopsy and submit that to the pathologist for evaluation to confirm that. 

Videos

Rachel Allbaugh, DVM, MS, DACVO, explains her squamous cell carcinoma diagnosis procedure, beyond just the clinical signs

Diagnosing squamous cell carcinoma in horses

Merck Animal Health announced the expansion of the recently USDA-approved NOBIVAC NXT vaccination platform to include a solution against feline leukemia virus (FeLV)—one of the most common feline infectious diseases.

 NOBIVAC NXT FeLV is a nonadjuvanted, low volume 0.5 mL dose vaccination that uses the immune system’s natural strengths to preserve comfort and safety.

 The vaccine is labeled effective against persistent viremia and is indicated for the vaccination of cats 8 weeks or older. The expectation is for the vaccine to be available at veterinary clinics and hospitals nationwide in fall 2024.

“We are proud to extend our RNA-particle technology with a vaccine that protects against one of the most persistent threats to our feline patients,” Ian Tarpey, PhD, vice president, research and development, Merck Animal Health, said in a news release.

 “Merck Animal Health and our NOBIVAC brand have a rich history in vaccine innovation, and we’re continuing to prove our dedication to ensuring there are safe and effective treatment options for veterinary professionals with the latest development of NORBIVAC NXT FeLV.”

NOBIVAC NXT FeLV becomes the only vaccine against FeLV to be built on Merck Animal Health’s RNA-particle technology platform. The vaccine uses the same technology that was used for the June 2024 launches of NOBIVAC NXT Rabies and NOBIVAC NXT Canine Flu H3N2 in Canada and the US, respectively.

 The vaccine is intended to be administered in 2 doses, separated by 3 to 4 weeks, according to the label and the recommendation of the American Association of Feline Practitioners (AAFP).

 The product has a proven duration of immunity (DOI) of 2 years, as recommended by the AAFP.

FeLV is among the most common and important infectious diseases in cats. The virus is considered a retrovirus, meaning it could become incorporated into a cat’s genome and may not be cleared over time. Infected cats can shed infectious viral particles in their saliva, feces, urine, and milk.

 The virus commonly spreads through mutual grooming, fighting behavior, and shared food, water, and litter. Exposure to infected cats poses the greatest risk of infection. Although any cat exposed to the virus is susceptible to a FeLV infection, kittens are at a greater risk than adult cats due to their immature immune systems.

FeLV infected cats initially show no symptoms, although as the virus persists, they can develop cancer, severe blood disorders, and other infections associated with compromised immune systems. Generally, when a cat is exposed to FeLV, their body can react in a few different ways, resulting in either abortive, regressive, or progressive infections:

 20-30% of cats exposed to FeLV develop abortive infections. In these instances, cats can mount effective immune responses against the virus, destroying it before it gets the chance to incorporate itself into the cat’s genome. The cats will gain antibodies against the virus, and they will never test positive for infection using routine tests or show any clinical signs.

 Roughly 30-40% of cats infected with FeLV develop regressive infections as a result of partially effective immune responses. The virus is incorporated into the cat’s genome, but the immune system prevented prolonged viral replication, leaving no viral particles in the cat’s blood after the initial infection. It’s unlikely for these cats to experience clinical signs, and they cannot actively infect other cats. There is a chance for the virus to reactivate if they become immunosuppressed, which could leave them symptomatic and contagious.

The worst prognosis of FeLV infection, 30-40% of cats infected with FeLV develop progressive infections, although studies suggest this number is higher in kittens than adults. Cats with progressive FeLV infections are at risk for developing potential fatal associated diseases. Their bone marrow becomes infected, leading to continual viral replication, and they are contagious to other cats.

“Nearly 4% of cats in North America alone are affected by this disease, a notable percentage when there have been guidelines for prevention in place for decades, and especially since the virus can lead to life-threatening diseases,” Meg Conlon, DVM, executive director, veterinary professional services, Merck Animal Health, said.

 “That’s why education and awareness of the importance of vaccinating against this disease is so important.”

Merck Animal Health is a division of Merck & Co., Inc., headquartered in Rahway, New Jersey, and known as MSD outside of the United States and Canada. The company has been at the forefront of medical, vaccination, and innovative health-related research for more than a century.

 Their newest vaccine development could help protect cats across the country from FeLV infections.

Merck Animal Health Announces Expansion of NOBIVAC NXT Platform with the First and Only RNA-Particle Technology Vaccine for Feline Leukemia Virus. News release. Merck Animal Health. September 24, 2024. Accessed September 24, 2024. 

https://www.businesswire.com/news/home/20240924377048/en/Merck-Animal-Health-Announces-Expansion-of-NOBIVAC%C2%AE-NXT-Platform-with-the-First-and-Only-RNA-Particle-Technology-Vaccine-for-Feline-Leukemia-Virus

Norbivac NXT FeLV. Merck Animal Health. Accessed September 24, 2024. 

https://www.merck-animal-health-usa.com/nobivac/nobivac-nxt-felv#overview

Feline Leukemia Virus. Cornell University College of Veterinary Medicine. Accessed September 24, 2024. 

https://www.vet.cornell.edu/departments/cornell-feline-health-center/health-information/feline-health-topics/feline-leukemia-virus

The technological innovation is an expansion of the NOBIVAC NXT platform, and a breakthrough achievement against one of the most common feline diseases

New vaccine protects against feline leukemia virus 

CureLab Veterinary Inc, a biopharmaceutical company that develops cancer treatments for pets, announced a Regulation D fundraising offering to develop its gene therapy, ElenaVet, which enhances the body’s anticancer immune response and reduces chronic inflammation. The offering is being carried out in compliance with Rule 506(c) of Regulation D, which was issued under the amended Securities Act of 1933.

Under Regulation D, the company will be able to raise an unlimited amount of funds. However, the offering is exclusively open to accredited investors, per Rule 506(c).

 CureLab aims to raise up to $15 million from the offering.

Funds from the offering will be used with the goal of securing conditional market authorization from the United States Department of Agriculture (USDA) for ElenaVet, as well as to establish a USDA-certified DNA/RNA manufacturing facility and reach profitability. According to CureLab, it is striving to attain profitability in 4 years.

According to a news release, the therapy has looked promising in early clinical studies, showing signs of effective treatment of several canine and feline cancers, including mammary tumors and melanoma.

 It has also shown potential for treating chronic inflammatory conditions in pets, such as osteoarthritis, inflammatory bowel disease, renal disease progression, and metabolic syndrome.

The treatment is a therapeutic plasmid, otherwise known as supercoiled circular DNA, that has the gene-encoding protein p62/SQSTM1 inserted into it. Upon injection into a patient, the product enters cells at the injection site and in the bone marrow, triggering those cells to generate the p62 protein, which produces a range of physiological effects, including decreased proinflammatory mediators through a change and decrease in the tumor microenvironment.

 Additionally, ElenaVet lowers chronic inflammation by reducing proinflammatory cytokines while raising anti-inflammatory ones.

“ElenaVet reduces chronic inflammation systemically because it can “rejuvenate” mesenchymal stem cells (MSCs). When a body is young, MSCs secrete mostly anti-inflammatory signals. When the body is old, MSCs secretome becomes predominantly pro-inflammatory,” reads the company’s website.

 “Also, in the bones of a young animal, MSCs differentiate into bone cells, osteoblasts, while in the old one, MSCs produce fat cells within the bone, adipocytes. ElenaVet turns the clock, making MSCs from an older animal act like they were from a young one.”

According to the Veterinary Cancer Society, cancer is the primary cause of death in dogs past middle age, with 25% of canines estimated to receive a cancer diagnosis.

 Meanwhile, cancer was found to be the leading cause of death in 32% of cats.

"At CureLab Veterinary, our mission is to help pets live longer, healthier, and happier lives," Robert Devlin, DVM, president at CureLab Veterinary, said in a news release.

 "We believe that every pet deserves access to affordable and effective healthcare, and we are dedicated to developing innovative solutions that make a real difference in the lives of pets and their families. With ElenaVet, we are one step closer to achieving our goal of providing cutting-edge cancer treatments for our beloved companions."

CureLab Veterinary announces $15 million Regulation D offering to advance cancer and inflammatory disease treatments for pets. News release. CureLab Veterinary Inc. September 19, 2024. Accessed September 24, 2024. 

https://prnmedia.prnewswire.com/news-releases/curelab-veterinary-announces-15-million-regulation-d-offering-to-advance-cancer-and-inflammatory-disease-treatments-for-pets-302253385.html

Private placements under Regulation D – investor bulletin. United States Securities Exchange Commission. August 17, 2022. Accessed September 24, 2024. 

https://www.sec.gov/resources-for-investors/investor-alerts-bulletins/private-placements-under-regulation-d-investor-bulletin

CureLab Veterinary Inc. offering platform. CureLab Veterinary Inc. Accessed September 24, 2024. 

Pet owner resources. Veterinary Cancer Society. Accessed September 24, 2024. 

https://vetcancersociety.org/resources/pet-owners/pet-owner-resources/#:~:text=It%20is%20estimated%2C%20however%2C%20that,in%20their%20life%2C%20develop%20cancer

CureLab Pitch Deck. CureLab Veterinary Inc. Accessed September 24, 2024. 

https://invest.curelabveterinary.com/pdfs/CureLabVeterinaryInvestmentDeck.pdf

CureLab Veterinary Inc is conducting a Regulation D fundraising offering for its gene therapy, ElenaVet

Biopharmaceutical seeks to raise $15M to develop cancer therapy for pets

Riley, a 7-year-old German Shepherd, was diagnosed with disseminated aspergillosis. (Image courtesy of UC Davis College of Veterinary Medicine)

In the Spring of 2023, Anthony Lan and his partner Elora Paule, noticed their 7-year-old German shepherd, Riley, had slowed down and appeared to be in pain sometimes. At first when they brought Riley to the veterinarian, they suggested it was due to age-related joint issues and prescribed her with anti-inflammatory medication, but it did not seem to improve Riley's condition.

“Then on a walk one day, I noticed she was markedly slower,” said Paule, in a news release.

 “By that afternoon, she lost function of her hind legs.”

For nearly 2 hours, Lan and Paule searched for an emergency room open to bring Riley to and when they finally found one and brought her in, Riley was diagnosed with disseminated aspergillosis. According to the release from UC Davis College of Veterinary Medicine,

 disseminated aspergillosis is a widespread and severe mold infection that results in discospondylitis, the infection of the vertebra and intervertebral discs, kidney infection, and left eye infection. In Riley’s case, her vertebra was damaged and led to instability of her spine, leading to spinal cord damage and paralysis.

Aspergillosis is an infection that is caused by the 

fungus, which grows on dead leaves, stored grain, compost piles, or other decaying vegetation. Aspergillosis is considered an ‘opportunistic pathogen’ and usually affects pets whose immune systems are compromised or suppressed. The 

fungi shed microscopic spores that float in the air and can then be easily inhaled.

Once Riley was diagnosed, Lan and Paule were told she would not likely survive and should consider taking her home for a final night. However, not wanting to stop fighting for their pet, Lan began researching the condition and discovered a paper talking about a different German shepherd with the same predicament. That German shepherd survived 5 years with the intervention of a certain antifungal medication. Lan went back to the veterinarians treating Riley and asked about this medication. The team did not have access to it but told Lan that it was available at UC Davis.

Lan and Paule brought Riley to the UC Davis veterinary hospital where her diagnosis was confirmed. The emergency room specialists consulted with the neurology/neurosurgery service, and then performed an MRI on Riley. According to the organizational release,

the results of the MRI showed veterinary professionals that the infection led to a compression of her spinal cord, causing her to lose her ability to walk and declared her not a candidate for surgery.

The UC Davis team also consulted with its ophthalmology services, who concluded Riley was blind in her left eye and if she survived the fungal infection, her eye should be removed. Despite all the challenges and considerable bad news, her owners never gave up hope and continued to advocate for her survival.

Riley was eventually transferred to the internal medicine services and Sarah Michalak, DVM, began working with faculty with backgrounds on infectious diseases to begin treating Riley, and hopefully improving her health. Riley was hospitalized for a month on 2 IV antifungal therapies, pain medications, 2 oral antifungal therapies, fluids, and supportive care.

“We visited her almost every day,” said Paule. “She would get so excited to see us. I think that gave her a lot of willpower to continuing fighting.”

Riley’s left eye was removed during her hospitalization, and she was placed on a feeding tube when she was unwilling to eat. She also began being treated by Ronald Koh, DVM, MS, DACVSMR, CVA, CCRV, CVCH, CVFT, CCRP, CVMMP, and Sayaka Shiomitsu, DVM, who used passive modalities such as acupuncture and range of motion exercises.

Riley was eventually moved to inpatient/outpatient care, with weekends at home, over the next several months, leading to various levels of outpatient care as they continued to provide her with antifungal medication and rehabilitation exercises. She was also given a home-cooked diet plan from the nutrition service at UC Davis that was appropriate for her kidney disease. Riley showed signs of enjoying the new diet and began to gain the weight needed to remove the feeding tube.

“We never second-guessed anything we had to do throughout the process,” Paule said, in the release.

 “We even moved from a second-floor apartment to one on the first floor to ease getting Riley outside, since our building doesn’t have an elevator.”

As her rehabilitation progressed, Riley became strong enough to move herself with her front legs. Because of this, it was suggested that she would be a good candidate for a wheelchair, and Riley adapted to the wheelchair with "great success." Riley’s owners also began to notice that her hind legs were moving, something they had not seen in weeks.

“When we told [Koh], he said to us, ‘We’re going to get her walking again,’” said Paule.

The team continued Riley’s rehabilitation sessions and were able to work to her walking with assistance on the underwater treadmill. She gradually improved her mobility and strength and by October 2023, Riley was able to support herself while standing and walking with support. Then in late November 2023, she was walking on her own and no longer needed her wheelchair and the antifungal medication worked to ease the compression on her spinal column.

“Her vertebra are still not normal, but they have remodeled and stabilized, easing the compromising of her spine,” said Michalak.

 “While we’re unlikely to cure Riley of the infection, we’re stopping it in its tracks and keeping it from causing further damage to her vertebra and kidneys.”

The team at UC Davis believes Riley will stay on the antifungal medication for the rest of her life. However, with a year since her first visit to UC Davis, Riley appears to be winning her battle against this disease.

“She’s like a completely different dog now,” Lan concluded.

 “Her personality has changed, and she has different reactions to little things like receiving scratches that we’ve never seen before. It’s like she knew she got a second chance at life.”

Dog with Fungal Infection Beats Overwhelming Odds. News release. UC Davis College of Veterinary Medicine. September 23, 2024. Accessed September 24, 2024. 

https://www.vetmed.ucdavis.edu/news/dog-fungal-infection-beats-overwhelming-odds

Weir M. Aspergillosis in Dogs. VCA Animal Hospitals. Accessed September 24, 2024. 

https://vcahospitals.com/know-your-pet/aspergillosis-in-dogs#:~:text=The%20deadliest%20form%20of%20aspergillosis

After a year of hospitalizations, antifungal medications, and rehabilitation, Riley the German shepherd beat the odds on her ‘grave prognosis’