Clinical Trial: Novel Pain Management Therapy in Dogs with Severe Elbow Dysplasia

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A Funded Clinical Trial to Evaluate a Novel Pain Management Therapy in Dogs with Severe Elbow Dysplasia

Trial Specifics

This study is designed to evaluate the tolerability, safety and effectiveness of a novel therapy (not yet approved by FDA) to manage pain associated with moderate to severe elbow dysplasia and secondary osteoarthritis in dogs. The investigational drug is administered as an intra-articular injection into both elbows. There is no placebo treatment.

The one-time treatment will be administered under sedation or general anesthesia to approximately 28 client-owned dogs. Owners are required to complete periodic pain assessment surveys and record short at-home videos assessing the dog’s gait. The study staff will train owners on how to complete the assessments.

The dog’s activity also will be tracked through the use of an activity monitor worn on the dog’s collar. Study visits include the dog’s initial consultation, treatment day (Day 0), and then recheck visits on Days 14, 28, 56, and 84.

Medications targeted at the treatment of osteoarthritis / elbow dysplasia pain, except for CBD and other cannabinoids, are acceptable, provided they have been administered for at least 2 weeks prior to enrolling in the study.

Trial Funding

The study is fully funded for its entire duration (approximately 84 days). Funding includes: the initial consultation, the study treatment and administration, radiographs prior to treatment (if not already performed within 2 weeks of enrollment), recheck visits, required bloodwork, and management of side effects that are thought to be directly related to study participation.

Trial Eligibility

Trained veterinarians at the trial sites will evaluate each dog for eligibility.

Dogs are eligible if they meet the following inclusion criteria:

  • Dog’s body weight 10-50 kg
  • Dog has clinical signs and radiographic evidence of elbow dysplasia
  • Dog is experiencing elbow-associated pain that is refractory to standard pain management or owner opts for pain management that is distinct from conventional treatments

Dogs are not eligible if they meet any of the following exclusion criteria:

  • Dog has a life expectancy of < 3 months
  • Dog has any underlying disease that will affect the study objectives or patient safety
  • Dog has concurrent or prior immune-mediated or other disease resulting polyarthropathy
  • Dog is impaired due to neurological disease or other orthopedic disease
  • Dog is pregnant or lactating
  • Dog is participating in another study
  • Dog may be unavailable for the entire trial duration or is felt to be unsuitable by the investigator for any other reason
  • Dog requires medications or supplements during the course of the study that interfere with the objectives of the studyincluding but not limited to TRPV1 agonist or antagonist drugs that could interfere with RTX mode of action (such as cannabinoids like CBD and anandamide).

 

Contact:

Please contact Dr. Sean Aiken, DACVS at 858.875-7500.

First-Ever, Nationwide, Multicenter, Prospective Study of Canine Splenic Hemangiosarcoma

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Cutting Edge Cancer Research in Veterinary Specialty Practice: Ethos Veterinary Health Completes First-Ever, Nationwide, Multicenter, Prospective Study of Canine Splenic Hemangiosarcoma

Woburn, Mass. — Jan. 15, 2019 — Ethos Veterinary Health (Ethos) has completed the patient accrual phase of their new Canine Hemangiosarcoma Molecular Profiling (CHAMP) study.

Hemangiosarcoma is one of the most malignant forms of cancer in dogs and CHAMP is the first nationwide, multicenter, prospective study of canine splenic hemangiosarcoma, which is a cancer of the blood vessels often affecting the spleen.

“Ethos is proud of this unprecedented milestone and of our investments in innovation that will improve outcomes for our patients,” said Ames Prentiss, CEO of Ethos Veterinary Health.

The clinical description of this population of dogs with splenic tumor rupture, a common diagnosis made on an emergency basis, is expected to be submitted for publication before the end of Q1 2019 by Dr. Sam Stewart, DACVECC and colleagues at Ethos.

“I expect the CHAMP study to change many misperceptions of hemangiosarcoma in the veterinary community, and ultimately help pet owners and veterinarians make better decisions regarding treatment,” said Sam Stewart, DVM, DACVECC, Science Commercialization Fellow at Ethos Veterinary Health.

The study also provided state-of-the-art care to dogs with splenic tumor rupture over a 12-month period and allowed for the collection samples for molecular analysis. CHAMP will result in a molecular characterization of genomic alterations in canine hemangiosarcoma which will help identify dogs with distinct prognoses and potentially life-saving molecularly-targeted therapies. Publication of these genomic data is expected in Q2 2019.

“When viewed from the perspective of a veterinarian trained to treat cancer – I am a veterinary Oncologist – the new genomic analysis of this highly aggressive cancer has already provided an opportunity for me to treat dogs differently,” said Chand Khanna, DVM, PhD, DACVIM (Onc), Chief Science Officer of Ethos Veterinary Health. “We are very excited to now launch clinical trials that will assess these new treatments and change outcomes for dogs with this very aggressive cancer.”

A critical component of this prospective study will be the molecular characterization of the disease recently completed through a collaboration of Ethos and The Translational Genomics Research Institute (TGen), an affiliate of City of Hope. This Ethos-TGen collaboration allowed for the use of advanced next generation sequencing technology of tumor and blood samples collected from the CHAMP dogs.

Will Hendricks, Ph.D., Assistant Professor, Integrated Cancer Genomics Division of TGen, added: “The results of this collaboration between TGen and Ethos will bring needed evidence to the field of molecular and precision medicine. We are not only excited about the application of these data to dogs, but also to human patients with very similar cancers as part of a comparative approach to cancer biology and therapy, so-called comparative oncology.”

These new trials will open through Ethos practices in Q2 2019. In parallel, additional studies are ongoing to develop a molecular diagnostic to help define the prognosis of individual dogs and identify optimal molecularly derived treatments for each patient.

 

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About Ethos Veterinary Health

Ethos is a veterinary health company with hospitals across the U.S. providing advanced medical care for pets. Our approach includes a focus on transformative science, continuous learning and growth for team members and collaboration. For more information, visit ethosvet.com.

About Ethos Discovery

Ethos Discovery is a 501(c)(3) non-profit incubator of scientific innovation that seeks to improve health outcomes in pets and humans with complex medical problems, including cancer. For more information, please visit ethosdiscovery.org.

About TGen, an affiliate of City of Hope

Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life changing results. TGen is affiliated with City of Hope, a world-renowned independent research and cancer and diabetes treatment center: www.cityofhope.org. This precision medicine affiliation enables both institutes to complement each other in research and patient care, with City of Hope providing a significant clinical setting to advance scientific discoveries made by TGen. TGen is focused on helping patients with neurological disorders, cancer, diabetes, and infectious diseases, through cutting edge translational research (the process of rapidly moving research towards patient benefit). TGen physicians and scientists work to unravel the genetic components of both common and rare complex diseases in adults and children. Working with collaborators in the scientific and medical communities literally worldwide, TGen makes a substantial contribution to help our patients through efficiency and effectiveness of the translational process. For more information, visit: www.tgen.org.

Contacts

Ethos Veterinary Health
Nadja Torling, Director of Marketing
ntorling@ethosvet.com

 

Ethos Veterinary Health LLC Recapitalization with Brown Brothers Harriman Capital Partners

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Brown Brothers Harriman Completes Investment in Ethos Veterinary Health LLC

New York, NY, JANUARY 9, 2019BBH Capital Partners (“BBHCP”) announced today that it has completed a recapitalization of Ethos Veterinary Health LLC (“Ethos” or the “Company”). Headquartered in Woburn, Massachusetts, Ethos is one of the largest pure-play independent providers of specialty veterinary health services, including 24/7 emergency care, surgical procedures, radiology services and internal medicine. Ethos operates 21 specialty and emergency hospitals and employs over 300 doctors of veterinary medicine. In addition, Ethos provides a complementary suite of reference laboratory and compounding pharmacy services and has developed a well-regarded continuing education and training platform to support the ongoing professional development of its veterinarians and technicians.

Ethos has earned a national reputation among veterinary professionals for providing exceptional quality-of-care, world-class professional development as well as a veterinarian-first culture. After the recapitalization, Ethos remains majority owned by its founders and professionals in the veterinary industry under the leadership of CEO and Co-Founder Ames Prentiss and is well capitalized to further accelerate a growth strategy that will continue to focus on expanding existing hospitals, acquisitions and growth of the complementary suite of services.

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About Ethos Veterinary Health

Ethos is a veterinary health company with 17 hospitals across the U.S. providing advanced medical care for pets. Our approach includes a focus on transformative science, continuous learning and growth for team members, and collaboration. For more information, visit ethosvet.com.

About BBH Capital Partners

BBH Capital Partners (“BBHCP”), a private equity strategy of Brown Brothers Harriman & Co., provides friendly capital solutions to growth-oriented middle-market companies. Our flexible investment mandate gives us the ability to act as a control or non-control investor and to structure our investments as a combination of equity and subordinated debt securities as needed. BBHCP typically invests between $30 million and $125 million per platform investment, and our capital is used to support a variety of transactions, including management or leveraged buyouts, growth financings, recapitalizations (including dividend recapitalizations), buy-and-build strategies and acquisitions.

Contacts

Ethos Veterinary Health
Nadja Torling, Director of Marketing
ntorling@ethosvet.com