Anivive Announces Completion of LAVERDIA®-CA1 Pivotal Field Study for Canine Lymphoma USA - English English

• Clinical trial sites across nine states have closed for one of the largest canine lymphoma studies
• Effectiveness data will soon be finalized for statistical review and FDA submission

LONG BEACH, Calif., Feb. 14, 2025 /PRNewswire/ -- Anivive, a software-driven pet health company, today announced the successful completion of its pivotal field study evaluating the safety and effectiveness of LAVERDIA®-CA1 (verdinexor tablets) in dogs with lymphoma. The randomized, placebo-controlled, double-masked study—conducted across 12 clinical trial sites nationwide—enrolled 150 dogs, selected from more than 700 applicants using AniviveTrial.

The final study site was closed on December 12, 2024, marking the end of patient treatment and data collection. This achievement represents a key milestone in Anivive's mission to deliver innovative cancer treatments to companion animals, such as this new first-in-class XP01 blocker.

With data collection complete, Anivive has locked the database to begin statistical analysis. Results are expected in the coming months, and Anivive aims to submit the Effectiveness technical section for regulatory review this summer. All other major technical sections of the NADA have been deemed complete by the FDA.

Pending data package finalization, Anivive will also be submitting for full approval in Brazil, Australia, the United Kingdom, and the European Union. In 2021, Anivive successfully received conditional approval from the FDA for LAVERDIA®-CA1 to treat lymphoma in dogs. The drug has the potential to be a cutting-edge oral treatment option for canine lymphoma, offering a non-invasive approach for veterinary oncology patients.

"The completion of our critical study for LAVERDIA®-CA1 marks a major milestone in bringing forward an innovative therapy for canine lymphoma", said Dylan Balsz, CEO of Anivive. "We are excited to analyze the data and move closer to making an oral treatment option available for dogs living with this challenging disease."

Anivive is dedicated to developing novel treatments that improve the lives of companion animals facing cancer and other serious diseases. In 2024, Anivive expanded its portfolio of veterinary services by offering specialty pathology services and a next-generation tumor genomic sequencing test with its SearchLight DNA^™ that was developed in partnership with TGen, the Translational Genomics Research Institute, part of City of Hope. By using trailblazing research and vigorous clinical development, Anivive is breaking new ground in veterinary medicine and transforming pet healthcare around the globe.

About Anivive Lifesciences

Anivive Lifesciences is a software-driven pet pharmaceutical company at the forefront of biotechnology, artificial intelligence, and veterinary medicine. Our mission is to transform veterinary healthcare by accelerating the development of novel, affordable treatments for life-threatening diseases in pets. Through our proprietary AI platform, we are pioneering first-in-class therapeutics in Oncology, Antivirals, and Antifungal Vaccines, setting new standards for innovation and excellence in the industry. To learn more, visit anivive.com

SOURCE Anivive Lifesciences Inc.