FORT COLLINS, Colo.–(BUSINESS WIRE)–VetDC, Inc., a veterinary cancer therapeutics company, today announced
that the Company has completed all required major and minor technical
sections for Tanovea™
(rabacfosadine for injection) and filed its administrative New
Animal Drug Application (NADA) for conditional approval with the U.S.
Food and Drug Administration’s Center for Veterinary Medicine (FDA-CVM).
The administrative NADA submission is the final step required for FDA
conditional approval of Tanovea, and an approval decision is anticipated
within 60 days. Upon FDA approval, VetDC intends to commence
commercialization in early 2017.
“This is an incredibly exciting time for VetDC, as we are now in the
home stretch toward introducing the first FDA-approved drug for use in
dogs with lymphoma, one of the most common cancers affecting pets
today,” stated Steven Roy, VetDC’s President and CEO.
Tanovea™ (rabacfosadine for injection) is a novel small molecule drug
designed to preferentially target and attack cancer cells implicated in
lymphoma, one of the most common cancers seen in companion animals. In
multiple clinical studies in over 300 client-owned dogs with naturally
occurring lymphoma, Tanovea has consistently demonstrated robust
anti-tumor activity in both naïve and relapsed cases, with a generally
well-tolerated safety profile. Tanovea has a rapid onset of action and
is being investigated as a convenient, every-three-week treatment for up
to five doses, representing a substantial reduction in client visits
relative to non-approved, ‘human’ generic multi-agent chemotherapy
regimens commonly utilized in dogs with lymphoma.
VetDC has an exclusive North American license from Gilead Sciences to
develop and commercialize Tanovea for companion animal cancer.
About VetDC, Inc.
is changing the way new cancer medicines are developed for companion
animals, leveraging novel advancements from human biotechnology that
have demonstrated success in animal studies. VetDC currently has two
cancer programs in development, Tanovea for lymphoma and VDC-597 for
Steven Roy, 303-859-2072