seeh2o Posted December 24, 2017 Share Posted December 24, 2017 OMG, OMG, OMG! This is a Christmas miracle! Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on the licensing, development and commercialization of innovative therapeutics for dogs and cats, today announced the United States Department of Agriculture (USDA) Center for Veterinary Biologics granted Aratana conditional licensure for Canine Osteosarcoma Vaccine, Live Listeria Vector (AT-014) for the treatment of dogs diagnosed with osteosarcoma, one year of age or older. http://aratana.investorroom.com/2017-12-20-Aratana-Therapeutics-Granted-Conditional-License-for-a-Canine-Osteosarcoma-Therapeutic Quote Sunsands Doodles: Doodles aka Claire, Bella Run Softly: Softy aka Bowie (the Diamond Dog) Missing my beautiful boy Sunsands Carl 2.25.2003 - 4.1.2014 Link to comment Share on other sites More sharing options...
Time4ANap Posted December 24, 2017 Share Posted December 24, 2017 Awesome! Quote Camp Broodie. The current home of Mark Kay Mark Jack and Gracie Kiowa Safe Joan. Always missing my boy Rocket Hi Noon Rocket, Allie Phoenix Dynamite, Kate Miss Kate, Starz Under Da Starz, Petunia MW Neptunia, Diva Astar Dashindiva, and LaVida I've Got Life Link to comment Share on other sites More sharing options...
MaryJane Posted December 24, 2017 Share Posted December 24, 2017 It is an XMAS gift. Note, it's only gong to be available in 24 vet centers across the US. Quote Link to comment Share on other sites More sharing options...
JohnF Posted December 24, 2017 Share Posted December 24, 2017 ANY good news on that front is welcome. Quote Link to comment Share on other sites More sharing options...
seeh2o Posted December 24, 2017 Author Share Posted December 24, 2017 (edited) I think Healthy Paws will cover it since it's considered USDA approved now. I have to call them. Bowie is due for regular x-rays the first week of January. So long as she qualifies, she's getting it, even if it means a 6 hour roadtrip to UC Davis, or wherever the closest location is. I've already left a message for her oncologist. Edited December 24, 2017 by seeh2o Quote Sunsands Doodles: Doodles aka Claire, Bella Run Softly: Softy aka Bowie (the Diamond Dog) Missing my beautiful boy Sunsands Carl 2.25.2003 - 4.1.2014 Link to comment Share on other sites More sharing options...
greysmom Posted December 24, 2017 Share Posted December 24, 2017 Quote Chris - Mom to: Felicity (DeLand), and Andi (Braska Pandora) siggy by Chris Harper, on Flickr Angels: Libby (Everlast), Dorie (Dog Gone Holly), Dude (TNJ VooDoo), Copper (Kid's Copper), Cash (GSI Payncash), Toni (LPH Cry Baby), Whiskey (KT's Phys Ed), Atom, Lilly Link to comment Share on other sites More sharing options...
ramonaghan Posted December 24, 2017 Share Posted December 24, 2017 Wow! Wonderful news. Quote Rachel with Doolin Doodle Dooooo, boss cat Tootie, and feline squatters Crumpet and Fezziwig. Missing gentlemen kitties Mud, Henry, and Richard and our gorgeous, gutsy girlhounds Sweep and Willa. Link to comment Share on other sites More sharing options...
BatterseaBrindl Posted December 24, 2017 Share Posted December 24, 2017 Quote Nancy...Mom to Sid (Peteles Tiger), Kibo (112 Carlota Galgos) and Joshi. Missing Casey, Gomer, Mona, Penelope, BillieJean, Bandit, Nixon (Starz Sammie), Ruby (Watch Me Dash) Nigel (Nigel), and especially little Mario, waiting at the Bridge. Link to comment Share on other sites More sharing options...
seeh2o Posted December 24, 2017 Author Share Posted December 24, 2017 I've been in the brink of tears since I read it this morning...and I'm not a crying kind of gal. Quote Sunsands Doodles: Doodles aka Claire, Bella Run Softly: Softy aka Bowie (the Diamond Dog) Missing my beautiful boy Sunsands Carl 2.25.2003 - 4.1.2014 Link to comment Share on other sites More sharing options...
Rickiesmom Posted December 24, 2017 Share Posted December 24, 2017 I've been in the brink of tears since I read it this morning...and I'm not a crying kind of gal. My reaction too - this really is the best possible Christmas gift. I hope it will be licensed up here soon! Quote Link to comment Share on other sites More sharing options...
EllenEveBaz Posted December 24, 2017 Share Posted December 24, 2017 Living over a year more than the control group. That's a lot of living for a dog. Quote Ellen, with brindle Milo and the blonde ballerina, Gelsey remembering Eve, Baz, Scout, Romie, Nutmeg, and Jeter Link to comment Share on other sites More sharing options...
MP_the4pack Posted December 24, 2017 Share Posted December 24, 2017 Tanzi's getting it too!! (As long as her back improves) Quote Link to comment Share on other sites More sharing options...
4My2Greys Posted December 24, 2017 Share Posted December 24, 2017 :confetti . :confetti Quote Link to comment Share on other sites More sharing options...
Beachbum1 Posted December 24, 2017 Share Posted December 24, 2017 Fantastic!! Quote Link to comment Share on other sites More sharing options...
seeh2o Posted December 24, 2017 Author Share Posted December 24, 2017 Tanzi's getting it too!! (As long as her back improves) Yes!!!! Quote Sunsands Doodles: Doodles aka Claire, Bella Run Softly: Softy aka Bowie (the Diamond Dog) Missing my beautiful boy Sunsands Carl 2.25.2003 - 4.1.2014 Link to comment Share on other sites More sharing options...
greyhndz Posted December 26, 2017 Share Posted December 26, 2017 Bummer alert: This is potentially very exciting news, but it's going to be a while before it will be available outside of the designated study group: As required by USDA to progress from conditional licensure to full licensure, Aratana plans to conduct an extended field study in a clinical setting and anticipates initiating the study in early 2018. Initially, the therapeutic will be made available for purchase at approximately two dozen veterinary oncology practice groups across the United States who participate in the study. So, it's been conditionally licensed for the purpose of conducting a more extensive clinical study. If you'd like to find out where they will be recruiting participants, here's a place to start: http://vetcancersociety.org/pet-owners/clinical-trials/ The new clinical study for 2018 is not yet listed. The previous field study, however, is, and though recruitment ended 2/2017, contact info for the trial investigator is supplied. The study to search for is AAHSD000419. Hopefully they can provide specifics for the next phase of testing. Realistically, the vaccine may still be a long time from full licensure, and will depend on the results of the clinical study once completed. Jordan Tim and Tessa (galgos) & Jesse and Buddy (iggies) Missing lots of angels, most recently: Galgos Dandi, Teo, Mafi & Gigi Quote Link to comment Share on other sites More sharing options...
seeh2o Posted December 26, 2017 Author Share Posted December 26, 2017 Here is the language from the USDA document: TO: Biologics Licensees, Permittees, and Applicants Directors, Center for Veterinary Biologics Veterinary Services Leadership Team FROM: Byron E. Rippke, Director SUBJECT: Issuance of a Conditional License for Canine Osteosarcoma Vaccine, Live Listeria Vector The Animal and Plant Health Inspection Service (APHIS) has issued a conditional United States Veterinary Biological Product License to Antelope Valley Bios, Inc., Establishment No. 419, Lincoln, Nebraska, for the manufacture and distribution of Canine Osteosarcoma Vaccine, Live Listeria Vector. A veterinary biological product regulated under the Virus-Serum-Toxin Act must be shown to be pure, safe, potent, and efficacious before a veterinary biological product license may be issued. The regulations in title 9, Code of Federal Regulations, part 102, regarding the licensing of veterinary biological products provide that a conditional veterinary biological product license may be issued to meet an emergency condition, limited market, local situation, or special circumstance. The special circumstance addressed here is the need for a biological intervention for canine osteosarcoma in order to afford veterinarians another post-surgical treatment option beyond traditional chemotherapeutic intervention. Conditionally licensed products are required to be pure and safe, and have a reasonable expectation of efficacy. This conditional license was issued on the basis that a reasonable expectation of efficacy was demonstrated during field trials conducted in dogs that had been clinically diagnosed with osteosarcoma and undergone surgical removal of the primary appendicular tumor. Dogs were then treated with carboplatin. Following radiographic confirmation of the absence of pulmonary metastasis, affected dogs received a 3-dose primary vaccination series with the canine osteosarcoma vaccine and then median survival time was compared to historical standards. The conditional license will expire one year from the date of the license. APHIS will evaluate the firms progress throughout the next year toward regular licensure in order to consider reissuance of the conditional license. Quote Sunsands Doodles: Doodles aka Claire, Bella Run Softly: Softy aka Bowie (the Diamond Dog) Missing my beautiful boy Sunsands Carl 2.25.2003 - 4.1.2014 Link to comment Share on other sites More sharing options...
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