Christmas Miracle

[seeh2o]

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

[Time4ANap]

Awesome!

[MaryJane]

It is an XMAS gift. Note, it's only gong to be available in 24 vet centers across the US.

[JohnF]

ANY good news on that front is welcome.

[seeh2o]

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

[greysmom]

[ramonaghan]

Wow! Wonderful news.

[BatterseaBrindl]

[seeh2o]

I've been in the brink of tears since I read it this morning...and I'm not a crying kind of gal.

[Rickiesmom]

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!

[EllenEveBaz]

Living over a year more than the control group. That's a lot of living for a dog.

[MP_the4pack]

Tanzi's getting it too!!

 

(As long as her back improves)

[4My2Greys]

:confetti

.

:confetti

[Beachbum1]

Fantastic!!

[seeh2o]

Tanzi's getting it too!!

 

(As long as her back improves)

Yes!!!!

[greyhndz]

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

 

 

 

[seeh2o]

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.