We ended our first day of the ACVIM Forum experience with a reception on Thursday evening. Hosted by the Aratana Therapeutics team, attendees learned about the Aratana philosophy and got a preview to some of the exciting, innovative products that are in the Aratana pipeline for development.
Also on Thursday, Nicola Mason, B.Vet.Med, PhD, DACVIM, of the University of Pennsylvania, School of Veterinary Medicine, presented preliminary research based on her clinical work with the osteosarcoma vaccine immunotherapy candidate. This novel HER2/neu-directed cancer immunotherapy (AT-014, ADXS-cHER2) is licensed by Aratana exclusively from Advaxis, Inc. The preliminary results from this study suggest that AT-014 is able to delay or prevent metastatic disease and prolong overall survival in dogs with osteosarcoma that had minimal residual disease following amputation and chemotherapy. Median survival in control dogs was 316 days (n = 13), and at the time of Dr. Mason’s presentation, the median survival in treated dogs had not yet been reached, with 80% of the dogs that received the complete vaccine series remaining alive (n = 15). Dr. Mason is conducting a second study evaluating combination therapy with AT-014 immunotherapy and radiation for dogs with primary osteosarcoma that cannot undergo amputation.
During the Aratana sponsored Friday breakfast symposium, Duncan Lascelles, BSc, BVSc, PhD, CertVA, DSAS(ST), DECVS, DACVS, Professor of Small Animal Surgery, North Carolina State University, College of Veterinary Medicine discussed the unmet need in extended post-operative pain management for pets, and presented the concept of AT-003 as a potentially safe and effective, long-acting local anesthetic, based on its success as an FDA-approved product for use in humans and its preclinical safety profile in dogs and other animals. This bupivacaine extended-release injectable suspension (AT-003) aims to help manage post-operative pain in cats and dogs following surgery. Aratana expects to initiate a pilot field study of AT-003 in client-owned dogs in 2014 and continues to anticipate U.S. Food and Drug Administration (FDA) approval in 2016. Aratana will initiate a pilot study in laboratory cats in 2014.
In the second half of the breakfast symposium, Butch KuKanich, DVM, PhD, DACVCP, Associate Professor of Analytical Pharmacology at Kansas State University, College of Veterinary Medicine, discussed various categories of pain drugs and their specific mechanisms of action. He presented information on the piprant class of therapeutics, a new chemical classification, and the therapeutic candidate grapiprant (AT-001), which is in clinical development for treatment of osteoarthritis (OA) pain in dogs and cats. AT-001 selectively blocks the prostaglandin E2 receptor EP4. Aratana has initiated a pivotal field effectiveness study of grapiprant in client-owned dogs with a once-daily dose and continues to anticipate FDA approval in 2016. Aratana also anticipates starting a pilot field study in client-owned cats in 2014.
The safety profile of grapiprant was demonstrated in an abstract poster displayed in the research abstracts exhibit. Reporting data from the Company’s pivotal safety study showed that grapiprant (AT-001) was well tolerated by Beagles over the treatment course of nine months at doses greater than ten times higher than the anticipated therapeutic dose for dogs with OA (up to 50 mg/kg).
In addition, the Aratana oral ghrelin agonist for appetite stimulation, capromorelin (AT-002), was highlighted in two abstract posters demonstrating its effects on appetite, weight gain, and relevant physiological markers including serum growth hormone and IGF-1. In a laboratory study, Beagle dogs were dosed orally with capromorelin or placebo for seven days. Dogs given capromorelin demonstrated a statistically significant increase in food consumption and body weight compared to dogs in the placebo group, and positive effects on growth hormone and IGF-1 levels. These positive results were reflected clinically by a multi-site, randomized, blinded field study, of 36 inappetent client-owned dogs treated with capromorelin or placebo. Compared to placebo, treatment with AT-002 resulted in a statistically significant and highly correlated increase in appetite and body weight. The Aratana pivotal field effectiveness trial in client-owned dogs is currently enrolling patients, and the company continues to anticipate FDA approval in 2016. Aratana also anticipates starting a pilot field study in client-owned cats in mid-2014.
On the exhibit floor, we met and talked with dozens of pet health professionals who stopped by our booth. Visitors learned about our innovative future through a highly engaging and visual interactive experience.
We also surveyed many veterinarians who shared their own beliefs on the biggest areas of unmet or underserved needs in pet medicine for their practices. Results from the surveys we conducted at the booth show pain management and oncology products were some of the top of mind areas of concern among many ACVIM attendees, making what Aratana wants to bring to the market an even more compelling story for them.
We had a great time at the ACVIM Forum in Nashville. But this is just the beginning. We look forward to meeting more veterinary professionals at IVECCS in Indianapolis in September. In the meantime, come back for more updates on our progress as we explore new beginnings for pets and the families who love them.
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