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Aratana osteosarcoma immunotherapy gets USDA conditional licence

Dec 22, 2017 - Animal Pharm
By Joseph Harvey
Animal Pharm
December 22, 2017

Aratana Therapeutics has paved the way for its next full product approval by securing a conditional USDA licence for a canine cancer treatment.

The osteosarcoma vaccine, live listeria vector (also known as AT-014), is for the treatment of dogs diagnosed with osteosarcoma at one year of age or older. This new tool aims to modernize the standard of care for dogs with osteosarcoma – the most common primary canine bone tumor.

Aratana already has plans to secure full USDA licensure for the product. The company has scheduled an extended field study in a clinical setting for early 2018. The vaccine will initially be made available for purchase at around 24 veterinary oncology practice groups across the US, which will participate in the upcoming study.

The immunotherapy was developed by Aratana using a listeria-based antigen delivery system licensed from Advaxis in 2014. The vaccine is a lyophilized formulation of a modified live, attenuated strain of listeria that activates cytotoxic T-cells.

Leawood, Kansas-based Aratana said: "Because the therapeutic expresses a tumor-associated antigen, it directs the T-cells to fight cancer cells, even after the bacteria are cleared. Thus, the therapeutic capitalizes on the dog's immune system and its ability to attack bacterial infections, redirecting it to fight cancer cells."

The company highlighted data from a clinical study in 18 client-owned dogs with osteosarcoma, which suggested the immunotherapy "may be able to delay or prevent metastatic disease and may prolong overall survival in dogs with osteosarcoma".

Aratana added: "The single-arm study evaluated dogs that had primary tumor removal and four doses of carboplatin chemotherapy, followed by the therapeutic vaccine every three weeks for three doses. Median survival time was 956 days compared to 423 days for a historical control group (p<0.05). A separate field safety study submitted to the USDA for conditional licensure demonstrated that the most common adverse events included lethargy, diarrhea and fever. Four serious adverse events were observed."

This conditional licence helps Aratana end the year on a positive note. Recently, the firm received results for a stem cell therapeutic that did not achieve protocol-defined efficacy success criteria. Last month, Aratana pulled out of an offering of common shares.

However, November also saw Aratana making its first steps in the European market. Galliprant (grapiprant tablets) received a positive opinion ruling for marketing authorization from the European Medicines Agency's Committee for Medicinal Products for Veterinary Use.

After a monumental 2016 that saw three notable product approvals, Aratana has used this year to focus on ramping up sales. Animal Pharm caught up with the company's founder, president and chief executive Steven St. Peter earlier this year to find out more about the firm's commercialization efforts.

Reprinted with permission of Animal Pharm News




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