Aratana Therapeutics Presents Safety and Clinical Findings at 2014 ACVIM Forum
Data Presented from Company's Pain, Cancer Immunotherapy, and Inappetence Programs
KANSAS CITY, Kan., June 9, 2014 /PRNewswire/ -- Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for cats, dogs and other companion animals, today announced findings from the company's ongoing safety and clinical programs, which were presented at the 2014 American College of Veterinary Internal Medicine (AVCIM) Forum. Safety and efficacy data were highlighted for Aratana's pet therapeutics programs in pain, cancer immunotherapy, and inappetence, including three peer-reviewed poster presentations.
Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics, stated, "As our company continues to grow, we are committed to broadening our outreach to the practicing veterinarian community. We're proud to have such a significant presence at ACVIM this year as our first opportunity to introduce the Aratana brand to this important audience. Simultaneously with this conference, we have also added new sections to our website for veterinarians and pet owners. Both our exhibit booth and our sponsored breakfast symposium were very well attended and productive, and we look forward to continuing to build upon this presence at various other trade shows throughout 2014."
The ACVIM Forum attracts more than 3,300 veterinary specialists in the field of internal medicine, general practitioners, and veterinary technicians from around the world, and focuses significantly on exploring the latest cutting-edge developments in pet therapeutics.
The data presented at the Forum are summarized below:
Butch KuKanich, DVM, PhD, DACVCP, Associate Professor of Analytical Pharmacology at Kansas State University College of Veterinary Medicine, reviewed the differential effects of various categories of pain drugs as a result of their specific mechanisms of action during Aratana's breakfast symposium. He presented Aratana's therapeutic candidate grapiprant (AT-001), which is in clinical development for treating osteoarthritis (OA) pain in dogs and cats. Dr. KuKanich discussed potential benefits of the selective blockage of the prostaglandin E2 receptor EP4 by grapiprant, a member of the new chemical classification, the piprant class, in comparison to the inhibition of cyclooxygenase enzymes by non-steroidal anti-inflammatory drugs (NSAIDs) that are used commonly today.
The safety profile of grapiprant was further demonstrated in a poster presentation. Reporting data from the Company's pivotal safety study, lead authors Drs. Lesley Rausch-Derra and Linda Rhodes of Aratana Therapeutics showed that grapiprant (AT-001) was well tolerated by Beagle dogs 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). Treatment with grapiprant in this study had no adverse impact on mortality, body weight, food consumption, ophthalmology, electrocardiograms, hematology, coagulation, organ weights, or gross pathology. Grapiprant was associated with minimal toxicity, primarily mild gastrointestinal signs. Additionally, systemic exposure to grapiprant was significant and dose proportional, as measured by serum concentration.
Aratana has initiated a pivotal field effectiveness study of grapiprant in client-owned dogs with a once-daily dose and continues to anticipate U.S. Food and Drug Administration (FDA) approval in 2016. Aratana also anticipates starting a pilot field study in client-owned cats in 2014.
Bupivacaine extended-release injectable suspension (AT-003)
During the second half of the breakfast symposium, Aratana's bupivacaine extended-release injectable suspension (AT-003) for managing post-operative pain in cats and dogs following surgery was highlighted by Duncan Lascelles, BSc, BVSc, PhD, CertVA, DSAS(ST), DECVS, DACVS, Professor of Small Animal Surgery, North Carolina State University College of Veterinary Medicine. Dr. Lascelles 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.
Aratana expects to initiate a pilot field study of AT-003 in client-owned dogs in 2014 and continues to anticipate FDA approval in 2016. Aratana will initiate a pilot study in laboratory cats in 2014.
As part of the Forum's Scientific Sessions, Nicola Mason, BVetMed, PhD, DACVIM, of the University of Pennsylvania School of Veterinary Medicine, presented her work on the novel her2/neu-directed cancer immunotherapy, AT-014 (ADXS-cHER2) for the treatment of canine osteosarcoma, which Aratana licensed exclusively from Advaxis, Inc. (NASDAQ: ADXS) in March 2014.
Dr. Mason discussed preliminary findings from an ongoing clinical study of AT-014 in client-owned dogs with osteosarcoma. The study suggests that AT-014 is safe and well tolerated at doses up to 3 x 109 CFU, with no evidence of cardiac, hematological, or other systemic toxicities. In fact, the maximum tolerated dose was not reached in these canine patients. Importantly, 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 had not yet been reached, with 80% of the dogs that received the complete vaccine series remaining alive (n=15).
Immunological analysis is currently underway for this study, and 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.
Aratana's oral ghrelin agonist for appetite stimulation, capromorelin (AT-002), was highlighted in two 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. Over the course of treatment, 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, 36 inappetent client-owned dogs were treated with capromorelin or placebo. Owners used a questionnaire to assess appetite, and body weight was measured before and following seven days of treatment. Compared to placebo, treatment with AT-002 resulted in a statistically significant and highly correlated increase in appetite and body weight. Mean change in appetite score was an increase of 79.4% for capromorelin compared to 22.2% for placebo (p = 0.0251). The increase in appetite was also associated with increased body weight, showing a mean percent increase of 3.2% for capromorelin compared to a decrease of 0.52% for placebo (p = 0.0239). The correlation of the changes in appetite assessment score and percent change in body weight at Day 6 yield a Pearson correlation coefficient of 0.503 (p = 0.0054).
Aratana's pivotal field effectiveness trial in client-owned dogs is currently enrolling patients, and the company continues to anticipate FDA approval in 2016. Aratana anticipates starting a pilot field study in client-owned cats in mid-2014.
About Aratana Therapeutics
Aratana Therapeutics is a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for cats, dogs and other companion animals. Aratana believes that it can leverage the investment in the human biopharmaceutical industry to bring therapeutics to pets in a capital and time efficient manner. The company's pipeline includes more than fifteen therapeutic candidates targeting pain, inappetence, cancer, viral diseases, allergy and other serious medical conditions. Aratana believes the development and commercialization of these therapeutics will permit veterinarians and pet owners to manage pets' medical needs safely and effectively, resulting in longer and improved quality of life for pets. For more information, please visit www.aratana.com.
Forward-Looking Statements Disclaimer
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our expectations regarding the approval of products; expectations regarding development programs, trials, studies, approvals and commercialization; expectations regarding in-license initiatives and partnerships; and expectations regarding the Company's plans and opportunities.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; our lack of commercial sales; our failure to obtain any necessary additional financing; our substantial dependence on the success of certain of our lead product candidates, AT-001, AT-002, AT-003, AT-004, AT-005, AT-006 , AT-007, AT-008 and AT-014; our inability to identify, license, develop and commercialize additional product candidates; our inability to obtain regulatory approval for our existing or future product candidates; the lack of commercial success of our current or future product candidates; uncertainties regarding the outcomes of studies regarding our products; our inability to realize all of the anticipated benefits of our acquisitions of Vet Therapeutics and Okapi Sciences; effects of competition; our failure to attract and keep senior management and key scientific personnel; our complete reliance on third-party manufacturers and third parties to conduct all our target animal studies and certain other development efforts; our lack of a sales organization; our significant costs of operating as a public company; our lack of effective internal control over financial reporting; changes in distribution channels for pet therapeutics; consolidation of our customers; impacts of generic products; unanticipated safety or efficacy concerns; our limited patents and patent rights; our failure to comply with our intellectual property license obligations; our infringement of third party patents and challenges to our patents or rights; our failure to comply with regulatory requirements; our failure to report adverse medical events related to our products; legislative or regulatory changes; the volatility of our stock price; our status as an "emerging growth company," as defined in the JOBS Act; the potential for dilution if we sell shares of our common stock in future financings; the significant control over our business by our principal stockholders and management; the potential that a significant portion of our total outstanding shares could be sold into the market in the near future; effects of anti-takeover provisions in our charter documents and under Delaware law; and our intention not to pay dividends. These and other important factors discussed under the caption "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 26, 2014, along with our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
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