Aratana Therapeutics Initiates and Doses First Patient in Market Development Studies of AT-005 for Treating Canine T-cell Lymphoma
KANSAS CITY, Kan., June 18, 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 that it is currently enrolling patients in two nationwide clinical trials to evaluate its monoclonal antibody for canine T-cell lymphoma, AT-005, which is conditionally licensed by the USDA to aid in the treatment of dogs with lymphoma.
These studies are not required by the USDA to obtain a full product license for AT-005, for which it is currently under review. They were designed by veterinary oncologists to evaluate AT-005 under real practice conditions, which will help Aratana and oncologists understand the clinical value of AT-005 once it is fully licensed by the USDA, which is anticipated to be in 2015. Specifically, the studies will evaluate AT-005 in combination with two different chemotherapy regimens used to treat dogs diagnosed with intermediate- to high-grade peripheral T-cell lymphoma.
Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics, stated, "Aratana is committed to demonstrating the full clinical potential of our novel pet biologics, which may offer veterinarians a new paradigm for treating lymphoma in dogs. In addition to the positive safety and efficacy data upon which the USDA based our product licenses for our canine lymphoma monoclonal antibodies, we believe the results of these two market development studies will be instrumental for demonstrating the potential benefit of adding a biologic to standard chemotherapy. Similar regimens have had meaningful impact on patient outcomes in human drug development, and we believe our ability to demonstrate a similar effect for AT-005 will facilitate its adoption by veterinarians and pet owners."
The studies are being conducted in coordination with Animal Clinical Investigation, LLC (ACI). Details are as follows:
T-CHOMP (T cell – CHOP + Monoclonal antibody)
Patient dosing has initiated in this randomized, blinded, placebo-controlled field study, which will enroll an estimated 48 client-owned dogs and is designed to assess the benefit of adding AT-005 to multi-agent CHOP chemotherapy (Cyclophosphamide, Hydroxydaunorubicin, Oncovin, and Prednisone).
All patients will receive standard CHOP chemotherapy and will be randomized (1:1) to receive supplemental AT-005 or placebo. Patients will be dosed twice weekly for four weeks, once weekly for another 15 weeks, and monthly thereafter. The study duration is 18 months; however, if progressive disease occurs before the 18-month visit, dogs will be removed from the study at that time. The primary efficacy endpoint is progression-free survival (PFS), with a secondary endpoint of objective response rate (ORR). Investigators will also monitor patients for overall survival (OS). Adverse events will be evaluated and compared between treatment and placebo groups.
This study is currently enrolling patients. For more information, please visit http://www.animalci.com/trials/t-chomp.
T-LAB (T cell – Lomustine + monocolonal AntiBody)
This randomized, blinded, placebo-controlled field study will enroll an estimated 60 client-owned dogs, and is designed to assess the benefit of adding AT-005 to single-agent lomustine (CCNU) chemotherapy.
All patients will receive two three-week cycles of single-agent CCNU chemotherapy, after which patients that achieve partial or complete response will be randomized (1:1) to receive AT-005 or placebo twice per week for the next four weeks. Patients will continue to receive AT-005 or placebo every other week for another 8 weeks, after which they will be rechecked monthly. The total study duration is 12 months; however, patients will be removed from the study if their disease progresses before the 12-month visit. The primary efficacy endpoint is progression-free survival (PFS) and investigators will also monitor the duration of response and overall survival (OS). Adverse events will be evaluated and compared between treatment and placebo groups.
This study is currently enrolling patients. For more information, please visit http://www.animalci.com/trials/t-lab.
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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