AminoVet Phase I/II clinical study result
A PROSPECTIVE PHASE I/II OPEN LABEL, NON-RANDOMIZED CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF AMINOACT MULTI-KINASE INHIBITOR FOR THE ADJUVANT TREATMENT OF DOGS WITH SPONTANEOUSLY OCCURING CANCER
A small molecule complex (Aminoact) is a natural peptide mixture with multi-kinase inhibitory effects against epidermal growth factor receptor and insulin-like growth factor receptor-1. It lowers serum TNF-alpha,increase superoxide dismutase enzyme activity, and causes apopsotis in cancer cell lines. This study was designed to first assess safety and secondly the efficacy of three dosage levels of AX-3 in sustaining progression free survival (PFS) for dogs with cancer.
Materials and Methods
The prospective, open label study included dogs of different breeds with histologically confirmed malignancies. The first 13 dogs received Aminoact at 1g/m2; the second group of 7 dogs subsequently received the same dosage + 350 mg of Aminoact; and the third group of dogs subsequently received 2g/m2. Each dog was treated orally daily for six weeks along with 550 mg betaine HCl, that aids in peptide absorption. All patients were evaluated for toxicity using the VCOG-CTCAE and efficacy using the RECIST criteria via assessment of clinical parameters, blood work and client questionnaires.
No toxicity other than mild, transient (grade I) nausea was noted, nor were there any changes in hemograms or biochemical profiles in any patient. Dogs with tumors that were confirmed as responders (>50% reduction in size) include pulmonary adenocarcinoma, mast cell tumor, trichoepithelioma and soft tissue sarcoma. It appears in limited studies that the response rate may be more durable at higher dosages.
The response to Aminoact is dose dependent and only transient mild toxicity was observed. Further clinical studies will be valuable in determining the effective dosage and response duration.
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