Safety evaluation of targeted osmotic lysis therapy in Beagles.
| Autor: | Hunter RP; One Medicine Consulting, Olathe, AR., Randazzo JM; Attentive Science, Stillwell, AR., Miller PR; Oleander Medical Technologies, Baton Rouge, LA., Paul D; Oleander Medical Technologies, Baton Rouge, LA., Gould Iii HJ; Oleander Medical Technologies, Baton Rouge, LA., Mallozzi R; Phantom Laboratory, Greenwich, NY. |
|---|---|
| Jazyk: | angličtina |
| Zdroj: | American journal of veterinary research [Am J Vet Res] 2024 Dec 16, pp. 1-6. Date of Electronic Publication: 2024 Dec 16. |
| DOI: | 10.2460/ajvr.24.09.0284 |
| Abstrakt: | Objective: The objective of this study was to satisfy the US FDA's Center for Devices and Radiological Health regarding the safety of targeted osmotic lysis (TOL), a novel treatment for advanced carcinomas, in Beagle dogs. Methods: 12 intact Beagle dogs, 6 males and 6 females, were divided into 2 treatment groups of 6, each receiving 3 TOL cycles. For each 6-day cycle, digoxin was administered orally at 0.007 mg/kg q 12 h X 6 days to achieve steady-state plasma concentrations. On days 5 and 6 of each cycle, the animals were exposed to pulsed electric field (PEF) stimulation at a field strength of either 18 or 40 V/min for 2 hours. Following the completion of cycles 1 and 2, animals were observed for 7 days. On the day following the end of cycle 3, the animals were euthanized. A complete macroscopic examination was performed, and tissues were collected for microscopic examination. Results: As there were no concurrent untreated control animals, only qualitative comparisons were performed to assess potential differences between group 1, which received the digoxin plus 18 V/min PEF, and group 2, which received digoxin plus 40 V/min PEF. No adverse events related to TOL exposure were observed in either group. Conclusions: Neither group demonstrated gross or microscopic lesions following 3 rounds of exposure to TOL. Clinical Relevance: Due to the lack of toxicity noted in the treated animals, TOL warrants consideration as either a standalone treatment option or as an adjunct to surgery or chemotherapy for managing malignant cancer. |
| Databáze: | MEDLINE |
| Externí odkaz: |
|