Oasmia Pharmaceutical, a developer of a new generation of drugs within human and veterinary oncology, today presented positive results from a recently completed dose-finding study of weekly administration of Apealea (Paclical).
The company said that the study included 48 patients with metastatic breast cancer that were treated weekly with Apealea (Paclical) starting at 100 mg/m2 and increasing in steps of 10 mg/m2 until 250 mg/m2 was reached. The pre-defined, dose-limiting toxicity as defined in the study protocol was not reached until 250 mg/m2 per week. An overall analysis of all adverse events recorded in the study defined 180 mg/m2 as the level for dose-limiting toxicity. The suggested dose for further development of weekly administration of Apealea is 170 mg/m2.
Margareta Eriksson, Vice President of Clinical Development at Oasmia Pharmaceutical commented: “This study within the indication of breast cancer, one that affects so many women worldwide, positions Apealea as having significant potential for both patients as well as the physicians who treat them.”