Berg reports Phase II data for ubidecarenone in metastatic pancreatic cancer

In September, Berg LLC (Framingham, Mass.) reported data from 5 evaluable patients with advanced pancreatic cancer in a Phase II trial showing that second-line treatment with IV ubidecarenone (Coenzyme Q10; BPM 31510) alone or in combination with gemcitabine led to an overall response rate (ORR) -- the primary endpoint -- of 40%. Specifically, the compound led to 1 partial response and 1 case of stable disease. The product was well tolerated. Data were presented at the European Society for Medical Oncology meeting in Madrid.

The open-label, U.S. trial is enrolling 10 patients in the monotherapy arm to receive 110 mg/kg ubidecarenone and 10 patients in the combination arm to receive ubidecarenone plus gemcitabine. The expansion stage will enroll an additional 15 patients. Secondary endpoints include overall survival (OS), progression-free survival (PFS), time to progression, tumor response using adaptive molecular responses, change in CA19.9 (sialyl Lewis A) levels and patient-reported quality of life (QOL) as measured by the FACT-HEP instrument. ...