Novelos Releases NOV-002 Phase 2 Trial Results

The trial trial was designed to determine if preoperative administration of NOV-002 in combination with doxorubicin and cyclophosphamide followed by docetaxel (AC-T) results in at least a doubling in the rate of pathologic complete response (pCR) compared to a historical control.

Alberto Montero, principal investigator of the study, said: “In this trial where now 39 breast cancer patients have been enrolled from three different hospitals we have 12 confirmed pathologic complete responses out of 31 patients (39%) who have undergone surgery, which is higher than what has been previously reported with preoperative chemotherapy, consisting of doxorubicin and cyclophosphamide followed by docetaxel, in HER-2 negative breast cancer patients.

“We also continue to observe very high pCR rates in the breast cancer subtype least sensitive to chemotherapy, hormone receptor positive breast cancer, also known as luminal subtype, thus far we have confirmed pCR in approximately 11/26 (42%) of all ER+ pts. These results I believe provide preliminary data that further trials of NOV-002 plus chemotherapy in breast cancer are warranted.”

Christopher Pazoles, vice president of R&D of Novelos, said: “The efficacy seen in this trial is of particular interest in relation to our growing understanding of NOV-002’s mechanism of action.

“Recent findings suggest that, due to its anti-tumor immunomodulatory activities, NOV-002 may be particularly well-suited for combination with certain ‘immunogenic’ chemotherapy agents including cyclophosphamide and doxorubicin which are commonly used to treat breast cancer and are part of the treatment regimen used in this trial.”