Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company developing therapeutics to treat cancer, announced that today a poster highlighting positive results in a Phase 2 trial of NOV-002 in combination with neoadjuvant chemotherapy treatment in patients with stage IIB-IIIC HER-2/neu negative invasive breast cancer is being presented by the Braman Family Breast Cancer Institute at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine at the AACR Breast Cancer Symposium in San Antonio, TX. Alberto Montero, MD, Assistant Professor of Medicine at the Miller School and medical oncologist at Sylvester, is the Principal Investigator. The poster, Phase 2 study of neoadjuvant treatment with cellular redox modulator NOV-002 in combination with doxorubicin and cyclophosphamide followed by docetaxel (AC-T) in patients with stage II-III HER-2(-) breast cancer, can be viewed at www.novelos.com ‘Our Products’, ‘NOV-002’ section.
The Phase 2 open-label, single-arm, Simon 2-Stage breast cancer 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. The trial efficacy criterion of 12 pCRs was met in July 2010 prior to all patients completing the trial. The Phase 2 trial design can be found on www.clinicaltrials.gov – ID: NCT00499122, or via a link at www.novelos.com ‘Clinical Trials’ section.
“In this trial where now 41 breast cancer patients have been enrolled from three different hospitals we have 15 confirmed pathologic complete responses out of 38 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,” said Dr. Montero. “By comparison the published pCR rate in several trials with an anthracycline followed by a taxane chemotherapy in patients with HER-2 negative breast cancer is in the range of 10-20%. These results I believe indicate that further investigation of NOV-002 plus chemotherapy in breast cancer is warranted.”