Novelos reports positive results from NOV-002 Phase 2 neoadjuvant breast cancer trial

Jul 12 2010

Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company developing therapeutics to treat cancer and hepatitis, today announced 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, conducted by the Braman Family Breast Cancer Institute at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine. Alberto Montero, MD, Assistant Professor of Medicine at the Miller School and medical oncologist at Sylvester, is the Principal Investigator.

“We are very pleased that NOV-002 has demonstrated positive results in this Phase 2 neoadjuvant breast cancer trial”

This Phase 2 open-label, single-arm, Simon 2-Stage 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. For NOV-002 to be declared active at the end of the trial, a minimum of 12 patients must achieve a pCR. This criterion of 12 pCRs has been met prior to all patients completing the trial. Patient enrollment continues and some patients are still in the NOV-002 treatment stage. Trial results have been submitted for presentation to the AACR Breast Cancer Symposium taking place in San Antonio, TX, in December 2010. 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 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," 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%. 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."

"We are very pleased that NOV-002 has demonstrated positive results in this Phase 2 neoadjuvant breast cancer trial," said Harry Palmin, President and CEO of Novelos. "We look forward to working with Dr. Montero, Sylvester Comprehensive Cancer Center, as well as key opinion leaders and the FDA on a design for a possible larger randomized controlled trial in breast cancer."

"The efficacy seen in this trial is of particular interest in relation to our growing understanding of NOV-002's mechanism of action," said Christopher Pazoles, Ph.D., Vice President of Research & Development of Novelos. "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."