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. 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.” About Breast Cancer Breast cancer remains a serious public health concern throughout the world. According to the American Cancer Society, approximately 192,000 women in the U.S. were expected to be diagnosed with breast cancer in 2009, and approximately 41,000 were expected to die from the disease. Neoadjuvant or preoperative systemic chemotherapy is commonly employed in patients with locally advanced stage-III breast cancer and in some patients with stage-II tumors. Administration of neoadjuvant chemotherapy reduces tumor size, thus enabling breast conservation surgery in patients who otherwise would require a mastectomy. Furthermore, several studies have shown that pathologic complete response (pCR) following neoadjuvant chemotherapy is associated with a significantly higher probability of long-term survival. However, only a small fraction of patients with HER-2 negative breast cancer achieve a pCR with standard neoadjuvant chemotherapy. About NOV-002 for Breast Cancer Cytotoxic chemotherapy is generally regarded as immunosuppressive because of toxicity towards dividing cells in the bone marrow and peripheral lymphoid tissue. It is now understood, however, that some chemotherapeutic agents referred to as “immunogenic” may enhance the antitumor effects of immunotherapy by acting directly on the tumor and host environment. Immunogenic chemotherapy agents commonly used in the treatment of breast cancer include cyclophosphamide, anthracyclines (such as doxorubicin) and gemcitabine. NOV-002 is believed to act via generation of oxidative signals that mimic physiological regulatory mechanisms for a variety of redox-sensitive cell processes and functions. In tumors, this results in inhibition of cell proliferation and of tumor invasiveness/metastasis. Of particular interest in the context of breast cancer therapy, NOV-002 displays multiple forms of in vivo immunomodulation which, when combined with immunogenic chemotherapy, may increase anti-tumor efficacy. Thus, NOV-002 alone increased effector T cell responsiveness to tumor antigens and elevated levels of memory T cells in tumors and spleen in animal tumor models. When combined in such models with the immunogenic chemotherapy agent cyclophosphamide, NOV-002 increased survival and decreased tumor growth compared to chemotherapy alone. It also inhibited the activity of myeloid-derived T cell suppressor cells. Such data supports the hypothesis that the immunomodulatory activities of NOV-002 may enhance the anti-cancer efficacy of immunogenic chemotherapy such as that commonly used in treating breast cancer. About Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine opened in 1992 to provide comprehensive cancer services and today serves as the hub for cancer-related research, diagnosis, and treatment at UHealth -- the University of Miami Health System. Sylvester handles nearly 1,600 inpatient admissions annually, performs 2,700 surgical procedures, and treats more than 3,700 new cancer patients. All Sylvester physicians are on the faculty of the Miller School of Medicine, South Florida’s only academic medical center. In addition, Sylvester physicians and scientists are engaged in more than 200 clinical trials and receive more than $36 million annually in research grants. Sylvester at Deerfield Beach opened in 2003 to better meet the needs of residents of Broward and Palm Beach counties. A major expansion has recently been completed. Deerfield Beach offers appointments with nearly 30 physicians from 12 of Sylvester’s 15 Site Disease Groups, complementary therapies from the Courtelis Center, and education and outreach events. www.sylvester.org About Novelos Therapeutics, Inc. Novelos Therapeutics, Inc. is a biopharmaceutical company developing oxidized glutathione-based compounds for the treatment of cancer and hepatitis. Our lead compound, NOV-002, has been administered to approximately 1,000 cancer patients in clinical trials and is in Phase 2 development for solid tumors in combination with chemotherapy. Novelos is seeking to expand our pipeline through licensing or acquiring clinical stage compounds or technologies for oncology indications. For additional information about Novelos please visit www.novelos.com Novelos Therapeutics, Inc.
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