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.”
“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.”Additionally, on November 30, 2010, Novelos effected a share exchange by issuing 340,935,801 shares of common stock in exchange for all outstanding shares of two series of preferred stock. The preferred stock represented a cumulative liquidation preference of $27.3 million prior to exchange into common stock and had been convertible at $0.65 per common share. In the share exchange, the common stock was issued at $0.08 per common share, calculated as the liquidation preference divided by the number of shares issued, representing a 100% premium over market price. The share exchange eliminated special voting rights previously held by the preferred stockholders, $2.4 million of accumulating annual dividends and the $27.3 million liquidation preference. Following the share exchange, Novelos has approximately 453 million shares of common stock outstanding. “We are very pleased that NOV-002 demonstrated positive results in this Phase 2 neoadjuvant breast cancer trial, and we will continue to explore NOV-002 development in combination with immunogenic chemotherapy,” said Harry Palmin, President and CEO of Novelos. “Meanwhile, the recently completed share exchange simplifies our capital structure and is expected to facilitate ongoing efforts to expand our oncology pipeline through licensing or strategic acquisition.” 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 CancerCytotoxic 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—University of Miami Health System. Sylvester handles 1,300 inpatient admissions annually, performs 3,000 surgical procedures, and treats more than 4,300 new cancer patients. All Sylvester cancer specialists 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 $41 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, and now offers appointments with 30 physicians from 14 of Sylvester’s 15 Site Disease Groups, complementary therapies from the Courtelis Center, and education and outreach events. Sylvester recently opened a satellite facility in Kendall as well. http://www.sylvester.org About Novelos Therapeutics, Inc. Novelos Therapeutics, Inc. is a biopharmaceutical company developing oxidized glutathione-based compounds for the treatment of cancer. 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.
One Gateway Center, Suite 504Newton, MA 02458 This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators’ ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement.