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First patient enrolled in HCC phase 2 of cancer trial On June 5 Hollings Cancer Center enrolled the first patient in a second phase trial of neoadjuvant treatment with a new drug in combination with chemotherapy in patients with early-stage breast cancer.   The study involves the use of NOV-002, developed by Novelos Therapeutics, Inc., a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis. Alberto Montero, M.D., MUSC assistant professor of medicine, Division of Hematology-Oncology, is the principal investigator.   The objective of this open-label single-arm trial is to define the rate of pathologic complete response (pCR) in the affected breast after the preoperative administration of NOV-002 in combination with chemotherapy (doxorubicin and cyclophosphamide followed by docetaxel) in patients with stage IIB-IIIC breast cancer. Up to 46 women may be enrolled in the trial, and receive up to eight cycles of NOV-002 in combination with chemotherapy. Interim results are expected mid-2008. Visit http://www.novelos.com under ‘Clinical Trials’ section.   “We are very pleased to be expanding our collaboration with MUSC, a leading medical research institution,” said Harry Palmin, president and CEO of Novelos. “Our phase 2 cancer programs  include early-stage breast cancer in addition to chemotherapy-resistant ovarian cancer. Meanwhile, Novelos remains on-track for full enrollment of our pivotal Phase 3 trial of NOV-002 for lung cancer in the first quarter of 2008.”   Neoadjuvant therapy in early-stage breast cancer patients reduces the size of tumors, allowing for surgical removal with less tissue damage than if no prior chemotherapy was employed. Several studies have provided evidence that the development of pCR following neoadju-vant therapy may be associated with a higher probability of long-term survival. However, only approximately 20 percent of patients treated with current neoadjuvant chemotherapy achieve pCR.   “In patients with various advanced solid tumors, NOV-002 administered in conjunction with standard chemotherapy has significantly enhanced the anti-tumor efficacy as well as better toleration of chemotherapy,” said Montero.     Friday, June 22, 2007 Catalyst Online is published weekly, updated as needed and improved from time to time by the MUSC Office of Public Relations for the faculty, employees and students of the Medical University of South Carolina. Catalyst Online editor, Kim Draughn, can be reached at 792-4107 or by email, catalyst@musc.edu. Editorial copy can be submitted to Catalyst Online and to The Catalyst in print by fax, 792-6723, or by email to catalyst@musc.edu. To place an ad in The Catalyst hardcopy, call Island Publications at 849-1778, ext. 201.