NVLT..NOVELOS THERAPEUTICS ANNOUNCES POSITIVE PHASE 2 RESULTS
IN NOV-002 NEOADJUVANT BREAST CANCER TRIAL AT SYLVESTER
COMPREHENSIVE CANCER CENTER, AT THE UNIVERSITY OF MIAMI
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Tumor Response Target Achieved – Detailed Results Submitted for Presentation at
SABCS in December 2010
NEWTON, Mass., July 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.
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.
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