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Novelos Therapeutics Provides Product Pipeline Update

Stocks in this article: NVLT

MADISON, Wis., May 16, 2013 /PRNewswire/ --  Novelos Therapeutics, Inc. (OTCQX: NVLT), a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, today provided an update on its product pipeline, including I-124-CLR1404 (LIGHT) positron emission tomography (PET) imaging agent for solid tumor indications, I-131-CLR1404 (HOT) cancer-targeted molecular radiotherapeutic for advanced solid tumors and CLR1502 (GLOW2) optical imaging agent for intraoperative tumor margin illumination in real-time and non-invasive tumor imaging.

"We are excited to be advancing multiple product opportunities aimed at significant unmet needs, all based on Novelos' proprietary cancer-targeted delivery platform," said Harry Palmin, President and CEO of Novelos.  "Our development plan is centered on advancing compounds that we expect to most rapidly achieve significant development milestones.  Both LIGHT and GLOW2, subject to additional funding, are expected to reach such milestones by the end of 2014."

LIGHT is a small-molecule, broad-spectrum, cancer-targeted PET imaging agent.  LIGHT Phase 1-2 clinical trials are ongoing across 11 solid tumor indications.  These trials have demonstrated initial proof-of-concept in multiple tumor types, including primary and metastatic brain cancer.  Novelos expects to start a LIGHT Phase 2 imaging trial in brain cancer at the beginning of 2014 and, subject to additional funding, complete the trial by the end of 2014.  This trial will compare LIGHT imaging of glioma with standard of care based on pathology confirmation in approximately 30 patients.

"In early PET imaging trials with I-124-CLR1404 (LIGHT) in primary and metastatic brain cancer patients, we have observed high tumor-to-background ratios," said Lance Hall, M.D., Assistant Professor of Radiology at the University of Wisconsin Carbone Cancer Center, and the principal investigator for the Phase 1-2 trials in brain cancer.  "These data provide a strong rationale for rapidly transitioning to a Phase 2 trial in glioma patients to compare I-124-CLR1404 PET imaging to magnetic resonance imaging (MRI), the current standard of care in this patient population, where a significant unmet medical need exists for post-treatment efficacy assessment and differentiating tumor growth from pseudoprogression."

HOT is a small-molecule, broad-spectrum, cancer-targeted molecular radiotherapeutic that delivers cytotoxic radiation directly and selectively to cancer cells and cancer stem cells.  Novelos has completed the third cohort in a U.S. multi-center Phase 1b dose-escalation safety trial with HOT in cancer patients with advanced solid tumors.  Data from the two-patient third cohort  indicate the onset of dose-limiting hematologic toxicities with HOT, triggering enrollment into a five-patient fourth cohort at a dose midway between those used in the second and third cohorts, as per trial protocol.  To date, three of the six patients with advanced refractory solid tumors treated with HOT had stable disease for up to four months, according to standard response evaluation criteria in solid tumors (RECIST 1.1), and confirmed by independent review.  Details of the trial design are available on ID: NCT01495663, or at in the 'Clinical Trials' section.

"We are approaching the stated objective of the Phase 1b dose-escalation trial to determine the Maximum Tolerated Dose of I-131-CLR1404 (HOT)," said Glenn Liu, M.D., Associate Professor of Medicine and Director of the Cancer Therapy Discovery and Development (Phase I) Program at the University of Wisconsin Carbone Cancer Center, and the trial's principal investigator.  "We continue to observe selective uptake of I-131-CLR1404 in a variety of tumor types where it persists in excess of 21 days."

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