First Cohort of HOT Phase Ib in Solid Tumor Completed

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First Cohort of HOT Phase Ib in Solid Tumor Completed

Grant Zeng, CFA


On May 15, 2012, Novelos Therapeutics, Inc. (NVLT) announced that it has successfully completed the first cohort in a U.S. multi-center Phase Ib dose-escalation trial of its cancer-targeted molecular radiotherapeutic compound I-131-CLR1404 (HOT) in cancer patients with advanced solid tumors.  

The first two-patient cohort was successfully dosed with approximately 20 mCi of HOT, triggering enrollment into the second cohort at approximately 40 mCi. First patient has been enrolled in the second cohort, and additional results will be available in 3Q12.

Glenn Liu, M.D., University of Wisconsin Carbone Cancer Center, is the trial's principal investigator.  Detailed trial results are expected to be presented at a scientific venue at a later date.

Based on animal data, results from a completed Phase Ia dosimetry trial, and now initial data from this Phase Ib trial, HOT appears to deliver radiation directly and selectively to cancerous tumors. Data from the first cohort indicates HOT was well-tolerated, without any grade 3 or 4 toxicities, enabling enrollment of the first patient in the second cohort.  HOT uptake in cancerous tumors persisted for at least 21 days.  One patient with advanced prostate cancer remains on trial at two months following treatment with HOT, while another patient with advanced colorectal cancer has completed the trial.

NVLT looks forward to adding two additional clinical investigators to the trial, Joanne Mortimer, M.D., at the City of Hope and Michael Pishvaian, M.D., Ph.D., at Georgetown University.

NVLT intends to combine the data from this trial with calculation of effective doses for HOT based on quantitative positron emission tomography (:PET) tumor imaging data using I-124-CLR1404 (:LIGHT), the Company’s small-molecule cancer-targeted PET imaging agent. Together, these data will enable NVLT to commence HOT Phase II proof-of-concept trials in 1Q13 in cancer patients.

We are glad that NVLT is on track to advance its clinical programs. Current valuation for NVLT is low and represents an opportunity to get in at this time.  

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