Novelos Therapeutics, a Madison, Wis.-based pharmaceutical company focused on cancer, has successfully completed the first cohort in a 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 20mCi of HOT, triggering enrollment into the second cohort at approximately 40mCi.
"Patients with advanced solid tumors need safer and more effective therapies," said Glenn Liu, M.D., the trial's principal investigator. "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.
"We intend 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), our small-molecule cancer-targeted PET imaging agent," said Harry Palmin, president and CEO of Novelos. "Together, we believe these data will enable us to commence HOT phase II proof-of-concept trials in the first quarter of 2013 in cancer patients that have significant unmet medical need."