Initial LIGHT Data from Phase I/II Trial Are Encouraging
Grant Zeng, CFA
Early today (April 24, 2012), Novelos Therapeutics, Inc. (NVLT) announced that the University of Wisconsin Carbone Cancer Center has successfully completed the first cohort in a Phase I/II PET imaging trial of I-124-CLR1404 (:LIGHT), a cancer-targeted PET imaging agent, in patients with advanced non-small cell lung cancer (:NSCLC).
As a reminder, an investigator-sponsored Phase I/II trial of LIGHT as a PET imaging agent for lung cancer was initiated in December 2011 at the University of Wisconsin Carbone Cancer Center (:UWCCC) and first patient was enrolled in February 2012. Dr. Anne M. Traynor at UWCCC is the principal investigator. Novelos provides funding for the trial and the data is shared with Novelos while the study progresses and at the conclusion of the study. Up to 12 patients will be enrolled across two dose levels (3 mCi and 5 mCi) in this Phase I/II trial. The trial will be completed in 2012.
The first cohort comprised three patients dosed with LIGHT at 5 mCi. The first cohort has demonstrated positive initial imaging results. In fact, in one of NSCLC patients, LIGHT PET scan clearly identifies a brain metastasis that FDG missed.
• LIGHT is safe and there is no adverse safety signals;
• Strong selective uptake of LIGHT in cancerous tumors against very low background has been observed;
• LIGHT PET scan clearly identifies a brain metastasis that FDG missed in a NSCLC patient
Detailed trial results are expected to be presented at a scientific venue at a later date.
Novelos is now planning to evaluate the next dose level at 3mci in three patients as the Company seeks to identify a minimally effective dose.
Our takeaways from the initial data:
• The preliminary results from the first cohort are positive; the more tumor-selective advantage of LIGHT over FDG for one patient is especially encouraging;
• The excellent safety profile and strong efficacy data could accelerate the completion of the Phase I/II trial of LIGHT as a lung cancer PET imaging agent;
• These data begin to establish proof-of concept for LIGHT as a PET imaging agent for NSCLC; could advance Novelos’ partnering discussions and could be used to calculate effective doses for Phase II clinical trials of I-131-CLR1404 (HOT);
We are glad that NVLT is on track to advance its clinical programs. Current valuation for NVLT is low, and does not reflect NVLT’s fundamentals in our view. The risk/return profile is biased to return at this point.
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