Aposense Ltd. (TASE: APOS) today reported the initial results of its ML-10 molecule, an imaging radiotracer for the early detection of response of brain tumors to chemoradiotherapy, which was found to be safe, but statistically insignificant in effectiveness. The share price fell 39% to NIS 6.91, giving a market cap of NIS 180 million.
The basis of the trial was to test whether the ML-10 molecule could immediately test whether chemoradiotherapy was effective in a patient, instead of waiting for weeks to check by MRI a change in the tumor's size. This would save unnecessary medication that does not work and maximize the effective of therapies.
43 patients at seven US oncology centers participated in the trial under US Food and Drug Administration (FDA) Investigation New Drug IND) protocols, of whom 31 patients completed the course. The number is logical for trials of brain tumor therapies, but also indicates the complexity of the treatment.
Analysis of the first 14 patients in the study found no statistically significant difference between ML-10 success 20-30 hours after treatment and MRI results several weeks later.
Aposense said that if it slightly changed the mathematical equation used for the predictions, it obtained statistically significant results, but that since it had already notified FDA of the equation for the study any retroactive change to the equation would be bad science.
Aposense is now considering whether to give up on ML-10, as it has other molecules in the pipeline, or complete the current study on all the patients using the current equation in hopes of obtaining statistically significant results, or to change the equation and repeat the study with FDA approval.
Published by Globes [online], Israel business news - www.globes-online.com - on December 16, 2012
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