Thanks for taking the time translate the halftime score, LOL
IBX5Cancer Evasion01. Very fortunate to make the
"Annual SABCS submission deadline", and gain industry exposure.
2. Excellent "halftime adjustment" -
Based on the learnings from the first six subject data, we amended the protocol to improve the data collection.3. A leap forward when you can eliminate "Radiologist subjectivity" or "Operator Error" out of the analysis.
What we are seeing in the study is that by using the MagSense® nanoparticles the radiologist can still get the standard size/shape assessment but also gets added information that comes from the change in contrast (darkening of the image) resulting from the nanoparticles when they become attached to tumor cells (the “molecular signature”). The amount of contrast is different if the node is “normal” vs when tumor cells are present. The conclusion being that a test with a molecular imaging agent could provide better radiological assessment and improve on the current clinical standard of care.
This is exactly the use we have been aiming for. Rather than use imaging to identify a “region of interest” or “suspicious lesion”, use a molecularly targeted approach to determine if, in fact, cancer cells are present.4.
The goal of our Phase I study has been to bridge the gap between our pre-clinical studies and human biology. The data we have accumulated to-date recapitulates in human subjects what we found in our preclinical workups –that our imaging agent is detectable, andthe imaging signature helps differentiate when cancer cells are present.
5. Good call on using available funds in a prudent manner, holding off on developing the human sized Magsense Detector until there has been ascertainable data that the existing small animal MRX can verify its effectiveness in this FIH trials.
We have reported that for those patients where we have obtained sufficient tissue,there is a measurable MRX signal,indicating detectability, but we feel we need more samples/data before being able to draw any conclusions that would result in commitment of investment in developing the instrument system.
