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Biotech / Medical : BSD Medical (Long Term Investment Oriented)
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To: nothingoutofbounds who wrote (96)2/1/2013 12:50:26 PM
From: fwhco2 Recommendations  Read Replies (1) of 178
 
I am interested in why you believed that the trial would meet its endpoints? And did you think that the success was going to help BSD? nothingoutofbounds

As I posted, "Given that RFA is not too effective on tumors >3cm [my understanding is HCC, SOC for RFA, limits usage to <=3cm]. I was very surprised the endpoint wasn't achieved. To me that means the fault must lie with the chemo selected because Thermodox as a delivery system works."

It was my understanding that RFA was limited in Standard-OF-Care for HCC to tumors <3 cm. HEAT was comparing "RFA-alone" in tumors from 3cm to 7cm vs. RFA+T-DOX with the same tumor range. That higher range of tumor size meant to me that the trial success was assured if T-Dox performed as expected, and I believe that was a reasonable expectation. Unfortunately, for Celsion the RFA arm performed 20% better than expected, and the T-Dox arm performed worse than expected so the trial was doomed.

The HEAT trial was started using RFA when it was the only type of ablation available, so the trial needed to be completed using RFA. Had BSD's MicroThermX been used, I would not have expected HEAT to be successful with the parameters set out because MWA does not have a 3cm limitation and is capable of ablation in tumors up to 7 cm.

If the HEAT trial had been successful, I believe there would have been a switch from using RFA to MWA [read MicroThermX]. That would have been very good for BSD because they have the best MWA machine on the market. IMO, MWA will become the SOC for HCC ablations without the use of T-Dox. Using T-Dox held out the promise that any margins left behind would be eliminated.

As you and Ray, I also believe that BSD is at the forefront in hyperthermia.
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