Almost all phase 1 trials I've seen have been tiny. There are very few exceptions to this in the hem/onc world, particularly for unproven cancer therapies.
On point 2: this is an encouraging early sign, and it tracks with about what I expected to see as far as efficacy. Tumor cell infiltration by immune cells, an early correlate that SOMETHING is going on.
The big sticker is whether observations of stable disease is going to be enough. Obviously, if you can keep a patient's cancer stable, then you've technically turned it into a chronic disease. However, in traditional therapy, stable disease generally signals that treatment has not worked, or that it is about to stop working.
Therefore, I don't view "stable disease" results as inherently negative, especially with immunotherapy. But ADXS is definitely going to have its work cut out for it when it comes to convincing others that something meaningful is going on, since they're not seeing bona fide responses (which is not surprising for a phase 1 study).
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