$5.5m raised from rights issue, page-64

Okay so I have done some of my own research trying to learn about drug trial phases although I must admit I am still quite confused. It seems that the nature and rarity of the disease means the normal protocols and numbers are not really followed.

-These are my understandings/assumptions-

Patrys started a trial to consist of four cohorts of three patients each with escalating dosages primarily to test safety and secondarily to test effectiveness.

Cohort 1 - 3 patients are given a low dosage that could only be expected to test safety. No issues with the drug but also no effect (as expected so good result).

Cohort 2 - 3 patients are given 1mg/kg. I'm not sure if this was expected to have an effect but one patient had stable disease. This patient later required additional treatment. No negative safety effects on drug.

Cohort 3 - 3 patients are given 3mg/kg. Again no negative effect. One patient had stable disease. At the time of announcement (+82 days) this patient has not required additional treatment.

Cohort 2 and 3 - of the 6 patients, 5 went on to receive additional treatment, of these 5, 2 responded positively to treatment that they had previously been resistant to. Median time to next treatment is 42 days.

Cohort 4 - 3 patients are given 6mg/kg, this is stated to be more in line with the dosage levels of other antibodies. Of the two patients that are evaluable neither show any negative effects. Of the two that are evaluable both have shown stable disease (no days count provided as to how long after test this has been).

This trial has been referred to as a Phase I/IIa trial. From wikipedia (maybe not the best source) Phase I is a sub therapeutic dose to test safety. Phase IIa is a therapeutic dose primarily to determine what is the best prescribed dose. Phase IIb is designed to test efficacy as is Phase III.

-Questions if anyone is able to help-

1) Since the aim of Phase I is to determine safety, is it assumed that it is safe at levels up to 6mg/kg but not beyond? Are we now limited in any further (larger scale) trials to this dosage level unless we repeat a smaller trial? Or can it be inferred that the drug is safe at a higher level for further trials?

2) Since the aim of Phase IIa is to determine the best therapeutic dose, have Patry's decided this is 6mg/kg? If there was a 66% confirmed (and potentially 100%) stable disease rate at 6mg/kg why not go higher (assuming third patient shows no safety issues)? How do Patry's determine what level to use in the Onyx trial?

3) What phase is the Onyx trial? Is this still a detail to be determined?

4) What are the (positive) effects of the drugs currently on the market? Do they achieve more than stable disease? The reason I ask is that we achieved stable disease in 4 out of 11 patients that had no success with other treatments*, to me this seems sensational, imagine the effectiveness if this was the frontline treatment.

5) A follow on from my statement above marked by an asterix. Can we assume that they did not achieve stable disease with the other treatments or could the previous treatments have had an initial positive effect that then subsided or was not repeatable/maintainable?

6) For (at least) one patient, the treatment showed stable disease but then required additional treatment after the test. If this drug was not in trial stage, would another round of PAT-SM6 be a viable treatment option or would all the possible effect be gained from one round of treatment (e.g. that didn't work, onto the next treatment option OR that worked but didn't solve it, repeat same treatment)?

Questions from previous post still stand.

I appreciate any help and realise that this is a pretty large imposition.