Tao Synergies Inc (TAOX)

[InTheTrenches]

Kid2:

I listened to the Noble presentation, and I had the same reaction as you: it seemed like she just breezed over the Phase 2a results, answering someone's question at the end. Something like "we got what we were expecting", "we saw responses after a few hours", "we're going to release the results in a future presentation/journal". I thought she was just brushing off the questions, and it was concerning to me.

So, I did a little digging into past PRs, and I now feel much better about holding my investment here.

The purpose of the Phase 2A was to test safety, tolerability, PK/PD and efficacy of a single dose. Animal studies showed that a single dose isn't expected to have efficacy.

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Here are the 2 press releases on the Phase 2a results:

1. 2/24/15 PR (top-line results):

"...positive top-line results from its...single dose Phase 2a clinical trial evaluating bryostatin-1 for Alzheimer’s...no safety signals...well tolerated. The secondary objectives...were the preliminary evaluation of the efficacy of a single dose of bryostatin in the treatment of patients with AD, its pharmacokinetics and pharmacodynamics...


2) 3/17/15 PR (final results):

CEO Ramat said: "...confirm the preliminary findings of the Phase 2a study...showing good safety and tolerability. Now we can add that we achieved expected outcomes on the exploratory endpoint of PKCe activation...this is a small trial population [but] we are still greatly encouraged...”

----> An additional secondary objective of the study was the evaluation of efficacy following a single dose of bryostatin. As expected with a single dose of bryostatin, there was no measurable improvement in cognition in this mildly impaired patient population. It is important to note that in previous animal studies improvement of learning and memory was first observed following multiple doses of bryostatin. <----


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Multiple doses are required. In the Phase 2b, I believe there are 2 initial doses, followed by 9 doses over 12 weeks. There are 2 groups, each with a different dose level (20ug and 40ug).