RE:RE:RE:RE:Q3 Results + UpdateI bought more.
Phase 1 of a clinical trial determines whether the drug is safe to check for efficacy.
Phase 2 determines whether the drug can have any efficacy; at this point, the drug is not presumed to have any therapeutic effect whatsoever
Phase 3 determines a drug's therapeutic effect;
TR is in Phase 1a i.e., "Single ascending dose" to determine whether the drug is safe for efficacy.
In a single ascending dose study a small group of subjects are given a single dose of the drug while they are observed and tested for a period of time to confirm safety.
Typically, a small number of participants, usually three, are entered sequentially at a particular dose. If they do not exhibit any adverse side effects, and the pharmacokinetic data are roughly in line with predicted safe values, the dose is escalated, and a new group of subjects is then given a higher dose.
If unacceptable toxicity is observed in any of the three participants, an additional number of participants, usually three, are treated at the same dose.
This is continued until pre-calculated pharmacokinetic safety levels are reached, or intolerable side effects start showing up (at which point the drug is said to have reached the maximum tolerated dose (MTD)). If an additional unacceptable toxicity is observed, then the dose escalation is terminated and that dose, or perhaps the previous dose, is declared to be the maximally tolerated dose.
This particular design assumes that the maximally tolerated dose occurs when approximately one-third of the participants experience unacceptable toxicity. Variations of this design exist, but most are similar.
Once a maximally tolerated dose is established the clinical trial is continued to Phase 1b and Phase 2 etc...
The TR conference call will discuss the maximally tolerated doses that were found so far.
The Nov 10 news release (that started the huge decent):
Over the last several months, we’ve continued to advance our lead drug candidate, TTI-621, in the clinic,” said Niclas Stiernholm, president and CEO of Trillium Therapeutics. “We established a well-tolerated dose of TTI-621 in first part of the Phase 1a/1b trial in relapsed or refractory hematologic malignancies and look forward to presenting data at next month’s ASH meeting. We are now in the multi-cohort expansion portion of the trial, seeking to further characterize safety and preliminary antitumor activity of TTI-621 in multiple cancer types. We will also evaluate the agent in combination with rituximab in patients with CD20-positive lymphomas. Separately, we are commencing the Phase 1 clinical trial of TTI-621 in solid tumors and mycosis fungoides.”
what is is so worrisome of these comments?