Post by dig on Mar 22, 2016 18:11:50 GMT -5
Question: 1) regarding the 2001 extension, I was curious about the 2 or 3 patients that are no longer eligible. I assume that something has changed that they now meet Key Exclusion Criteria.
Answer) a few of the patients were dosed at a different site that they did not open for the extension.
Question) Can you talk about 2001 extension study a little? From what I hear dosing started in January. Can you verify this? Can you give me an idea of participation rates?
Answer) no he would not talk about it
Question: 2) regarding recently reported reoccurring AE (headache and upper repertory infection.) I understand headache but, upper repertory infection? Can that be related? During the annual share holder meeting Chris Anzalone mentioned we should expect to see SAE’s in phase 2.
Answer: I got the impression they were going to report AE’s as they encounter them. Maybe everyone is completely aware of how this works but, Every AE is reported during the entire test period so if a patient gets a headache or upper repertory infection during the test period it gets reported. They will be dosing nearly 300 patients for the better part of a year. During the entire year if someone gets a headache or …… it will be reported, so they are expecting AE’s and SAE’s. That does not mean they expect it to be drug related.
Question: 3) Monarch I got the impression that Monarch is going to be expanded beyond Australia and New Zealand. Is this the intent?
Answer: The reason they started in Australia and New Zealand is they are more open to a novel – novel drug combination. He indicated it is not out of the question to open sites in other countries.
Question: 4) will 521 KD the x protein in the IDNA or just sAg?
Answer: He gave me a more technical explanation but, what I got out of it is trigger they kept from 520 should KD the truncated x.
He did say they have been talking about the importance of the x protein for years and the rest of the field is starting to catch up. He indicated that they took that into consideration when they chose the triggers for ARC-520.
Question: 5) Regarding Collaborations will preclinical tests need to be done on the drug combinations?
Answer: they did not think it would be necessary depending on the combination but, it will be up to the regulators.
Question: 6) During the annual share holder meeting Chris Anzalone mentioned 6 clinical programs currently or 8 with sub q. can you comment on the 2 additional sub-Q programs
Answer: He would not elaborate on what the additional sub-q candidates were but, he did make it sound as if they were not going to do ARC-520 sub-Q. This leads me to believe these are new targets.
Question: 7) I am aware of the study to minimize the infusion rates but, what are the current infusion rates with arc-520
Answer: ARC-520 infusion rate is currently about 18m to 20m.
