RE:RE:RE:RE:RE:RE:RE:Updated time line
Wino115 wrote: Right - seems most severe in midwest, FL and some New England parts right now. Mid Atlantic a bit too. Hopefully they will get Cedars Sinai in LA open as a center as that could probably fill half the quota of 1b right there given it's status and population center.
If we get lucky and the path is similar to South Africa, it should start fading in a month or so (although we have winter now). It doesn't appear they will be rolling in to the extension portion of the trial for 2-3 months at best. Maybe even longer as you point out. It will likely look a lot different by then, but who knows with this crazy virus!
Let's just focus on getting to 1b results!! I really just want to get a read on how this pipeline's potential is measuring up. That will do a whole lot to move our "outcome probability curve" further to the positive and hopefully eliminate some of the negative tail and increase the positive tail --even just a tad of POC would do that. I'll worry about 1b once that commences, but I would just be wildly excited about starting it with the right patients to show what targeting sortilin on a tumor can actually do in humans.
jeffm34 wrote: It's 100% staffing issues right now. Every facility is struggling to keep basic services open.
Wino115 wrote:
I think the oncology centers are generally separate type of facilities. Some are only oncology centers, some are the oncology soecialization within a larger hospital system. While they can still have staffing issues, I don't think crowded ICUs are an issue for enrollment. Just the normal Covid issues with patients and staffs.
Without guidance, any timeframe could be right. I suspect it will be longer but they will announce some data points each quarter or at conferences if they are meaningful and they have definitive answers. Let's hope the FDA pushes for accellerated and breakthrough and that gets them more support with patients and study centers to move quicker. The FDA would have an incentive to see an unmet need with safety pushed fast for the sake of patients. No delay boys!
jeffm34 wrote:
I guess you don't know anything about clinical trials. Just like last year when I said we wouldn't see any initial efficacy data from the phase 1 trial until first quarter 2022 at minimum. You all said we would see some by the middle of 2021.
We are still at least a month (or 2) from part 2 starting.
How long do you think it takes to enroll 40 patients? Throw in what COVID is doing to hospitals right now and all the other experimental treatments competing for those same patients. 4-6 months is not unreasonable to enroll 40 patients.
What is treatment and follow up time for each patient? How many cycles will each receive? 3 cycles and follow up would be around 3 months.
How long do you think it takes to compile and release data from a trial? 2-3 months
So no, it is not unreasonable to think we won't see the full phase 1 trial results until 2023.
The company has said they would release individual data points along the way if it looks good but don't expect to see the full trial results for another year and a start date for a 2 year phase 2 trial around mid 2023.
jfm1330 wrote: Yes, this guy is posting messages with false content. That being said, phase Ia is taking longer than expected, that is clear, but it is false to assume that phase Ib will take as long. Phase Ib will not involve sequential dose escalation. In theory the planned 40 patients could be treated all at the same time with the same dose per body surface area (m2). It will not happen for practical reasons, but it is likely to take much less than a year if enrollment is easy.
longterm56 wrote: I think I'll wait to hear from THTX, rather than assume the worst and create fictional schedules without any facts. "Fear, uncertainty, and doubt (often shortened to FUD) is a propaganda tactic used in sales, marketing, public relations, politics, polling and cults. FUD is generally a strategy to influence perception by disseminating negative and dubious or false information and a manifestation of the appeal to fear."
jeffm34 wrote: According to the clinical trial website the estimated completion date for the phase 1 trial was March 2022.
https://clinicaltrials.gov/ct2/show/NCT04706962
Now we know part 1 should likely be completed by March 2022. Almost 1 year after they started. Part 2 will involve more patients so we can assume it will take as long or more likely longer than part 1. So now we are looking at least March 2023 to finish the phase 1 trial which means the trial is already a year behind schedule!
I think the pandemic has forced changes to our ways to get things done. From increasing digital marketing to remote health care and conducting clinical trials among others. They are now suggesting decentralized trials so some information is exchanged through virtual communication and others by home visits. Obviously the pandemic will end at some point but some of these new electronic communications will probably will replace the traditional face to face interactions due to the fact that they are more efficient, less time consuming and costly. Another thing to factor in is late stage cancer patients are very motivated so there will be high compliance to adapt. So again in my opinion absent any updates all we know is their estimates were rather underestimates for the time line as this is an unique trial and the extended duration is based on the fact that they pause few weeks between cycles and gather data. Of course there could be some Covid related issues but I doubt that would explain such a extended time line. On a side note I actually tested positive for covid19 4 days ago now I am triple vaccinated and I have to say apart from mild symptoms in the first two days I feel quite good now. Ontario like US has shortened the quarantine days to 5 to deal with staffing issues. The argument behind it the transmissibility of the infection is reduced by 90 per cent after 5 days. I think eventually we are all looking at some sort of herd immunity and the virus looses it’s strength like omicron and that would be the end of this madness.
“For example, in one fully decentralized registry for Duchenne Muscular Dystrophy conducted by THREAD, participant registration increased 50% in 2020 compared to previous years, driving recruitment for over a dozen clinical trials [15]. The use of eConsent, eCOA, surveys, and remote health solutions alleviate participant concerns while providing sponsors with robust data collection. While studies running when the pandemic struck may have struggled to adjust to changing circumstances, these data suggest a higher degree of resilience for decentralized trials.
These industry trends mirror our experience where we have seen a significant increase in decentralized study interest from both sponsors and CROs. This includes the use of eConsent, telehealth, home health, and remote data collection methods. Studies specifically targeting COVID-19 have incorporated several decentralized elements.
For example, the University of Cambridge’s HEAL-COVID study is a pragmatic platform trial of widely-available generic medications attempting to reduce mortality and hospital readmissions in the post-hospitalization period of COVID-19 [19]. The study takes a hybrid approach with participants recruited and consented on discharge from hospital with a smartphone app to capture ePROs on breathlessness, fatigue, and other symptoms in seven languages, along with analysis of linked real-world data from NHS digital.”
https://www.tandfonline.com/doi/full/10.1080/17434440.2021.2014818