What do you think about THLD?
Will they give us TH302 updates after each cycle, especially if tumors dissappear completely as they did with the mice?
How about G+G?
How will THLD survive?
If it has a too high toxicity, of course the FDA will stop the trial anyway. I am still waiting to hear from Denise to confirm if phase 2 results are still scheduled to be released during 3rd qarter and I will post as soon as I hear.
Perhaps you could ask Denise in a different way and get a "better" answer:
If TH302 is not working at all, or is toxic after a couple of cycles, would Threshold stop the trial let investors know?
This way, the longer we don't hear anything, the more likely it's working?
I'm just saying, if tumors disappear completely in ALL of the early enrollments, will they let us know?
I know the answer is "no". I'm just surprised, because if they can cure cancer, and because we all have almost a total loss here, the least they could do is let us know...say, before bankruptcy next year.
It has been my contention that Sofinnova, Selick, Powell, etc. want this company to go bankrupt so they can own the pipeline for free. Then, TH 302 cures cancer and THEY become billionaires.
It all points to that. I am sure they are pissed off at you, me, and everyone else who keeps bending their ear. So what better way to get revenge: steal.
I just got an email from Denise. She said they will not release any intermitent data from the TH302 trial. She said they will announce when they expect to have results after they have completed enrollment of the trial. When that happens who knows.
SMAC - don't hold your breath for interim TH302 data - I haven't seen any companies that disclose clincial results in a piecemeal fashion - it could be illegal/improper (from an SEC full disclosure perspective) or it could just be bad form (anything but a statistically complete result would be dismissed by the market).
What THLD desperately needs is positive data from the G+G trial, which should be coming soon, right? If the P2 pancreatic trial fails, the market will write Glufo off, and you'll be left with whatever the company can salvage by selling the pipeline to another company - a stock offering is out of the question if the P2 pancreatic trial fails.
For better or worse, management bet the farm on the pancreatic cancer indication, which in hindsight looks pretty stupid. Remember, Glufo is just an advanced formulation of an already approved chemo agent that is used in a range of cancers, but not pancreatic. They jumped on the pancreatic indication because of a single complete remission in an earlier trial (see the website) and because there was a void in the market for pancreatic treatments, so a win would be huge. But then they go and waste alot of resources on the P3 end-stage, standalone trial, which had very little chance of success - by management's own admission (after the trial failed), they were essentially treating patients on their death beds, who were so sick that very few of them could handle more than one cycle of treatment, let alone respond to it? So, now we're left with a prayer on the P2 trial - the odds are better, but it is pancreatic cancer, so the odds are probably not good? But if you've held on this long, you might as well see the finish - good luck!
Tredleon... Not quite true regarding the phase III trial based on one patients complete response as there was a phase II trial reported in 2003 with glufos in pancreatic cancer, i guess this was a first line phase II trial...
<In the Phase 2 trial in patients with advanced pancreatic cancer, two of 34 patients achieved a partial response (defined as 30% or greater tumor diameter shrinkage) and 11 of 34 patients achieved stable disease (defined as less than 30% tumor diameter shrinkage and less than 20% growth in tumor diameter). Overall median survival with glufosfamide was estimated at 5.6 months, and two-year survival was estimated at 9%. The preliminary results of this study, published in the European Journal of Cancer in November 2003, reported a median survival of 5.3 months.>
Gemzarr phase III results as first line therapy roughly equal...
<Gemzar is the standard of care for the first-line therapy of advanced metastatic pancreatic cancer. The largest published trial of Gemzar in advanced pancreatic cancer reported a median survival of 5.4 months. In Gemzar's Phase 3 registrational trial, median survival was 5.7 months, and no patient survived beyond two years. In this study, patients treated with 5-flurouracil, or 5-FU, the previous standard of care, had a median survival of 4.2 months, and no patient survived beyond two years. None of the 126 patients treated in both arms of this study achieved tumor shrinkage.>
SO gemzar alone in this setiing median survival 5.7 months, glufos alone in first line therapy median survival 5.3 months.
The animal data are suggestive that gemzar and Glufos together gives better results than gemzar alone, and with the response data of this phase II trial known, and they are suggestive of potentially improved response, gives reason to be a little bit optimistic.
The phase III trial had 19% better median survival compare to normal care, so if they can get median survival in this phase II trial to be 19% better than gemazar results alone that would be good enough, to warrant a phase III trial. The key number then is can the combo get median survival up to 6.8 months,.
Tarceva was approved for treatment with gemzar in pancreatic cancer with just a 2 week improvement in survival!!!! Since the phase III trial increased median survival by 3 weeks after failing gemzar, they should easily beat tarceva gemzar combo results in pancreatic cancer.
The competition is tough though in pancreatic cancer, re Pfizer...
< Interim results from a Phase II trial showed the addition of axitinib to Eli Lilly's Gemzar conferred a median overall survival of 6.9 months compared to 5.6 months for single-agent Gemzar, which translated into a 26% reduction in the risk of death.>
This phase II result by pfizer was reported in june of this year, and is probably the reason why THLD has drifted lower since june as the bar was raised for their combo trial results based on the Pfizer trial.
Interesting that in the phase II trial the Pfizer combination had a 22% partial response rate! Similar to Glufos combo partial response rate.
So i think this phase II combo trial for glufos has a chance.
SO 6.9 months of median survival will be needed to get me excited again about glufos combo... as Pfizer is expected to start a phase III trial for its combo in pancreatic cancer shortly.
PS. One more thing, in our favor I hope:
The list of credentials for the team at Threshold is absolutely incredible. I cannot believe that Dr. Matteucci and everyone else would have allowed their name to be associated with this and Selick if they didn't believe in what they were doing - setting out to cure/treat cancers. There is no way this can be the end for their reputations. I don't see Matteucci involved in any stock shennanigans esp. via Sofinnova, options repricing, etc., so he must be doing this for the cause alone, IMHO.
If THLD fails into BK, Selick and Powell are Mudd as far as I'm concerned for the rest of our lives.
Re: letting us know if the first TH 302 cycles are working.
1. Since the mice were "cured", I'm hoping that they observe such stellar results right away, they feel compelled to let everyone know.
2. If G+G fails, this company is pretty much done. Sofinnova or someone else with questionable connections to the company will probably scoop this up after BK, and get all the rights to TH 302, 2DG, etc. etc. Selick's picture is on the Sofinnova website, along with Michael Powell who is the brother of Denise Powell, the THLD IR person, so they all seem to be in bed together.
If G+G succeeds and TH 302 shows good results, perhaps the stock will soar and we'll all have a good time.
Selick appears to be still holding a large number of shares. I would say this suggests he is in our corner, except for that little connection with Sofinnova (he'll make bank either way, probably).
You can tell I am very angry about Selick. Why shouldn't I be?:
1. He's getting (us) sued for TH 207
2. His wife does work for THLD as the CEO of Medbic
3. There's some weird relationship with Sofinnova.
4. Glufo by itself (failure)
BUT, miracles do happen.
This is pretty much a total write off for me, and certainly my very last experience with Biotechs if not all individual stocks as a whole.
"P2 trial - the odds are better, but it is pancreatic cancer, so the odds are probably not good?"
Of course odds are not good. That�s the main reason PPS is @ present levels.But????? well I think you know. Rather, I know you know. Excelent post!