I have reviewed the data from phase II trials and as an oncologist, I predict the trials will be negative, that is, Rubitecan will not show an improvement in survival compared to Gemcitabine(study #1) (lucky if it is equal), or compared to 5fu in gem-refractory patients (study #2) or compared to most apprpriate chemo in patients who have failed multiple regimens (study #3).
Pancreatic cancer is very resistant to treatment and I cannot see a weak agent like Rubitecan cause an improvement in survival.
Why do I think Rubitecan is weak? It has shown no activity in chemo-naive patients with colorectal cancer where its sister drug irinotecan has shown significant activity.
It has also shown no sgnificant responses in refractory non-small cell lung cancer:
As far as advanced pancreatic cancer goes, I have read the article on original phase II study which was published in the International Journal of Oncology in 1999. 107 patients were enrolled in the study. Not all patients had advanced disease; 16 patients had stage I or II disease. Although the study claims a 31.7% response rate, this percentage excludes 47 patients who did not complete a minimum of 2 courses of treatment, which obviously selects out the good patients; 31.7%(19/60) was using 60 patients as the denominator and 19 as the number of responding patients. Only 9 of 107 (8.4%) patients had documented reduction of over 50% on their CT scans, a so-called partial response, according to the article. This is truly the the only objective way of measuring a major response. Of the 9 patients with partial responses, 4 had either stage I or II disease.
Of the 19 patients classified as having a reponse, 17 patients had improvement in quality of life, meaning 16 percent (17/107=16%).
Gemcitabine has a PR of about 8-13% and improves QOL in about 23% of patients. So in my mind, there is no way that Rubitecan will come out superior to Gemcitabine.
Regarding the Gem-refractory patients, at ASCO 2000, and updated later that year in another meeting, it was reported in their phase II study of gem-refractory patients that 9% responded to Rubitecan.
If these results are duplicated in the phase III study, you can bet there will be no significant improvement in survival.
The third study which compares Rubitecan to most appropriate chemo agent is predisposed to failure also, because advanced pancreatic cancer patients who have failed multiple chemo regimens are in very bad shape and have very short survivals and a lot of them are unlikely to be even able to complete/tolerate further treatment, and a weak agent like Rubitecan is not going to change that.
To see how difficult it is to improve the survival of pancreatic cancer patients, read some of the randomized studies that were reported at last year's ASCO:
The fact that they have not released any data yet, even though they said last year that they would file an NDA by the end of the year 2001, makes me more confident in my prediction of negative results.
Let me emphasize, however, that this is all only my opinion as a radiation oncologist, and based on the review of the available data.
I am just waiting for dreamers to do their maximal pumping and I'll short it again soon! I would never buy SUPG as long as the company refuses to disclose all the information that it should.
Selling your shares will be one of the smartest things you ever did as an investor. At least you have some rules, and you are disciplined. Even though you think the drug has activity, you sold because they did not file and did not give any explanation. I admire your lack of blind faith in the company. You are not a dreamer like some other folks on this board. Does anyone have any explanation for the lack of filing/NDA? Maybe they will never release the results and hope people forget about Rubitecan for pancreatic cancer!
Ok... so you're not German.
Onto my next guess. Not British as it has been stated that English is your second language. Legality irrelevant. My curiosity just doesn't go that far.
Commentary -- #2 is not nearly as interesting (or telling) -- except for the "When I'm not too busy" part, as #4.... "All of MY money..."
You're not Latin either. ;o)
Ead, honest, what follows was writen by my wife:
1. I don't know any details about German guys.
2. I have two Ivy League degrees, but I learned to spell in elementary school. When I'm not too busy, I help him with his spelling.
3. Oh, yes, he is a foreigner, but he's legal, and with two beers he loses his accent completely and can be mistaken for a yankee.
4. All of my money is in mutual funds.
My wife, I think I'll keep her!
Thime and Pathiense are The Wai to Profitz!
I'm surfing around looking for somewhere to go ski tonight and tomorrow with my FAMILY and decide to check-in to my favorite dysfunctional message board only to find you're having delusions of my real-life interest again.
Chill out. Ok... so you're not Indian or thereabouts.
German? (They hide behind their wives a lot) Also rumored to be the world's lousiest lovers. Does your wife have an opinion on that?
"But you are a little bit -- in a way. If you could paint delicate little swirls all over my body with henna, I'd really dig that."
I showed the post to my wife and she explained to me what "henna" is. The downside, however, is that now I can't do it!
Time and Patience are The Way to Profits!
Tell me you're some kind of Latin and my fantasy will be complete.
Let's see... you learned English from the ENGLISH. My guess is that you're from a country that was once a British Colony or at least British occupied. If English isn't you're first language, then you're not quite "British." But you are a little bit -- in a way. If you could paint delicate little swirls all over my body with henna, I'd really dig that.