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To: gonnahappensoon who wrote (17323)2/8/2012 10:49:55 AM
From: stockdoc77
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I've mentioned before that FOLFORINOX changed the landscape for PAM, this release confirmed it. We remain primarily a bet on SLE. 2 years till data.

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To: idahoranch1 who wrote (17321)2/8/2012 11:18:57 AM
From: weatherproof
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>>FOLFIRNOX's efficacy opens up new avenues of investigation, stressed Dr. Welch, including using it as a backbone on which to piggy back other treatments, particularly targeted therapies that don't have overlapping toxicities. The regimen also needs to be "dissected" and optimized to determine if all four drugs are required or if dosages can be adjusted so that the efficacy can be maintained while alleviating or mitigating some of the regimen's serious side effects.<<

cancer.gov

I don't see IMMU's strategy for cmAb as "bad" thing, or a "good" thing. It is simply working with the results they are seeing in an experimental therapy, in the context of what is already out there. What are the facts, or at least, early indications of cmAb's utility in pancreatic cancer?

1. There is some activity seen with Y90-hPAM4 alone.
2. Increasing the dosage and/or number of treatment cycles does seem to correlate with response.
3. On the other hand, increasing Gem in this regimen does not correlate with better responses.
4. Given the toxicity with Folfirinox, and concerns about administering this therapy to patients with low performance status, or older in age, new therapies that do not show overlapping toxicities w/chemo are being sought.

As mentioned before, it would be much easier to get approved as a second or third line therapy, than it would be to go head-to-head in a first line approach. I don't know how one can make an assessment on IMMU's abilities, or lack thereof, based on their devising a strategy that makes most sense given the limitations of an experimental approach to PC. I think you're right, Idaho, in that this can actually lessen the time for approval. Of course, that is based on a lot of things having to go right, and there's just no one who can offer those kinds of guarantees in this business. Let's find the quickest way to approval, and let the patients and docs decide what makes sense for them. I think I saw where only 25% of patients with metastatic PC are candidates for Folfirinox. Please check me on that if you have some time.

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To: stockdoc77 who wrote (17324)2/8/2012 11:26:11 AM
From: idahoranch1
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The phase lb is going to be two arms (I talked to IR this morning), an arm of hPAM4/gemzar and an arm of hPAM4 in patients who are not responders to whatever treatments they are being treated with, FOX or otherwise.

Don't you think Doc, that since last June when we didn't get updated data and the data for FOX being released, the expectation for hPAM4 being approved for first line treatment was very low? There was some hope that quality of life during treatment might be a path to approval, but there were no allusions from anyone here on the board that OS hPAM4 would even come close to FOX's OS numbers, especially given the lack of a control group in the FOX study to use as a baseline.

If they had come out this morning and said the phase lll was starting mid year, and OS was a primary end point, there would be little confidence here that it would be approved, it would be less than 50/50 approvable in my view. We know hPAM4 has benefited patients, gets tumor reduction in a lot of patients and seems to help with pain, but without a year of OS, that may not be enough. I'm OK with going for a more sure approval since my expectations have been lowered in the last 7 months.

Yes, we are two years out from data for E-mab, but we are 3+ years out from data for hPAM4 no matter how they go after it. I don't see much of a difference in that regard.

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To: weatherproof who wrote (17325)2/8/2012 11:31:17 AM
From: mokelumne river
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Note the discussion below under "Viewpoint" as to the best candidates for FOLFIRINOX:

FOLFIRINOX Versus Gemcitabine for Metastatic Pancreatic Cancer Conroy T, Desseigne F, Ychou M, et al
N Engl J Med.2011;364:1817-1825

Study Summary Gemcitabine has long been the standard of care for treatment of advanced pancreatic cancer. Numerous randomized clinical trials conducted in the past 2 decades have attempted to build upon single-agent therapy. For the most part, gemcitabine-based doublets have not shown substantial improvements in survival, although the gemcitabine-erlotinib combination has received US Food and Drug Administration approval as the first-line indication. In this article, investigators from France report on the utility of an aggressive regimen combining gemcitabine given in standard doses with both oxaliplatin and irinotecan (the FOLFIRINOX regimen). The study was a randomized phase 2 trial that was subsequently expanded to phase 3 design, in which 342 patients were randomly assigned to gemcitabine or FOLFIRINOX.

All of the study endpoints favored FOLFIRINOX: overall survival (11.1 vs 6.8 months), progression-free survival (6.4 vs 3.3 months) and response rates (31.6% vs 9.4%). Incidences of grade 3 or 4 neutropenia, febrile neutropenia, thrombocytopenia, diarrhea, and sensory neuropathy as well as grade 2 alopecia were significantly higher in the FOLFIRINOX arm. At 6 months, 31% of the patients in the FOLFIRINOX group had definitive reductions in their scores on the Quality of Life scale vs 66% in the gemcitabine group, suggesting that despite increased adverse events, patients receiving FOLFIRINOX had a better quality of life.

Viewpoint This is the first study to show substantial improvements in survival in advanced pancreatic cancer. It is unfortunate, however, that this gain occurs with an aggressive multichemotherapy regimen rather than with the addition of targeted therapy as many had hoped for. Although the efficacy of the regimen is clear and substantial, concerns about toxicity and tolerability are ongoing. Anecdotally, many oncologists are empirically reducing starting doses for this regimen, especially of irinotecan. The use of growth factor support should also reduce the risk for febrile neutropenia. Careful patient selection is exceedingly important: Patients who are younger, wishing to seek more aggressive treatment, and who have an excellent performance status are the best candidates for FOLFIRINOX.

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From: EagleRare2/8/2012 11:42:51 AM
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Guess I was right afterall (back down to test $3.60 after sell on the no-news). Bummer.

Well, on the bright side, IMMU is now using the former resistance line as support.

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To: EagleRare who wrote (17328)2/8/2012 11:50:04 AM
From: gonnahappensoon
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200 Day Moving average is right in this range. That is where the support/resistance will come from.

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To: idahoranch1 who wrote (17326)2/8/2012 12:02:37 PM
From: stockdoc77
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Given the excitement that was generated by PAM in 2008, this is a massive comedown in expectations. I think it makes a huge difference to the stock whether we have only 1 product in P3 or 3 or 4 products. With the latter we have a much higher market cap and can actually raise some money to advance our pipeline. The remarks made 2 weeks ago about how broad our pipeline is neglected to mention that other than Emab in SLE, that entire pipeline is at a total standstill clinically. And now PAM instead of advancing to P3 is going back to P1, and to imply that we have an easier path to approval because of this is really a leap. I don't see that at all.

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To: stockdoc77 who wrote (17330)2/8/2012 12:14:29 PM
From: gonnahappensoon
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I still want to know if the FDA required the additional trial and if so WHY didn't the company release that info? Again, the transparency at this company is awful especially when you throw in the nepotism.

I am sorry, but how many times is this company going to backward on trials? I guess we now know why nobody wanted to partner with iMMU on HPAM.

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From: Fitzhughlaw2/8/2012 12:37:34 PM
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Doright found the Phase I trial almost immediately after it was published (see his post 16970) and as usual, Li wa all over it, questioning why another Phase I was being planned (see his post 16974, which stated: " Why are they screwing around with this, when they should be saving their nickels and dimes for a registration trial? I don't understand what the point is of starting another Phase I trial."). I guess now we know why....

P.S.: Weatherproof actually nailed in post 16977: "I guess it's a hedge. Let's face it, we don't know if we'll beat Gem and F'nox in a head-to-head way down the line. But we do know with pretty much total certainty that PC patients will fail both of those therapies at some point, assuming they start them. I suppose IMMU is attempting to reserve a place in line should Plan A fail (that's if there is a Plan A - i.e. ph III for PC)." Plan A appears to have been a "fluid situation" as the term is used to connote a situation when there's really no plan that's firmed up.....

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To: Fitzhughlaw who wrote (17332)2/8/2012 1:06:56 PM
From: mokelumne river
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From the clinical trial page cited earlier for the 1b study:

Estimated enrollment: 40
Study start date: March 2012
Study completion date: March 2015
Estimated primary completion date June 2014 (Final data collection date for primary outcome measure)

clinicaltrials.gov

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