Sorry to be the bearer of bad news but Pfizer pulled their armed anti-CD33, Mylotarg, for AML from market:
"Pfizer said a measure known as the fatal induction toxicity rate, or the death rate during initial treatment, showed it was significantly higher among patients receiving Mylotarg plus standard chemotherapy. Specifically, 16 patients out of 283 patients, or 5.7%, treated with Mylotarg plus chemotherapy died compared to four patients out of 281 patients, or 1.4%, who received only chemotherapy."
I am now less confident than ever that SGN-33 will work.
I'm long SGEN and MITI.
I figure Miti is at least 1 1/2 years out from SGEN. If SGEN does as expected, I would roll some profits into MITI., (maybe 10 to 1). I have good size long shares in both companies.
SGEN is still the best place to be through out next year.
Looking for pre-treated 60+ populatin = Micromet (MITI) Inho this will in time be the company for Bite anti-body needs.I was long sgen now I`m longer miti.The future of using a persons own immune system is unfolding now.
Even at the time of its expedited approval, Mylotarg was associated with fatal hepatic veno occlusive disease. I guess the potential survival extending benefits outweighed the risk of this dreaded complication. Whether the HVOD was due more to the Mylotarg or the recommended 4g of acetaminophen recommended with dosing to control severe chills and fever is yet to be determined, but I don't think we have seen such serious complications relating to SGN 33 and I do not think side effects have been severe enough to the point of SG recommending high dose acetaminophen to help patients deal with any side effects. All reports I believe indicate minimal side effects in this very vulnerable patient population. With Mylotarg gone hopefully there will be some alternative to offer these patients and a reason for the FDA to expedite approval with post market additional studies.Hopefully SGN 33 will be that alternative offering.
Thanks! (I did get a cookie error, but this cleared up after I hit the homepage and tries the link again).
I came up with about your same answer. Looks to me like the Burnett data hit 11.5% at 20 months. Just going from the mean of the enrollment curve (estimated in Sep.) matches your May estimate.
I do know that I should really break the enrollment curve up month by month (best guess), do the calc and add it back up, but that is too much work for today.
BTW, this stuff is fun but anybody basing investment decisions on it is making a mistake.
See if this works. Its the whole paper publishied in 2/2007. The chart is Table 6. You might note that there are two arms. one hydroxyurea that had 99 patients, and the other hydroxyurea + low dose ara-c that had 103 patients. Sounds familiar.
Their latest guidance for release of initial info is between now and the end of August. The timing is driven by when 186 "events" (deaths) have occurred.
In his recent webcast Dr. Siegall referred to this time period as their "current" guidance. Don't know if that indicates a possible future change in their guidance or if it just reflects the fact that previously their guidance was earlier.