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Oncothyreon Inc Message Board

  • dan_xia dan_xia Mar 23, 2010 9:24 AM Flag

    A Smart Explanation from a Long

    As I said I am a long, so this may be biased:

    Merck KGAs wanted to know what is really going on because it has a lot of stake on these two PHIII trials. Nonetheless, it has no way to have a peek on the trials (dealths already happened, why?)

    Now, it reported a strange case from PHII trial, and FDA agreed that Merck KGAa must make sure what is the cause; now all data is available for Merck KGAs for its investigation

    Now you knwo what is going on!

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    • Actually the FDA will have little to do with removing the hold. The DSMB is in charge of such things, and they notify FDA as to their decisions.


    • Here is some info on this theory:

      Japanese encephalitis (JE) is the most common cause of viral encephalitis in the Asian Pacific region. The virus exists in a transmission cycle between mosquitoes and pigs and/or water birds such as herons and egrets which are the main host reservoir. JE is therefore a mosquito-borne zoonotic viral infection, the reservoir of which is water birds and in which pigs play the role of amplifying host in rural areas. JE used to be mostly prevalent in countries with a temperate climate, including Japan, but data from tropical countries (Thailand, Cambodia, Indonesia) show that these zones also are favorable for JE transmission. Indeed, JE can now be found from the extreme south-eastern part of Russia to the North of Australia and Papua New Guinea, and from Japan to the west of India. Some 50,000 cases of JE occur annually, with 25%-35% case fatality rates, and more than 30 % severe long-term disabilities in survivors.

      Recent epidemics have led to increased demand for more effective, safe and affordable JE vaccines, leading to an extended registration and use of a live-attenuated vaccine that was previously largely confined to China. To meet increasing demand and to comply with GMP standards, a new plant for the vaccine is being built in China, which should become operational by 2010 and produce vaccines at GMP standards. Together with the licensing of second generation JE vaccines, the global need for this vaccine should thus be met. It is anticipated that the mouse brain inactivated vaccine will be replaced by the less reactogenic and better controlled Vero cell-derived inactivated vaccine, which, together with the live attenuated SA14-2-14 vaccine and the live YF-JE chimeric vaccine hold great promise for programmatic use in developing countries. Their accelerated clinical development and evaluation has been facilitated by the WHO.

      Were the patients in the Asian arm?

    • Junky,

      Someday you'll learn, (probably not but anyways) but he beauty of Cancer trials is that people die.

      You can hide a lot of sins.

    • me second that-- I would have been minus 5K in one week. Will they send us the check for the difference? Of course not.

      Something is not right in Denmark, Seattle, Germany and Canada.

    • Wow Junky, Your ability to comprehend a sentence rivals your ability to pick a stock. I said there were no other cases.

      """"My best guess is that while no other patients developed encephalitis per se, they probably have noticed some type of neurological problems in the past. """"

    • Nono,

      My best guess is that while no other patients developed encephalitis per se, they probably have noticed some type of neurological problems in the past.

      I wouldn't think one case of encephalitis would promote the FDA to put the trials on hold unless there was something else.

      Of course Junky and Bio77 could be right that an infected mosquito was hiding in the Onc's office.

    • A view from a leading biotech expert...

      They (merck) will find the problem but it will take awhile....

      Which means I think that buzz is right, some of the enrollees may not be valid if their vaccine and placebo dosing schedules are interrupted...

      Which means the trial may be delayed at best...

      In my opinion...

      so far though the patient has not died from the encephalitits.

    • Junk,

      They wouldn't have stopped the trial if it was only a week.

      They have to file with the FDA to restart the trials, and it takes a guy at the FDA a week just to find his office.

      Stop your bullshit, you hurt enough people.

    • They are testing the limit or threshold. Now they encountered this. So I guess they will first make sure what is the cause? If the cause is cyclophosphamide (regiment used higher than that used in current PhIII trials), the test (PhII mutiple mylenoma) will contitue until they find the limit; if the cause is Stimuvax, the test (PhII mutiple mylenoma) will be stopped. Now, Merck KGAs knows the threshold for a much more sensitive mutiple mylenoma indication. In either case, PhIII trials will immediately resume.

      The good thing is that now they know how hard they can push forward with Stimuvax + cyclophosphamide, and FDA will be also happy because a potential NDA question from FDA is already answered.

    • >> do not know why they used a different dosing schedule of cyclophosphamide than in any of the other trials, phase II or phase III. <<

      Cytoxan is standard treatment with MM, maybe they used the standard dose concurrent to Stimuvax treatment.

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