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ImmunoCellular Therapeutics, Ltd. Message Board

  • fansteman fansteman Jan 17, 2013 1:02 AM Flag

    CLARIFICATION: enrolled vs. treated

    I am always amazed how quickly simple questions can make people loose their temper when a look at the mere facts provides the answers and helps reduce the issue to its core question:

    Enrollment=signing of informed consent form: It is in the nature of the disease treated with ICT-107 ("brain cancer") and of the rules and regulations governing human participation in clinical trials that one has to get the patients' consent to participate and signature before the initial surgical removal of the tumor. (Plus, patients have to right to withdraw a once given consent at any time post surgery)

    "treated" patients: As in every clinical trial protocol, inclusion and exclusion criteria guide the investigator to determine which patient qualifies. In the case at hand, these criteria can only be checked AFTER a couple of serious therapeutic interventions, namely brain surgery and radio-chemotherapy (called "Standard Therapy" or STUPP-scheme). First of all, we are looking at over three months elapsing between the enrollment and the start of the experimental part of the trial (start of ICT-107 treatment). A lot can happen in a patient population like ours in 3 months, due to the underlying disease (e.g., its anatomical location) and co-morbidities, due to treatment (e.g., typical complications of brain surgery or cranial radiation), due to hospitalization (e.g., infection), etc. etc. Furthermore, between surgery and radio chemotherapy patients in this trial have to do an apheresis which separates the immunecells from the rest of the blood that get sent in to the company for antigen pulsing. Patients have to be fit enough post-op to undergo this procedure and the apheresis product has to be of sufficient quality for the processing at the company.

    In other words, lots of factors (and I have alluded to only a few) that impact the number of patients enrolled which ultimately make it to the experimental part of the trial.

    So, if it is not "smoke in the mirror" or "IMUC Talk", what is the real issue at the core of this "enrollment/treatment" ratio? The real question is: Is the experience from this trial pointing us towards the risk that the ultimate market potential of ICT-107 is only about one half of the incidence of glioblastoma and what does that mean for the value of the asset/the company?

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