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Ich hatte Kontakt zur IR und stelle hier mal die Antworten mehr oder weniger strukturiert rein. Nochmal zu der oben angesprochenen Diskussion zu den P2a Daten/fehlende Placebokontrolle: Our placebo patients are also given saline. You will note that viral shedding data from our most recent trials, with 45 patients per arm, showed that there was essentially no change in the placebo group immediately post dosing and significant and durable reductions in most of our active dose arms out to 12 months. Trends in genital lesion rate reductions were also consistent with viral shedding rate reductions. We only included a placebo arm thru the immediate post dosing observation period in the dose optimization trial for acute safety comparison reasons. We saw highly consistent efficacy across multiple dose groups for viral shedding and clinical endpoints over 12 months and we believe that we compare favorably with historical results reported from clinical trials for chronic daily antivirals. Erste Daten der laufenden PIIb werden übrigens schon in diesem Quartal erwartet (nach den 3 Impfungen). Anders als bei der letzten Studie werden hier nur Sicherheitsdaten und Daten zum viral shedding (nicht aber genital lesions) bekannt gegeben. Das scheint vernünftig, weil es eben keine brauchbaren Daten nach so kurzer Zeit gibt. Mal sehen ob sich dann alle drüber aufregen, so nach dem Motto: Habens sie weggelassen, um etwas zu verschleiern. We will be reporting safety and viral shedding data later this quarter and at around the end of the year we will be reporting clinical efficacy data versus placebo, including % lesion free at 6-months, median time to first recurrence and genital lesion rate for the entire 6-month period post dosing. Viral shedding data at 6 months will be reported at a later date given the assay work required to generate the data. Wie werden/wurden die Daten erhoben: Genital lesions We collect clinical data by patient diaries – in the last trial this was via paper diary and in the ongoing Phase 2b trial, we are now using an electronic diary. The different clinical endpoints use this data in different ways. For the percent lesion free at 6 and 12 months and the time to first recurrence endpoints, the first lesion a patient has post dosing during the trial is used. Patients are also required by the protocol to arrange a doctor’s visit when they have their first lesion to enable a clinical diagnosis and swab sample to be taken. For the genital lesion rate in the last trial, the total number of days with lesions a patient reports over the 28 day observation periods (see answer 3 below for timing of these observation periods) is divided by the total number of days to derive the rate. viral shedding: Patients swab their anogenital region twice a day for 28 days at four time periods during the trial: before dosing to establish each patient’s baseline shedding rate, immediately post dosing, 6 months post dosing and 12 months post dosing. Swabs are then analyzed for the presence of HSV-2 DNA via PCR. The endpoint is determined by the presence or absence of DNA (Binary). Zum Adjuvant, dass soweit ich weiß von Novavax kommt und noch nicht zugelassen ist: Matrix M is an integral component of GEN-003, and will therefore be approved, if successful, as part of the approval. Adjuvants are no approved in isolation because the vaccine product is the combination of antigens and adjuvants and different antigens may interact with adjuvants differently. Zu den Unterschieden zwischen der 2a und 2b Studie: The ongoing Phase 2b trial is very similar in design to the recently completed Phase 2 dose optimization study – we are enrolling the same type of patients at the same sites and measuring the same endpoints. The major differences are as follows: The placebo arm is being followed for 12 months; there are only 2 active arms; we will not be measuring any clinical endpoints immediately post dosing, only viral shedding; the first clinical data will come out at 6-months and will include percent lesion free, time to first recurrence and the genital lesion rate (measured over the entire 6 month period rather than just the 28 day observation periods) – all versus placebo; finally we are using material manufactured with improved processes at larger scale. So richtig spannend wird es also erst gegen Ende des Jahres... SG kmastra |
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| aus der Diskussion: | Genocea - Verarsche oder |
| Autor (Datum des Eintrages): | kmastra (04.08.16 01:48:22) |
| Beitrag: | 7 von 63 (ID:52985608) |
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