Bavarian Nordic — August 2016

[bb]

Så er zikavirus-virussen kommet til Florida http://www.usatoday.com/story/news/2016/08/01/florida-announces-10-more-homegrown-zika-cases/87910664/

[Helge_LarsenPI-redaktør]

Enig ienk.

[nik_hs1990]

Tror både Zealand og Bavarian er langt højere i kurs når vi slutter 2016. Regner med en zealand godkendelse her i august, og jeg krydser fingre for positive prostvac nyheder engang i efteråret.

[JohnW]

Er der nogen nærmere dato i august for hvornår vi kan forvente at høre fra FDA vedr. Lixilan/iGlarLixi?

[KongFais]

Forskningsresultater fra july 2016:

[KongFais]

Samarium-153-EDTMP (Quadramet) with or without vaccine in metastatic castration-resistant prostate cancer: A randomized Phase 2 trial

[KongFais]

This phase 2 multi-center trial randomized patients to Sm-153-EDTMP alone or with PSA-TRICOM vaccine. Eligibility required mCRPC, bone metastases, prior docetaxel and no visceral disease. The primary endpoint was the proportion of patients without radiographic disease progression at 4 months. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and immune responses

[KongFais]

This phase 2 multi-center trial randomized patients to Sm-153-EDTMP alone or w
ith PSA-TRICOM vaccine. Eligibility required mCRPC, bone metastases, prior docetaxel and no visceral disease. The primary endpoint was the proportion of patients without radiographic disease progression at 4 months. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and immune responses

[KongFais]

There was no statistical difference in the primary endpoint, with two of 18 (11.1%) and five of 21 (23.8%) in Sm-153-EDTMP alone and combination arms, respectively, having stable disease at approximately the 4-month evaluation time point

[KongFais]

Median PFS was 1.7 vs. 3.7 months in the Sm-153-EDTMP alone and combination arms (P = 0.041, HR = 0.51, P = 0.046). No patient in the Sm-153-EDTMP alone arm achieved prostate-specific antigen (PSA) decline > 30% compared with four patients (of 21) in the combination arm, including three with PSA decline > 50%

[KongFais]

These results provide the rationale for clinical evaluation of new radiopharmaceuticals, such as Ra-223, in combination with PSA-TRICOM

[Koglen]

Endnu et positivt resultat for en phase 2 prøve. Det begynder snart at blive spændende. Her er der lidt nyt omkring det globale marked. http://finance.yahoo.com/news/global-prostate-cancer-market-report-090500891.html

[KongFais]

13 mia usd i 2024 er alt for lavt. http://www.bccresearch.com/pressroom/phm/global-prostate-cancer-market-reach-$50.3-billion-2017
.

[KongFais]

Jeg tror Prostvac har potentialet til at nå et peaksale på 5 mia usd, hvis det godkendes i pre-chemo setting. Teoretisk set burde vaccinen virke bedst så tidligt som muligt.

[KongFais]

Pga. bivirkningsprofilen og vaccine effekten vil det være meget fordelagtigt at give prostvac til patienter snarest muligt

[KongFais]

det er i de tidlige stadier der er flest patienter

[KongFais]

Når man tester nye stoffer, så starte man i post-chemo setting og bevæger sig mod patienter med mildere cancere. Mange af de nye phase-2 forsøg er med patienter med mildere cancere, så her burde prostvac have en stor effekt, hvis det virker

[KongFais]

jeg tror personligt, at der er gode chancer for en godkendelse

[KongFais]

hvis ikke i mCRPC, så i pre-chemo setting

[Helge_LarsenPI-redaktør]

Gode tanker Fais..Hvad er det præcis som gør dig så optimistisk?