What even is this?!
Other ways to bring Betalutin® to patients quicker being explored (e.g. PRIME, PIM, Breakthrough Therapy)
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• Final analysis from LYMRIT 37-01 study (n=74) expected in 2H 2018, targeting ASH 2018 for read-out (December)
(Slide 19)
får vi da vite om 20/100 bedre enn 15/40?
Nei, det er for få pasienter enda. Men du får en mye bedre indikasjon på om 20/100 er en bra dose!
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Sjekk side 37. Archer 1 - FPD?
Edit: ser nå at den ikke er haket ut.
Dette her var fint funn på en onsdagskveld! 20/100 data blir utrolig spennende!
Dosimetridataene virker så lovende og er fine å dra frem igjen. Slide 18
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Når kommer PIM er nå min nye kjepphest.
Edit: Promising Innovative Medicine (PIM) by the Medicines and Healthcare Products Regulatory Agency (MHRA).
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Jeg synes det begynner å lukte vel mye fugl her. Den presentasjonen var milevis bedre, både kvalitativt og kvantitativt, enn hva jeg har sett tidligere fra Nano.
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FPD i Archer skal hakes av i løpet av inneværende år… Som første read out og analyse av 37-01.
Synes den nye firmapresentasjonen ser sterk ut. Håper den gir nok lim på fingrene til å takle børsuroen.
Firmapresentasjoner lages vel med tanke på…innsalg.
La også merke til at Nano er obs på antall potensielle pasienter både i US og Europa. Slide 9.
Bra gravd @kiakia 
Takk!
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Prøv å redigere en 4 gang så får du den nok!
Alle gode ting er tre, og da følger som regel den fjerde med 
Firmapresentasjoner 
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Hehe, takk! Keitete i dag.
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Skjønner godt det!
For å si det på Finnmarksk: æ bruke å kuke det til æ også, de der tastan e nu så djævelsk små! 
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Nordic Nanovector’s Betalutin® Receives Promising Innovative Medicine (PIM) Designation in the UK for the Treatment of Follicular Lymphom
Oslo, Norway, 25 October 2018
Nordic Nanovector ASA (OSE: NANO) today announces that Betalutin® (177Lu
-satetraxetan-lilotomab) has been granted a Promising Innovative Medicine (PIM)
designation by the UK’s Medicines and Healthcare Products Regulatory Agency
(MHRA) for the treatment of patients with advanced relapsed/refractory
follicular lymphoma (R/R FL). The designation was granted based on data from the
first part of the Phase 1/2 LYMRIT 37-01 trial.Lisa Rojkjaer MD, Nordic Nanovector CMO, commented: “We are delighted by the
MHRA’s decision to award PIM designation to Betalutin®. This acknowledges the
high unmet medical need of this patient population as well as the potential of
Betalutin® to offer therapeutic benefits to FL patients. Both the PIM and Fast
Track designations (granted by the FDA in June) are very encouraging, as they
provide opportunities for enhanced dialogue with health authorities and the
potential to bring Betalutin® to patients more quickly.”PIM designation constitutes Step 1 of the UK Early Access to Medicines Scheme
(EAMS). EAMS aims to give patients in the UK early access to medicines that do
not yet have a marketing authorisation but meet a medical need that is currently
not being met. PIM designation means that a medicinal product is a promising
candidate for the EAMS, for the treatment, diagnosis or prevention of life
-threatening or seriously debilitating conditions with an unmet need.For further information, please contact:
IR enquiries
Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44 7561 431 762
Email: [email protected]
International Media Enquiries
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44 207 638 9571
Email: [email protected]
About Betalutin®
Betalutin® is a tumour-seeking anti-CD37 antibody (lilotomab) conjugated to a
low-intensity radionuclide (lutetium-177). It has shown promising efficacy and
safety in the first part of the Phase 1/2 LYMRIT 37-01 clinical study in
relapsed/refractory follicular lymphoma (R/R FL). A global, randomised Phase 2b
trial, PARADIGME, in third line (3L) FL patients who are refractory to anti-CD20
immunotherapy (including rituximab, RTX) is currently on-going.
Betalutin® is also being investigated in the Phase 1b Archer-1 study in
combination with RTX in second-line FL patients, and in the Phase 1 LYMRIT 37-05
study in patients with R/R diffuse large B-cell lymphoma (DLBCL), the most
common form of non-Hodgkin’s lymphoma (NHL).Betalutin® has been granted Fast Track designation (in June 2018) in the US for
the treatment of patients with R/R FL. Betalutin® also received Orphan Drug
designations for FL in both the USA and Europe in 2014.
Betalutin® is selective for CD37, which is highly expressed on the surface of B
-cell non-Hodgkin’s lymphoma (NHL) cells. When bound to CD37 on tumour cells,
Betalutin® is internalised, causing DNA damage and cell death.About Nordic Nanovector
Nordic Nanovector is committed to develop and deliver innovative therapies to
patients to address major unmet medical needs and advance cancer care. The
Company aspires to become a leader in the development of targeted therapies for
haematological cancers. Nordic Nanovector’s lead clinical-stage candidate is
Betalutin®, a novel CD37-targeting antibody-radionuclide-conjugate designed to
advance the treatment of non-Hodgkin’s lymphoma (NHL). NHL is an indication with
substantial unmet medical need, representing a growing market forecast to be
worth nearly USD 20 billion by 2024. Nordic Nanovector intends to retain
marketing rights and to actively participate in the commercialisation of
Betalutin® in core markets. Further information can be found at
www.nordicnaEkstern link: http://www.newsweb.no/index.jsp?messageId=461936
Nyheten er levert av OBI.
http://www.netfonds.no/quotes/release.php?id=20181025.OBI.20181025S10
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PIM designation constitutes Step 1 of the UK Early Access to Medicines Scheme (EAMS). EAMS aims to give patients in the UK early access to medicines that do not yet have a marketing authorisation but meet a medical need that is currently not being met. PIM designation means that a medicinal product is a promising candidate for the EAMS, for the treatment, diagnosis or prevention of life-threatening or seriously debilitating conditions with an unmet need.
Hmmmmm
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Der… 
Noen som kan forklare hva PIM innebærer?
Noe ala Fast Track fra FDA?
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«Both the PIM and Fast
Track designations (granted by the FDA in June) are very encouraging, as they
provide opportunities for enhanced dialogue with health authorities and the
potential to bring Betalutin® to patients more quickly.”
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Ja det sto i meldingen, det kan jeg lese selv.
Tenker om noen vet betydningen av dette, ikke om noen kunne klippe og lime en setning
Hvis jeg ikke husker helt feil så kom vel mange av pasientene i Lymrit 37-01 fra UK-siter?
Tenker at UK KOL, leger etc har hatt tett kontakt med myndigheter i UK og gitt sin anbefaling.
Bra!
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