Det er klart det er veldig lovende og spennende resultater med Humalutin fra preklinisk…
MEN 300mbq per kg er jo ganske mye høyere stråling enn det jg ser for meg at blir aktuelt i mennesker… (dlbcl)
Uansett bevises det jo at det er effekt her som fordrer videre testing.
4 Likes
Angående formulering rundt US markets, kan dere se fra MR sine plansjer tidligere at det er kun arbeid til US som er gjort. I hvertfall som er presentert på detaljnivå. Det sammen med å kle gamle postere i nye klær, meget god lesing, tenker jeg handler om distanse til historikk og LC uttalelser, ikke nødvendigvis partneravtale.
Tror ikke de ville omformulert for partneravtale før den generelt børsmeldes.
“All patients to receive 375 mg/m^2 RTX on day 14”,
Har dette blitt nevnt tidligere??
I så fall har ikke jeg fått det med meg. Det betyr jo så vidt jeg kan skjønne at de sniker inn Archer i paradigme. Kan det tenkes at kombinasjonen Betalutin+RTX kan få godkjenning raskere enn vi aner?
Day minus 14 
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Dette har de gjort hele tiden. Rituxan på day -14, og forbehandling + Betalutin 14 dager senere. Etter det er pasienten ferdig med behandling
Jepp, dette er gammelt nytt. De ‘‘renser’’ blodet for b-celler ved hjelp av Rituximab for å bedre distribusjonen av Betalutin.
Sjekk ut denne, forklares på en enkel og forståelig måte:
1 Like
Haha! Ja da gir det plutselig mer mening Jeg falt nesten av stolen her 
Beklager forvirringen!
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Som sagt, det lukter fugl! 
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Synes det begynner å smake fugl også! Jeg var mentalt forberedt på 10% ned i dag, satte i gang prosess med å lukke short posisjoner i krypto for å gå inn med mer, men så kommer denne gladmeldingen. Nå begynner jeg (desverre?) å tenke mer og mer langsiktig med også det jeg kjøpte under 50 for å trade med!
1 Like
Fornybar
Prøver å tenke litt her, 48 designations i løpet av 4 år høres jo “mye” ut, men det er kun 12 i året, og når det er en intensjon om mulighet for at britiske pasienter KAN få dette 12 til 18 mnd innen designasjonen er gitt er dette en veldig spennende melding.
Det absolutt viktigste er å få et produkt godkjent. Om det skulle komme i UK i 2020 og i US ikke før i 2023 betyr det ingenting, er det først godkjent et sted klarer man å bryte i gjennom et annet sted med stor sannsynlighet.
Jeg mener selvsagt ikke at det vil bli godkjent mye senere andre steder, det vesentlige her er å få produktet godkjent, nær sagt hvor som helst. UK er fint som snus.
Tenker at NANO har bitt seg fast i leggen med dette, og da er det ingen grunn til å slippe taket.
Erna reacted with 
2orionen and kaei reacted with 
10
Svar
I går kl 20:44556
- In tumour cell lines
- In preclinical lymphoma models
Begge deler er nok i sin helhet celleforsøk, altså in vitroforsøk på menneskelige kreftceller. Nano har formodentlig ikke behov for å kjøre museforsøk på Humalutin. Med erfaringen med Betalutinforsøkene, som bygger på murint(mus) basert lilotomab er det nok i stor grad unnagjort, uten å kreve annet enn tilleggsforsøk med Humalutin som er NNV003(chimeric) menneskebasert lilotomab på menneskeceller. Nano kjenner veldig godt til egenskapsforskjellene på disse stoffene.
Uansett er det veldig interessante hva combobehandling med Rituximab og Humalutin kan komme til å resultere i. Antagelig blir det en combo som kommer til å kunne bli svært interessant.
Men Nano har smart nok spisset pengene inn mot Betalutin, der Nano har kommet lengst, og der sannsynligheten for godkjennelse for 3FL raskt er veldig stor. Dette også fordi det regnes med at Betaultin passer best for 3FL, mens Humalutin vil ha en bredere NHL anvendelse. Betalutin kan dermed bane vei for neste godkjennelser.
[Merlin]
I går kl 15:171292
focuss skrev Greia mellom Merlin og Korsar er at Merlin ser på seg selv som investor og fester blikket lengre fre…
>En annen ting jeg stusser på i presentasjonen er at de fortsatt viser bedre effekt av 15/40 enn 20/100.
Det er ikke noe å stusse på. Det er basert på eldre tall, ikke de nye vi får presentert på ASH og antagelig også på posteren 1. november. Som kjent var 20/100 3.mndrs. avlesninger, bedre enn 15/40 pr. 3 mndr. Men siden 15/40 hadde bedre 6 mndrs. avlesning enn 20/100 pr. 3 mndr. og siste tall på begge er benyttet er altså tallene for 15/40 og 20/100 ikke direkte sammenlignbare. Det blir de forhåpentligvis på ASH. Det er ikke mye som skal til for at 20/100 viser vesentlig bedre tall etter 6 mndr. Men med det lave antall pasienter, er det vanskelig å si noe entydig pr. nå. Andre forhold kommer også inn og det er i hvilken grad forskjellige doseringer virker individuelt på den enkelte pasient. Muligvis må en del av Paradigmestudiet gjennomføres for å komme nærmere svaret, men de seneste avlesningene fra Lymrit 37-01 vil nok gi noen indikasjoner. Forhåpentligvis er de så klare at man kan modifisere og forenkle Paradigme.
Husk at også disse tallene vil bli oppdatert i børsmeldingen som sendes ved avholdelsen av konferansen.
1 Like
Nordic Nanovector Announces Opening of First US Site for PARADIGME Trial of Betalutin® in Third-line Follicular Lymphom
Oslo, Norway, 26 October 2018
Nordic Nanovector ASA (OSE: NANO) announces that the first clinical site in the
United States (in Long Beach, CA) for the pivotal PARADIGME trial has been
initiated to enable enrolment of patients.PARADIGME is a global randomised Phase 2b clinical trial comparing two
Betalutin® (177Lu-satetraxetan-lilotomab) dosing regimens (15 MBq/kg Betalutin®
following 40mg lilotomab pre-dosing; 20 MBq/kg Betalutin® following 100mg/m2
lilotomab pre-dosing) in 3L follicular lymphoma patients who are refractory to
anti-CD20 therapy (including rituximab). The trial aims to enrol 130 patients
across 80-85 sites in approximately 20 countries.Lisa Rojkjaer MD, Nordic Nanovector CMO, commented: “The enrolment of patients
into North American sites is important for the overall clinical development
program of Betalutin® in NHL. We are pleased to have opened the first US site in
the PARADIGME trial and anticipate further clinical sites coming on-board in the
coming months.”The objective of PARADIGME is to determine the best dosing regimen for
Betalutin® as a new treatment option for 3L FL patients. The primary endpoint
for the trial is overall response rate (ORR) and secondary endpoints include
duration of response (DoR), progression free survival (PFS), overall survival
(OS), safety and quality of life. The data from this trial are expected to
support market authorisation applications for Betalutin® as a new treatment
option for 3L FL patients.The initial efficacy and safety data read-out for PARADIGME is targeted for the
first half of 2020.In June, Betalutin® received Fast Track designation in the US for the treatment
of patients with 3L R/R FL, and on 24 October, the MHRA granted Betalutin® a
Promising Innovative Medicine Designation in the treatment of advanced
relapsed/refractory follicular lymphoma.-End-
For further information, please contact:
IR enquiries Malene Brondberg, VP Investor Relations and Corporate
CommunicationsCell: +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
tolerability in the Phase 1/2a LYMRIT 37-01 clinical study in
relapsed/refractory follicular lymphoma (R/R FL) and is currently in a global,
randomised Phase 2b trial, PARADIGME, in third line (3L) FL patients who are
refractory to standard-of-care anti-CD20 immunotherapy (including rituximab).Betalutin® is also being investigated in the Phase 1b Archer-1 study in
combination with rituximab 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, a novel therapeutic target protein that 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 about the Company can be found at www.nord
Ekstern link: http://www.newsweb.no/index.jsp?messageId=462123
Nyheten er levert av OBI.
http://www.netfonds.no/quotes/release.php?id=20181026.OBI.20181026S6
6 Likes
Og der er US senter nr 1 åpnet. Spennende tider !
2 Likes
Haha, wtf Nano, dobbel-whammy her nå? The good ol’ left, right, upper-cut? For en herlig melding å våkne opp til!
5 Likes
Oi! Dette er bra greier! Hjemmekontor i dag tror jeg. Poppe champis i lunchdippen 
3 Likes
Nordic Nanovector Announces Opening of First US Site for PARADIGME Trial of Betalutin® in Third-line Follicular Lymphoma
Oslo, Norway, 26 October 2018
Nordic Nanovector ASA (OSE: NANO) announces that the first clinical site in the United States (in Long Beach, CA) for the pivotal PARADIGME trial has been initiated to enable enrolment of patients.
PARADIGME is a global randomised Phase 2b clinical trial comparing two Betalutin® (177Lu-satetraxetan-lilotomab) dosing regimens (15 MBq/kg Betalutin® following 40mg lilotomab pre-dosing; 20 MBq/kg Betalutin® following 100mg/m2 lilotomab pre-dosing) in 3L follicular lymphoma patients who are refractory to anti-CD20 therapy (including rituximab). The trial aims to enrol 130 patients across 80-85 sites in approximately 20 countries.
Lisa Rojkjaer MD, Nordic Nanovector CMO, commented: “The enrolment of patients into North American sites is important for the overall clinical development program of Betalutin® in NHL. We are pleased to have opened the first US site in the PARADIGME trial and anticipate further clinical sites coming on-board in the coming months.”
The objective of PARADIGME is to determine the best dosing regimen for Betalutin® as a new treatment option for 3L FL patients. The primary endpoint for the trial is overall response rate (ORR) and secondary endpoints include duration of response (DoR), progression free survival (PFS), overall survival (OS), safety and quality of life. The data from this trial are expected to support market authorisation applications for Betalutin® as a new treatment option for 3L FL patients.
The initial efficacy and safety data read-out for PARADIGME is targeted for the first half of 2020.
In June, Betalutin® received Fast Track designation in the US for the treatment of patients with 3L R/R FL, and on 24 October, the MHRA granted Betalutin® a Promising Innovative Medicine Designation in the treatment of advanced relapsed/refractory follicular lymphoma.
-End-
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 tolerability in the Phase 1/2a LYMRIT 37-01 clinical study in relapsed/refractory follicular lymphoma (R/R FL) and is currently in a global, randomised Phase 2b trial, PARADIGME, in third line (3L) FL patients who are refractory to standard-of-care anti-CD20 immunotherapy (including rituximab).
Betalutin® is also being investigated in the Phase 1b Archer-1 study in combination with rituximab 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, a novel therapeutic target protein that 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 about the Company can be found at www.nordicnanovector.com
Nyheten er levert av Cision.
http://www.netfonds.no/quotes/release.php?id=20181026.Cision.20181026:BIT:3071:0
Goood steam!
1 Like
Fantastiske nyheter! Skulle jo selvfølgelig komme når jeg skulle forsøke en trade på den nte dippen ned til 46-48 fra 51-52. 
Er vel bare å komme seg inn nå og svelge tapet?
2 Likes