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Nordic Nanovector - det neste Algeta? (3)
yemaya 2
14.06.2017 12:32
#8457

Jeg har ikke stopploss.

Endret 14.06.2017 12:31 av yemaya 2
OldNick
14.06.2017 13:01
#19195

Vi får legge inn meldingen, og link til "poster"

NANO: Single dose Betalutin® continues to show promising efficacy and safety in recurrent indolent NHL patients

Updated results reported at the International Conference on Malignant Lymphoma


Børsmelding
14.06.2017

Oslo, Norway - Nordic Nanovector ASA (OSE: NANO) announces that updated results from its ongoing LYMRIT 37-01 Phase 1/2 clinical trial of Betalutin® (177Lu-satetraxetan -lilotomab) in patients with recurrent indolent non-Hodgkin's lymphoma (iNHL) are being presented at the International Conference on Malignant Lymphoma (ICML) on June 14-17 in Lugano, Switzerland.

The LYMRIT 37-01 study is a Phase 1/2 open label, dose escalation study investigating the optimal treatment regimen of single dose Betalutin® with lilotomab pre-dosing in patients with recurrent iNHL.

The updated data confirm Betalutin®'s promising efficacy and safety profile as a single agent in recurrent iNHL patients, who have failed multiple prior treatments, and who are eligible for assessment. The results, based on the data cut-off date of 6 May 2017, were presented by the study's Principal Investigator Dr. Arne Kolstad from the Department of Oncology at the Oslo University Hospital, Radiumhospitalet.

Key conclusions

- Single dose Betalutin® is highly active in recurrent iNHL:
--- 64% Overall Response Rate (ORR) and 28% Complete Responses (CR) in the 47 evaluable patients
--- Significant activity was seen in 33 patients with recurrent follicular lymphoma (FL) with 70% ORR and 27% CR
--- 87% of patients showed a reduction in tumour size

- Betalutin® was well-tolerated with no unexpected safety findings in the 59 patients evaluated for safety, with a predictable and manageable safety profile:
--- The most common grade 3/4 adverse events were thrombocytopenia and neutropenia, transient and reversible
--- No grade 4 neutropenia/thrombocytopenia observed for patients receiving higher lilotomab pre-dosing

Dr. Arne Kolstad, MD commented: "Betalutin® continues to demonstrate a very promising clinical profile in relapsed NHL patients who have received numerous prior therapies, including those who have failed standard CD20-targeted chemo immunotherapy. The dataset in FL patients is particularly encouraging given this is the primary NHL population for which Betalutin® is being developed."

Dr. Lisa Rojkjaer, MD, Nordic Nanovector's Chief Medical Officer, added: "These updated results are very encouraging, underlining the potential of a single administration of Betalutin® for treatment of relapsed NHL. We look forward to following these patients and to reporting on longer term outcomes. Data continue to support the company's strategy in Betalutin®'s development and the intent to initiate our pivotal Phase 2 PARADIGME study, in the second half of 2017."

The poster is available at: Link to poster (PDF).

For further information, please contact

IR enquiries:
Tone Kvåle, Chief Financial Officer
Cell: +47 91 51 95 76
Email: ir@nordicnanovector.com

Media enquiries:
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44 207 282 2948/+44 207 282 2949
Email: nordicnanovector@citigatedr.co.uk
LinPiao
14.06.2017 13:49
#2881

Det kan være at den stiger fint etter at seriøse aktører har fordøyd hva tallene faktisk sier. Kjøpte noe nå på 90.25 og 90,50.
Savepig
14.06.2017 15:30
#424

Jeg sitter helt i ro og trader ikke i NANO. Kommer ikke til å redusere før noen som helst tegn på at forskningen feiler kommer.

Men tviler på at det skjer mye positivt med kursen før senere i år nå.

Treet er nok derimot godt rystet.
Stockamateur
15.06.2017 10:46
#12055

yemaya 2
14.06.2017 12:32
#8457

En grei faktaopplysning.

Hvor smart det er er en annen sak...
renud
15.06.2017 11:04
#15896

En annen faktaopplysning:
Cash per aksje er (visstnok) ca 15 NOK.
motbedreviten
15.06.2017 14:53
#2535

slik jeg vurderer det:
En gruppe pasienter med tilbakefall av NHL men ikke veldig syk (indolent)
blir behandlet med betalutin + pre-dosing.
circa 1/3 del lite eller ingen bedring.
circa 1/3 del betydelig bedring
circa 1/3 del godt resultat.
Ingen med varige bivirkninger.

er dette godt nok for prisen?
.
Savepig
15.06.2017 16:09
#425

NORDIC NANOVECTOR
Reported strong data at ICML2017
The company presented updated clinical data from its ongoing phase I/II trial yesterday. We consider the data strong and believe it stacks up well compared with other drugs under development. The safety profile was also strong, particularly for high pre-dosing patients. Also yesterday, the company changed its data reporting structure - the market reacted negatively to this, but we believe this was unwarranted. We reiterate our BUY recommendation and NOK145 target price.
Strong data reported at ICML. The company reported an ORR of 64% and a CR of 28% for the total material (47 patients of 59 enrolled) had been followed long enough to evaluate efficacy. For the largest patient group (relapsed FL patients) the company reported an ORR of 70% and a CR of 27%. Previously, the company split out patients in phase II and reported data on these separately from all phase I/II patients, but has now changed reporting to type of tumour (rFL, MZL, MCL etc.). This is more in line with how most other companies report data and should not be seen as strange, we believe.Strong safety data from 20MBq/kg - 100mg/m2 dose. Even though the company did not give separate efficacy data for the 20/100 patients in the LYMRIT 37-01 trial, it did give strong safety data. There were no cases of Grade 4 neutropenia or thrombocytopenia side effects with the high pre-dosing and the timing of haematological side effects looked as expected.
Timelines for PARADIGME should be intact. We believe the company will be able to finalise the details of the upcoming phase II trial and start enrolment as expected during H2 2017. In addition, the company has started to enrol patients in an expansion cohort of Arm 4 in the 20/100 dose with the aim of adding at least 15 patients.BUY recommendation and NOK145 target price reiterated. From our point of view, the data presented was strong and still stacks up well with other drugs under development for the same indication. With this in mind, we believe yesterday's negative share price reaction was an overreaction.
LinPiao
15.06.2017 16:37
#2882

Veldig bra melding fra DNB over her. Sier med klare ord at markedet overreagerte i går og gjentar kursmålet på 145.
fomlusen
15.06.2017 17:42
#437

Motbedreviten

Hør oppsummering fra radforsk på Soundcloud ep 20
Einarsson går gjennom dataene.

Meget sterke data.
yemaya 2
15.06.2017 20:19
#8458

For bekvemmelighetens skyld. Her er podkast 20
LinPiao
15.06.2017 21:06
#2883

Hva er neste nå? Bekreftelse en gang i neste halvår at paradigmet er igang? Q2-rapporten i august? Det endelige dosevalget i Q3?
yemaya 2
15.06.2017 21:09
#8459

Neste er vel OBX.
yemaya 2
15.06.2017 21:11
#8460

Men neppe noen større faglige oppdateringer før en gang på høsten
yemaya 2
15.06.2017 21:19
#8461

Det burde vel gi rom for stokkis' teoremer.
motbedreviten
15.06.2017 22:51
#2536

fomlusen,

Tok podcast 20.
Faktisk overrasket over hvor bra det bildet jeg dannet, kom overens med deres på radforsk, men:
De benekter at det er indolente pasienter
De forventer mye av ytterlige finjusteringer av doseringen
De hinter at FL pasienter vil ha bedre effekt, men jeg mener å huske at FL (folliculær L) heletiden har vært hovudmål gruppe.
LinPiao
15.06.2017 22:58
#2884

Stokkis teoremer? Er de hyggelige? Eller er det beviser for at amerikanerne aldri har landet på månen?
yemaya 2
15.06.2017 23:01
#8463

Stokkis teoremer innebærer garantert profitt under en ørkenvandring.
LinPiao
15.06.2017 23:09
#2885

Jødenes ørkenvandring under Moses varte i 40 år.
yemaya 2
15.06.2017 23:12
#8464

Desto større muligheter for multipler. Fikk ikke Moses 10?
LinPiao
16.06.2017 06:57
#2886

Jo. 7+3.
CandC
16.06.2017 10:02
#11

Jeg har sett litt nærmere på de tallene som ble presentert i Lugano. Dette var jo først og fremst en bekreftelse på at 'safety' delen er i boks. Hva angår 'efficacy' er det en liten del av materialet som er behandlet med 20/100. Så her forventer jeg høyere 'efficacy' etterhvert som 20/100 utgjør stadig større del av statistikken. Tall på dette kommer vel til høsten.
Stockamateur
16.06.2017 10:09
#12056

y2/LP

Tullebukkene ;-)
renud
16.06.2017 11:59
#15904

En emoji, fra Stokkis? 😱
LinPiao
17.06.2017 22:00
#2887

Nano deltar på European Health conference i London 20.-21.juni.

Kan det være at noe blir lagt fram her. Antagelig ikke.
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