Bli medlem
Bli medlem

Du är här

2016-04-15

Nordic Nanovector: Nordic Nanovector ASA: Betalutin® continues to show promising efficacy and increasing Duration of Response (DoR)

Date: 15.04.2016        Press Release no: 14/2016

Updated results to be reported at the American Association of Cancer
Research Annual Meeting 2016

Oslo, Norway, 15 April 2016: Nordic Nanovector ASA (OSE: NANO), a
biotechnology company focusing on the development of novel targeted
therapeutics in haematology and oncology, announces updated results
of its ongoing Phase 1/2 study with Betalutin® in relapsed
non-Hodgkin lymphoma (NHL) patients. Betalutin® was generally well
tolerated and showed a 63.2% Overall Response Rate (ORR) including
31.6% Complete Response (CR) among 21 patients with previously
treated CD37+ NHL patients. This data include two additional patients
whose efficacy data has become available following submission of the
abstract.

Data and analysis will be presented on Tuesday 19 April in a poster at
the American Association for Cancer Research (AACR) annual meeting
(16-20 April 2016, New Orleans, LA, USA) by Dr. Jostein Dahle, Nordic
Nanovector's Chief Scientific Officer. A conference call to discuss
the results will be held on Monday 18 April at 8:30am CEST. Please
see conference call details below.

The data being presented in the poster at AACR are from the ongoing
Phase 1/2 single dose, open label, dose-finding study investigating
three dose levels of Betalutin® in 21 patients with relapsed CD37+
NHL, 19 with Follicular Lymphoma and two with Mantle Cell Lymphoma,
previously treated with one to eight treatment regimens. One patient
recruited into the study had transformed disease and was excluded
from the response rate calculation.

The updated data in the poster confirm the favourable safety profile
of Betalutin® and its promising efficacy as a single agent in
patients who have failed many prior regimens, characterised by a
sustained duration of response.

Key conclusions from the update include:

· Betalutin® is well tolerated, with a predictable and manageable
safety profile: most adverse events are haematological in nature, and
all have been transient and reversible

· Betalutin® delivers a highly favourable response rate (best
response) in this heavily pre-treated patient population (Overall
Response Rate 63.2% and Complete Response 31.6%)

· The median Duration of Response (DoR) has not yet been reached.
Clinical responses observed are sustained, with DoR exceeding 12
months in most responders

Luigi Costa, Nordic Nanovector's Chief Executive Officer, commented:
"These new data continue to confirm Betalutin's efficacy potential
and favourable safety profile. In addition, Duration of Response
(DOR) in patients who responded to treatment with Betalutin® has
further improved confirming the product's potential to become a
significant treatment of NHL. These encouraging results support the
continued clinical development of Betalutin®. We are pleased with the
progress that we are making in executing our revised Phase 1/2 study
and look forward to confirming the optimal dosing regimen for the
pivotal Phase 2 study, PARADIGME, expected in Q1 2017."

The poster will be presented between 8.00am -12.00pm Central Daylight
Time (CDT)/3:00pm - 7:00pm CEST on 19 April and will be available at:
http://www.nordicnanovector.com/product-info/scientific-posters at
the same time.

The abstract (No. LB-252) was published today online at AACR abstract
(http://www.abstractsonline.com/Plan/ViewAbstract.aspx?mID=4017&sKey=5412...).

Conference call details

A conference call to discuss the results will take place on Monday 18
April at 8.30am CEST.

Please make sure to dial in 5-10 minutes prior to scheduled conference
call start time using the number and confirmation code below:

Local - Norway +47 21 00 26 10

Local - UK +44 (0) 203 043 2002

Local - USA and International +1 719 457 1036

Conference ID: 5241435

The presentation for the conference call will be publicly available at
www.nordicnanovector.com in the section; Investor relations/Reports
and Presentation/Presentation/2016.

For further information, please contact:

IR enquiries:

Luigi Costa, Chief Executive Officer

Cell: +41 79 124 8601

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

About Nordic Nanovector

Nordic Nanovector is a biotech company focusing on the development and
commercialisation of novel targeted therapeutics in haematology and
oncology. The Company's lead clinical-stage product opportunity is
Betalutin®, the first in a new class of
Antibody-Radionuclide-Conjugates (ARC) designed to improve upon and
complement current options for the treatment of non-Hodgkin Lymphoma
(NHL). NHL is an indication with substantial unmet medical need and
orphan drug opportunities, representing a growing market worth over
$12 billion by 2018. Betalutin® comprises a tumour-seeking anti-CD37
antibody (HH1) conjugated to a low intensity radionuclide
(lutetium-177). The preliminary data has shown promising efficacy and
safety profile in an ongoing Phase 1/2 study in a difficult-to-treat
NHL patient population. The Company is aiming at developing
Betalutin® for the treatment of major types of NHL with first
regulatory submission anticipated in 1H 2019. Nordic Nanovector
intends to retain marketing rights and to actively participate in the
commercialisation of Betalutin® in core markets, while exploring
potential distribution agreements in selected geographies. The
Company is committed to developing its ARC pipeline to treat multiple
selected cancer indications. Further information about the Company
can be found at www.nordicnanovector.com

Forward-looking statements

This announcement may contain certain forward-looking statements and
forecasts based on uncertainty, since they relate to events and
depend on circumstances that will occur in the future and which, by
their nature, will have an impact on Nordic Nanovector's business,
financial condition and results of operations. The terms
"anticipates", "assumes", "believes", "can", "could", "estimates",
"expects", "forecasts", "intends", "may", "might", "plans", "should",
"projects", "will", "would" or, in each case, their negative, or
other variations or comparable terminology are used to identify
forward-looking statement. There are a number of factors that could
cause actual results and developments to differ materially from those
expressed or implied in a forward-looking statement or affect the
extent to which a particular projection is realised. Factors that
could cause these differences include, but are not limited to,
implementation of Nordic Nanovector's strategy and its ability to
further grow, risks associated with the development and/or approval
of Nordic Nanovector's products candidates, ongoing clinical trials
and expected trial results, the ability to commercialise Betalutin®,
technology changes and new products in Nordic Nanovector's potential
market and industry, the ability to develop new products and enhance
existing products, the impact of competition, changes in general
economy and industry conditions and legislative, regulatory and
political factors. No assurance can be given that such expectations
will prove to have been correct. Nordic Nanovector disclaims any
obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.

This information is subject to a duty of disclosure pursuant to
Section 5-12 of the Securities Trading Act.

-----------------------------------------------------------
http://news.cision.com/nordic-nanovector/r/nordic-nanovector-asa--betalu...

Författare WKR

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.