OSLO, Norway--(BUSINESS WIRE)--Date: 17.06.2015 Press Release no: 33/2015
Nordic Nanovector ASA (OSE:NANO), a company focusing on the development and commercialization of novel targeted therapeutics in haematology and oncology, today announces updated results of its ongoing Phase 1/2 study with Betalutin™ in relapsed CD37+ non-Hodgkin lymphoma (NHL) patients. Data and analysis are presented in a poster (abstract 287) at the 13th International Conference on Malignant Lymphoma (13-ICML, Lugano, Switzerland) by Dr. Arne Kolstad, Senior Consultant in Medical Oncology and Radiation Therapy at the Oslo University Hospital, Norwegian Radium Hospital, and the study’s Principal Investigator.
This Phase 1/2 single dose, open label, dose-finding study is investigating three dose levels of Betalutin™ in 13 patients with relapsed CD37+ NHL, previously treated with a number of regimens ranging from 1 to 8. The updated data confirm the favourable safety profile of Betalutin™ and its promising efficacy. New data also highlight that clinical responses observed are sustained, with 5 out of 7 patients still in response, and a duration of response ranging from 6 to 21+ months.
Other key findings are consistent with those presented at the American Society of Hematology (ASH) Conference in December 2014, and include: • Betalutin™ is well tolerated, with a predictable and manageable safety profile: most adverse events are haematological in nature, all transient and reversible;
• 15 MBq/kg b.w. Betalutin™ with HH1 pre-dosing is currently recommended for part 2 of this Phase 1/2 study. This dose was endorsed by the Safety Review Committee;
• Betalutin™ delivers a highly favourable response rate (best response) in this patient population (Overall Response Rate 64% and Complete Response 36%).
Further updates will be presented at future conferences.
A new study arm is currently open for enrolment to evaluate safety and efficacy of both 15 MBq/kg b.w. and 17.5 MBq/kg b.w. without HH1 pre-dosing.
The poster can be viewed at the following address: http://www.nordicnanovector.com/product-info/scientific-posters
Cristina Oliva, Nordic Nanovector’s Chief Medical Officer, commented: “Based on these encouraging data, we are eager to continue the clinical development of Betalutin as a promising therapeutic option for the treatment of patients with relapsed non-Hodgkin lymphoma. We will continue the assessment of the safety and efficacy of Betalutin in this ongoing Phase 1/2 study and we are moving ahead with our pivotal Phase 2 study, PARADIGME, in relapsed/refractory CD37+ follicular lymphoma patients, which is expected to commence in the coming months.”
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). It has shown promising efficacy and a favourable safety profile in a Phase 1/2 study in a difficult-to-treat NHL patient population. The Company is aiming at rapidly developing Betalutin™ for the treatment of major types of NHL with first approval anticipated by the end of 2018. 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.
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