Nordic Nanovector presented phase I study data reporting promising clinical activity
OSLO – Nordic Nanovector presented late Sunday evening (US PST) in a poster session at the 56th American Society of Hematology (ASH) Annual Meeting in San Francisco, CA the data from the phase I study of its lead product candidate Betalutin™, the first Radio-Immuno-Therapy (RIT) targeting the CD37 antigen expressed on lymphoma cells. Betalutin™ confirms its potential role in the treatment of relapsed B-cell non-Hodgkin lymphoma (NHL).
“Betalutin™ does appear to be effective and well tolerated in patients with relapsed non-Hodgkin Lymphoma. These preliminary results from the ongoing phase I/II study are very encouraging,” said Dr. Arne Kolstad of Oslo University Hospital, The Norwegian Radium Hospital and principal investigator of the study.
The poster reports the preliminary efficacy and safety data of NHL patients enrolled in a 3+3 dose escalation phase I study, testing 3 different dose levels of Betalutin™.
The study demonstrates that the safety profile is both predictable and manageable. The clinical data are encouraging and warrant further clinical development of Betalutin™ as a new targeted agent for the treatment of B-cell NHL.
• The maximum tolerated dose was identified at 20 MBq/kg with thrombocytopenia as the dose-limiting toxicity.
• Betalutin™ also delivered a promising clinical response at every dose level, with a 64% Overall Response Rate (ORR) and a 36% Complete Response Rate (CRR), in patients who had received several lines of prior treatments.
• The results are achieved with a one-time injection.
“We are very satisfied with the results of this study. The 64% overall response rate and 36% complete response rate are further reinforcing our belief in Betulatin’s potential,” said Luigi Costa, CEO of Nordic Nanovector. “The degree of clinical activity observed in this trial, coupled with the product’s manageable safety profile, supports our efforts in the further development of Betalutin™ as a new targeted agent for the treatment of B-cell NHL.”
Betalutin™ is currently moving into phase II clinical development.
About non-Hodgkin Lymphoma:
NHL is a life-threatening blood cancer that originates in lymphocytes and spreads and develops in lymph nodes and other lymphoid tissues. The incidence rate of NHL worldwide has been dramatically increasing over the past decades and NHL is today the 10th most commonly diagnosed cancer and is associated to a high mortality rate. Despite recent improvements in available therapies, there is still a high unmet medical need. NHL market is expected to grow by 7% annually for the next four years to exceed USD 12 billion in 2018 worldwide.
Further details of the phase I clinical trial can be found in the poster published on:http://www.nordicnanovector.com/product-info/scientific-posters
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Source: Nordic Nanovector