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Smerud Medical Research International AS

Smerud Medical Research International AS is a clinical contract research organization (CRO) that provides full-service clinical trial services to biotech, pharma, med-tech, and academic sponsors.The company specializes in proof-of-concept clinical trials and pivotal regulatory trials, and it also invests in co-development projects, grants, and self-financed R&D to drive innovation in key therapeutic areas.

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Astatine-211 based radionuclide therapy: Current clinical trial landscape

Affiliations.

• 1 Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden.
• 2 Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
• 3 Department of Radiation Physics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
• 4 Smerud Medical Research International AS, Oslo, Norway.
• PMID: 36687417
• PMCID: PMC9859440
• DOI: 10.3389/fmed.2022.1076210

Astatine-211 ( 211 At) has physical properties that make it one of the top candidates for use as a radiation source for alpha particle-based radionuclide therapy, also referred to as targeted alpha therapy (TAT). Here, we summarize the main results of the completed clinical trials, further describe ongoing trials, and discuss future prospects.

Keywords: alpha particle; astatine-211; clinical trial; human; radionuclide; targeted alpha therapy.

Copyright © 2023 Albertsson, Bäck, Bergmark, Hallqvist, Johansson, Aneheim, Lindegren, Timperanza, Smerud and Palm.

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Conflict of interest statement

PA, TB, KS, SP, EA, and SL are co-founders of Aprit Biotech AB. EA and SL are the co-founders of Atley Solutions AB. KS is the founder of Smerud Medical Research Group. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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• Corson DR, MacKenzie KR, Segrè E. Possible production of radioactive isotopes of element 85. Phys Rev. (1940) 57:459. 10.1103/PhysRev.57.459 - DOI
• Hamilton JG, Durbin PW, Parrott MW. Accumulation of astatine211 by thyroid gland in man. Proc Soc Exp Biol Med. (1954) 86:366–9. 10.3181/00379727-86-21100 - DOI - PubMed
• Feng Y, Zalutsky MR. Production, purification and availability of (211)At: near term steps towards global access. Nucl Med Biol. (2021) 100:12–23. 10.1016/j.nucmedbio.2021.05.007 - DOI - PMC - PubMed
• Lindegren S, Albertsson P, Back T, Jensen H, Palm S, Aneheim E. Realizing clinical trials with astatine-211: the chemistry infrastructure. Cancer Biother Radiopharm. (2020) 35:425–36. 10.1089/cbr.2019.3055 - DOI - PMC - PubMed
• Guérard F, Maingueneau C, Liu L, Eychenne R, Gestin J-F, Montavon G, et al. . Advances in the chemistry of astatine and implications for the development of radiopharmaceuticals. Acc Chem Res. (2021) 54:3264–75. 10.1021/acs.accounts.1c00327 - DOI - PubMed

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Smerud Medical Research International AS (SMERUD) is a European drug development company and contract research organisation (CRO) with headquarters in Oslo, Norway. The core competence is strategic drug development including regulatory affairs planning. They manage clinical exploratory trials, proof-of-concept trials (phase IIa) as well as pivotal phase III trials, and they liaise with regulatory agencies world-wide to agree study plans. SMERUD has been involved in more than 1000 clinical trials. The core business idea is to develop biotech drug candidates in collaboration with small-to-medium sized biotech partners and academic institutions.

CLINICAL TRIAL MANAGEMENT

• Planning of clinical development programmes
• Feasibility studies
• Setting up and management of trial centres
• Patient recruitment
• Periodic monitoring
• Closing of trial centres

PROJECT FUNDING

• Research grants
• Venture capital
• Market analyses
• Project strategy
• Clinical development programmes
• Regulatory strategy
• Local advice - regulatory and ethics

DATA MANAGEMENT

• Case report form design and production
• Database design
• Data validation

BIOSTATISTICS

• Study design
• Sample size estimations
• Power analysis
• Randomisation
• Analysis planning
• Statistical analysis and reports

MEDICAL WRITING

• Study protocols
• Study reports
• Articles for publications
• Review articles
• Investigator brochures
• Clinical summaries / clinical overview
• Regulatory dossiers

REGULATORY AFFAIRS

• Marketing authorisation applications
• Local translations and harmonisation of texts
• Clinical trial applications
• Pharmacovigilance

QUALITY ASSURANCE

• Site audits
• In-house audits
• Standard operating procedures - development and revision
• Training courses

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Smerud Medical Research International AS

P.o. box 81 Skøyen, N-0212 Oslo, Norway

Visiting address: Thunes vei 2, N-0274 Oslo, Norway.

 +47 2327 2000

 +47 2327 2001

 [email protected]

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Smerud Medical Research Group in Finland

E-mail:   [email protected]

Web:   https://www.smerud.com

Phone:   +358 9452 0780

Fax:   +358 9452 07874

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Jorvas High-tech Center, Hirsalantie 11, 02420 Jorvas, Finland

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• United Kingdom

About Smerud Medical Research Group

The Smerud Medical Research Group (SMERUD) is a full-service clinical Contract Research Organisation operating in the Northern European area with head office in Norway and subsidiary offices in Denmark, Finland, Sweden, United Kingdom, Germany, Austria, Poland and Canada. In recent years, SMERUD has achieved an unrivalled position in Europe as the CRO for obtaining public grants for clinical trials. Our consistent and huge investment into internal R&D projects has enabled us to act both as a successful grant writer and as a risk-sharing co-development partner for many of our clients. Our project-orientated co-investment service has been particularly welcomed by smaller, cash-strapped biotech companies – seeing this offer as an excellent source of non-dilutive funding. SMERUD has – together with its associated venture firm Scandinavian Biotech Venture AS – become one of the largest private biotech investors in the Nordic countries

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Smerud Medical Research Germany GmbH

(Amtsgericht Mannheim HRB 720151 Geschaeftsfuehrer Dr. Hans Mueller) O7, 1, D-68161 Mannheim, Germany.

 +49 171 1275 932

 +49 621 1702 849 28

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