Photo: Handlingsplan for kliniske studier, regjeringen.no

New political paper: Action Plan for Clinical Studies

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illustrasjon av handlingsplan for kliniske studier

The Norwegian government wants to double the number of clinical studies by 2025, but is this goal ambitious enough?

The highly anticipated political paper “Action Plan for Clinical Studies (2021-2025)” was released in Norway by the Ministry of Health and Care Services this week. The government’s vision is to make clinical studies an integrated part of patient care.

A clinical study is a type of research study that tests how well new medical approaches, such as screening, prevention, diagnosis, or treatments, work in people.

The action plan is the first of its kind and has been requested by researchers, clinicians, the health industry and patient organisations for several years.

The number of clinical studies in Norway is on a negative, spiralling trend. This is especially alarming for cancer patients, who are eager to receive novel treatments.

The Norwegian Health Minister Bent Høie now sets the goal to double the number of clinical studies in Norway and include 5% of all patients in the specialist health services before 2025.

“The action plan includes many important points, we believe the bar should be raised higher,” commented Ketil Widerberg, general manager of Oslo Cancer Cluster.

“Our goal should be to make clinical studies available for all cancer patients in Norway – not just a small fraction.”

The government also announced in the State Budget proposal in October 2020 that NOK 30 million will be allocated through the NorTrials scheme. The funds will be used to employ study nurses and improve competency in clinical research.

The Norwegian Health Minister also calls for a change in work culture, in order to make clinical trials an integrated part of patient treatment.

Another major obstacle is the difficulty to recruit patients quickly. The regional health authorities are now tasked with developing a best practice for patient recruitment.

Oslo Cancer Cluster contributed input to the development of this political paper in September 2019. Our major suggestions included:

  • the need for financial incentives to improve patient recruitment,
  • establishing Norway and the Nordic countries as an international testbed for innovative medicine,
  • authorities to collaborate with industry on guidelines on how to approve precision medicine treatments and the documentation requirements.

Read our entire input here (in Norwegian): Innspill Kliniske Studier til Helse- og omsorgsdepartementet (September 2019) fra Oslo Cancer Cluster

 

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Dr Deborah Owen, Partner, Dehns, is looking forward to help Norwegian companies in the cancer field. Photo: Dehns

Dehns acquires Norwegian office

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Dr Deborah Owen, Partner, Dehns. Photo: Dehns

Our member Dehns announced this week that the company will set up a local office in Oslo.

The law firm Dehns has acquired the Norwegian Intellectual Property consultancy firm Leogriff. This means Dehns will now have an active Norwegian presence with a local office in Oslo.

Dehns is a law firm specialized in patents and trademarks. Dehns’ attorneys have insight in many different technologies in the engineering, chemistry and biotechnology sectors.

With this acquisition, Dehns gains the highly-experienced Leogriff team with all their additional competencies, skills and expertise in Intellectual Property. Leogriff’s clients include companies, investors, research institutes and universities.

What does this mean for Norwegian companies in cancer innovation and life science?

“Companies in the cancer field and life science sector face many challenges and need an excellent network of advisors to navigate these successfully.”
Dr Deborah Owen, Partner, Dehns.

“Intellectual Property (IP) issues are key to such companies at all stages, and we are delighted that the opening of the Dehns’ Norwegian office provides an expansion of the Dehns’ team to provide even greater experience and expertise in areas relating to IP management and strategy consultancy, which will be of real benefit to Norwegian companies of all sizes in these sectors,” continued Owen.

Dehns was founded in 1920 and is one of Europe’s leading firms of patent and trademark attorneys. The company has more than 230 staff across 8 offices: London, Munich, Oxford, Brighton, Manchester, Bristol, Sandwich and, now, Oslo.

Dr Adrian Samuels, Partner, Dehns. Photo: Dehns

Dr Adrian Samuels, Partner, Dehns. Photo: Dehns

“We are delighted that, having been working closely with Norwegian innovators and industry leaders for over half a century, Dehns’ ongoing success will be supported by this direct investment in Norway.”
Adrian Samuels, Partner, Dehns.

For more information, please read Dehns’ press release or visit Dehns official website.

Carlos de Sousa, CEO of Ultimovacs, who has launched a new collaboration study in ovarian cancer with the Nordic Society of Gynaecological Oncology, the European Network of Gynaecological Oncological Trial Groups and AstraZeneca. Photo: Ultimovacs

New clinical study in ovarian cancer

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Carlos de Sousa, CEO of Ultimovacs

Our member Ultimovacs has announced a new Phase II clinical trial for ovarian cancer patients.

DOVACC is a new clinical study from Ultimovacs that will investigate the effect of combining the cancer vaccine UV1 with a checkpoint inhibitor and a PARP inhibitor in patients with ovarian cancer.

This is the first time this type of combination treatment is tested in a clinical study. Patients with advanced ovarian cancer, who have relapsed after receiving two rounds of chemotherapy treatment are eligible for the study.

The study will be sponsored by the Nordic Society for Gynaecological Oncology – Clinical Trial Unit (NSGO-CTU). This group is a part of the European Network of Gynaecological Oncological Trial Groups (ENGOT), which is also a part of the study.

“The collaboration with the NSGO-CTU and ENGOT is exciting for us as they are very experienced with conducting clinical trials in the field of gynaecological oncology. Their expertise and network will support the recruitment of patients at multiple participating study sites across Europe,” commented Jens Bjørheim, Chief Medical Officer at Ultimovacs.

The global pharmaceutical company AstraZeneca, will contribute with two different cancer drugs to the study. These include the checkpoint inhibitor durvalumab and the PARP inhibitor Olaparib.

Ultimovacs is evaluating the company’s universal cancer vaccine UV1 and has also received NOK 10 million from Innovation Norway.

“A key benefit of UV1 is its safety profile, which enables a triple combination study with a PD-L1 inhibitor and now for the first time also with a PARP inhibitor, in an indication in desperate need of new treatment options,” commented Carlos de Sousa, CEO of Ultimovacs.

“The evaluation of UV1, durvalumab and olaparib in this Phase II triple combination study is an important next step in changing the standard of care for patients with ovarian cancer,” added Dr. Mansoor Raza Mirza, Medical Director of the NSGO-CTU and Chair of the ENGOT.

DOVACC is a randomised study, which will include 184 patients. The study is divided into three control arms, or patient groups. The first group includes 46 patients who will receive PARP inhibitor. The second group includes 46 patients who will receive both the PARP inhibitor and the checkpoint inhibitor. The third group includes 92 patients who will receive UV1 and both AstraZeneca drugs.

The multi-centre study will be held at more than 30 hospitals in about 10 countries in Europe.

The first patient will be recruited during the first half of 2021 and results are expected in 2023.

Ultimovacs currently have a broad clinical development programme, with over 500 patients enrolled in Phase II trials.

Read more in the press release from Ultimovacs