Clinical trials at SentoClone AB

SentoClone AB is undertaking clinical trials with the purpose of evaluating its patented immunotherapy clinically on different types of cancer. The clinical trials are undertaken in a number of large and small hospitals in Sweden.

So far, research on the immunotherapy has been carried out on, amongst other indications, colon cancer and malignant melanoma.

Ongoing clinical trials

Col-Swe-01

A Phase II multicentre study that included 47 patients who were treated with the immunotherapy for metastasised colon cancer. The aim of the study was to evaluate patients through radiological examination and a blood testing regime with, for example, tumour markers.
Inclusion was stopped in September 2009 and the patients are now followed-up. Results will be evaluated and form the basis of the final report.

The primary endpoint is response. Response is defined as: Complete Response (CR) or Partial Response (PR), measured according to the RECIST criteria (Response Evaluation Criteria in Solid Tumours).

T-lymphocytes are extracted from the patient's sentinel nodes. They are then cultivated and returned to the patient via a transfusion. The patients have also been monitored for their quality of life at several points during the study.

The study protocol was approved by the Ethical Review Board and the study was undertaken at 10 clinics.

Every patient is monitored for 24 weeks. Patient follow-up is ongoing.

Mel-Swe-01

In October 2009 we started a randomised Phase II study on malignant melanoma, where patients are randomised between the immunotherapy and standard treatment (DTIC or Temodal). The clinical trial is expected to last for 1.5-2 years and will include 140 patients.

Planned clinical trials

SentoClone AB plans to conduct a small exploratory open multicentre study on non-resectable malignant mesothelioma.
Renal cancer and urinary bladder cancer are other indications for which we plan to conduct small studies to evaluate efficacy of the immunotherapy.

Medical Director is Dr. Freddi Lewin.
Telephone: 08-5012 652

Last Updated Tuesday, 29 June 2010 08:34