Clinical studies performed

Biovica has performed initial clinical trials on the use of DiviTum™ on renal carcinoma (kidney cancer), breast cancer and prostate cancer patients. These studies have been performed as part of the product documentation. Some of these studies are not yet published in full but the essentials of the findings will be presented here. For further information, please contact the head of R&D Dr. Gronowitz at: simon@biovica.com.

Renal carcinoma
All patients in the retrospective study had been selected to undergo nephrectomy (surgical removal of the kidney) based on the judgment by the treating physician that the cancer was not spread outside the kidney. Blood samples had been taken before surgery and then with even intervals over a period of up to five years after surgery, or up to relapse. The study showed that the serum thymidine kinase (s-TK) level before nephrectomy was highly indicative of relapse. Of all patients with an s-TK level of 160 Du/L or higher (twice the upper normal value of 80 Du/L), 90% got a relapse within five years. For lower s-TK levels, this fraction was lower.

The interpretation is that since the nephrectomy failed to fully remove the tumor, it was already locally spread and this was manifested by pathological s-TK levels. Most of the relapses could be seen before clinical symptoms of the relapse emerged by increasing s-TK levels after surgery. s-TK was thus shown to have a highly prognostic value, indicating at an early stage to the treating physician that adjuvant therapy need to be administered and it was also shown how DiviTum™ can be used to monitor a patient after treatment to identify possible relapses earlier.

This study was presented at the annual meeting of the European society of medical oncology in Stockholm in September 2008

Breast cancer
The breast cancer data is still under analysis by the Swedish institute performing the study.

Prostate cancer
The prostate cancer data is still under analysis by the Swedish institute performing the study.
Some data was however released at the World Cancer Conference (UICC) in Geneva in August 2008 and that data showed that spread prostate cancer is connected to pathological levels of s-TK.

The trial also showed that s-TK does not correlate with PSA which means that tumor growth rate as a complement to PSA adds additional information in the diagnostic process.

Combined with the slow growth rate of prostate cancer tumors this finding opens for the application suggested under Proposed prostate cancer usage where prostate cancer overtreatment can be reduced and unnecessary biopsies avoided. Click here for further information (link to PDF file).

However, Biovica will perform more clinical trials on this promising application.