Request for cooperation in an Orphan Drug project
Thymophysin® (thymostimuline) is a drug prepared from the extract of peptides from bovine thymus glands. Following removal of high-molecular cell components and proteins, the low-molecular active thymus peptides are isolated and standardized to a defined protein fraction.
The Drug Product was a licensed immunomodulating drug in Germany (MA elapsed in 2010) and has been used in phase II/III trials in patients with hepatocellular carcinoma (HCC), because of the interest in drugs containing thymic peptide preparations for their potential anti-tumerous properties.
Although Thymophysin® (thymostimuline) had no healthful effect on tumor progression, and did not improve survival, a lower incidence of malignant ascites was observed in patients treated with thymostimuline as compared with placebo (Dollinger M, et al. Thymostimulin versus placebo for palliative treatment of locally advanced or metastasised hepatocellular carcinoma: a phase III clinical trial. BMC Cancer. 2010; 10:457).
According to the data of German Robert-Koch-Institute the incidence for HCC is 5.6 (female) to 13.1 (male) per 100,000 in Germany (2008). Data about the incidence of malignant ascites following HCC are not available in official indices, but is estimated to be below 5/10,000 (rare disease - orphan drug status).
We are convinced that preliminary data are reasonable to proceed with the product towards the acknowledgement of the orphan drug status of Thymophysin for an indication like “treatment of malignant ascites as accompanying symptom of HCC”.
We are looking for a partner to make this project succeed.
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