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Clinical Trials

Date: 2011-07-13

Type of information:

phase: 2

Announcement: results

Company: Cytavis Biopharma (Germany)

Product: Aviscumine (CY503)

Action mechanism: This recombinant version of viscumin, a protein found in the mistletoe plant, is an immune potentiator. It influences the immune system via multiple modes of action: activating antigen-presenting cells, evoking strong T-cell response, increasing the cytotoxic activity of killer cells, and inducing the release of key cytokines which mediate the anti-cancer activity of the immune system.

Disease: refractory metastatic melanoma (stage IV)

Therapeutic area: Cancer Oncology

Country: Germany

Trial details: The open-label Phase II multicenter trial (NCT00658437) was designed to test the influence of subcutaneous injections of Aviscumine (CY503) on progression-free survival (PFS) and overall survival (OS) of patients with unresectable metastatic melanoma (stage IV) after antineoplastic treatment failure. The trial included 31 eligible patients and was conducted at four German sites.

Latest news: Cytavis BioPharma GmbH has announced Phase II data demonstrating that its lead compound Aviscumine (CY503), an immune potentiator, may improve survival of patients with refractory metastatic melanoma (stage IV).
The progression-free survival rate after 3 months was 32.3%, while the 1-year-survival rate was 45.0% and median overall survival time (mOS) 11 months in the full analysis set/intention to treat population (FAS/ITT). In case of the standard therapy with Dacarbazine the 1-year-survival rate is usually about 30% and the mOS between 6 and 8 months, respectively. The majority of treatment-related adverse events were not severe application site reactions and pruritus. The results of this trial therefore are very encouraging and require confirmation in a large randomized phase III trial.
The safe administration of Aviscumine has already been shown in three Phase I studies in patients with different solid tumors and in a Phase I/II trial in patients with superficial bladder cancer.

Is general: Yes