Cytavis Starts Phase II Clinical Trial with Aviscumine in Metastatic Colorectal Carcinoma Patients

Hamburg/Germany, September 14, 2009 – Cytavis GmbH, a biopharmaceutical company developing derivatives of natural compounds for the treatment of oncological and immunological diseases, today announced the start of a Phase II trial with its lead compound Aviscumine (CY-503) in patients with chemotherapy-refractory metastatic colorectal carcinoma (NCT 00932724).

The placebo-controlled, double-blind, randomized multicenter study will be conducted in Germany and Austria and will include more than 200 patients with progressing metastatic colorectal carcinoma after failure of antineoplastic standard treatments. Primary endpoint will be progression free survival, secondary endpoints will be overall survival, safety and quality of life, as assessed using the EORTC (European Organisation for Research and Treatment of Cancer) standard questionnaire. In addition, the effect of Aviscumine on several immune functions will be assessed.

Aviscumine (CY-503) is a recombinant version of viscumin, a protein found in the mistletoe plant. It induces the so-called programmed cell death (apoptosis) of tumor cells by blocking their protein synthesis. It can be used at very low doses, i.e. picomolar concentrations, to activate the immune response against cancer cells. 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 study in patients with superficial bladder cancer. A phase IIa study in metastatic melanoma patients is ongoing, with results expected at the end of the year.

„This study will comprehensively evaluate the activity, tolerability and therapeutic effects of Aviscumine in a larger population of patients," said Hans Lentzen, CEO of Cytavis. "Our goal is to show efficacy as last line treatment. Already, there is a lot of evidence that the compound has great potential in the treatment of various tumors.”

About Cytavis

Cytavis GmbH is a biopharmaceutical company developing derivatives of natural compounds for the treatment of oncological and immunological diseases. The company was founded in 2005 by BioAgency (Hamburg) and acquired the assets of Viscum AG, a biotech company that had initiated pharmaceutical, pre-clinical and clinical development of Aviscumine. The lead compound Aviscumine (CY-503) is in clinical development stage Phase II. Additional compounds, polyketides based on Fredericamycin A, are in lead optimization. Cytavis is developing its projects in collaboration with academic and corporate partners. In 2009, Cytavis has partnered with Toxavis GmbH to develop Aviscumine-based immunotoxins for the treatment of various cancers. These molecules have reached preclinical stage.

About colorectal cancer

Colorectal cancer has an incidence of about 1 million new cases diagnosed each year and is the second leading cause of cancer-related death in Western nations. There are a couple of approved standard therapies for the treatment of metastatic colorectal cancer (MCRC) with cytotoxic agents and antibodies against vascular endothelial growth factor A and epidermal growth factor receptor, resp. However, with standard treatment median survival is rarely more than 20 months in MCRC patients. Patients who experience disease progression after standard therapy have no further treatment option. Therefore, there is a huge unmet medical need in MCRC after failure of standard therapy regimes.

Contact

Prof. Dr. Hans Lentzen, CEO
Cytavis BioPharma AG
Schnackenburgallee 116a
D-22525 Hamburg
Germany
Tel. +49 (22 04) 40 26 65
Fax +49 (22 04) 42 77 60
Email: hans.lentzen@cytavis.com

www.cytavis.com