CYTAVIS? Aviscumine Improves Survival of Patients with Metastatic Melanoma in a Phase II Trial Hamburg

Hamburg/Germany, July 13, 2011 – CYTAVIS BioPharma GmbH, a biopharmaceutical company developing derivatives of natural compounds for the treatment of oncological and immunological diseases, today 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 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.

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 clearly suggest that CY503 is active in patients with metastatic melanoma, and they add to our evidence that the compound has great potential as a highly active immunotherapeutic,” said Hans Lentzen, CEO of CYTAVIS. “We see activity in all grades of metastatic melanoma, in particular in repeatedly pretreated melanoma patients.”

“More than 70% of the patients in this trial were suffering from the most severe stage IV M1c metastatic melanoma,” said the principle investigator of the trial, Dr. Peter Mohr from the Elbe Klinikum Buxtehude, Germany. “These patients already have developed distant metastases, e.g. in the liver, have an elevated lactate dehydrogenase level and have experienced previous treatments. The results of this trial therefore are very encouraging and require confirmation in a large randomized phase III trial. Furthermore, the subcutaneous application of the drug is of advantage for allowing an outpatient treatment and has shown a good compliance.”

About CYTAVIS

CYTAVIS BioPharma 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 AG (Hamburg) and acquired the assets of Viscum AG, a biotech company that had initiated pharmaceutical, pre-clinical and clinical development of Aviscumine. CYTAVIS is developing its projects in collaboration with academic and corporate partners.

About Aviscumine

Aviscumine (CY503) is a recombinant version of viscumin, a protein found in the mistletoe plant. 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. 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.

About metastatic melanoma

Worldwide incidence of melanoma is about 160,000 cases per year. Treatment options include surgical removal of the tumor, adjuvant treatment, chemo- and immunotherapy, or radiation therapy. If discovered early, treatment often successfully eliminates the cancer. However, in about 10% of cases, patients develop metastatic melanoma which is graded stage III or stage IV. In stage III, patients have developed regional metastases, and 5-year survival rates are between 25% and 60%, depending on the number of metastases and affected lymph nodes. Stage IV melanoma patients have 5-year survival rates of between 9% and 15% only. These patients either have developed distant skin, subcutaneous, or lymph node metastases (stage IV, M1a), lung metastases (stage IV, M1b) or any other visceral, or distant metastases or elevated lactate dehydrogenase (LDH) levels (stage IV M1c).

Contact:

Prof. Dr. Hans Lentzen, CEO CYTAVIS BioPharma GmbH Schloßstr. 20 (Nord) D-51429 Bergisch Gladbach, Germany Tel.: +49 (2204) 402 665 Fax: +49 (2204) 427 760 hans.lentzen@cytavis.com

Dr. Ludger Weß, Managing Partner Akampion Hasenhöhe 29 D-22587 Hamburg, Germany Tel.: +49 (40) 88165964 Fax: +49 (40) 88165965 ludger@akampion.com

Posted: July 2011

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