The results from a 7-year follow-up to a phase II/III clinical study that evaluated the use of Multiferon, natural human alpha interferon, for the treatment of malignant melanoma after surgical removal of all tumour masses compared to surgery alone conducted by Viragen Inc and its majority-owned subsidiary, Viragen International Inc was announced recently.
The analysis confirmed a statistically significant increase in overall survival for patients treated with adjuvant dacarbazine (DTIC) followed by Multiferon, compared to patients with no adjuvant treatment. The study data will serve as the basis for an application that Viragen intends to file in Sweden to seek expanded approval for Multiferon to include the first-line adjuvant treatment of high-risk malignant melanoma, according to company sources.
In a controlled, randomized, multi-centre trial conducted in Germany, the study evaluated the adjuvant sequential treatment of Malignant Melanoma (Stage IIb, IIIa, IIIb; high risk) with dacarbazine (DTIC) followed by Multiferon (Highly purified, multi-subtype, natural human alpha interferon) versus untreated controls, in patients who underwent complete surgical removal of all tumour masses. The study was followed up for a minimum of 7 years in each individual patient.
After a 7-year follow-up, the results showed an actual 51.3 per cent overall survival in high-risk patients treated with short-term DTIC, followed by Multiferon as adjuvant low-dose treatment for 6 months versus 30.3 per cent overall survival among patients who underwent surgery only (p=0.0077).
A follow-up beyond 7 years was obtained in most patients and 9-year follow-up results showed an estimated 50.9 per cent overall survival in the treated population versus 23.5 per cent in the control group. This suggests that a significant survival benefit is sustained beyond 7 years.
"We intend to submit an application for registration with the Swedish regulatory authorities for this new indication this year, which if approved, could provide us with the opportunity to proceed with Mutual Recognition Procedure (MRP) in the European Union (EU)," stated Viragen's president & CEO, Charles A. Rice. He added, "This study is of paramount importance as part of our strategy to expand approvals for Multiferon into major global markets, as well as enhance our ability to attract key strategic partners."
Skin cancer is the most common type of cancer, accounting for more than 50 per cent of all cancers. Melanoma accounts for approximately 4 per cent of skin cancer cases, but causes 79 per cent of skin cancer deaths. About 132,000 people worldwide are diagnosed with melanoma each year, and more than 37,000 die from the disease annually.
Research and Markets reports that the worldwide melanoma therapeutics market is estimated at $265 million in 2004 and is expected to exceed $630 million worldwide by 2009.
Viragen is a biotechnology company specializing in the research, development and commercialization of natural and recombinant protein-based drugs designed to treat a broad range of viral and malignant diseases.