Viragen, Inc. and its subsidiary, Viragen International, Inc. has filed an application with the Swedish regulatory authorities seeking to expand the approval for Multiferon to include the first-line adjuvant treatment of high-risk malignant melanoma, following dacarbazine (DTIC) after surgical removal of tumours. This submission represents the initial step of the Company's plans to seek broader European approvals for Multiferon.
In a controlled, randomized, multi-centre trial conducted in Germany, the investigators evaluated the adjuvant sequential treatment of Malignant Melanoma (Stage IIb, IIIa, IIIb; high risk) with 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.
The analysis confirmed a statistically significant increase in overall survival for patients treated with adjuvant DTIC followed by Multiferon, compared to patients with no adjuvant treatment.
"The use of alpha interferon may not be new in the treatment of melanoma, but we believe that our Phase II/III study results differentiate our product and demonstrate that low-dose, six-month treatment with Multiferon, our unique human leukocyte-derived alpha interferon, represents a significant advantage to physicians, payors and patients in terms of efficacy, cost and safety," stated Charles A. Rice, Viragen's president and CEO.
Viragen also reported that it intends to request a meeting with the FDA to review its melanoma clinical trial and to discuss an outline for clinical work that would be required to bring Multiferon to the US market.