Viragen is seeking to have the approval include the first-line adjuvant treatment of high-risk malignant melanoma following dacarbazine (DTIC) after surgical removal of tumors. This submission represents the initial step of the company’s plans to seek broader European approvals for Multiferon.
Viragen’s executive vice president of operations, Mel Rothberg, commented on how the company’s melanoma strategy may impact partnering activities: “While we are monitoring a number of new products in the development pipeline for the treatment of melanoma, we are not aware of data reported that represents such an improvement over conventional therapies as does this regimen of Multiferon.
“Related to partnering, we continue in discussions with a number of candidate companies, including those who are interested in marketing Multiferon as the ‘natural choice’, not only in Europe, but also in available territories in South America and Asia,” he continued.
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.
The Swedish filing has sent shares in Viragen Inc up by over 4.5%.