Avax Technologies Inc announced that the Food and Drug Administration (FDA) has confirmed that there are no outstanding issues with regard to the Company's Investigational New Drug (IND) applications for, M-Vax and O-Vax, its AC Vaccine Technology candidates for the treatment of melanoma and ovarian cancers. The Company filed the applications on September 9, 2002, and the FDA has thirty days after the filing in which to request additional information before the applicant commences the clinical trial. The absence of outstanding issues at the end of the thirty-day review period allows Avax to proceed with these clinical trials as planned.
David L. Tousley, President and Chief Operating Officer of Avax stated, "We are pleased that we are now in a position, from a regulatory standpoint, to be able to proceed with these important clinical programs. Prior to making these filings and during the thirty-day review period, we have had extensive dialogue with the FDA concerning our planned clinical trials, and have refined our INDs and clinical protocols to reflect their guidance. This is a significant milestone for AVAX in that it indicates that the Company has successfully redeveloped the vaccine in a way that it now meets the regulatory requirements for treating cancer patients in clinical trials and has satisfied FDA's earlier concerns regarding patient safety."
Avax will provide further information once the clinical trials are underway.