Biomoda to launch multisite Phase III clinical trials of CyPath assay

Medical diagnostics company Biomoda, Inc. (OTCBB: BMOD) is taking preliminary steps to launch multisite Phase III clinical trials of its in-vitro diagnostic for early-stage lung cancer, trademarked under the name CyPath®.

“As the Phase II trial wraps up, we are making sure that all the pieces are in place to move immediately to a nationwide Phase III,” Biomoda President John Cousins said. “Most significantly, Dr. Thomas Bauer, the Principal Investigator (PI) overseeing Phase II, has agreed to continue in the same role for our Phase III trials. Dr. Bauer is widely recognized as one of the top lung cancer researchers in the field, and we are privileged to be working with him.”

Bauer, chief of thoracic surgery at the Helen F. Graham Cancer Center, Christiana Care Health System, and head of Christiana’s participation in the International Early Lung Cancer Action Program (I-ELCAP), is coordinating site selection for the final phase of testing on the CyPath® assay. Bauer’s work with Biomoda follows the I-ELCAP Enrollment and Screening Protocol, and all sites selected for the Phase III trials will be I-ELCAP approved.

Cousins said that Biomoda is finalizing the protocol for its Phase III trials for submission to an Institutional Review Board (IRB) in early 2010. IRB review protects research subjects by making sure the study protocol adheres to U.S. Food and Drug Administration (FDA) and U.S. Department of Health and Human Services regulations, that risks to participants are minimized and acceptable in light of the possible benefits, that the informed consent document is accurate, and that the research is conducted in an ethical manner.

Biomoda is seeking FDA approval of its cytology-based screening technology as a Class III medical device under the Pre-Market Approval (PMA) process. “When Phase II results are complete, probably by the end of January 2010, we will report them immediately to the FDA along with the pre-IDE (Investigational Device Exemption) filing,” Cousins said. “Based on feedback from the FDA to date, we anticipate no delays in moving forward with Phase III.”