Millenium Biologix withdraws Peptos IDE submission, cites 'limited resources'

By Elaine Rigoli

Tampa, Fla., May 5 - Millenium Biologix Corp. said Friday that it has withdrawn its request to the Food and Drug Administration for an Investigational Device Exemption for its Peptos bone-graft product.

"The decision to withdraw the IDE submission for Peptos is consistent with our previously announced partnering strategy for our orthobiologics portfolio, as we consider clinical trial activity is best undertaken in concert with future commercial partners," interim chief executive officer Brian Fielding said in a news release.

"We believe that the Bone and Cartilage Stimulating Peptides (BCSP) program, which includes our Peptos bone-graft product, has tremendous value and represents an exciting program with significant upside potential to attract world-class partners; however, we have limited resources that we must focus on our lead Actes program."

Millenium said a multi-phase regulatory approach will ensure the earliest introduction of the Actes system into the marketplace, and it will pursue early approval of Actes as a lab instrument for clinical use by centers currently providing cell therapy procedures for the treatment of cartilage damage.

Located in Kingston, Ont., Millenium Biologix is focused on the development and commercialization of cell culture and tissue engineering systems that will drive change from synthetic implants to more effective biologics-based solutions.

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