Cardium Therapeutics' wholly-owned subsidiary, Tissue Repair Company, has entered into a multi-year supply agreement with Devro Medical Limited, part of Devro plc, a public limited company registered in Scotland, for the supply of highly-refined fibrillar bovine Type I collagen, an important component of Cardium's new Excellagen formulated collagen product candidate, which is pending US FDA 510(k) clearance. A detailed slide presentation on the final data analysis of the Matrix phase-2b clinical study, demonstrating a statistically significant acceleration of wound healing following a one-time application of the Excellagen product candidate.
Under this supply agreement, the collagen component of Excellagen will be manufactured at Devro's new cGMP manufacturing facility which is currently undergoing final process validation activities and awaiting a formal accreditation audit for ISO certifications. Devro also plans to establish a Device Master File with the US FDA following completion of ISO certifications of other component manufacturing processes. In addition, Cardium has also entered into a clinical manufacturing and supply agreement with its US-based fill and finish contract manufacturer to provide final processing and assembly of the market ready Excellagen product.
"After a detailed review of potential commercial suppliers of medical-grade collagen fiber formulations for our Excellagen product candidate, we believe that Devro Medical is uniquely qualified to ensure a timely supply of highly-refined material of a quality and consistency designed for use in treating diabetic wounds and other important medical applications. Rigorous specifications have been engineered into our formulated collagen by our researchers, which we believe contribute to the significant healing response that has been observed and now reported in our recently completed Matrix phase-2b clinical study," stated Christopher J Reinhard, chairman and chief executive officer of Cardium.
Reinhard added, “The final steps for regulatory clearance of Excellagen involve providing confirmatory product and process testing information obtained with the final market-ready product. With our commercial supplier now in place, we expect to have market-ready material finalized and tested within the next quarter so that we can be in position for final US FDA clearance and commercial launch. In parallel, we are now initiating activities associated with launch, including packaging and other final product requirements, and are in discussions with potential commercialization partners for the marketing and sale of Excellagen in the US and internationally.”
Reporting on the final data analysis of the Excellagen cohorts from the Matrix phase-2b clinical study, Reinhard stated that, "Excellagen appeared to be both safe and well tolerated and showed a statistically significant 173 per cent relative improvement in the acceleration of wound healing (reduction in wound size) during the first week following a one-time application (generally applied following surgical debridement) compared to patients receiving standard of care therapy." He also noted that, "Researchers believe that more frequent treatments of Excellagen in response to observed wound healing rate slowdowns and plateaus and in association with all surgical debridement procedures during a 12-week treatment regimen may potentially offer the opportunity to substantially increase the already robust healing effect that was reported in the Matrix study (which specified only one or two administrations during the 12-week study period). Given this important new supplemental data, we plan to continue building on our unique initial wound management product candidate with the potential development of new product opportunities by incorporating other agents into the Excellagen formulation, including antimicrobials, DNA and/or other biologics, which would be designed to address particular aspects of the wound care market."
Devro Medical is part of the Devro group, the world's largest collagen processor. Devro has been supplying technically advanced collagen products for medical device production for more than 20 years.
Cardium is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations.