On August 28 2015 Telesta Therapeutics Inc. (TSX: TST) (PNK: BNHLF) reported that it has received its BLA Filing Notification for MCNA from the U.S. Food and Drug Administration (FDA). This formal letter communicates that the FDA has completed its initial review of Telesta’s Biologics License Application (BLA) submitted on June 29, 2015 and has accepted it for filing (Press release, Telesta Therapeutics, AUG 28, 2015, View Source [SID:1234507865]). In the same letter, the FDA communicated that it has designated the file for 6 month Priority Review and has set February 27, 2016 as the review goal date for MCNA. The FDA has also advised that it will be organizing an advisory committee to discuss the BLA application.
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Commenting on the FDA letter, Dr. Michael Berendt, Chief Executive Officer and Chief Scientist noted: "Today is a historic day for Telesta Therapeutics and for all of our staff and collaborators who have worked so diligently to advance our new treatment for non-muscle invasive bladder cancer towards potential regulatory approval early next year. While we recognize that the FDA must complete its full review of our BLA filing before rendering its ultimate decision, we are working extremely hard, at all levels, to prepare for commercial launch in the United States."
About MCNA
MCNA is a biologic therapy developed to provide high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from front line therapy with a therapeutic alternative to surgery. MCNA is derived from the cell wall fractionation of a non-pathogenic bacteria. Its activity is believed to be through a dual mechanism of immune stimulation and direct anti-cancer effects. MCNA was developed to be delivered as a sterile suspension for intravesical administration by urologists and urology nurses, following the same dosing paradigm as first-line bacillus Calmette-Guérin (BCG) therapy, with the advantage that it can be prepared, handled and disposed of easily and safely. The efficacy, duration of responses and safety data from MCNA’s pivotal Phase 3 trial was recently published in The Journal of Urology. The FDA has set February 27, 2016 as its review goal date for MCNA’s potential approval.
About Telesta Therapeutics Inc.
Telesta Therapeutics Inc. is a late stage therapeutics company with near term commercial potential focused on the manufacturing, marketing and licensing/acquisition of proprietary and innovative therapies for the global health market. The Company’s primary goal is to develop and commercialize products that advance human health and increase shareholder value. For more information, please visit www.telestatherapeutics.com