Telesta Announces FDA Advisory Committee Date for MCNA1MONTREAL , Sept. 28 2015 /CNW Telbec/ - Telesta Therapeutics Inc. (TST.TO)(BNHLF) today announced receipt of a notice from the U.S. Food and Drug Administration (FDA) confirming that they have organized an advisory committee to review Telesta's Biologics License Application (BLA) for MCNA. This advisory committee will be held on Wednesday, November 18 th. The details of the advisory committee are as follows: Name of Committee: Cellular, Tissue, and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee. Date and Time: November 18, 2015, from 8 a.m. to 5 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Agenda: The safety and efficacy of Biologics License Application (BLA) 125593, Mycobacterium phlei Cell wall-Nucleic Acid complex (MCNA), submitted by Telesta Therapeutics, Inc. The proposed indication (use) for this product is treatment of non-muscle invasive bladder cancer at high risk of recurrence or progression in adult patients who failed prior Bacillus Calmette-Gurin (BCG) immunotherapy, e.g., in patients who are BCG-refractory or BCG-relapsing. Meeting Material: FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site Webcast: A webcast will be available. Please consult the FDA's website for details. Commenting on the upcoming public advisory committee meeting, Dr. Michael Berendt , Chief Executive Officer and Chief Scientist noted that "This advisory committee is another critical step on our path towards potential approval of MCNA as the first new therapeutic for bladder cancer patients in decades. We will continue to work with the FDA and their advisory committee in exactly the same fashion as we have conducted ourselves over the last 18 months, with full transparency, candor and scientific rigor. We know that high risk BCG-refractory and BCG relapsing patients are in great need of a non-surgical option for bladder preservation and we believe that this is exactly what MCNA will provide." ___________________________ 1Mycobacterium phlei cell wall-nucleic acid complex 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 bacillus Calmette-Gurin (BCG) 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 BCG therapy, with the advantage that it can be prepared, handled and disposed of easily and safely. The efficacy, duration of response 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.