Telesta Announces FDA Advisory Committee Date for MCNA[1]
28 Sep, 2015, 12:00 BST
MONTREAL, September 28, 2015 /PRNewswire/ --
Telesta Therapeutics Inc. (TSX:TST; PNK: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 18th.
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-Guérin (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."
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-Guérin (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.
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 http://www.telestatherapeutics.com
Except for historical information, this news release may contain "forward-looking statements" and "forward-looking information" within the meaning of applicable securities laws that reflect the Company's current expectation regarding future events. Forward-looking statements and information are necessarily based upon a number of estimates and assumptions that, while, considered reasonable by management, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Readers are cautioned that any such forward-looking statements and information are not guarantees and there can be no assurance that such statements and information will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements and information. These forward-looking statements and information involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. The Company expressly disclaims any intention or obligation to update or revise any forward-looking statements and information whether as a result of new information, future events or otherwise. All written and oral forward-looking statements and information attributable to us or persons acting on our behalf are expressly qualified in their entirety by the foregoing cautionary statements.
1. Mycobacterium phlei cell wall-nucleic acid complex
For further information:
Donald Olds, Chief Operating Officer
Telesta Therapeutics Inc.
Telephone: +1-514-394-7921
Donald.Olds@telestatherapeutics.com
SOURCE Telesta Therapeutics Inc.