MONTREAL, April 12, 2016 /PRNewswire/ - Telesta Therapeutics Inc. (TSX: TST) (PNK: BNHLF) today announced that a Type A meeting has been scheduled with the U.S. Food and Drug Administration (FDA) on Friday, April 15, 2016. This Type A meeting will be focused on the FDA’s responses to Telesta’s questions concerning the regulatory pathway forward for approval of MCNA1 in the United States.
As previously announced, it is possible that the answers received to our first set of questions on the approval pathway and further clinical development of MCNA will require the preparation for and scheduling of a second meeting with the agency in order to be confident that the regulatory pathway in the U.S. is actionable for us or for a future partner for MCNA. In addition, we continue to collaborate with our key development partners to aggressively define and develop the regulatory approval pathway in their respective jurisdictions.
Telesta will provide a corporate update following an analysis of the Type A meeting’s outcome and distribute this update via a press release on Monday, April 18, 2016.
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 first-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.
About non-muscle invasive bladder cancer (NMIBC)
Treatment options for high-risk NMIBC patients who fail first-line BCG treatment are extremely limited and treatment guidelines in most countries around the world call for radical cystectomy, which entails a surgical removal of the bladder and adjacent organs and glands. Bladder removal is a complex surgery associated with at least 28% to 45% surgical complications and up to 8% mortality, in addition to negatively impacting multiple aspects of quality of life. Patients who refuse or are not medically fit to undergo bladder removal face an increased risk of progression to muscle-invasive disease, likely leading to metastases and death.
About Telesta Therapeutics Inc.
Telesta Therapeutics Inc. is a well-capitalized public company focused on developing and commercializing human therapeutics for the U.S. market that advance human health and increase shareholder value. For more information, please visit 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 | |
SOURCE Telesta Therapeutics Inc.
