MONTREAL, Dec. 14, 2015 /PRNewswire/ - Telesta Therapeutics Inc. (TSX: TST) (PNK:BNHLF) today provided an update on the Biologics License Application (BLA) for their drug MCNA1 that the US Food and Drug Administration (FDA) is currently reviewing under Priority Review.
On December 10, 2015, Telesta and the FDA conducted a scheduled late-cycle teleconference with the objective of discussing any substantive review issues identified to date by the FDA. The review issues discussed were related to Chemistry, Manufacturing and Control issues (CMC) and Telesta's manufacturing facility. As part of the meeting, the FDA briefly discussed the recent Advisory Committee and provided answers to several questions posed by the sponsor. A late-cycle meeting is not a decisional meeting and is used by the FDA to share information, identify deficiencies, and discuss any substantive review issues identified to date by the FDA and plan the rest of the review.
Dr. Michael Berendt, noted: "We are working closely with the FDA as they continue their review of MCNA and are providing additional information and as requested. We continue to believe that MCNA offers a positive risk-benefit ratio for the treatment of high-risk, non-muscle invasive bladder cancer patients who have failed front-line therapy, and remain optimistic that the FDA will come to the same conclusion as they complete their review."
"Since the completion of the recent Advisory Committee, we have received an extremely high volume of correspondence from the bladder cancer community (patients, physicians, family members), investors and other interested parties seeking additional information about the probability of potential approval and availability of MCNA in the United States. Given the confidential nature of our discussions with the FDA and our development partners, we are not in a position at this time to provide any additional detail. We have updated the Frequently Asked Questions (FAQ) of our website to respond as best we can to the most common questions. As additional information can be made public, we will do so in an expeditious manner."
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. The FDA has set February 27, 2016 as its review goal date for MCNA's potential approval. MCNA offers a new therapeutic option for high-risk NMIBC patients and, if approved, will represent the first new therapeutic approved for these patients in the United States since 1989.
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 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.
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.