MONTREAL, Feb. 2, 2016 /PRNewswire/ - Telesta Therapeutics Inc. (TSX:TST) (PNK:BNHLF) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to Telesta's Biologics License Application (BLA) for MCNA1. In this letter, the FDA communicated that an additional Phase 3 clinical trial for MCNA would be necessary to adequately establish MCNA's efficacy and safety. The FDA also encouraged Telesta to meet with them to discuss further clinical development of MCNA.
Dr. Michael Berendt, noted: "We are very disappointed with the FDA's decision. Since we began our dialogue with the FDA in February, 2014, we have clearly communicated that we believe that MCNA is a safe and efficacious agent for the treatment of high risk non-muscle invasive bladder cancer patients who have failed front line BCG therapy. The FDA decision, at this point, to require an additional clinical trial, is a setback for under-served bladder cancer patients, our dedicated staff, and our investors who have funded our efforts to obtain MCNA approval in the US. MCNA would have been the first new bladder cancer therapeutic to reach the market since 1998.
We will, over the next few months, work closely with the FDA, our advisors and our development partners to analyze the clinical and regulatory path forward in the United States and Europe, as well as the current competitive landscape and the costs and timelines to conduct a second Phase 3 trial for MCNA. In parallel, with our board, investors and advisors, we are carefully analysing the multiple strategic options that can best leverage our financial and human resources to create value for our shareholders. The current climate of uncertainty in the financial markets has created opportunities for well-capitalized companies that were simply not available even a few months ago."
Telesta Therapeutics will be reporting its second quarter financial results for the 6 month period ending December 31, 2015 on February 12th and will at that time confirm the timing and details of a management conference call to provide a corporate update.
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.