TELESTA THERAPEUTICS INC Montreal, Quebec, Canada. November 19, 2015. Telesta Therapeutics Inc. (TSX:TST; PNK:BNHLF) today announced the results of the US Food and Drug Administration's (FDA) Joint Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee ('Advisory Committee') held on November 18, 2015 to discuss the safety and efficacy of Telesta's
Biologics License Application (BLA) for MCNA1.
The Advisory Committee voted 18 no to 6 yes, with no abstentions, on the following question: 'Does MCNA have an overall favorable benefit-risk profile for the treatment of non-muscle invasive bladder cancer at high risk of recurrence or progression in adult patients who failed prior BCG immunotherapy, e.g., in patients who are BCG-refractory or BCG-relapsing?'
The FDA is not bound by the Advisory Committee's recommendation but does takes its advice into consideration when considering the approval of a new therapeutic. The FDA's Prescription Drug User Fee Act (PDUFA) review goal date for MCNA is February 27, 2016.
Dr. Michael Berendt, CEO & Chief Scientist, said: 'While we are disappointed by the Advisory Committee's vote, we remain hopeful that the FDA will recognize the value of providing a new treatment option to adult patients with high risk non-muscle invasive bladder cancer who are refractory to or relapsing from front-line BCG therapy. We were also encouraged that the majority of practicing urologists on the Advisory Panel voted yes in support of MCNA.
We look forward to working closely with the FDA over the next three months to ensure that it has the data and analysis it needs to complete it's evaluation of the safety and efficacy of MCNA. We continue to believe that MCNA represents a much-needed new treatment option for bladder cancer patients who have failed front-line therapy. We will discuss appropriate next steps internally and with our development partners, including our ex-US global partner Ipsen and communicate this strategy to our shareholders in the weeks to come.'
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.
1
Mycobacterium phlei cell wall-nucleic acid complex
-2-
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.
For further information:
Donald Olds, Chief Operating Officer Telesta Therapeutics Inc.
Telephone: (514)-394-7921 Donald.Olds@telestatherapeutics.com
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