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Type A Meeting request submitted to US FDA - Expenditure reductions implemented and ongoing
- Strategic review process initiated
MONTREAL, March 9, 2016 /PRNewswire/ - Telesta Therapeutics Inc. (TSX:TST)(PNK:BNHLF) today announced that it has submitted a request to meet with the U.S. Food and Drug Administration (FDA). This "Type A" meeting request includes specific questions concerning the regulatory path forward for Telesta's therapeutic MCNA1 in the United States. Telesta expects, based on FDA guidance, that the meeting or teleconference (at the FDA's discretion) will be held within 30 calendar days. Telesta's objective is to obtain clarity on what the FDA will require to consider commercial approval of MCNA for high-risk non-muscle invasive bladder cancer patients who have failed front-line BCG therapy.
Commenting on the process, Monique Champagne, Vice President Clinical and Regulatory added: "Depending on the FDA's written responses to our questions, it may or not be necessary to hold the actual meeting with the FDA. It is also possible that the answers received to our first set of questions 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 are collaborating with our key development partners to aggressively define and develop the regulatory approval pathway in their respective jurisdictions."
Telesta has conducted a review of its discretionary staffing and expenditures. As a result, the company has reduced staffing levels by 15% with most of these departures coming from Telesta's Montreal manufacturing facility. The company has also reduced internal and consulting expenditures in order to ensure that cash reserves are conserved as the company conducts a full review of its strategic options.
Dr. Michael Berendt, Chief Executive Officer and Chief Scientist of Telesta stated: "We have worked extremely hard over the last 18 months to build a focussed human health company around our core MCNA asset which is why our top priority over the next several months is to determine the exact regulatory pathway for ultimate approval of MCNA in both the United States and Europe. In parallel, we are working with our board of directors to review of all of our strategic options over the next few months. We are very aware that this review must be conducted and completed in a timely fashion to ensure that we conserve our key cash resources. Regulatory insight from the U.S. FDA is a critical element in our decision process and in the final selection of a strategic path forward. As we make progress on these initiatives we will provide timely further public updates to our shareholders.
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-Gurin (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.
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| 1 | Mycobacterium phlei cell wall-nucleic acid complex |
SOURCE Telesta Therapeutics Inc.
For further information: Donald Olds, Chief Operating Officer, Telesta Therapeutics Inc., Telephone: 514-787-3456, Donald.Olds@telestatherapeutics.com
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