MONTREAL, April 18, 2016 /PRNewswire/ - Telesta Therapeutics Inc. (Telesta) today announced the outcome of its Type A meeting with the U.S. Food and Drug Administration (FDA), which was held via teleconference on Friday, April 15th. Telesta's questions for this meeting were centered on whether the FDA would permit Telesta to resubmit their BLA for MCNA1 under Accelerated Approval, with a more restricted label. Based on their review of Telesta's regulatory filing and the additional information provided by Telesta in the briefing package prepared for the Type A meeting, the FDA has ruled that any potential commercial approval of MCNA would require an additional Phase 3 clinical trial to be completed prior to resubmission of the MCNA BLA.
Telesta currently estimates that U.S. Regulatory approval for MCNA could not be obtained for a period of at least 5 years and possibly longer depending on the exact clinical trial design and required patient follow-up period. As a result, and in the interest of building earlier value for our shareholders, Telesta has determined that it will not pursue another Phase 3 clinical trial on its own. Rather, the Company will seek a partner for the future development of MCNA in the U.S. and accelerate its review of other strategic options in order to best preserve and utilize its strong cash position. As part of this succession plan for MCNA, Telesta will continue to work with the FDA in the months to come to precisely define the exact parameters of the clinical trial that will be acceptable to the U.S. FDA so that the exact costs and timeline of the trial can be quantified for the eventual partner or third party.
Commenting on this strategic option process, Dr. Michael Berendt, Chief Executive Officer and Chief Scientist noted:
"Since we received our Complete Response Letter with the U.S. FDA in February, we have been working closely with our board of directors, to identify strategic options that will deliver value for our shareholders in the event that commercial approval for MCNA in the United States would require another long term clinical study. This strategic option review includes the sale and/or merger of the company, the sale and/or licensing of our assets and the acquisition of commercial and/or pre-commercial healthcare assets that could be developed leveraging our current cash and human resources. This process is ongoing and will accelerate now that we have a definitive ruling from the FDA and may involve the engagement of an investment bank to assist and facilitate this review process.
My management team and our board of directors are acutely aware that one of our key assets is our current cash position of approximately C$44 million. As such, we continue to review and will implement additional cost reduction strategies in the near term and in the future as they are identified. A further report on these efforts will be made in conjunction with the release of our third quarter results expected the week of May 9th."
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. As demonstrated in the Phase 3 Study submitted to the FDA to support approval of MCNA, 1 in 4 patients (25%) who had failed first-line therapy with BCG were disease-free at 1 year. Furthermore, these patients experienced a long lasting response, preserving the bladder for approximately 3 years.
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. MCNA offers a new treatment option for these patients.
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.