FDA issues complete response letter to Telesta’s BLA for MCNA

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.

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-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.