March 9, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Montreal, Ontario-based Telesta Therapeutics, Inc. announced today that it has requested a “Type A” meeting with the U.S. Food and Drug Administration (FDA). This kind of meeting request involves specific questions regarding Telesta’s therapeutic MCNA regulatory pathway in the U.S.
It is possible that the meeting won’t be necessary, pending the FDA’s answers to written questions. “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 is actionable for us or for a future partner for MCNA,” said Monique Champagne, Telesta’s vice president clinical and regulatory, in a statement. “In addition, we are collaborating with our key development partners to aggressively define and develop the regulatory approval pathway in their respective jurisdictions.”
MCNA is a biologic compound developed to treat high-risk, non-muscle invasive bladder cancer patients who are refractory to or relapsing from first-line therapy with bacillus Calmetta-Guerin (BCG). On Feb. 2, the FDA sent Telesta a Complete Response Letter regarding the company’s Biologics License Application (BLA). The FDA indicated that the company would need another Phase III clinical trial to further determine MCNA’s safety and efficacy. It also urged the company to meet with them to discuss further clinical development.
“We are very disappointed with the FDA’s decision,” said Michael Berendt, chief executive officer and chief scientist of Telesta, in a statement at the time. “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 U.S.”
On Feb. 12, Telesta announced its second quarter financial statements. It indicated a net income for a six-month period ending Dec. 31, 2015 of $8.2 million, which was compared to an $8.2 million loss for the same period the previous year. Total research-and-development expenditures for the half-year period were $6.3 million, almost double of $3.2 million from the same period a year before. The company indicates those expenses are primarily related to non-recurring consulting fees for the BLA, increased expenses related to new production and quality control staff, and a cut in government assistance.
As a part of this review and the request for a Type A meeting, Telesta has cut staff by 15 percent. The majority of those cuts are from its manufacturing plant in Montreal. It has also reduced internal and consulting expenses in order to save cash.
“We have worked extremely hard over the last 18 months to build a focused human health company around our core MCNA assets 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,” said Berendt, in a statement. “In parallel, we are working with our board of directors to review all of our strategic options over the next few months. We are 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.”
