April 18, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Montreal, Canada-based Telesta Therapeutics announced today that after meetings with the U.S. Food and Drug Administration (FDA), it will not start another Phase III clinical trial on its own of MCNA, a drug for high-risk, non-muscle invasive bladder cancer patients.
On Feb. 2, the FDA sent Telesta a Complete Response Letter regarding its Biologics License Application (BLA). The FDA indicated then that Telesta would need another Phase III clinical trial to further study MCNA’s safety and efficacy. It also urged the company to meet with them to discuss further clinical development. So Telesta requested a “Type A” meeting, which was held via teleconference on Friday, April 15.
“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,” said Michael Berendt, Telesta’s chief executive officer and chief scientist, in a statement. “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.”
A significant part of the Type A meeting revolved around whether Telesta would be allowed by the FDSA to resubmit their BLA for MCNA under Accelerated Approval, but with a more restrictive label. Basically the FDA said no, it would need another Phase III clinical trial in order to resubmit the MCNA BLA.
Telesta estimates that even if it did decide to go forth on its own, it would take at least five years to receive approval. So it is, among several considerations, looking to partner with someone to continue development of MCNA in the U.S. while reviewing other strategic choices.
The company further indicates that it has about $44 million (Canadian) in cash. And as it continues to review the study and make plans, it will implement cost cuts short- and long-term. It expects to announce those strategies on May 9 as part of its third-quarter results.
At its second-quarter financial reporting, it showed a net income for a six-month period of $8.2 million, which ended on Dec. 31, 2015. Total research-and-development expenditures for the six-month period were $6.3 million, almost double the $3.2 million from the same period a year earlier. Those expenses were 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.
The company already cut its staff by 15 percent as a part of the review and request for the Type A meeting. Most were from its manufacturing facility in Montreal.
