October 14, 2016
By Mark Terry, BioSpace.com Breaking News Staff
TG Therapeutics took a dive on news that it was modifying the protocols in its Phase III clinical trial of TG-1101 for relapsed/refractory high-risk chronic lymphocytic leukemia (CLL). Shares traded for $8.25 on October 12 and are currently trading for $7.06.
Originally, the clinical trial was designed with two sections. The first tested TG-1101 in combination with AbbVie ’s drug for CLL, Imbruvica, on 200 patients. The primary endpoint of part one was the change in overall response rate (ORR). The second part of the study was to evaluate the drug combination’s effect on progression-free survival.
Yesterday’s announcement by TG Therapeutics indicated that the second part was being completely eliminated, and that part one’s target enrollment was being cut to 120 patients. The U.S. Food and Drug Administration (FDA) has agreed to the changes. If the study is positive, TG Therapeutics will still be able to file for accelerated approval. The company also indicates that the changes will save more than $10 million over the next two years in development costs.
Brian Feroldi, writing for The Motley Fool, says, “While these changes sound positive, investors are clearly interpreting this news as a net-negative for the company. That’s likely because they believe that the risk of winning approval is now higher since the application will not include progression-free survival data.”
The company’s executive chairman and interim chief executive officer, Michael Weiss, tried to put a positive spin on the study changes, saying, “Today’s announcement marks an important milestone for the Company. Given the GENUINE enrollment challenges we’ve faced to date, we are very excited to accelerate the trial to a rapid conclusion, while also maintaining the ability to potentially file the data for accelerated approval. The GENUINE study, as amended, remains a robust, randomized clinical trial, which we believe, if positive, could support accelerated approval for patients with relapsed/refractory high-risk CLL. Moreover, we believe the amended study and revised regulatory strategy is consistent with the recent accelerated approvals for novel agents in CLL, which notably were not pursuant to an SPA but occurred after the finding of positive ORR results.”
Adam Feuerstein, writing for TheStreet, is having none of it. He said, “Sure, if you define milestone as blowing up a Special Protocol Assessment reached with the FDA, cutting planned enrollment by one third, eliminating important efficacy endpoints and generally loading up the study and the company’s regulatory strategy with way more risk. Excellent!”
TG Therapeutics is clearly looking at its financial runway. At its second-quarter financials it indicated it had $75 million in cash. Previously it had indicated that would allow operations to continue into the second quarter of 2018. By saving $10 million with these study changes, it should be able to continue a while longer, at least time enough to be able to release top-line study results without having to try and drum up more money.
Feroldi writes, “TG Therapeutics remains a fascinating company, and if TG-1101 works out, then I could easily see shares returning to their former highs. However, the chances of failure are still quite high, so only investors with a huge tolerance for risk should consider buying on today’s dip.”
