TG Therapeutics Inc (TGTX)

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TG Therapeutics CEO: Market reaction to Unity-CLL drug was 'misplaced,' survival will be better gauge in test
10:39 26 Sep 2018
Progression Free Survival is the primary endpoint of the study and not the Overall Response Rate


The chief executive of TG Therapeutics Inc (NASDAQ:TGTX) said Wednesday the negative reaction to the results of the Unity-CLL Phase 3 trial for treating leukemia was misunderstood by the market when it punished the company's stock harshly in the previous session.

"We believe the market reaction was overblown and misplaced," TG Therapeutics CEO Michael Weiss told Proactive Investors in an email interview. "We can understand that the timelines needed to be adjusted which could cause a modest price decline but the thesis floating around that this news lowers the probability of success of UNITY-CLL is incorrect in our opinion."


The Data Safety Monitoring Board (DSMB) said the results were not sufficient to conduct an Overall Response Rate (ORR) analysis for the drug treating leukemia.

Shares fell to a fresh 52-week low at $5 before recovering to trade just 0.5% down at $5.12 in morning trade. The stock tumbled Tuesday after the news and finished at $5.15.

READ: TG Therapeutics stock sinks after Phase 3 test of leukemia treatment falters, but still has 5 key tests in the pipeline
Weiss said the study for the drug "was designed under the assumption that the driver of improvement in Progression Free Survival (PFS) (is) the primary endpoint for the study."

That is so "because our U2 combination would have a significantly better durability of response not by materially increasing the number of people responding (or ORR). So in essence, even if we had the same number of responders, if each responder in the U2 arm on average survived without progression twice as long as the control arm responders, U2 would be successful in the PFS outcome."

The DSMB seems to bear him out. It said after reviewing the data, there were no safety concerns and recommended the trial continue without any modification.

TG-1101 (ublituximab) is a glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202 (umbralisib), an orally available PI3K delta inhibitor for various hematologic malignancies.

Weiss said the study was crafted "so those endpoints would be assessed independently and the success of one was not contingent on the success of the other. Had we believed that PFS was contingent on a large difference in ORR, we would have designed the study statistically to reflect that, but we did not. We believe this point has been misunderstood by the street."

TG Therapeutics said the success of the drug's test should be focused on patient survival because "PFS is the gold standard for the FDA."

"Certainly, patients care about living longer without progressive disease. Our drug, umbralisib, is from a class of drugs that are known to provide enhanced PFS and also are known to keep the disease in check versus killing it quickly. So certainly, under the circumstances, PFS is the endpoint that can really showcase the benefit our drug has for patients," said Weiss.

TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. The company is based In New York City.



http://www.proactiveinvestors.com/companies/news/205781/tg-therapeutics-ceo-market-reaction-to-unity-cll-drug-was-misplaced-survival-will-be-better-gauge-in-test-205781.html