TG Therapeutics (TGTX) Receives IDSMB Recommendation to Continue UNITY-CLL Phase 3
- Top 10 News for 12/2: Crude Rips on OPEC Cut; Starbucks' Schultz Steps Down; Nonfarm Payrolls Flat in Nov.
- Unemployment Rate Drops to 4.6%
- Bond yields slip on U.S. jobs data, euro steady before Italy vote
- Alibaba (BABA) Founder Jack Ma Discuss Plans to Retire; 'I Don't Want to Die at the Office'
- Starbucks Coffee (SBUX) CEO Howard Schultz to Step Down, Appointed Executive Chairman; Kevin Johnson New CEO
Find out which companies are about to raise their dividend well before the news hits the Street with StreetInsider.com's Dividend Insider Elite. Sign-up for a FREE trial here.
TG Therapeutics, Inc. (Nasdaq: TGTX) announced that the independent Data Safety Monitoring Board (DSMB) providing oversight for the UNITY-CLL Phase 3 trial reviewed the cumulative safety data from the ongoing clinical study and informed the Company that it has identified no safety concerns, and recommended the continuation of the study with no modifications. Per the protocol’s pre-specified DSMB charter, the DSMB is scheduled to meet approximately every 6-9 months to review cumulative safety data. “We are encouraged by the positive outcome of the first DSMB safety review, especially since over two-thirds of the patients currently enrolled in the study are treatment naive CLL patients. Many may recall, as reported by Dr. Jennifer Brown at last year’s ASH meeting, and published earlier this year in Blood, that idelalisib in treatment naive CLL patients was observed to cause rapid (most within <5 weeks) and profound (Grade 3/4) liver toxicity in approximately 50% of the patients treated. Given those findings, we are pleased to report that the DSMB did not find any safety concerns and recommended the study continue without modification,” stated Michael S. Weiss, the Company’s Executive Chairman and Interim Chief Executive Officer. Mr. Weiss continued, “We are also excited to report that the UNITY-CLL study continues to enroll well and we are still targeting completion of enrollment in the first half of 2018.”
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- PICO Holdings (PICO) Announces Leadership, Governance Changes; Terminates Central Square Agreement
- Sears Holdings (SHLD) Director Mnuchin Resigns Amid Trump Nod
- GlaxoSmithKline (GSK) Announces Filing Regulatory Submission with EMA for FF/UMEC/VI as COPD Treatment
Create E-mail Alert Related CategoriesCorporate News, Hot Corp. News, Management Comments
Related EntitiesDefinitive Agreement
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!