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TG Therapeutics, Inc. Announces Poster Presentation Highlights For Ublituximab (TG-1101) And TGR-1202 From The 54th American Society Of Hematology Meeting

NEW YORK, Dec. 10, 2012 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (OTCBB:TGTX) today announced highlights from the TG-1101 and TGR-1202 posters presented at the 54 th Annual Meeting of the American Society of Hematology (ASH), held this past weekend, at the Georgia World Congress Center in Atlanta, Georgia. Three posters on TG-1101, two posters on TGR-1202 and one poster on the combination of TG-1101 and TGR-1202 were presented, some of the highlights from the conference were:

TG-1101 (Ublituximab)

  • In vitro / in vivo results demonstrate superior efficacy with ublituximab compared to rituximab in primary central nervous system lymphomas, including a significant reduction in tumor burden (p=0.0014) and survival (p=0.016). CNS Lymphoma Poster Presentation – Poster 2755.
  • Ublituximab induced higher levels of ADCC than rituximab in B-cell NHL cell lines as well as caused a higher degree of CDC lysis in patient-derived tumor cells than rituximab. Non-Hodgkin Lymphoma Poster Presentation – Poster 2756.
  • Ublituximab is more effective than rituximab in inducing ADCC at low doses (p<0.01), and more importantly suggest that ublituximab could be more efficient than rituximab both to induce NK cell activation and ADCC in the presence of peripheral tumor cells from Waldenstrom Macroglobulinemia patients. Waldenstrom's Macroglobulinemia Poster Presentation – Poster 1654.

TGR-1202

  • In a blinded comparison study of TGR-1202 and GS-1101 completed at Duke University Medical Center, TGR-1202 demonstrated equal efficacy to GS-1101 in regards to in vitro induction of apoptosis and toxicity as well as in suppressing Akt phosphorylation (pAkt) in CLL patient cells. Chronic Lymphocytic Leukemia (CLL) Poster Presentation – Poster 3914.
  • TGR-1202 is a potent and selective inhibitor of PI3Kδ demonstrating significant inhibition in Akt phosphorylation (pAKT) in AML and ALL cell lines and patient cells as well as marked anti-tumor activity in a MOLT-4 (AML) subcutaneous xenograft mouse model.  Acute Leukemia (AML/ALL) Poster Presentation – Poster 2610.

TG-1101 (Ublituximab) + TGR-1202

  • TGR-1202 is a potent and selective inhibitor of PI3Kδ exhibiting single agent activity against B-lymphoma cell lines. Of notable interest, TG-1101 and TGR-1202, when combined is highly effective in the induction of G2/M arrest and apoptosis in B-lymphoma cell lines.  B-Cell and T-Cell Lymphoma Poster Presentation – Poster 3725.

A copy of the above referenced posters can be viewed on the Investors & Media section of our website at www.tgtherapeutics.com.

In addition to the poster presentations, TG Therapeutics, in conjunction with Brean Capital and Ladenburg Thalmann, hosted a discussion on Sunday, December 9 th at the Omni Hotel in Atlanta, entitled "Novel Targeted Therapies in NHL & CLL". During the event feature presentations were given by Dr. Owen O'Connor, Professor of Medicine and Director, Center for Lymphoid Malignancies at New York Presbyterian Columbia Medical Center, NY, who focused on anti-body directed therapy, including TG-1101, and Dr. Howard "Skip" Burris, Chief Medical Officer and Executive Director, Drug Development Program, Sarah Cannon Research Institute, Nashville, TN, who discussed PI3K targeted agents, including TGR-1202. The audio file and slides from the above presentations are available on the Investors & Media section of our website at www.tgtherapeutics.com .

Dr. O'Connor discussed early clinical data on the safety and efficacy from two ongoing Phase I trials of TG-1101. Data from the single agent TG-1101 trial in NHL to date (n=6), has demonstrated an acceptable safety profile with no Grade 3 or 4 events reported, and early hints of clinical activity with a rituximab refractory Marginal Zone Lymphoma patient achieving a Complete Response. In the second clinical trial of TG-1101 in combination with lenalidomide in patients with NHL or CLL where TG-1101 is administered as a single agent on Day 1 and 8 with lenalidomide started on Day 9, Dr. O'Connor shared a case report on a CLL patient (patient 0001) who after the first infusion of TG-1101 had a significant reduction in their White Blood Count (drop from 312,000 to 16,000) and significant visible reduction in the patient's lymph and abdominal nodes.

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