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TG Therapeutics, Inc. Announces Poster Presentations for Ublituximab (TG-1101) and TGR-1202 at the Upcoming 54th American Society of Hematology Meeting

Dec 06, 2012

NEW YORK, Dec. 6, 2012 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (OTCBB:TGTX) (the "Company") today announced that the following abstracts for TG-1101 (ublituximab), the Company's novel, third generation anti-CD20 antibody, and TGR-1202, the Company's PI3K delta inhibitor, have been selected for poster presentation at the upcoming 54th Annual Meeting of the American Society of Hematology (ASH), to be held December 8 -11, 2012, at the Georgia World Congress Center in Atlanta, Georgia:

TG-1101 (Ublituximab)

Waldenstrom's Macroglobulinemia Poster Presentation

  • Title: Ublituximab, an Optimized Anti-CD20 Monoclonal Antibody, Demonstrates Greater NK-Mediated ADCC Than Rituximab in Waldenstrom's Macroglobulinemia Patients Supporting a Therapeutic Strategy with Ublituximab (#1654)
  • Session: Lymphoma - Pre-Clinical - Chemotherapy and Biologic Agents: Poster I
  • Date/Time: Saturday, December 8; 5:30 PM - 7:30 pm EST
  • Presenter(s): Dr. Magali Le Garff-Tavernier, Professor Véronique Leblond, MD, PhD, et. al. Service d'Hématologie Clinique, Pitié Salpétriere, Paris, France

Non-Hodgkin Lymphoma Poster Presentation

  • Title: Ublituximab (TGTX-1101), A Novel Anti-CD20 Monoclonal Antibody (mAb), Demonstrates Activity in Rituximab-sensitive and Rituximab—resistant B Non-Hodgkin Lymphoma (B-NHL) Pre-clinical In Vitro and In Vivo Models (#2756)
  • Session: Lymphoma - Pre-Clinical - Chemotherapy and Biologic Agents: Poster II
  • Date/Time: Sunday, December 9; 6:00 PM - 8:00 pm EST
  • Presenter(s): Matthew Barth, MD, Myron Czuczman, MD, et. al. Roswell Park Cancer Institute, Buffalo, NY

CNS Lymphoma Poster Presentation

  • Title: Ublituximab (TGTX-1101), a Novel, Third-Generation Anti-CD20 Antibody Demonstrates Enhanced Antitumor Activity Compared to Rituximab in Primary CNS and Intraocular Lymphoma Murine Models (#2755)
  • Session: Lymphoma - Pre-Clinical - Chemotherapy and Biologic Agents: Poster II
  • Date/Time: Sunday, December 9; 6:00 PM - 8:00 pm EST
  • Presenter(s): Sabrina Donnou, Sylvain Fisson, et. al. Institute National de la Santé et de la Recherche Médicale (INSERM), UMRS872, Paris, France

TGR-1202

Acute Leukemia (AML/ALL) Poster Presentation

  • Title: TGR-1202 Suppresses AML and ALL Cells Via Selective Inhibition of PI3K-delta Kinase (#2610)
  • Session: Acute Lymphoblastic Leukemia - Therapy, excluding Transplantation: Poster II
  • Date/Time: Sunday, December 9; 6:00 PM - 8:00 pm EST
  • Presenter(s): Michael Savona, MD, Swaroop Vakkalanka, PhD, et. al. Sarah Cannon Research Institute, Nashville, TN and Rhizen Pharmaceuticals, SA

Chronic Lymphocytic Leukemia (CLL) Poster Presentation

  • Title: Comparison of the PI3K-delta Inhibitors TGR-1202 and GS-1101 in Inducing Cytotoxicity and Inhibiting Phosphorylation of Akt in CLL Cells in Vitro (#3914)
  • Session: CLL - Biology and Pathophysiology, excluding Therapy: Poster III
  • Date/Time: Monday, December 10; 6:00 PM - 8:00 pm EST
  • Presenter(s): Daphne Friedman, MD, Mark Lanasa, MD, PhD, et. al.  Duke University Medical Center, Durham, NC

TG-1101 (Ublituximab) + TGR-1202

B-Cell and T-Cell Lymphoma Poster Presentation

  • Title:Novel PI3K Inhibitors Demonstrated Marked Cytotoxicity in T Cell Lymphoma Models, Caused Apoptosis and Were Synergistic with A Novel Anti-CD20 Monoclonal Antibody Ublituximab in B Cell Lymphoma Models (#3725)
  • Session: Lymphoma - Pre-Clinical - Chemotherapy and Biologic Agents: Poster III
  • Date/Time: Monday, December 10; 6:00 PM - 8:00 pm EST
  • Presenter(s): Changchun Deng, MD, PhD, Owen A. O'Connor, MD, PhD, et. al. Center for Lymphoid Malignancies, Columbia University Medical Center, New York, NY

A copy of the above referenced abstracts can be viewed online through the ASH meeting website at www.hematology.org.

In addition to the poster presentations, TG Therapeutics in coordination with Brean Capital & Ladenburg Thalmann, will host a discussion on Sunday, December 9th from 7:45 pm9:00 pm at the Omni Hotel in Atlanta, entitled "Novel Targeted Therapies in NHL & CLL". Dr. Owen O'Connor, Professor of Medicine and Director, Center for Lymphoid Malignancies at New York Presbyterian Columbia Medical Center, NY, will focus on anti-body directed therapy, including TG-1101 (Ublituximab), and Dr. Howard "Skip" Burris, Chief Medical Officer and Executive Director, Drug Development Program, Sarah Cannon Research Institute, Nashville, TN will be discussing PI3K targeted agents, including TGR-1202.

ABOUT TG-1101 (UBLITUXIMAB)

TG-1101 is a novel, third generation chimeric monoclonal antibody targeting a unique epitope on the CD20 antigen found on B-lymphocytes. TG-1101 has been bioengineered for enhanced biological activity with an increased ability to trigger an immune response, delivering superior ADCC effects to aid in B-cell depletion. TG-1101 has displayed high single agent activity in a Phase I/II clinical trial in patients with relapsed Chronic Lymphocytic Leukemia, and is being developed by TG Therapeutics in multiple oncology and autoimmune indications. TG-1101 has been granted orphan status in Europe and in the USA for B-cell Chronic Lymphocytic Leukemia.

ABOUT TGR-1202

TGR-1202 is a highly specific, orally available, PI3K delta inhibitor, targeting the delta isoform with nanomolar potency and several fold selectivity over the alpha, beta, and gamma isoforms of PI3K. Inhibition of PI3K delta signaling with TGR-1202 has demonstrated robust activity in numerous pre-clinical models and primary cells from patients with hematologic malignancies. TG Therapeutics, Inc. and Rhizen Pharmaceuticals, SA are jointly developing TGR-1202 on a worldwide basis, excluding India for various hematologic malignancies. An IND for TGR-1202 is expected to be filed by the end of 2012.

ABOUT TG THERAPEUTICS, INC.

TG Therapeutics is an innovative, clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of innovative and medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs. Currently, the company is developing two advanced therapies targeting hematological malignancies. TG-1101 (ublituximab) is a novel, third generation monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes, currently in clinical development for patients with relapsed and refractory non-Hodgkin's lymphoma. TG Therapeutics is also developing TGR-1202, a highly specific, orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. TG Therapeutics is headquartered in New York City. 

The TG Therapeutics logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=11857

Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for TG-1101 and TGR-1202 may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete pre-clinical and clinical trials for TG-1101 and TGR-1202; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data analyses from prior pre-clinical and clinical trials; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

TGTX - G

CONTACT: Jenna Bosco

         Director- Investor Relations

         TG Therapeutics, Inc.

         Telephone: 212.554.4484

         Email: ir@tgtxinc.com

TG Therapeutics Logo

Source: TG Therapeutics, Inc.

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