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TG Therapeutics, Inc. Opens Expansion Cohorts in Its Phase I/II Trial of TG-1101 (Ublituximab) in Patients With Rituximab Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Feb 11, 2013
The trial, entitled "An Open Label Phase I/II Trial of the Efficacy and Safety of Ublituximab in Patients with B-cell Non-Hodgkin Lymphoma who have Relapsed or are Refractory After CD20 Directed Antibody Therapy," (NCT01647971) has completed enrollment in 3 cohorts (450, 600 and 900mg) in the Phase I dose escalation component. All patients continue to be stratified by subtype of B-cell Lymphoma and all enrolled patients will be relapsed or refractory to Rituxan® or a Rituxan® containing regimen, and in most cases multiple other lines of therapy.
In addition to the cohort expansion, the study was amended to now allow enrollment of patients with Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL) as well as Primary Central Nervous System Lymphoma (PCNSL). Phase I data from a trial conducted in
Dr.
"We are very excited about the early results from this first U.S.-based study of ublituximab in NHL. The early activity seen thus far, along with the activity seen in our Phase 1 study in patients with CLL, gives us a high degree of confidence that ublituximab is an active anti-CD20 monoclonal antibody for the treatment of B-cell malignancies," stated
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
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is an innovative, clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of 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. 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. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies. TG Therapeutics is headquartered in New York City.
The
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 and 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 early clinical results that supported our decision to move forward into expansion cohorts will not be reproduced once additional patients are treated with TG-1101; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced 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.
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CONTACT:Source:Jenna Bosco Director - Investor RelationsTG Therapeutics, Inc. Telephone: 212.554.4484 Email: ir@tgtxinc.com
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