NEW YORK, May 16, 2013 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (TGTX), 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, today announced that Phase 1 Data for single-agent Ublituximab (TG-1101) will be presented at the American Society of Clinical Oncology Meeting on June 2, 2013. Abstract #8575 entitled "A phase I dose-escalation trial of ublituximab (TG-1101), a novel anti-CD20 monoclonal antibody (mAb), for rituximab relapsed/refractory B-cell lymphoma patients", is available online at (http://abstracts2.asco.org/AbstView_132_117724.html).
Importantly, the Company notes that since the abstract was submitted, the Company has reported additional efficacy information. As of the last corporate update, of 8 evaluable patients, 4 patients achieved either a complete or partial response. On the Company's last quarterly call, the Company guided that efficacy data from at least 10 patients would be available for the ASCO presentation with all 12 patients (4 cohorts of 3 patients each at 450, 600, 900 and 1200mg) for this dose escalation study evaluable for safety.
Commenting on the upcoming presentations, Michael S. Weiss, executive chairman and interim CEO said: "We are excited to present the details of the safety and efficacy from our dose escalation phase 1 trial for TG-1101. We, and Dr. Owen O'Connor, our lead investigator, have been impressed with the performance of the drug and its safety profile to date in this rituximab relapsed and refractory NHL patient population, and we look forward to sharing the updated data with the medical community. Our goal is to continue to actively enroll patients into our recently opened expansion cohorts and be able to present a much larger and robust safety and efficacy data base for the American Society of Hematology meeting (ASH) at the end of the year."
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 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.
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 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; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, 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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