TG Therapeutics, Inc. Announces Publication of Clinical Data from the Phase 1/2 Trial of TG-1101 (ublituximab) Monotherapy in the British Journal of Haematology
"We want to thank Dr. Owen O'Connor, and the team from Columbia Presbyterian Medical Center and the
"The addition of an anti-CD20 monoclonal antibody to other treatments, whether chemo-based or novel targeted therapies, has demonstrated to be an impactful way to enhance responses for patients with NHL and CLL. Acquired resistance to rituximab is a significant clinical issue for which many patients need an alternative effective agent to overcome the resistance. We are highly encouraged by the results we have seen in the clinic with ublituximab and
believe the drug's safety profile, as well as shortened infusion times as compared to other anti-CD20s, can provide meaningful benefit to patients," stated Dr.
Some of the statements included in this press release, particularly those with respect to anticipating the timing of the completion of the GENUINE study, timing of top-line data for the GENUINE study, the usability of the results from GENUINE for accelerated approval, timing of initial data from the UNITY-DLBCL study, timing of the release of data and commencement of our MS pivotal program 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 the GENUINE, the UNITY-CLL or the UNITY-DLBCL trials; the risk that the clinical results from the GENUINE, UNITY-CLL and/or UNITY-DLBCL studies will be not positive and/or will not support regulatory approval of TG-1101 or TGR-1202; the risk that the FDA will not grant us a pre-BLA meeting to discuss the results of the GENUINE study; the risk that we will not file a BLA for TG-1101 or an NDA for TGR-1202 based on either the GENUINE or the UNITY-CLL; the risk that despite early positive trends in enrollment in the UNITY-CLL study that enrollment will be delayed beyond our projections; the risk that the planned interim analysis will not allow early closure of the single agent arms in the UNITY-CLL study, necessitating enrollment beyond the projected 450 patients, which would extend enrollment beyond our projections; the risk that safety issues or trends will be observed in the GENUINE study, the UNITY-CLL and/or the UNITY-DLBCL study that prevent approval of either TG-1101 and/or TGR-1202 or require us to terminate either the GENUINE study or the UNITY-CLL or the UNITY-DLBCL study prior to completion; 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; the risk that the GENUINE study, as amended or the UNITY-CLL or the UNITY-DLBCL studies, or any of our other registration-directed clinical trials as designed or amended may not be sufficient or acceptable to support regulatory approval; the risk that trials will take longer to enroll than expected; the risk that the projected cost savings to be realized by amending the GENUINE trial will not be realized; 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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Jenna BoscoVice President, Investor Relations TG Therapeutics, Inc.Telephone: 212.554.4351 Email: email@example.com
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