TG Therapeutics Announces Long-term Follow-up Data from the Phase 2 Trial of Ublituximab in Patients with Multiple Sclerosis

- May 7th, 2019

TG Therapeutics (NASDAQ:TGTX) has announced presentation of long-term follow-up data of its Phase 2 open label extension trial of ubiltuximab (TG-1101) the company’s treatment in treating patients with relapsing forms of multiple sclerosis. As quoted in the press release: The data are being presented today at the American Academy of Neurology 71st Annual Meeting taking place … Continued

TG Therapeutics (NASDAQ:TGTX) has announced presentation of long-term follow-up data of its Phase 2 open label extension trial of ubiltuximab (TG-1101) the company’s treatment in treating patients with relapsing forms of multiple sclerosis.

As quoted in the press release:

The data are being presented today at the American Academy of Neurology 71st Annual Meeting taking place in Philadelphia, PA. Highlights from the presentation are outlined below.

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, “We are highly encouraged by the long-term safety data presented today at AAN, demonstrating that ublituximab continues to be well tolerated with no patients discontinuing treatment due to a drug related AE at a median follow-up of 97.5 weeks. These data support our ongoing Phase 3 ULTIMATE program which is fully enrolled with data expected next year.”

Today’s presentation includes long-term follow-up data for 45 patients from the Phase 2 that enrolled into the OLE and recaps the final efficacy data on patients enrolled in the Phase 2 study through 48 weeks of treatment.

Presentation Highlights:

  • Ublituximab continues to be well tolerated, with a median duration of follow-up of 97.5 weeks.
  • No subjects discontinued due to an Adverse Event (AE) related to ublituximab on the Phase 2 or during the OLE.
  • AEs deemed at least possibly related to ublituximab were infrequent during the OLE with all patients dosed 450mg of ublituximab administered in a one-hour infusion (Phase 3 dose).
  • Infusion Related Reactions (IRRs) were rare during the OLE, occurring in only 4 patients (9%), all Grade 1 or 2.

Click here to read the full press release.

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