What: Shares of TG Therapeutics (NASDAQ:TGTX), a clinical-stage biopharmaceutical company primarily focused on developing novel therapies to treat cancer, briefly spiked higher this morning by as much as 11% after announcing preliminary clinical results from its phase 1 study involving TG-1101 and TGR-1202 for patients with previously treated chronic lymphocytic leukemia, or CLL, and aggressive lymphomas. Shares have since given up all of their gains and dipped as much as 9% since its early morning pop.
So what: According to TG Therapeutics' press release the combination of TG-1101 and TGR-1202 demonstrated "compelling early activity" in treating CLL and aggressive lymphomas in preliminary phase 1 results.
Per its data, four of the five evaluable CLL and small lymphocytic leukemia, or SLL, patients achieved a partial response at their first assessment, while the fifth patient demonstrated stable disease with 44% nodal reduction noted. However, all five patients exhibited an absolute lymphocyte count (ALC) reduction equal to or greater than 50% by the first assessment with one of the five patients achieving a 80% reduction or greater in ALC (essentially a complete normalization) by the first assessment. The combo also appeared to be safe and well-tolerated.
In the second portion of its phase 1 study which combined TG-1101 and TGR-1202 to combat non-Hodgkin's lymphoma or patients with Richter's syndrome, out of the 10 evaluable patients nine demonstrated signs of stable disease or better. Specifically, TG Therapeutics notes that one patient in the single-agent phase 1 study receiving TGR-1202 with GCB-subtype diffuse large B-cell lymphoma had a greater than 40% reduction in tumor mass which remained stable for more than six months.
Now what: On one hand we have extremely positive early stage data that clearly got investors excited this morning. This follows other key recent news, such as its global licensing agreement of Ligand Pharmaceuticals' IRAK4 inhibitor research program, and its stellar combo results last month involving TG-1101 when combined with Pharmacyclics' Imbruvica. Then again, we have to remember that we're looking at a very small evaluable pool of patients, and a lot can change when a drug moves into a larger scale study. TG Therapeutics has already seen a huge run higher and has basically doubled over the past two months, so much of that optimism may already be baked into its shares. Personally, I find the company's early work extremely intriguing and I've added it to my Watchlist, although I'd like to see more encompassing data before considering taking the plunge.
Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.
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