Pharmacyclics Scores an Early Phase 3 Victory
Shares of Pharmacyclics (NASDAQ:PCYC) were halted at the start of today’s trading session as the company announced that an independent data monitoring committee recommended that a Phase 3 study comparing IMBRUVICA to ofatumumab be stopped early because of statistically significant improvement in progression free survival and overall survival. Shares of Pharmacyclics are up approximately 20 percent as of this writing.
Pharmacyclics is a biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. The company has one approved product called IMBRUVICA that is used to treat patients with mantle cell lymphoma (or, MCL) who have received at least one prior therapy. In addition to the approved indication, Pharmacyclics is also evaluating IMBRUVICA’s ability to treat the following diseases:
- Chronic Lymphocytic Leukemia “CLL” – Phase 3 Evaluation
- Diffuse Large B-Cell Lymphoma – Phase 3 Evaluation
- Multiple Myeloma – Phase 2 Evaluation
- Follicular Lymphoma – Phase 2 Evaluation
- Waldenstrom’s Macroglobulinemia – Phase 2 Evaluation
Today’s announcement was in regards to the Phase 3 trial for CLL. In addition to hitting the primary and secondary endpoints, IMBRUVICA demonstrated an acceptable safety profile which measured up with prior clinical experience. Although the company still needs to wait for FDA approval, this is certainly an encouraging step towards approving IMBRUVICA for multiple indications and increasing the company’s cash flow.