Allos Therapeutics, Inc. (Nasdaq: ALTH) announced final results from its pivotal Phase 2 PROPEL trial of pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). As previously reported in preliminary results released in early December, 27% of patients achieved a response (full or partial), the study’s primary endpoint. Final results showed the Kaplan-Meier estimate for the median duration of response, a key secondary endpoint, to be 287 days or 9.4 months. The most frequent grade 3/4 adverse events were thrombocytopenia (32% of patients), mucosal inflammation (21%), neutropenia (20%), and anemia (17%). Based on these results, Allos plans to file a New Drug Application (NDA) with the FDA in the first half of the year for the use of pralatrexate to treat patients with relapsed or refractory PTCL.
Investors responded positively to this news, which was released just after trading closed yesterday, with Allos’ stock price jumping from a close of $8 yesterday to open at $9.25 today. It has since given back most of these gains and sits at $8.49 as of midday ET. Pralatrexate, which represents the lead compound for Allos, is a targeted antifolate designed to accumulate preferentially in cancer cells. The compound is also in trials for non-small cell lung cancer, bladder cancer, and other types of lymphoma. Allos, headquartered in Westminster, Colorado, is a biopharmaceutical company focused on developing and commercializing innovative small molecule drugs for the treatment of cancer.
