BiotechTracker - Point Therapeutics Steps Up to the Challenge of Pan-Stimulation of Blood Cells
May 29, 2003 Although Amgen (NASDAQ: AMGN) owes much of its success to drugs that stimulate specific populations of blood cells, development of drugs that prime more than one blood cell precursor lineage at a time has been difficult. Failures have come from Human Genome Sciences (NASDAQ: HGSI), Millennium (NASDAQ: MLNM), Telik (NASDAQ: TELK), Immunex (now a subsidiary of Amgen), and others. Point Therapeutics (OTC: POTP) is now advancing a compound designed to stimulate multiple marrow cell lineages. The drug, PT-100, has begun to show promise in attempts to stimulate red cell and white cell precursors from bone marrow. Significant platelet precursor stimulation remains elusive.  PT-100 is an orally available small molecule that has demonstrated preclinical evidence of white cell and red cell precursor stimulation in mouse models of neutropenia and acute hemolytic anemia. Point Therapeutics cites additional evidence showing that the compound may stimulate various cytokines and chemokines in such a manner as to also augment the in vivo immunological defenses against malignant tumors. A manuscript will be published in the September 1, 2003 issue of the American Society of Hematology’s journal, Blood. The paper, currently available online, features preclinical data.  Phase I investigation of 7 days of PT-100 200mcg, 400mcg, and 800mcg in chemotherapy-induced neutropenia has revealed the drug’s:  reassuring tolerability and safety profiles  dose-neutrophil recovery response relationship  association with an approximate two-day reduction in the median days of severe neutropenia when administered at 800 mcg  confirmatory in vivo chemokine and cytokine stimulation profile.  PT-100 is currently in a phase I/II clinical trial as an adjunct for the treatment of neutropenia in patients receiving chemotherapy. Study of an additional dosing group (1200 mcg per day) is underway, with results expected in the third quarter of 2003. Phase II investigation of the compound’s capacity to treat both neutropenia and anemia associated with the use of chemotherapy would follow a fully successful phase I trial. Additionally, a phase I/II combination trial of PT-100 plus IDEC (NASDAQ: IDPH) and Genentech’s (NYSE: DNA) Rituxan is slated to commence in June. The phase I protocol, for determination of PT-100 maximum tolerated dose in appropriate study subjects, is expected to be completed by the first half of 2004, after which will follow a phase II combination trial in patients with non-Hodgkin lymphoma or chronic myelogenous leukemia.
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