Wednesday, August 16, 2006
Ligand Collaborator Drug Shows Encouraging Results in Thrombocytopenia; GlaxoSmithKline Releases Phase II Data; Ligand Drug for Thrombocytopenia Targe
SAN DIEGO -- Ligand Pharmaceuticals Incorporated (Pink Sheets:LGND) announced today that results reported by GlaxoSmithKline (NYSE:GSK) in phase II studies of eltrombopag, SB-497115 ("115"), a small-molecule drug that mimics the activity of thrombopoietin (TPO), a protein factor that promotes growth and production of blood platelets, were promising.
On November 30, 2005, during a review of its oncology portfolio, GSK presented data from a phase II dose-ranging clinical trial that showed 115 significantly raised platelet counts in adult patients. GSK described the phase II studies well underway in three major indications: idiopathic thrombocytopenia purpura (ITP), hepatitis C (HCV) and chemotherapy-induced thrombocytopenia (CIT). The phase II results in adult patients with chronic ITP that had failed at least one prior therapy and with platelet counts less than 30,000 showed that 66% of patients receiving the 50 mg dose and 87% of patients treated with 115's highest dose (75 mg/day) had counts greater than or equal to 50,000 after six weeks and many of those had reached normal platelet levels within the first two to three weeks of treatment.
In comparison, only 13% of placebo-treated patients showed platelet increases greater than or equal to 50,000 after six weeks. The frequency of side effects was comparable between patients treated with placebo and those treated with eltrombopag. Additional data presented at the meeting showed encouraging results in an interim analysis in a phase II study in HCV patients.
"We are pleased to see that our vision of the early 1990's of the emergence of an exciting, new TPO pharmaceutical market is now rapidly being translated to concrete product assets with great potential to meet unmet patient needs and for shareholder value. The assets eltrombopag and SB-539448 resulted from a collaboration agreement GSK entered into with Ligand in 1995, and which incorporated TPO as a target in 1997 while an internal program initiated following completion of the collaborative program has produced LGD4665, now targeted for IND filing in the first half of 2006," said David E. Robinson, Chairman, President and Chief Executive Officer of Ligand Pharmaceuticals. "We believe the size and potential of the emerging thrombocytopenia market will clearly support multiple once-a-day oral product entries and therefore have made LGD4665 our top new chemical entity product development priority."
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