Ligand Pharma (LGND) Completes PG-Free Melphalan Phase II, Issues Update
Tweet
Share
E-mailGet Alerts LGND Hot Sheet
Join SI Premium – FREE
Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) announced that results from the Phase II study of its Captisol-enabled, propylene glycol-free (PG-free) Melphalan program were featured this evening in a poster presentation at the combined annual meetings of the Center for International Blood & Marrow Transplant Research (CIBMTR) and the American Society for Blood and Marrow Transplantation (ASBMT) in San Diego.
The Phase II study was completed in late 2011 and compared the safety, tolerability and pharmacokinetic profiles of the PG-free Melphalan intravenous formulation and the current clinically-used intravenous formulation of melphalan (sold by GlaxoSmithKline as Alkeran® for Injection) for multiple myeloma patients undergoing autologous transplantation. The Captisol-enabled product is expected to allow for longer administration durations and slower infusion rates, potentially enabling clinicians to safely achieve a higher dose intensity of pre-transplant chemotherapy, which may lead to better therapeutic outcomes.
Ligand is preparing to initiate a 60-patient Pivotal trial in 2012. Given the robust data set compiled to date along with the efficient final study design, Ligand believes it will have a submission-ready NDA at the end of this study. Although Ligand is preparing to conduct the trial with the objective to potentially launch the product itself, the company is also currently evaluating entering a partnership for the program.
The Phase II study was completed in late 2011 and compared the safety, tolerability and pharmacokinetic profiles of the PG-free Melphalan intravenous formulation and the current clinically-used intravenous formulation of melphalan (sold by GlaxoSmithKline as Alkeran® for Injection) for multiple myeloma patients undergoing autologous transplantation. The Captisol-enabled product is expected to allow for longer administration durations and slower infusion rates, potentially enabling clinicians to safely achieve a higher dose intensity of pre-transplant chemotherapy, which may lead to better therapeutic outcomes.
Ligand is preparing to initiate a 60-patient Pivotal trial in 2012. Given the robust data set compiled to date along with the efficient final study design, Ligand believes it will have a submission-ready NDA at the end of this study. Although Ligand is preparing to conduct the trial with the objective to potentially launch the product itself, the company is also currently evaluating entering a partnership for the program.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Petros Pharmaceuticals (PTPI) Expands Online Distribution for Prescription STENDRA
- Artelo Biosciences (ARTL) Reports Publication of Peer-Reviewed Article Highlighting FABP7
- Independent Bank (IBCP) Appoints Stephen L. Gulis, Jr. as Board Chair
Create E-mail Alert Related Categories
Corporate News, FDASign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
