TAP Advancing Clinical Trials
The LLS Therapy Acceleration Program’s Academic Concierge Division continues to successfully leverage LLS research investments by helping select LLS-funded academic investigators move new therapies toward market approval. On April 22, 2009, LLS will present one of its Academic Concierge projects, headed by Principal Investigator Aaron D. Schimmer, F.R.C.P.C., M.D., Ph.D., Ontario Cancer Institute (shown here), at a meeting with Health Canada (the Canadian equivalent of the U.S. Food and Drug Administration) and discuss next steps toward opening a Phase I clinical trial. Barring any concerns from Health Canada, the program is on track to open LLS’s first AC Division clinical trial in the fall of 2009.
In conjunction with the LLS National Board of Directors meeting held March 13th in Newark, N.J., the Therapy Acceleration Program Governance Committee reviewed the progress of the Cleveland Clinic partnership in the Clinical Trials Program Division and approved a third LLS-supported trial to open at the Clinical Trial Center for Hematologic Malignancies. This Phase I/II trial will combine two approved therapies, Lenalidomide and Rituximab, for maintenance therapy following high-dose chemotherapy and autologous stem cell transplantation in patients with B-cell non-Hodgkin’s lymphoma.
Also exciting is news that the Cleveland Clinic will utilize three of its community treatment centers when it becomes a trial site for LLS’s partner, Aegera Therapeutics, and the ongoing Phase I/II trial of a new drug (AEG35156). The Cleveland Clinic’s main campus and three regional hospital centers will begin recruiting patients with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma or follicular lymphoma for treatment with Aegera’s AEG35156, that inhibits a molecule called X-Linked Inhibitor of Apoptosis (XIAP). This is a significant step toward LLS’s goal of enhancing access to clinical trials by “taking the trial to the patient.”
In order to leverage its successful clinical trial partnership with the Cleveland Clinic and to further address issues that currently limit clinical trial participation, LLS hosted a 1 1/2 day workshop this past February in San Francisco. Ron Levy, M.D., professor and chief, Division of Oncology at Stanford University, led discussions in which clinical trials experts reviewed ongoing models for early phase blood cancer treatment trials, including roles for-profit companies and government agencies can play, and considered how LLS can best use its resources to help increase participation in practice-changing trials. Workshop discussions provided many insights that will enable future partnerships for the LLS Clinical Trials Program.
Source: LLS.org (eNewsline)