JANUARY 2009
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The Therapy Acceleration Program is on its way to creating an end-to-end solution to drug development for blood cancer patients. The goal of the program and its three divisions is to open bottlenecks, getting more new therapies to more patients faster and addressing critical, unmet medical needs.
The Biotechnology Accelerator Division collaborates with the private/corporate sector. Four sponsored research alliances were launched in the past year, two of which initiated clinical trials immediately upon receiving funds from The Leukemia & Lymphoma Society (LLS). Aegera Therapeutics of Montreal, Canada, began a Phase I/II trial of a new drug (AEG35156) for patients with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma or follicular lymphoma. AEG35156 inhibits a molecule called X-Linked Inhibitor of Apoptosis (XIAP), which is involved in multiple cancers, including leukemias and lymphomas. Within two months of executing a collaboration agreement with LLS, Aegera treated the first patient on trial at Princess Margaret Hospital in Toronto, Canada. The Phase I study will determine the safety and optimal dose of AEG35156 in patients. The anticipated Phase II study will then address the effectiveness of the highest safe dose.
Memgen, of Dallas, TX, also immediately began accruing CLL patients to a clinical trial with LLS funding. The Phase I trial is testing a novel immuno-stimulatory therapy (ISF35), along with chemotherapy in CLL patients whose leukemic cells are lacking a portion of chromosome 17 and/or are refractory to standard chemotherapies. The therapeutic options for these patients are currently severely limited and new treatments are urgently needed. Currently, one patient has been enrolled and the trial is actively seeking additional patients.
In conjunction with the LLS National Board of Directors meeting in Kansas City, MO, the Therapy Acceleration Program Governance Committee met and reviewed the progress of two additional partnerships as presented by company representatives. Anjin Group Inc., of Maryland, is developing a targeted-toxin therapy for patients with acute myelogenous leukemia (AML). Early research on this approach had been previously vetted and supported by LLS through the grant program, but animal studies required by the project contract were not accomplished by Anjin in the contracted timeframe. Therefore, the LLS committee decided to discontinue this partnership.
The second project reviewed by the committee was support for MannKind Corp.'s program to develop drugs for patients with T-cell leukemia or lymphoma. The drug target is novel. MannKind's lead compounds are highly specific and potent, but still need to be optimized for safety.). The LLS committee encouraged MannKind to continue its research to resolve toxicity issues before additional LLS funding might be available to further advance this novel therapy.
Related Links
- Want to participate in one of the trials above? Click here.
- For more general information about clinical trials see the Clinical Trials section of www.LLS.org.
The Academic Concierge Division continues to successfully leverage LLS research investments by helping select LLS-funded academic investigators move new therapies toward approval by the U.S. Food and Drug Administration (FDA). The division partners academics with commercial service providers who provide expertise in critical applied sciences. Contracts have been signed with three service providers to support four LLS-funded investigators. One project brings Provid Pharmaceuticals, a medicinal chemistry company, together with John Bushweller, Ph.D., an LLS Specialized Center of Research leader at the University of Virgina, to redesign and advance pre-clinical compounds as therapies for AML. The goal of this project is to develop small molecule drugs that recognize and inactivate abnormal AML proteins.
In other Academic Concierge projects, LLS brings together the University of Kansas Cancer Center's Office of Therapeutics, Discovery and Development to assist with drug formulations. One Kansas project is assisting Michael Caligiuri, M.D., an LLS Translational Research Program grantee from The University of Ohio, with the development of a vaccine for lymphoproliferative diseases that too frequently follow organ transplantation. Kansas is also repurposing an FDA-approved, antifungal drug into an oral formulation for Aaron Schimmer, M.D., an LLS Clinical Scholar at the University of Toronto. The drug will be tested in clinical trials for patients with AML.
The third division of the Therapy Acceleration Program, the Clinical Trials Program, was launched in October 2007 when LLS announced its partnership with the Cleveland Clinic Taussig Cancer Institute to create a Clinical Trial Center for Hematologic Malignancies. The center's mission is to increase enrollment in clinical trials and advance new treatments. In addition, it will test a unique community-based model that addresses an important barrier to clinical trial accrual - namely access. Year 1 of the program witnessed the assembly and training of the center's team. Highly-skilled personnel are now serving as project manager, protocol coordinator, clinical research assistant, research administrator, medical secretary, regional research managers and principal investigators. The community sites are being brought in line with main campus capabilities critical to optimal patient accrual and to the collection of clinically annotated tissue samples used in the correlative laboratory studies that are important to translating clinical findings into further improved treatment protocols.
In July 2008, the Clinical Trial Center opened its first LLS-sponsored trial, A Phase I Trial of the Combination of Everolimus (RAD001) and Bortezomib (Velcade®) for Relapsed or Refractory Indolent and Mantle Cell Non-Hodgkin Lymphomas. Four patients have been enrolled in this trial over a four-month period. As noted above, this Phase I trial is intentionally accruing slowly and sequentially so as to determine the highest safe dose with lowest risk to participating patients.
Preparation is underway for a second trial at the center. If the trial starts in early 2009, as anticipated, center activity will be ahead of the original schedule.
About the Program
The Therapy Acceleration Program has been widely recognized as an innovative model to create effective partnerships that focus on therapies for patients. As a result, many organizations have extended invitations to LLS to present its Therapy Acceleration Program and experience at various forums including: - The Biotechnology Industry Association Investor Forum, October 2008
- The National Health Council, Chief Medical Officer's Meeting, November 2008
- The Cleveland Clinic Satellite Symposium, December 2008
- The MassBio 2008 Investor Forum, December 2008
Views of the Therapy Acceleration Program -
The Therapy Acceleration Program was created to move therapies through the development phase, a key bottleneck to getting drugs to patients:
The Therapy Acceleration Program funds projects across many blood cancers:
The Therapy Acceleration Program has activated projects in all three of its divisions:
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