LLS's Lead Therapy Acceleration Program in MDS Gets Boost from Major Industry Licensing Agreement

Phase 3 clinical study of rigosertib, a novel therapy for patients with myelodysplastic syndromes, supported by LLS funding

News provided by

The Leukemia & Lymphoma Society

Sep 20, 2012, 01:30 ET

WHITE PLAINS, N.Y., Sept. 20, 2012 /PRNewswire/ -- Thanks to support funding from The Leukemia & Lymphoma Society (LLS), Onconova Therapeutics, Inc. has been advancing rigosertib, the lead compound under development for treating patients with high-risk myelodysplastic syndrome (MDS).

In an announcement made this week, European commercial rights for rigosertib have been licensed to Baxter International providing significant resources to advance the program toward U.S. and European regulatory review and ultimately to MDS patients. Rigosertib is designed to inhibit critical pathways to the growth and survival of cancer cells.

"Advancing new therapies in areas of unmet medical need such as MDS is the bow of the ship for LLS," said LLS President and CEO John Walter. "The Baxter/Onconova agreement highlights a successful outcome for the LLS Therapy Acceleration Program (TAP)."

LLS and Onconova first announced their collaboration in June 2010. LLS has committed to providing up to $12.5 million in funding to support an ongoing multicenter, randomized, clinical trial of rigosertib versus best supportive care in adult patients with MDS who have relapsed or become resistant to azacitidine or decitabine. Onconova has announced that, to date, trial enrollment has successfully surpassed the half-way point and there are now 80 trial sites activated around the globe. Onconova is continuing to accrue patients for the clinical trial.

This partnership marks the first phase 3, approval-track clinical trial that LLS is supporting through TAP, a bold initiative designed to bring promising therapies to patients suffering from blood cancers more quickly. LLS is taking an active role in accelerating development of novel therapies for patients and has committed substantial, multi-year funding to support this collaboration with Onconova as part of TAP. LLS continues to partner directly with other biotechnology companies through TAP to accelerate the advancement of potential breakthrough therapies towards FDA approval.

LLS proudly recognizes the significant support provided by Edward P. Evans Foundation and Harry T. Mangurian, Jr. Foundation for this project.

About MDS
Myelodysplastic syndromes (MDS) are a group of diseases of the blood and marrow, with varying degrees of severity and life expectancy. In the general population, MDS occurs in 5 per 100,000 people. However, among individuals older than age 70, the incidence increases to between 22 and 45 per 100,000, increasing even further with age. Most often, people diagnosed with MDS first seek medical attention because they are experiencing fatigue and shortness of breath. MDS may be a primary (de novo) diagnosis or secondary to cancer treatment with chemotherapy and/or radiation therapy. MDS has been known as "smoldering leukemia," or "pre-leukemia," implying that MDS is only serious and problematic if it evolves into AML; this is not the case.

While there has been recent progress toward improving management of MDS, therapeutic options are limited for patients who have drug-resistant or refractory disease. The only potential cure is stem cell transplantation from a donor. However, patients who have MDS may not be candidates for this option due to their advanced age and underlying bone marrow deficit. Novel therapeutic strategies are needed and to date, rigosertib has shown clinical promise in multiple trials.

About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society^® (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world and provides free information and support services.

Founded in 1949 and headquartered in White Plains, NY, LLS has chapters throughout the United States and Canada. To learn more, visit www.LLS.org or contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 6 p.m. ET. www.lls.org.

Contact: LLS: Andrea Greif
(914) 821-8958 [email protected]

SOURCE The Leukemia & Lymphoma Society