Norwood begins phase 2 trial of Lupron for immune recovery in cancer patients

By Lisa Kerner

Erie, Pa., Feb. 21 - Norwood Immunology Ltd. said it is beginning the phase 2 clinical trial of Lupron in cancer patients receiving high-dose myeloablative chemotherapy therapy and autologous bone marrow transplant (also known as haematopoietic stem cell transplant) for the treatment of Hodgkin's disease, non-Hodgkin's lymphoma or multiple myeloma.

The double-blind, randomized phase 2 clinical trial is to determine whether there is enhanced immune recovery as a result of using Norwood's technology, according to a company news release.

Norwood licensed its immunology intellectual property to TAP Pharmaceutical Products Inc. for commercialization in the United States, using TAP's GnRH analogue, Lupron Depot (leuprolide acetate for depot suspension).

TAP and Norwood are exploring the use of Lupron Depot in regenerating the thymus gland to "re-boot" the body's immune system.

The first of 80 patients (40 treated; 40 control) for the phase 2 study has been enrolled at University of Texas, M.D. Anderson Cancer Center, of Houston. All patients will be randomized to receive either Lupron Depot or a placebo, the company said.

Recruitment is expected to begin soon at additional study sites, including The Dana-Farber Cancer Institute, Harvard Medical School, Boston and University of Minnesota Medical Center, Fairview.

The trial is open to male patients aged 18 to 60 years old and female patients aged 18 to 50 years old. Study participants will receive nine months of therapy with Lupron 3 Month Depot or a placebo, and will be studied for about 13 months.

The primary endpoint of the trial is T-cell response to a neo-antigen vaccine, as an indicator of enhanced immune response. Secondary endpoints include responses to three common vaccines and extensive analysis of T-cells and other immune cells in the blood, the release stated.

"Commencing this study is an important milestone for the company," Norwood chief executive officer Richard Williams said in the release. "I am pleased that we are now underway and appreciate the hard work of the teams at Dana Farber, M.D. Anderson, University of Minnesota and TAP in working closely with us to design and implement this high quality, and complex study."

TAP Pharmaceutical, located in Lake Forest, Ill., is a joint venture between Abbott and Takeda Pharmaceutical Co. Ltd. of Japan. TAP currently markets Lupron Depot and Prevacid (lansoprazole).

Norwood is focused on technologies and therapies to rejuvenate activity of the immune system, through re-growth of the thymus, improvements in bone marrow function and enhancement of T-cell functionality. The company is based in Victoria, Australia.

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