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- Title
MDX RA: 4197X-RA, Monoclonal Antibody Ricin A.
- Abstract
Adis Comments MDX RA [4197X-RA] is a therapeutic immunotoxin undergoing phase III development with Houston Biotechnology (a subsidiary of Medarex) in the USA for the prevention of secondary cataracts. The compound is a monoclonal antibody conjugated to ricin A, administered during primary cataract surgery. In December 1998, Medarex suspended further enrollment in the phase III trial after 2.3% (13/565) of patients experienced unexplained sight-limiting adverse events. These patients were distributed equally in the placebo and MDX RA treatment groups and Medarex commented at the time that it did not consider the events likely to be a result of MDX RA treatment. The company appears to have resumed enrolment in the trial. Currently, the only effective means of treating cataracts is to surgically remove the opaque lens and replace it with an artificial lens implant. After surgery, naturally occurring lens epithelial cells on the inside front surface of the lens capsule can gradually proliferate, clouding the lens and causing a secondary cataract. Approximately half of all patients undergoing primary cataract surgery eventually develop a secondary cataract. The antibody portion of MDX RA is highly specific for lens epithelial cells. At the close of primary cataract surgery, MDX RA is delivered directly into the eye as a single dose where it binds to and causes the destruction of the lens epithelial cells. This has the potential to prevent secondary cataracts. Medarex holds a non-exclusive licence from Sanofi (now Sanofi-Synthélabo) of France to use its patented method for conjugating antibodies involving the particular toxin and linker used by Medarex in the manufacture of MDX-RA. A royalty of $US1 per treatment unit of MDX RA is payable to Sanofi-Synthélabo for sales in countries where Sanofi-Synthélabo has patent rights. Santen has licensed MDX RA for Japan, where it is undergoing preclinical investigation. Medarex has licensed development and marketing rights in Europe and the Near East for MDX RA to Scil Biomedicals. Scil Biomedicals will pay Medarex $US4 million in upfront and licensing fees, as well as royalties on future sales, and has committed up to $US25 million to support further development of MDX RA. Upon achievement of specific clinical and regulatory goals, Scil Biomedicals is entitled to certain milestone payments from Medarex. In October 2000, Medarex announced that IDM (Immuno-Designed Molecules) had acquired rights to some of Medarex’s therapeutic products, including MDX RA, in exchange for certain ownership rights in IDM. IDM will receive royalty payments from any third-party sales of MDX-RA in Europe.
- Subjects
ANTIBODY-toxin conjugates; CATARACT; HOUSTON Biotechnology Inc.; CLINICAL trials; PREVENTION; THERAPEUTICS
- Publication
Drugs in R&D, 2002, Vol 3, Issue 2, p111
- ISSN
1174-5886
- Publication type
Article