St. Louis, MO, May 31, 2001--MetaPhore Pharmaceuticals, Inc. today announced that it has received FDA approval of its Investigational New Drug (IND) application to conduct clinical trials in the U.S. to evaluate M40403, one of its enzyme mimetic compounds.
MetaPhore has initiated a Phase I study to test the safety and tolerability and to determine the pharmacokinetics of the compound in normal, healthy human subjects, as a precursor to Phase II trials in which M40403 will be tested as a co-therapy with interleukin-2 (IL-2) for advanced skin and end-stage kidney cancers. This study is the first human clinical trial for MetaPhore and the companys proprietary family of enzyme mimetic compounds that effectively mimic the action of one of the bodys primary free-radical fighting mechanisms, the natural enzyme superoxide dismutase (SOD).
In addition to cancer, MetaPhore is developing these compounds as drug candidates for pain and other diseases and conditions that have been associated with free-radical damage to tissues and cells.
The opening of this IND marks a major step for MetaPhore and our SOD enzyme mimetic program. For many years, we have understood the free-radical fighting power of the bodys natural SOD enzymes, but only recently have we been able to reproduce that benefit in a stable and selective drug form, said Denis Forster, Chief Operating Officer of MetaPhore. These novel therapeutics have tremendous potential, based on the growing body of research linking free-radical mediated damage with a wide range of acute and chronic disease states.
Preclinical studies in animals, including several recently presented at the American Association for Cancer Research at the end of March, have shown that M40403 significantly improves the effectiveness of IL-2, an approved treatment for inoperable metastatic melanoma and metastatic renal-cell carcinoma. Approximately 80,000 cases of melanoma and renal-cell carcinoma are diagnosed in th
Contact: Punnie Donohue
Kupper Parker Communications