June 3, 2003
Business Editors/Health/Medical Writers
Source: Meyer Pharmaceuticals
Meyer Pharmaceuticals LLC announced today that the U.S. Patent & Trademark Office has issued U.S. Patent Nos. 6,569,664, and 6,573,062, with coverage directed to TNF Receptor Releasing Enzyme. The technology is licensed exclusively to Meyer Pharmaceuticals from the University of California at Irvine, and is being developed as a new biological agent for treating arthritis.
TRRE represents a family of human enzymes and regulatory proteins that cause TNF Receptors to be shed from the surface of cells. Receptor shedding is part of a natural process that limits cytokine signaling. TNF is the signaling molecule that plays a key role in the inflammation and tissue destruction that occurs in arthritis. Administering TRRE as a pharmaceutical composition gets to the center of the inflammatory reaction, thereby resolving the pathology of the disease and returning the patient to good health.
Tetsuya Gatanaga, Ph.D., executive vice president and chief operating officer of Meyer Pharmaceuticals, originally purified TRRE in the mid 1990's, when he was doing research at UC Irvine. Meyer Pharmaceuticals acquired the technology in 1997, and is engaged in the preclinical and clinical development of the enzyme. "We used to isolate TRRE from a human cell line," explains Dr. Gatanaga, "but then we cloned the gene, and now produce it by recombinant expression. The clone we have done the most testing with is designated MP8. The enzyme has proven to be extremely effective for treating inflammation in animal models for septic shock, edema, established arthritis, multiple sclerosis, and asthma."
U.S. Patent 6,569,664 claims any enzyme in the TRRE family that can be obtained from a particular cell line. It covers not only naturally produced protein, but also the same protein produced and purified from recombinant expression. U.S. Patent 6,573,062 covers the use of the enzyme for screening small-molecule enzyme inhibitor drugs that are potentially useful in the treatment of medical conditions associated with altered TNF Receptor signaling.
"These two new patents represent a significant milestone in the evolution of our intellectual property portfolio," says Michael O'Neill, president and chief executive officer of Meyer Pharmaceuticals. "These are the first U.S. Patents for TRRE, and provide a level of protection that will assure its future as a clinical product. There are patent applications being pursued for this technology throughout the world, including coverage for the cloned gene."
Meyer Pharmaceuticals is now completing formulation and scale-up to take MP8 into clinical trials later this year. Says O'Neill, "We think MP8 has a number of important advantages over current treatments for arthritis. For example, it can be produced much more cheaply and in larger quantities than antibody compositions. The patient can also be given a much smaller dose, because MP8 works as a catalyst, and simply boosts a natural anti-inflammatory pathway. There is a large unmet need for more effective biological agents, and the worldwide market is enormous.
"The initial Phase I/II trial is being financed entirely by Meyer Pharmaceuticals. We are currently talking with possible partners in the large pharmaceutical sector, to see how they can help us accelerate clinical development. Part of our mission is to get new therapies into the hands of clinicians for treating needy patients as soon as possible."
Meyer Pharmaceuticals LLC is a privately-held pharmaceutical company. It engages in discovery research, provides pharmaceutical research services under the service mark Meyer Pharmaceuticals(SM), and develops biological agents into compositions suitable for human clinical therapy. Its two core technologies are cellular cancer vaccines, and protein products that control inflammation by modulating cytokine signaling.
This news release contains forward-looking statements involving risks
and uncertainties inherent in pharmaceutical research, clinical development,
and intellectual property protection.
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