November 21, 2006                                      

SIU Research Scientist Awarded Patents and Licensure for New

Drug Application

Kathleen Campbell, Ph.D., in her lab

A research scientist from Southern Illinois University School of Medicine in Springfield has been awarded three U.S. patents and five international patents for the discovery of a new drug application.  The patents for this new application have been licensed by a pharmaceutical company and it is now being tested in clinical trials.

Kathleen C. M. Campbell, Ph.D., professor of otolaryngology head and neck surgery and director of audiology research for the surgery department at SIU, has discovered a new therapeutic use for D-methionine, an amino acid present in protein, especially fermented protein that is in cheese or yogurt.
Her research has found that D-methionine is effective in reducing hearing loss from very loud and long-term noise exposure in animal models.  “If the clinical trials find it works in humans as well as it does in animals, permanent hearing loss from prolonged loud noises and accidents such as military gunfire and automobile airbag detonation could be prevented for many people around the world,” said Campbell.  In animal studies the compound works even when first given soon after the noise exposure.

The drug also has been found to be effective against hearing loss caused by cisplatin, an anticancer drug used in chemotherapy.  Approximately 50 percent of ovarian cancer patients and 30 percent of lung cancer patients receiving cisplatin will develop hearing loss.

"Another big application for D-methionine may be for treating side effects of a group of antibiotics, called aminoglycoside antibiotics that inhibit bacterial protein synthesis and are active especially against gram-negative bacteria. This is a big health problem in Third World countries,” explained Campbell.

The patents for D-methionine have been licensed by Molecular Therapies, Inc., in Ann Arbor, Mich.  The company has developed a proprietary oral suspension formulation called MRX-1024 and is currently conducting clinical trials in humans, testing the drug’s effectiveness in treating severe mucositis, a side effect of radiation therapy in head and neck cancer patients.  Mucositis causes ulcers in the mouth which are very painful and create problems with eating, drinking and swallowing.  It can be life threatening.

Phase I of the trials, involving 25 people, showed D-methionine reduced the severity of mucositis from 70 percent to only 10 percent of participants.  Phase II trials are placebo controlled randomized double blind studies being conducted at four centers in India and a trial is being initiated at Johns Hopkins University Cancer Center in Baltimore, Md.

“Some of the trials are being done in India because a large number of people there have oral cancer as a result of Betel nut and tobacco chewing,” said Prasad Sunkara, Ph.D., chairman and chief executive officer of Molecular Therapies, Inc.

He expects the completion of the Phase II trials, which involve about 90 participants to be completed by fall of next year.  Then the company plans to meet with the Federal Drug Administration (FDA) by the end of next year to design a Phase III trial, which will greatly expand the number of people involved.  “Because of the huge need for this treatment, we hope the approval will be put on the fast-track,” explained Sunkara. 

In addition, two other Phase II clinical trials are being conducted in India for
D-methionine protection from hearing loss caused by cisplatin chemotherapy and aminoglycoside antibiotics.

"Getting a discovery patented is a very big step, but it’s even more exciting to see it progress to clinical trials,” said Campbell.  “Only about five out of every 1,000 patents go to clinical trials.”  Campbell works with SIU School of Medicine’s Technology Transfer office, which manages patents and licensing agreements.  University policy allows for the School and the investigator to share in any profits that may result from revenue of patented technology.

Her interest in finding help for hearing loss began when she worked as a clinical audiologist while also completing her doctoral research at the University of Iowa in Iowa City.  She became frustrated seeing patients with progressive hearing loss caused by chemotherapy and not being able to prevent further hearing loss, so she decided to pursue developing agents to protect against the hearing loss she observed.

Campbell, a certified clinical audiologist, has been doing audiology research for more than 20 years and researching protective agents for more than 10 years.  She has received three grants from the National Institutes of Health.  Some of her research has included working with other collaborators at SIU, the University of California, Irvine, the Navy Medical Center at San Diego and Oregon Health Sciences University.  Her future research plans are to continue working on developing agents to improve care for cancer patients and prevent radiation- and noise-induced hearing loss as well as other ototoxicities. 

She is the author of “Essential Audiology for Physicians” and “Pharmacology and Ototoxicity for Audiologists” as well as numerous book chapters and articles.  She is a recipient of a Clinical Investigator Development Award and the James A. Shannon Director’s Award, both from the National Institutes of Health and serves on the American Academy of Audiology board of directors.

Campbell joined the SIU faculty in 1989.  She earned her doctorate in clinical audiology at Iowa after completing a fellowship at the Veterans Administration Hospital (1988, 1989).  She earned her master’s degree at the University of South Dakota in Vermillion (1977) and her bachelor’s at South Dakota State University in Brookings (1973). 

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