Clinical Trials to Focus on First Antibody Treatment for PCP Addiction

JAN. 31, 2005 | InfleXion Therapeutics, LLC, the latest company started in the biomedical business incubator at the University of Arkansas for Medical Sciences (UAMS), has received a $3 million grant to conduct clinical trials for the first antibody treatment for addiction to the drug known as phencyclidine, or PCP.

A Jan. 27 news conference at UAMS introduced InfleXion Therapeutics and its plans for developing highly specific treatments that researchers anticipate can be extended to treat addictions to other drugs, including methamphetamine. In addition, the event put a face on drug addiction and talked about how the availability of new treatments, like those InfleXion is working toward, can work with recovery programs to address one of the nation’s most serious health care problems.

Michael Owens, Ph.D., director of the UAMS Center for Alcohol and Drug Abuse and a professor in the Department of Pharmacology and Toxicology in the UAMS College of Medicine, invented the addiction treatment. He and three partners, including another UAMS faculty member and a biology professor from the University of Arkansas at Fayetteville formed InfleXion Therapeutics in the BioVentures business incubator.

“We see this as just the beginning of a whole new therapeutic approach to drug addiction in the United States,” said UAMS College of Medicine Dean E. Albert Reece, M.D., Ph.D., M.B.A. “Translational research is an effort to speed the movement of research discoveries from the research bench to the patient bedside through effective collaboration and InfleXion has accomplished exactly this.

“These doctors have worked together to find new ways to combine their individual skills and disciplines and have promoted the creation of better integrated networks of academic centers working together at UAMS and the University of Arkansas at Fayetteville,” Reece said.

The business development grant from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) will provide funding for five years to obtain Food and Drug Administration approval and conduct clinical trials on a protein-based therapy that may blunt the effects of phencyclidine. InfleXion will further develop the process of customizing antibodies for use in blocking the adverse effects of drugs like PCP or methamphetamine on the brain. Through BioVentures, UAMS provides resources and becomes an equity partner in the company.

“InfleXion will focus on developing protective and preventive medicine for the improvement of human health,” Owens said. “Since antibodies are a natural product of our immune defense system we envision they will be a safe, effective way to reduce or prevent the adverse effects of drugs of abuse.

“Our first medicine will be for the treatment of PCP addiction but we plan to move quickly to extend the technology for treatment of methamphetamine addiction,” he said.

Owens said the business partners chose the company name from its meaning as “a curve or a bend.” He said he hopes the medications produced by the company promote a positive turning point in the lives of those fighting drug addictions.

PCP abuse has been increasing. According to the Drug Enforcement Administration, the number of PCP doses seized increased more than six-fold from 2001 to 2002. Emergency department visits across the country caused by and associated with PCP increased 28 percent from 1995 to 2002, according to NIDA, and by 42 percent from 2000 to 2002.

Phencyclidine was developed in the 1950s as an intravenous anesthetic but was abandoned because of the psychological effects it caused, including hallucinations and paranoia, which has led to violent or suicidal episodes.

“Drug addiction is a chronic, complex disease of the brain for which there are only a few medications for treatment,” said Brooks Gentry, M.D., an associate professor of anesthesiology, and pharmacology and toxicology, at UAMS and a partner in InfleXion. “Our goal is that our medications, in combination with conventional psychotherapy will help patients gain control of their lives.”

Cindy Crone, executive director of Arkansas CARES, a division of the UAMS
College of Medicine Department of Psychiatry and a prevention and treatment program for mothers who are affected by substance abuse and mental health disorders, talked about the importance of InfleXion’s work to those suffering from addiction.

“Drug abuse is the number one health problem in the United States and is costly in human and economic terms through health care costs and the loss of productivity,” Crone said. “That doesn’t even count the loss of life, hope and futures caused by drug addiction.

“But the good news is that treatment works and that our partners in science are also focusing on treatments for this chronic disease to give us another tool so we can offer hope and good outcomes.”

Crone introduced Stephanie Drake, a recovering alcoholic and drug-addicted mother who has been in the Arkansas CARES program. Drake, who brought her 3-year-old son, noted that while in the grip of her addictions her weight dropped to 86 pounds.

“I am grateful for Arkansas CARES,” Drake said. “They taught me how to live and helped me become a good mother. I have a disease but I am living in recovery and managing that disease.”

A unique aspect of InfleXion’s treatment approach is that the antibodies are produced in modified plants grown in a greenhouse. The antibodies are removed and purified for use in an injectable form. In the body they act to neutralize the drug’s adverse effects, just like a natural antibody protects against other diseases.

“Pharmaceutical production is expensive but we hope that the ability to produce the antibodies in plants can reduce the production costs,” Owens said.

The goal is to create therapeutic medications for drug overdose, for reduction of neurological and neurocognitive damage in binge users, for helping recovering addicts resist using the drug again, and to prevent or reduce the adverse effects to chronic users.

Owens and Gentry are joined by Ralph Henry, Ph.D., an associate professor of biology at the University of Arkansas at Fayetteville; and Barry Holtz, Ph.D., who was previously a senior vice president for the biopharmaceutical firm Large Scale Biology Corp. of Calif., to start InfleXion in early 2004. Holtz is the chief executive officer, Owens is the chief science officer, Gentry is the chief medical officer and Henry serves as a company vice president.

The venture also has roots in Arkansas’ tobacco settlement funding. The Arkansas Biosciences Institute (ABI), a partnership of scientists from institutions including UAMS and the University of Arkansas at Fayetteville, was created by the voter-approved Tobacco Settlement Proceeds Act and helped bring Holtz, Owens, Henry and Gentry together in 2000 to research plant-based treatments for drug addiction.

The UAMS BioVentures incubator started in 1994 with its mission to foster development of biotechnology companies that will stimulate the Arkansas economy by producing new revenues and creating high-paying jobs and new biomedical products.

“The UAMS Biotechnology and BioVentures Center has seen six companies graduate from the program, including nationally-recognized companies such as ContourMed, Safe Foods Corp. and Anabonix,” Reece said. “Currently we have 306 invention disclosures and 111 patents. We have six graduate companies that have 128 employees with an annual payroll of $7.6 million, seven incubator or client companies with four others in the pipeline and five emerging pre-pipeline companies.”

Links on This Page
News release –  http://www.uams.edu/update/absolutenm/templates/news_release_liz.asp?articleid=2573&zoneid=86

National Institute for Drug Abuse – http://www.nida.nih.gov/

UAMS Arkansas BioVentures – http://www.uamsbiotech.com/default.asp

Arkansas Cares – http://www.arcares.uams.edu/

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