Avigen, Inc. (Nasdaq: AVGN), a biopharmaceutical company innovating therapeutics for neurological care, today announced the launch of an exploratory study of the company's pipeline product, AV411 (ibudilast), for the treatment of opioid withdrawal symptoms. The study is largely funded by the National Institute on Drug Abuse (NIDA) and will be run jointly by the New York State Psychiatric Institute (NYSPI) and Columbia University.
"We are excited to participate in a study of this stature in partnership with NIDA, NYSPI and Columbia," said Kenneth Chahine, Ph.D., J.D., Avigen's President and Chief Executive Officer. "This trial builds upon our research of AV411's unique glial-attenuating properties and will complement Avigen's clinical studies of AV411 to treat neuropathic pain. We believe both of these exploratory paths may show that AV411 can become a breakthrough therapy for these disabling disorders."
"NIDA has chosen to fund this study based on its review of Avigen's research and its interest in the role of glial-attenuation as a novel way to treat opioid withdrawal symptoms, a common result of opioid abuse that can hinder recovery," said Frank J. Vocci, Ph.D., Director of the Division of Pharmacotherapies and Medical Consequences of Drug Abuse at the National Institute on Drug Abuse (NIDA). "This is truly an unmet medical need in this country. The nonmedical use or abuse of prescription drugs - primarily opioids - is a serious and growing public health problem. In fact, an estimated 33 million people have used prescription drugs for nonmedical reasons in their lifetimes - approximately 15 percent of the U.S. adult population."
About the Trial
The clinical study will assess the safety and tolerability of AV411, a non-opioid compound, when administered twice daily to heroin addicts who are maintained on morphine, a commonly used opiate analgesic drug, over a 14-day period. The trial will assess preliminary efficacy of AV411 for reducing the symptoms of opioid withdrawal.
"In preclinical studies, opioid treatment induces brain glial cell activation that correlates with both opioid tolerance and dependence," explained the study's principle investigator, Sandra D. Comer, Ph.D., Associate Professor of Clinical Neurobiology at NYSPI and Columbia University. "Preclinical studies have shown that AV411 can attenuate the behavioral signs of opioid withdrawal and corresponding glial cell activation without conferring adverse side effects. My research team and our partners are eager to confirm these findings in humans and help move this potentially important new medicine through clinical development."
About Opioid Withdrawal
Opioid medications, including morphine, have been used for centuries to relieve acute and chronic pain. The use of opioid drugs can cause the development of analgesic tolerance and physical dependence, which leads to withdrawal symptoms when opioid therapy is discontinued. Symptoms of withdrawal may begin as early as a few hours after usage is substantially lowered. Symptoms include a craving for the drug, restlessness, moodiness, insomnia, yawning, abdominal cramps, diarrhea, nausea and vomiting, and muscle aches. There are no approved drugs to treat withdrawal, and treatments employed often have undesirable side effects and may not provide enough relief from the intense physical and mental withdrawal symptoms, leading patients in detox to quit before completing their program.
AV411 is a first-in-class orally bioavailable small molecule, a glial attenuator that suppresses pro-inflammatory cytokines IL-1 beta, TNF alpha, and IL-6, and may upregulate the anti-inflammatory cytokine IL-10. While considered a New Molecular Entity (NME) in the United States and Europe, the drug was first approved in Japan more than 15 years ago. The drug has been prescribed to over one million patients for a different indication and has a good post-marketing safety profile in nearly 15,000 patients studied at the prescribed doses.
As part of its program investigating glial attenuation as a novel approach to the treatment of neuropathic pain, Avigen discovered that AV411 is efficacious in standard preclinical models of opioid withdrawal. While ibudilast was initially developed as a non-selective phosphodiesterase (PDE) inhibitor for the treatment of bronchial asthma, its efficacy in neuropathic pain models appears to be independent of this activity. Additional preclinical research has revealed that AV411 can attenuate opiate-induced glial activation and both behavioral and neurochemical markers of opioid-induced reward and withdrawal. Based on its research, Avigen has filed for patents protecting this use of AV411, as well as for patents on AV411 analogs which the company believes have the potential to be effective second generation molecules. Additional information on AV411 can be found on Avigen's website at www.avigen.com.
What are Opioids?For more information on what opioids are, and opioid-induced constipation (OIC), please see:
All About Opioids and Opioid-Induced Constipation (OIC)
Avigen is a biopharmaceutical company focused on developing and commercializing unique small molecule therapeutics to treat serious neurological disorders, including neuropathic pain and neuromuscular spasm and spasticity. Avigen's strategy is to complete the requirements of clinical development for each of the candidates in its product pipeline, and continue to look for opportunities to expand its pipeline through a combination of internal research, acquisitions, and in-licensing, with the goal of becoming a fully integrated commercial biopharmaceutical company that remains committed to its neurology products. Avigen is currently developing AV650 for spasticity and neuromuscular spasm and AV411 for neuropathic pain as well as opioid withdrawal and addiction. Additionally, the company is advancing toward clinical trials AV513, a novel therapy for the treatment of multiple bleeding disorders, including hemophilia A and B. For more information about Avigen, consult the company's website at www.avigen.com.
Statement under the Private Securities Litigation Reform Act
This press release contains forward-looking statements, which include, among others, statements relating to Avigen's belief that AV411 may be a breakthrough therapy for disabling disorders, and its intention of using this trial to build upon AV411's glial-attenuating properties; using AV411 analogs as second generation molecules; completing the requirements of clinical development for each of the candidates in its product pipeline; continuing to look for opportunities to expand its pipeline; and becoming a fully integrated commercial biopharmaceutical company. Other forward-looking statements include the statements that AV411 may have the potential to provide better tolerability with fewer side effects than existing treatments and that Avigen may pursue development of AV411 for the treatment of opioid withdrawal and dependence and chemotherapy-induced neuropathy. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include those detailed in reports filed by Avigen with the Securities and Exchange Commission, including Avigen's quarterly report on Form 10-Q for the period ended June 30, 2008, under the caption "Risks Related to Our Business" in Item 2 of Part I of that report, which was filed with the SEC on August 11, 2008.