ALAMEDA, Calif., Aug. 13, 2007 (PRIME NEWSWIRE) -- Avigen, Inc. (Nasdaq:AVGN), a biopharmaceutical company developing innovative therapies for the treatment of chronic neurological conditions, today announced it received approval from the U.S. Food and Drug Administration (FDA) to proceed with the U.S. clinical development of AV411 (ibudilast). The initial U.S. clinical trial for AV411, which is treated as a New Chemical Entity in the United States, will be a Phase I maximum tolerated dose study that is designed to build on data from Avigen's Phase I and exploratory Phase IIa studies in Australia. This larger U.S. Phase I trial is designed to assess the safety and tolerability of AV411. This trial is also intended to assess the effect of food on AV411 pharmacokinetics and tolerability. In parallel, Avigen's Australian Phase IIa trial is expected to provide safety and initial efficacy data of AV411 in patients with neuropathic pain and is expected to report by the end of 2007.
"We are excited to initiate the clinical development of AV411 in the United States," said Kenneth Chahine, Ph.D., J.D., Avigen's President and Chief Executive Officer. "In addition to our preliminary proof-of-concept work ongoing in Australia, the FDA approval of this Phase I clinical trial is an important step in Avigen's plans to design larger efficacy studies of AV411 in the United States for neuropathic pain and other indications like opioid withdrawal and dependence."
This first clinical trial for AV411 in the United States builds upon the global development that Avigen initiated in 2006. Earlier this year, Avigen announced findings from an initial safety and tolerability study performed in Australia that supported a dosing frequency of AV411 of twice daily. Avigen currently has a Phase IIa trial of AV411 ongoing in Australia to further assess safety and provide a preliminary indication of efficacy in patients suffering from neuropathic pain. Chahine further noted, "While ibudilast is approved in Asia at doses up to 30 mg per day, we are encouraged that our U.S. Phase I trial will create a clear path towards further development of AV411 at higher doses which we believe may be optimal for the neurological applications we are pursuing."
"Early development experience with AV411 indicates that it has the potential to provide better tolerability with fewer side effects, like dependence, when compared to many treatments currently available for patients suffering from neuropathic pain," said Kirk Johnson, Ph.D., Avigen's Vice President of Research and Development. "In addition, the combination of data from our preclinical studies and an active IND in the U.S. better positions us for future clinical research in other unmet neurological conditions for which AV411 may be uniquely suited, including opioid withdrawal and dependence and chemotherapy-induced neuropathy."
"There is a clear need for new approaches to the treatment of neuropathic pain. The promise of glial attenuation and AV411 is encouraging," said Wendye Robbins, M.D., Clinical Assistant Professor, Stanford University School of Medicine. "A product that addresses the long-term needs of patients with this disabling affliction would be most welcome in this underserved market." Robbins is also the Chief Executive Officer of Limerick NeuroSciences, Inc. and a consultant to Avigen.
About the Study
In the study, normal male and female volunteers will be randomized into cohorts of escalating doses of orally administered delayed-release AV411 capsules or placebo control. As designed, the study may involve the dosing of up to 48 subjects and is intended to establish the maximum tolerated dose and the effect of a standard meal on the tolerability and pharmacokinetics of AV411 when compared to the same subjects under fasted conditions.
About AV411
AV411 is a first-in-class orally bioavailable small molecule glial cell attenuator. It down regulates neurological inflammation potentially via suppressing pro-inflammatory cytokines IL-1 beta, TNF alpha, and IL-6. It has other activities that are still being validated. While considered a New Chemical Entity in the United States and Europe, the drug was first approved in Japan for bronchial asthma over 15 years ago. The drug has been prescribed to over a million patients and has a good post-marketing safety profile in nearly 15,000 patients dosed at the prescribed doses. Avigen is currently conducting a Phase IIa study of AV411 in Australia for the treatment of diabetic neuropathic pain and was recently approved by the FDA to initiate a large Phase I clinical trial in the United States. Additional information on AV411 can be found on Avigen's website at http://www.avigen.com.
As part of its program to investigate glial attenuation as a novel approach for the treatment of neuropathic pain, Avigen discovered that AV411 (ibudilast) was efficacious in standard animal models of this condition. While ibudilast was initially developed as a non-selective phosphodiesterase inhibitor for the treatment of bronchial asthma, its efficacy in the treatment of neuropathic pain is not dependent on this activity. Based on its research, Avigen has filed for patents protecting the use of AV411 in multiple clinical indications and for patents on analogs of AV411 which the company believes have the potential to become effective second generation molecules.
About Neuropathic Pain
Neuropathic pain is one of the most challenging medical conditions to treat. It is an extremely complex pain state that is most often preceded by tissue injury, although the pain state can continue after the initial injury has healed. Nerve fibers may be damaged, dysfunctional or injured, and this in turn sends incorrect signals to other pain centers. It can be an excruciating burning sensation stimulated by a touch that would not normally be perceived as painful, or it can present as constant tingles. Neuropathic pain has a significant negative impact on quality of life.
The precise causes of neuropathic pain are unknown, but conditions associated with the development of neuropathic pain include diabetes mellitus, chemotherapy, shingles, HIV infection, and trauma. Patients are often prescribed non-steroidal anti-inflammatory drugs or NSAIDs, opioids, anticonvulsants, and/or antidepressants, but in many patients these are ineffective or only partially effective and can lead to systemic side effects. Other options are needed to improve outcomes for these patients.
The U.S. market for neuropathic pain treatments has been estimated to be approximately $1.5 billion.
About Avigen
Avigen is a biopharmaceutical company focused on developing and commercializing 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. 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 http://www.avigen.com.
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Statement under the Private Securities Litigation Reform Act
This press release contains forward-looking statements, which include, among others, statements relating to Avigen's intention of initiating U.S. clinical development of AV411; assessing safety and preliminary efficacy in its Australian Phase IIa study of AV411; assessing safety, tolerability, maximum dose, food effect, and sedation in the current United States Phase I trial; pursuing additional clinical research in neuropathic pain and opioid withdrawal and dependence in the United States; 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, 2007, 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 8, 2007.