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Avigen Cleared by FDA to Begin Gene Therapy Trial for Parkinson’s Disease

  August, 17 2004 5:52
your information resource in human molecular genetics
ALAMEDA, Calif., August 12, 2004 -- Avigen Inc., (Nasdaq: AVGN) today announced that the Food and Drug Administration (FDA) has authorized initiation of the Phase I-II clinical trial of AV201 for the treatment of Parkinson’s disease. "Mid-to late-stage Parkinson’s disease is by and large an untreated condition. AV201 has shown considerable promise as a treatment in animal models of Parkinson’s disease, and we are excited to be moving this product into the clinic," said Dawn McGuire, MD, Avigen’s Chief Medical Officer.

Parkinson’s disease (PD) is the second most common neurodegenerative disease, affecting an estimated two million individuals in the United States and Europe. It is characterized by tremor, stiffness, difficulty walking, loss of balance, and increasing dependence on others for basic daily activities.

Early on, Parkinson’s disease can be effectively treated with available medications, primarily levodopa (L-Dopa). After two to five years, however, L-Dopa typically becomes less effective, requiring higher doses to maintain benefit. Abnormal involuntary movements and other side effects often limit treatment at this stage of the disease.

Avigen’s AV201 is designed to restore the therapeutic effectiveness of L-Dopa by delivery of a human gene into the striatum of the brain that enables more efficient utilization of the drug. Administration of L-Dopa acts as an "on-off" switch for expression of the gene product, potentially adding to the safety of this novel approach to Parkinson’s disease.

"After years of encouraging preclinical results, I am gratified that Avigen will soon be able to bring this promising new treatment into human trials, thereby offering hope to the Parkinson’s patient community which can greatly benefit from better therapeutic alternatives," said Avigen’s President and Chief Executive Officer Kenneth Chahine, PhD, JD.

Patient and Physician Contact Information

Patients or physicians who would like more information should contact the Clinical Development Department at clinicaltrials@avigen.com or call at 1-877-4-AVIGEN (428-4436).

Additional information on Avigen’s proprietary gene delivery products can be found at www.avigen.com

About Avigen

Avigen, Inc., based in the San Francisco Bay Area, is committed to developing innovative therapeutics to treat serious disorders, primarily focused on neurological conditions.

Avigen’s proposed gene delivery products are designed for direct administration to patients in order to achieve expression of therapeutic proteins within the body. In addition to AV201 for the treatment of Parkinson’s disease, Avigen is also developing another promising neurological product candidate. AV333 is undergoing preclinical testing for the treatment of severe chronic pain, a very poorly managed condition resulting from a variety of disease states. AV333 represents an innovative approach to the treatment of unremitting pain, with demonstrated success in reversing neuropathic pain in established preclinical models. Furthermore, Avigen is actively seeking to broaden its portfolio of drug development candidates through an in-licensing program. This effort has identified several validated compounded that are being investigated, some of which are currently in human clinical trials.

Investors Please Note: The statements in this news release regarding Avigen’s expectations for the development of AV201, and the potential for in-licensing drug development candidates, are forward-looking statements. Actual results may differ materially from current expectations due to a variety of factors, including uncertainty in obtaining or maintaining approvals and authorizations required by regulatory or institutional authorities due to a number of possible reasons, including unanticipated responses to the treatment; the uncertainty of being able to in-license drug development candidates on terms advantageous to Avigen; and if Avigen is able to in-license drug development candidates, they may displace or take resources away from Avigen’s current drug development candidates. In addition, there are many other risks and uncertainties inherent in the development of drug products. Other risks relating to Avigen are detailed in Avigen’s Quarterly Report on Form 10-Q for the period ended June 30, 2004, under the caption "Risk Factors" in Item 2 of Part 1 of that report, which was filed with the SEC on August 9, 2004.


Copyright © 2004-Avigen.

Message posted by: Frank S. Zollmann

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