Healthcare Industry News: compounding
News Release - December 19, 2006
Neurorecovery, Inc. Updates Clinical Development Program for Guillain-Barré Syndrome (GBS)
MEMPHIS, Tenn., Dec. 19 (HSMN NewsFeed) -- Neurorecovery, Inc. (NRI) a biopharmaceutical company focused on treatments for peripheral neuropathies provides an update on the clinical development plan for GBS. On December 14, 2005, NRI had a meeting with the Neuro-Pharm Division of the United States (U.S.) Food and Drug Administration (FDA). The objective of the meeting was to review the Phase IIa and Phase IIb (Part 1) clinical trial results and to obtain regulatory approval to initiate an NRI funded Phase IIb - (Part 2) clinical trial. The outcome of the meeting was that NRI received a regulatory pathway to move into a Phase III clinical trial. Our proposed indication is 4-Aminopyridine (4-AP) for the treatment of chronic functional motor and sensory deficits resulting from Guillain-Barre Syndrome (GBS).Dr. Jay Meythaler, head of NRI's Scientific Advisory Board, commented, "We are very excited to move into a Phase III pivotal trial for our version of 4- Aminopyridine, Ampydin (IR), for the treatment of chronic functional motor and sensory deficits resulting from Guillain-Barre Syndrome. NRI's mission is to improve the functionality of patients suffering from peripheral neuropathies and this announcement supports our mission to help patients suffering from GBS."
Mr. Edward Labry, Chairman of NRI, commented, "We are encouraged by what we believe was a very positive meeting with the FDA and we will move forward with their recommendations. NRI received a regulatory pathway to move into a Phase III trial and this announcement significantly enhances the development schedule of Ampydin (IR). This is a major milestone for Neurorecovery."
About Neurorecovery Incorporated. NRI is a biopharmaceutical company focused on treatments for peripheral neuropathies. Our lead product, Ampydin (IR), is an immediate release version of 4-Aminopyridine, or 4-AP. 4- Aminopyridine is currently on the FDA's compounding for compassionate use list for treatment of certain neuropathies and for spinal cord injury and MS. NRI is moving into a Phase III clinical trial with the proposed indication of 4- Aminopyridine for the treatment of chronic functional motor and sensory deficits resulting from Guillain-Barre Syndrome. The Phase IIa trial was partially funded by the National Institute of Disability, Rehab and Rehabilitation (NIDRR), and the Phase IIb trial was funded by a grant from the FDA Orphan Drug Office. We are a Delaware Corporation headquartered in Memphis, Tennessee.
Cautionary Note Regarding Forward-Looking Statements. This press release contains forward-looking statements that reflect Neurorecovery's current expectations about its prospects and opportunities, including, without limitation, expectations regarding Ampydin (IR) and its other products. Neurorecovery has tried to identify these forward-looking statements by using words such as "plans," "believes," "expects," "anticipates," "will," "should" or similar expressions, but these words are not the exclusive means for identifying such statements. Neurorecovery cautions that a number of risks, uncertainties, and other important factors could cause Neurorecovery's actual results, performance or achievements to differ materially from those expressed in, or implied by, these forward-looking statements. Drug development and commercialization involves a high degree of risk including the risk of unfavorable results from future studies of Ampydin (IR), delays in obtaining or failure to obtain FDA approval of Ampydin (IR), the ability to obtain additional financing to support Neurorecovery's operations, competition from the biotech and pharmaceutical industries, failure to protect its intellectual property or to defend against the intellectual property claims of others and other unexpected events.
Neurorecovery undertakes no obligation to update or revise any forward- looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially and investors should not place undue reliance on these statements. Neurorecovery disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
Source: Neurorecovery
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