Healthcare Industry News: metabolic disease
News Release - May 11, 2012
Ampio Pharmaceuticals Reports Pre-IND Meeting With the FDA to Obtain Clinical Path Guidance for Ampion(TM) for the Treatment of Chronic Pain of Osteoarthritis of the Knee and Schedules May 16th Webcast to Update ShareholdersGREENWOOD VILLAGE, Colo., May 11, 2012 -- (Healthcare Sales & Marketing Network) -- Ampio Pharmaceuticals, Inc. (AMPE), a biopharmaceutical company conducting clinical trials on its three lead drugs (Ampion™, Optina™ and Zertane™) announced completion of a pre-IND meeting with the Center for Biological Evaluation and Research (CBER) division of the FDA that took place on May 10th regarding Ampio's lead biologic, Ampion™ for the chronic treatment (repeat injections) of pain in osteoarthritis (OA) of the knee.
The purpose of the meeting with CBER was to obtain guidance for the clinical path to a Biologics License Application (BLA) for Ampion™ for OA of the knee in the US and clarity as to the steps necessary for Investigational New Drug (IND) submission. The discussions included manufacturing criteria and the scope and design of the phase III trial(s).
Michael Macaluso, Ampio's CEO, noted, "The Company agreed with all the guidance for Ampion™ provided by CBER and believes the regulatory path described is both reasonable and manageable by the Company. The results of these trials (two phase III, well conducted, placebo controlled trials, run concurrently) will form the basis for a BLA submission. The scope and design of these studies will be available in our IND submission."
The Company will hold a webcast on Wednesday, May 16, 2012 at 4:15 EDT to present a 30-minute overview of the Company's progress and future plans and then open the call to a Q & A session. A press release on May 14th will describe how the shareholders and the general public can join and listen to the call.
Ampion™, a molecule protected by a composition of matter and use patents, is naturally produced by humans in response to injury and is present in commercial human serum albumin (HSA) preparations.
Ampion™ is a non-steroidal anti-inflammatory drug that appears to have a significant role in the homeostasis of inflammation, so may have potential to treat a broad array of inflammatory conditions, which impact millions of patients.
Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for metabolic disease, eye disease, kidney disease, inflammation, CNS disease, and male sexual dysfunction. The product pipeline includes new uses for previously approved drugs and new molecular entities ("NMEs"). By concentrating on development of new uses for previously approved drugs, approval timelines, costs and risk of clinical failure are reduced because these drugs have strong potential to be safe and effective while their shorter development times can significantly increase near term value. A key strategy includes actively exploring partnership, licensing and other collaboration opportunities to maximize Ampio's product development programs. For more information about Ampio, please visit our website, www.ampiopharma.com.
Ampio's statements in this press release that are not historical fact and that relate to future plans or events are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by use of words such as "believe," "expect," "plan," "anticipate," and similar expressions These forward-looking statements include risks associated with clinical trials, expected results, regulatory approvals, successful commercialization and marketing of Zertane™ and the combination drug in Korea, and changes in business conditions and similar events. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including Ampio's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
Source: Ampio Pharmaceuticals
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