GREENWOOD VILLAGE, Colo., Nov. 10, 2011 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) ("Ampio" or the "Company"), a company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"), today announced that an IRB approved, randomized, vehicle-controlled, double-blinded study conducted at Centers for Allergy and Asthma in Denver, Colorado indicates that Ampion™ provides safe and effective anti-inflammatory relief when administered intranasally to patients with nasal inflammation.
According to Dr. David Bar-Or, Chief Science Officer of Ampio, "Twenty patients were randomized to receive either intranasal Ampion™, or saline, twice a day during a 10 day double-blind period which followed a one week washout period. The subjects reported reflective total nasal symptom scores (rTNSS) as well as instantaneous total nasal symptom scores (iTNSS) every 12 hours. A trend of improvements in rTNSS was observed in the intranasal Ampion™ group over the saline group. When stratifying patients by baseline severity of symptoms, Ampion™ was found to have greater efficacy in the moderately symptomatic patients (mean baseline rTNSS less than 7.5) and despite the limited number of patients in this stratum the difference between saline and Ampion™ reached statistical significance (p=0.045).
Dr. Vaughan Clift, Chief Regulatory Officer of Ampio, noted, "This trial is an important clinical milestone for the company as it is the first time that Ampion™ was administered as a stand-alone treatment for an inflammatory condition in humans and was well tolerated with no reported treatment related adverse events. This study expands the investigation of the anti-inflammatory mechanism of action for Ampion™ in our Ampion™-in-Knee (AIK) trial conducted in Australia as reported on October 26, 2011. This initial AIK study required the addition of a "standard of care" steroid in each arm as it was the first use of Ampion™ in humans. The absence of any adverse events in the initial AIK study provided the basis for IRB approval of the present intranasal trial in the USA as well as for the direct intra-articular comparison of Ampion™ to steroid in an expanded osteoarthritis of the knee trial in Australia, the results of which are expected early next year."
Dr. Clift further noted, "It is gratifying to accumulate proof of efficacy in the treatment of inflammatory conditions in humans with an already established safety record. Both the Australian and USA clinical trials will help us determine the study methods and choose the particular inflammatory condition to pursue for a pivotal clinical trial in the US and determine the number of patients required to achieve statistical significance."
Ampion™ is 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. Because HSA and blood derived products are currently managed by the Center for Biologics Evaluation and Research division of the FDA, Ampio believes this product will be classified as a biologic.
Ampion™ is a non-steroidal anti inflammatory drug that appears to have a significant role in the homeostasis of inflammation, so that it has the potential to be used in 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, 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.
Contact: -- Investor Relations --
Ampio Pharmaceuticals, Inc.-- 720-437-6500
|SOURCE Ampio Pharmaceuticals, Inc.|
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