Ampio Provides Progress Report On Clinical Programs In Preparation For Annual Shareholders Meeting

GREENWOOD VILLAGE, Colo., Nov. 14, 2012 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (AMPE), a biopharmaceutical company developing repurposed drugs and new molecular entities (NMEs) that treat inflammatory diseases, including osteoarthritis, diabetic macular edema (DME) and sexual dysfunction is providing this update on its recent activities ahead of its scheduled shareholder meeting that will take place on December 15, 2012. 

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"Our goal is to commercialize our extensive drug and patent portfolio to the benefit of our shareholders," said Michael Macaluso, CEO. "We are now entering the pivotal clinical trial phase for the three drugs and one diagnostic device which have most near term promise and will soon either be licensed, sold, partnered or directly distributed by Ampio. Once this is accomplished, we will move up other drugs from our pipeline into the development phase."

The update is as follows:

Ampion™

Ampion™ is a unique anti-inflammatory biologic being developed for the treatment of osteoarthritis of the knee.

• Ampio entered into a manufacturing agreement with Sypharma ( Australia) for the production of Ampion™ for intra articular injection. The initial production run was completed and the stability-testing program, conducted in parallel to the clinical trials, is underway.
• Ampio has recently met with the CBER division of the FDA and received guidance for the conduct of pivotal trials for approval in the USA. Both open label and placebo controlled trials will be conducted over the next year to provide the full 1,500 patient exposure for safety and clinical efficacy data.  The recent FDA discussions have indicated that if the results of these trials mirror the successful outcomes seen in the Australian trials it will be sufficient for registration as a chronic use therapy and an IND is being prepared.
• Multiple sites for the conduct of the trials have been identified and several CRO proposals were received and are being evaluated.
• Ampio has an extensive portfolio of patents for Ampion™ and expects additional patents to be awarded, worldwide that encompass composition of matter, uses and synthesis patents.

Optina™

Optina™ is an orally administered ultra-low dose of danazol for the treatment of diabetic macular edema (DME).

• A phase 2a clinical trial conducted in Canada demonstrated encouraging results.
• Scientific, peer-reviewed manuscripts, on the mechanism of action of the Optina™ were recently published in BBRC (Biochem Biophys Res Commun. 2012 May 18;421(4):707-12) and as a cover story was published in Retina Today ( October 2012 issue).
• Ampio has obtained the active ingredient, danazol, for the Optina clinical trial from CIPLA ( Mumbai, India).
• Ampio entered into a contractual agreement for the formulation of Optina™ with Green Mountain ( Denver, Colorado) to produce the ultra-low doses of Optina™, which will be used in the forthcoming phase 2b clinical trials in the USA and elsewhere. The trials will be conducted under a 505(b)2 pathway in adherence to  guidance provided by the FDA at a pre-IND meeting and an IND application is being prepared.
• Ampio will conduct pivotal trials in Europe (sites identified) for this indication.
• Ampio was recently awarded multiple patents both in the USA and worldwide for Optina™.
• Ampio is engaged in discussions with potential partners for Optina™.

Sexual Dysfunction drugs

This program includes Zertane™, for the treatment of premature ejaculation (PE), and Zertane ED™, for the treatment of comorbid premature ejaculation and erectile dysfunction (ED).

• Ampio has completed two phase 3 clinical trials in Europe on Zertane™.
• Ampio is poised to file an IND for pivotal trials under the 505(b)2 pathway in the USA adhering to the guidance provided by the FDA during our Pre-IND meeting.
• Ampio has identified sites to conduct its pivotal trials in the USA.
• Ampio will be filing for approval of Zertane™, based on the European trials results, in Australia (TGA). Approval in Australia will facilitate approval in many countries in Latin America and the Pacific Rim where we have already licensed Zertane™.
• Ampio has secured a manufacturing agreement with Ethypharm ( France) to produce the ODT formulation of Zertane™, which will be used for the pivotal trials in the USA.
• Ampio entered into a contract with Syngene ( Bangalore, India) to manufacture Zertane ED™, which will be used in clinical trials in South Korea, in compliance with FDA standards, by its partner/licensee Daewoong.
• Ampio was awarded multiple US and international patents on Zertane™ and was recently awarded patents on the combination treatment for PE and ED (as well as patents for the reduction of potential side effects of tramadol) in China, Europe and multiple other countries.
• Ampio has secured licenses in Brazil and S. Korea for these drugs and is currently in discussions with potential global partners.
• Ampio has contracted Pharmerit, Inc. ( Cambridge, MA) to complete the development of the Patient Outcome for Premature Ejaculation (POPE) patient reported outcome (PRO) tool for the evaluation of premature ejaculation therapy. When completed in the next few weeks this will be the only validated PRO tool for PE in the FDA environment.  The completion of the POPE trial will allow Ampio to file the IND in the USA and conclude its negotiations with pharmaceutical partners.

Methyl Phenidate derivative

NCE-001 was selected from a class of compounds belonging to analogues of methyl phenidates synthesized and patented by Ampio. In vitro experiments have demonstrated beneficial effects of NCE-001 on several cancer cell lines as well as on angiogenesis and inflammation cell models. The mechanism of action appears to be novel and will be published in peer reviewed journals.

• Ampio was awarded composition of matter patents as well as use patents worldwide for this compound and for several other analogues.
• Ampio recently entered into a preclinical development agreement for this lead compound with Syngene ( Bangalore, India).
• The initial selected indications to be developed in this preclinical phase will be for cancer in the orphan drug category and for neuroinflammatory conditions such as Alzheimer's disease.
• It is anticipated that this preclinical phase up to an IND filing will be completed in approximately 14 months.

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