Ampio (Nasdaq:AMPE) Announces Positive Clinical Trial Results

Palm Beach, FL 6/11/12 (StreetBeat) -- Ampio Pharmaceuticals, Inc. (Nasdaq:AMPE), a clinical stage biopharmaceutical company, whose lead drugs treat inflammatory diseases, including osteoarthritis and complications of Diabetes Mellitus such as diabetic macular edema (and others) announced today that it's CRO has completed analysis of the primary end point in the Optina™ clinical trial for DME conducted at St Michael Diabetes Hospital in Toronto Canada.

Dr. David Bar-Or, Ampio's Chief Science Officer (CSO), explained "The primary end point for efficacy was central subfield retinal thickness as measured by Optical Coherence Tomography (OCT) and reported in microns. The study was double masked and included 32 patients with moderate to severe diabetic macular edema (range 316-707microns) that were treated orally with either placebo or one of three doses of Optina™. Central retinal thickness and retinal volumes were measured at baseline and at 4 and 12 weeks of treatment. The results confirm a significant interaction between the patient's body mass index (BMI) and efficacy at the different doses of Optina™. For higher BMI (BMI=35) patients, higher doses of Optina™ were more effective and for lower BMI (BMI=26) patients, lower doses were more effective. The improvement of efficacy by adjusting the dose to the BMI is in agreement with both in vitro data as well as with the known strongly lipophilic nature of Optina™. At one of the low doses, regardless of BMI, there was a reduction of the subfield central retinal thickness of approximately 20% at 4 and at 12 weeks, which was statistically significant from placebo for the higher BMI group (p = 0.01). The lowest dose of Optina™ showed a trend towards statistically significant reductions in central retinal thickness in the lowest BMI groups (p = 0.11 and p = 0.13) at 4 and 12 weeks, despite the small number of patients randomized to this dose.

Dr. Vaughan Clift, Ampio's Chief Regulatory Officer (CRO) further explained "These results are very important in the planning of our US trial as dose adjustments by body weight/BMI of Optina™ will be part of the trial design. Ampio has requested and received confirmation of a pre-IND meeting with the FDA on Optina™ for DME, which will take place in July 2012. That discussion will include complete analysis of the data including secondary end points."

Ampio's CEO, Michael Macaluso, noted "The company is meeting all of its clinical goals, right on schedule. In addition to this confirmed July pre-IND meeting with the FDA for Optina™,

• On May 10, 2012, the company completed a pre-IND meeting with the FDA where agreement was reached on the design of a US pivotal clinical trial for Ampion™ to treat osteoarthritis in the knee.
• On June 20, 2012, the company will have a pre-IND meeting with the FDA to review its proposed design of a US pivotal clinical trial for Zertane™ to treat premature ejaculation (PE) in men.

Reaching these critical milestones to commercialization for our two most important anti-inflammatory drugs (OptinaTM and AmpionTM) and our lead sexual dysfunction drug (ZertaneTM) in a three month time frame is a tribute not only to the quality of the drugs but to the hard work and competence of our clinical team"

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Ampio (Nasdaq: AMPE) says eye drug shows promise in trial

Orlando, FL 3/19/12 (StreetBeat) -- Ampio Pharmaceuticals Inc (Nasdaq: AMPE) said a mid-stage trial of its experimental drug to treat retinal swelling in diabetic patients was ended ahead of schedule based on positive interim data.

The company's drug Optina is being tested to treat diabetic macular edema -- the most prevalent cause of moderate vision loss in patients with diabetes.

Ampio said it plans to meet the U.S. Food and Drug Administration to decide the design of a late-stage trial, under section 505(b)2 regulation for repurposed drugs.

A 505(b)(2) application permits a company to obtain the FDA's approval by relying, in part, on the agency's findings for a previously approved drug, and thus reduces the time and development cost on the drug.

Optina is an oral ultra low dose of danazol, which was approved by the FDA in the 1970s for endometriosis -- a condition where cells from the uterus lining grow on other organs.

More recently, it was approved for a rare genetic disorder, hereditary angioedema, Ampio said.

Shares of the company closed at $2.68 on Friday on the Nasdaq.

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Ampio Pharmaceuticals Announces Agreement to Acquire Key Drug Delivery Technology

Palm Beach, FL 12/5/11 (StreetBeat) --Ampio Pharmaceuticals, Inc. (NASDAQ:AMPE), a company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"), today announced it has signed an agreement to acquire certain rights relating to a patented orally disintegrating tablet (ODT) drug delivery technology that can be used worldwide to elevate the market acceptance of Ampio's Zertane™ product for premature ejaculation. The Zertane™ ODT formulation allows for rapid oral absorption, ease of use without the need for liquids and avoids unpleasant bitter taste. This acquisition provides additional intellectual property to protect Zertane™ ODT's unique formulation, over and above the many method of use claims for Zertane™ contained in patents Ampio already owns.

The Company indicated that acquisition of the rights to this technology is expected to speed and facilitate Ampio's filing of marketing authorization applications for product regulatory approvals of Zertane™ worldwide and is important for the additional planned licensing and pricing agreements currently in negotiations. The completion of the transaction is subject to customary conditions, including a certain third party consent and successful completion of a technology and materials transfer plan more fully described in a Form 8-K to be filed shortly.

"This acquisition of this technology is an important step in the manufacturing and commercialization plan for Zertane™. This agreement demonstrates our commitment to the fast and successful launch of a unique dosage and formulation of Zertane™. The Zertane™ commercialization plan is on course as outlined in the previous press releases and securities filings. We are committed to complete the development of a combination product of Zertane™ with a PDE5 inhibitor to simultaneously treat both premature ejaculation and erectile dysfunction. Our strategy with this line of products is to expeditiously pursue multiple licensing partners worldwide." stated Don Wingerter , Ampio's CEO.

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