- Open label portion of the STRUT study:
Seven (7) patients with moderate to severe osteoarthritis of the knee. We previously announced the favorable results of the primary and secondary endpoints (WOMAC A for pain, WOMAC B for stiffness and WOMAC C for function) at week 6 and at week 12. https://finance.yahoo.com/news/ampio-announces-results-open-label-200200453.html The 20-week data is expected in the fourth quarter of 2014.
- STRUT Study:
All 40 patients with severe osteoarthritis of the knee received either 3 intra-articular injections of Ampion™ or saline into the knee in this double blinded, placebo controlled study (1:1 randomization). The primary and secondary endpoints (WOMAC A for pain, WOMAC B for stiffness and WOMAC C for function) results at 20 weeks (end of FDA study) will be available in the first quarter of 2015. The study will however continue to 52 weeks to evaluate cartilage markers both by MRIs and synovial fluid proteomics.
- STRIDE Study:
All 320 patients have been enrolled and received at least the first injections in this double blinded, placebo controlled study (1:1 randomization). This study follows the same protocol as the STRUT study but without MRIs. This study is being conducted in 14 sites in the USA. The STRIDE study will conclude in the second quarter of 2015.”
Magnetic Resonance Imaging (MRI) and Proteomic Analysis
Dr. David Bar-Or, Ampio’s Chief Science Officer explained “The significant clinical improvement in all three WOMAC Scores including stiffness, clearly indicate that something valuable is happening in the joint.
“In order for us to fully understand and be able to report on the precise cause of this reduction in pain and stiffness experienced by the patients, the study includes proteomic assessment of synovial fluid and serum markers of cartilage growth. The results from the seven (7) patients in the open label study are being carefully analyzed by experts in tissue regeneration, including members of Ampio’s Scientific Advisory Board and the decision has been made to expand the analysis to include the forty (40) patients in the full STRUT study in order to provide more data to evaluate.”
Dr. Bar-Or continued, “As there has been significant interest by our shareholders in the MRI analysis, a more detailed explanation of the complexity of this analysis is provided.”
“First, It is important to note that the MRI has not previously been shown (in studies by others) able to resolve changes indicating progression of this disease in short time frames like 12 weeks. MRIs were also performed at 20 weeks. These MRI’s are being reviewed and analyzed by experts in the field. Almost all studies examining the changes produced by osteoarthritis in the knee are 12 to 24 months in duration. However, it was considered worthwhile to begin the process early to see if changes at 12 weeks could indicate the most valuable parameters to follow. Because of the complexities in analyzing the physical signals as well as proper timing in relation to the various compartments evaluated, the complete results and conclusions were not made available to the company as yet.
“The imaging protocol used was based on prolonged prospective trials published in the literature for the OsteoArthritis Initiative. The images were created without contrast. Sagittal, coronal and axial fat-suppressed proton density, coronal T1, sagittal fat-suppressed 3-D DESS sequences were performed using a 3 Tesla magnet. However, the resolution of MRI, even with the 3 Tesla magnet, is insufficient to provide much clarity at 12 weeks. However, it is indicating the specific parameters, such as medial compartment cartilage thickness, that we need to follow.”
“This MRI study was not designed to show improvements in the mechanical strength of the cartilage, which could also explain the clinical findings. The ongoing STRUT study has a primary endpoint of 20 weeks and will follow the patients for 52 weeks. With 40 patients rather than 7, the addition of a placebo control and the greater duration we are hopeful we will be able to quantify the observed changes properly.”
“We have also learned that, prior to Ampion™, no therapy has produced sufficient clinical improvement to determine which parameters are the important ones to study. The MRI data to date is suggesting that certain areas in the joint are changing greater than others but it is important to look at each compartment separately.”
“Some patients have disease predominantly in the medial compartment whereas others have more disease in the lateral compartment or more symmetrically. The 7 patient data has suggested that we need to compare medial compartment disease to appropriately matched placebo controls. We are now reviewing the saline control MRI patients from the STEP study. We hope to be able to identify matched patients with similar compartment disease and use them as a “untreated comparison” to guide the 40 patient placebo controlled phase.”
OPTINA™ for Diabetic Macular Edema:
This OptimEyes study is complete and included 355 patients. The data is being locked by our CRO. Once data validation is completed, it will be transmitted to an independent statistician for analysis and afterward submitted to the FDA for review with our request for a meeting. Considering the Holidays are near, we anticipate meeting with the FDA following the holidays. At that time we will report the findings and FDA guidance. Should the data fall short of our expectations we will issue a press release immediately.
Manufacturing validation runs are on schedule. Multiple engineering runs were performed and commercial Ampion™ vials will be manufactured in the first quarter of 2015.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a clinical trial stage biopharmaceutical company primarily focused on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. We are developing compounds that decrease inflammation by (i) inhibiting specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level; (ii) activating specific phosphatase or depletion of the available phosphate needed for the inflammation process; and (iii) decreasing vascular permeability.
Forward Looking Statements
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 statements regarding Ampio’s expectations with respect to the completion, timing and size of the registered direct offering, as well as 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 without limitation, under Ampio’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.
Ampio Pharmaceuticals, Inc.
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