|By PR Newswire||
|November 14, 2012 04:01 AM EST||
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.
"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™ 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™ 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.
Oxidation-reduction potential (ORP)
ORP is a point of care diagnostic platform developed by Ampio for multiple indications. The platform technology includes a specifically designed, battery operated, instrument-reader and of disposable electrodes/ strips- a concept analogous to a glucometer and its disposable strips. ORP is a homeostatic parameter reflecting the balance between pro and anti-oxidants in a system (it is a measure of electron transfer). An elevated blood ORP indicates increased oxidative stress.
- Ampio has just been awarded two USA patents for the disposable electrodes and multiple additional patents are pending worldwide on various aspects of the program including use patents and others. Other patented measured and calculated parameters indicate reductive reserves, meaning how much anti-oxidant reserve does a patient have before oxidative stress starts damaging important biological structures and molecules.
- Ampio entered into a manufacturing contract with UHV (San Jose, CA) for the manufacture of the single-use disposable electrodes and the instrument/reader is in its final stages of development/assembly.
- Multiple clinical studies have been completed (thousands of patients) encompassing the many potential indications for this platform technology and are awaiting final analysis and publication of results. Ampio will focus the initial clinical indication to the best obtained results from these extensive clinical studies.
- Ampio believes the ORP device will be cleared by the FDA under a 510(k).
- Ampio anticipates spinning-off this program into a separately financed entity.
Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for inflammation, eye disease, kidney disease, CNS disease, metabolic 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.
Contact: Rick Giles, Investor Relations, Ampio Pharmaceuticals, Inc. 720-437-6500
SOURCE Ampio Pharmaceuticals, Inc.
"We are an all-flash array storage provider but our focus has been on VM-aware storage specifically for virtualized applications," stated Dhiraj Sehgal of Tintri in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 9, 2016 04:30 AM EST Reads: 1,023
Redis is not only the fastest database, but it has become the most popular among the new wave of applications running in containers. Redis speeds up just about every data interaction between your users or operational systems. In his session at 18th Cloud Expo, Dave Nielsen, Developer Relations at Redis Labs, shared the functions and data structures used to solve everyday use cases that are driving Redis' popularity.
Dec. 9, 2016 04:15 AM EST Reads: 3,516
The WebRTC Summit New York, to be held June 6-8, 2017, at the Javits Center in New York City, NY, announces that its Call for Papers is now open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 20th International Cloud Expo and @ThingsExpo. WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web co...
Dec. 9, 2016 04:15 AM EST Reads: 1,439
Enterprise IT has been in the era of Hybrid Cloud for some time now. But it seems most conversations about Hybrid are focused on integrating AWS, Microsoft Azure, or Google ECM into existing on-premises systems. Where is all the Private Cloud? What do technology providers need to do to make their offerings more compelling? How should enterprise IT executives and buyers define their focus, needs, and roadmap, and communicate that clearly to the providers?
Dec. 9, 2016 04:00 AM EST Reads: 558
Amazon has gradually rolled out parts of its IoT offerings, but these are just the tip of the iceberg. In addition to optimizing their backend AWS offerings, Amazon is laying the ground work to be a major force in IoT - especially in the connected home and office. In his session at @ThingsExpo, Chris Kocher, founder and managing director of Grey Heron, explained how Amazon is extending its reach to become a major force in IoT by building on its dominant cloud IoT platform, its Dash Button strat...
Dec. 9, 2016 04:00 AM EST Reads: 6,335
"We are a custom software development, engineering firm. We specialize in cloud applications from helping customers that have on-premise applications migrating to the cloud, to helping customers design brand new apps in the cloud. And we specialize in mobile apps," explained Peter Di Stefano, Vice President of Marketing at Impiger Technologies, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 9, 2016 03:30 AM EST Reads: 464
Complete Internet of Things (IoT) embedded device security is not just about the device but involves the entire product’s identity, data and control integrity, and services traversing the cloud. A device can no longer be looked at as an island; it is a part of a system. In fact, given the cross-domain interactions enabled by IoT it could be a part of many systems. Also, depending on where the device is deployed, for example, in the office building versus a factory floor or oil field, security ha...
Dec. 9, 2016 03:00 AM EST Reads: 380
In addition to all the benefits, IoT is also bringing new kind of customer experience challenges - cars that unlock themselves, thermostats turning houses into saunas and baby video monitors broadcasting over the internet. This list can only increase because while IoT services should be intuitive and simple to use, the delivery ecosystem is a myriad of potential problems as IoT explodes complexity. So finding a performance issue is like finding the proverbial needle in the haystack.
Dec. 9, 2016 02:15 AM EST Reads: 6,229
The idea of comparing data in motion (at the sensor level) to data at rest (in a Big Data server warehouse) with predictive analytics in the cloud is very appealing to the industrial IoT sector. The problem Big Data vendors have, however, is access to that data in motion at the sensor location. In his session at @ThingsExpo, Scott Allen, CMO of FreeWave, discussed how as IoT is increasingly adopted by industrial markets, there is going to be an increased demand for sensor data from the outermos...
Dec. 9, 2016 02:00 AM EST Reads: 3,047
"Qosmos has launched L7Viewer, a network traffic analysis tool, so it analyzes all the traffic between the virtual machine and the data center and the virtual machine and the external world," stated Sebastien Synold, Product Line Manager at Qosmos, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 9, 2016 01:45 AM EST Reads: 987
Between 2005 and 2020, data volumes will grow by a factor of 300 – enough data to stack CDs from the earth to the moon 162 times. This has come to be known as the ‘big data’ phenomenon. Unfortunately, traditional approaches to handling, storing and analyzing data aren’t adequate at this scale: they’re too costly, slow and physically cumbersome to keep up. Fortunately, in response a new breed of technology has emerged that is cheaper, faster and more scalable. Yet, in meeting these new needs they...
Dec. 9, 2016 01:45 AM EST Reads: 1,955
When it comes to cloud computing, the ability to turn massive amounts of compute cores on and off on demand sounds attractive to IT staff, who need to manage peaks and valleys in user activity. With cloud bursting, the majority of the data can stay on premises while tapping into compute from public cloud providers, reducing risk and minimizing need to move large files. In his session at 18th Cloud Expo, Scott Jeschonek, Director of Product Management at Avere Systems, discussed the IT and busin...
Dec. 9, 2016 01:15 AM EST Reads: 3,977
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at 20th Cloud Expo, Ed Featherston, director/senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Dec. 9, 2016 01:15 AM EST Reads: 1,660
More and more companies are looking to microservices as an architectural pattern for breaking apart applications into more manageable pieces so that agile teams can deliver new features quicker and more effectively. What this pattern has done more than anything to date is spark organizational transformations, setting the foundation for future application development. In practice, however, there are a number of considerations to make that go beyond simply “build, ship, and run,” which changes how...
Dec. 9, 2016 12:45 AM EST Reads: 5,120
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, discussed how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team at D...
Dec. 9, 2016 12:45 AM EST Reads: 1,211