|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.
Software is eating the world. Companies that were not previously in the technology space now find themselves competing with Google and Amazon on speed of innovation. As the innovation cycle accelerates, companies must embrace rapid and constant change to both applications and their infrastructure, and find a way to deliver speed and agility of development without sacrificing reliability or efficiency of operations. In her Day 2 Keynote DevOps Summit, Victoria Livschitz, CEO of Qubell, discussed...
May. 4, 2015 06:00 AM EDT Reads: 4,692
Shipping daily, injecting faults, and keeping an extremely high availability "without Ops"? Understand why NoOps does not mean no operations. Agile development methodologies require evolved operations to be successful. In his keynote at DevOps Summit, David Tesar, Microsoft Technical Evangelist on Microsoft Azure and DevOps, will discuss how Microsoft teams who have made huge progress with a DevOps transformation effectively utilize operations staff and how challenges were overcome. Regardless ...
May. 4, 2015 05:00 AM EDT Reads: 788
SYS-CON Events announced today that AIC, a leading provider of OEM/ODM server and storage solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. AIC is a leading provider of both standard OTS, off-the-shelf, and OEM/ODM server and storage solutions. With expert in-house design capabilities, validation, manufacturing and production, AIC's broad selection of products are highly flexible and are conf...
May. 4, 2015 03:45 AM EDT Reads: 5,736
SYS-CON Events announced today that Vicom Computer Services, Inc., a provider of technology and service solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. They are located at booth #427. Vicom Computer Services, Inc. is a progressive leader in the technology industry for over 30 years. Headquartered in the NY Metropolitan area. Vicom provides products and services based on today’s requirements...
May. 4, 2015 02:00 AM EDT Reads: 2,424
SYS-CON Events announced today that Blue Box has been named “Bronze Sponsor” of SYS-CON's DevOps Summit New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. Blue Box delivers Private Cloud as a Service (PCaaS) to a worldwide customer base. Built on a technology platform leveraging decades of operational expertise in cloud and distributed systems, Blue Box Cloud is a managed private cloud product available in both hosted and on-prem versions. Each Blue Box ...
May. 4, 2015 01:00 AM EDT Reads: 1,915
Many of the well-known examples of DevOps success we read in blogs on the Internet paint an idyllic picture of DevOps productivity. A team was facing a stodgy, slow-moving operations department, teams weren’t delivering software on time. Those teams moved to DevOps, became proactive about infrastructure and deployment automation, and an overnight transition to productivity ensues. People are promoted, projects are successful, and developers and system administrators dance hand-in-hand in a final...
May. 3, 2015 10:15 PM EDT Reads: 1,869
Enterprise IoT is an exciting and chaotic space with a lot of potential to transform how the enterprise resources are managed. In his session at @ThingsExpo, Hari Srinivasan, Sr Product Manager at Cisco, will describe the challenges in enabling mass adoption of IoT, and share perspectives and insights on architectures/standards/protocols that are necessary to build a healthy ecosystem and lay the foundation to for a wide variety of exciting IoT use cases in the years to come.
May. 3, 2015 03:00 PM EDT Reads: 1,148
SYS-CON Events announced today that Secure Infrastructure & Services will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY, and the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Secure Infrastructure & Services (SIAS) is a managed services provider of cloud computing solutions for the IBM Power Systems market. The company...
May. 3, 2015 03:00 PM EDT Reads: 986
SYS-CON Events announced today that CenturyLink, Inc., a leader in the network services market, has been named “Platinum Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. CenturyLink is the third largest telecommunications company in the United States and is recognized as a leader in the network services market by technology industry analyst firms. The company is a global leader in cloud infrastructure and ...
May. 3, 2015 02:30 PM EDT Reads: 1,074
Docker is becoming very popular--we are seeing every major private and public cloud vendor racing to adopt it. It promises portability and interoperability, and is quickly becoming the currency of the Cloud. In his session at DevOps Summit, Bart Copeland, CEO of ActiveState, discussed why Docker is so important to the future of the cloud, but will also take a step back and show that Docker is actually only one piece of the puzzle. Copeland will outline the bigger picture of where Docker fits a...
May. 3, 2015 02:15 PM EDT Reads: 5,169
SYS-CON Events announced today the DevOps Foundation Certification Course, being held June ?, 2015, in conjunction with DevOps Summit and 16th Cloud Expo at the Javits Center in New York City, NY. This sixteen (16) hour course provides an introduction to DevOps – the cultural and professional movement that stresses communication, collaboration, integration and automation in order to improve the flow of work between software developers and IT operations professionals. Improved workflows will res...
May. 3, 2015 12:30 PM EDT Reads: 3,243
Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 16th Cloud Expo at the Javits Center in New York June 9-11 will find fresh new content in a new track called PaaS | Containers & Microservices Containers are not being considered for the first time by the cloud community, but a current era of re-consideration has pushed them to the top of the cloud agenda. With the launch ...
May. 3, 2015 12:00 PM EDT Reads: 3,739
A new definition of Big Data & the practical applications of the defined components & associated technical architecture models This presentation introduces a new definition of Big Data, along with the practical applications of the defined components and associated technical architecture models. In his session at Big Data Expo, Tony Shan will start with looking into the concept of Big Data and tracing back the first definition by Doug Laney, and then he will dive deep into the description of 3V...
May. 3, 2015 12:00 PM EDT Reads: 978
As cloud gives an opportunity to businesses to buy services externally – how is cloud impacting your customers? In his General Session at 15th Cloud Expo, Fabio Gori, Director of Worldwide Cloud Marketing at Cisco, provided answers to big questions: Do you see hybrid cloud as where the world is going? What benefits does it bring? And how does Cisco connect all of these clouds? He also discussed Intercloud and Cisco’s investment on it.
May. 3, 2015 12:00 PM EDT Reads: 4,997
SYS-CON Events announced today that B2Cloud, a provider of enterprise resource planning software, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. B2cloud develops the software you need. They have the ideal tools to help you work with your clients. B2Cloud’s main solutions include AGIS – ERP, CLOHC, AGIS – Invoice, and IZUM
May. 3, 2015 12:00 PM EDT Reads: 4,370