Enormous Blockbuster Discovered in Interview With CRO

On July 26, 2012, I interviewed Yvonne Lungershausen, the Senior Director of Clinical Services for CPR Services, a Clinical Research Organization in Perth Australia with 25 years experience performing clinical trials and recognized by the FDA. The purpose of the interview was to learn as much from CPR Services as they could say about the results of the recent clinical trial of Ampion™. One hundred patients who were suffering from severe pain from osteoarthritis of the knees and who were anticipating scheduling knee replacement surgery were treated with only one injection of Ampion, a natural substance produced by the body to stop inflammation.

I was expecting to hear really good news about Ampion™ because the FDA recently held a Pre IND meeting with 18 of their expert staff members. The conclusion of the meeting was successful because the FDA experts were compelled by the data from the prior clinical trials and the FDA provided guidance for a pivotal phase III trial for Ampion™.
Again, I was expecting to hear good news about Ampion™ but what I heard instead was completely unexpected and as you will soon see, a huge surprise.

The first thing Lungershausen said was, “In terms of safety issues, there were none”. “There were no adverse events and I would say that Ampion had an exceptional safety profile”.

When I asked her if there were any surprises she replied, “Yes, CPR has been performing clinical trials for over 20 years.” “Some of them failed miserably . . . some were slightly positive . . . but Ampion has been amazingly positive.” In only a few hours after the injection, the results were not what anybody was expecting.  They were shocking. “Patients came in hobbling, limping and depressed from the severe pain, but after they received an injection of Ampion™, they were literally skipping and laughing.”

“One man was in so much pain that he was bedridden for most of the time but after he received one injection of Ampion™, he was able to put on his shoes and take his dog for a walk . . . something he was not able to do for five years. Another man who loved to ride bicycles was unable to ride any longer because of the extreme pain in his knees. He received one injection of Ampion™ and the next day he rode his bicycle 150 kilometers.

Another story is Norm Johnson who was in so much pain he was ready to schedule knee replacement surgery. Then he heard about the Ampion™ trial and thought he had nothing to lose so why not give it a go. Within one hour after receiving the injection, his pain was completely gone and he was able to walk pain free.  Six months later and he remains pain free and he can even be seen climbing up and down a steep ladder.  Mr. Johnson cancelled his plans for knee replacement surgery. Here is a short video from Channel 9 News about Mr. Johnson’s recovery. 

Lungershausen went on, “Patients were followed up in 30 days and then again at day 84 with pain questions and CT scans and the data just kept getting better and better”. “Patients describe Ampion™ as a miracle and want to be involved in future trials.”  "We were really surprised at how many patients want to be involved in the next trial" Our patients had both knees that were bad and the trial treated only one knee so naturally they want to fix the other knee."

Dr. David Bar-Or is the inventor of Ampion™ and also the Director of Research at two of Colorado’s three Level I Trauma Centers. During his 30-year tenure in Trauma Centers, he observed that brain swelling from severe head injuries stopped very quickly compared to most swelling and deduced that there must be some natural body mechanism that shuts down the immune response of inflammation. After examining the blood and cerebrospinal fluid of severe head trauma patients, he was able to isolate two naturally occurring amino acids and reproduce them as Ampion™. Dr. Bar-Or has developed several other promising drugs for diabetes and sexual dysfunction and is now working on his most exciting discovery; a promising drug for cancer that has demonstrated remarkable results.

Ampion™ is within less than 30 days from beginning phase III pivotal trials that are expected to be completed by Q2 2013 that if successful, could qualify for a clearance from the FDA in late 2013 or early 2014 to begin marketing Ampion™ to the 27 million osteoarthritis sufferers in the United States alone and eventually to even larger markets for tendonitis, arthritis and pain and even more.

With profund results like these, Ampion™ has a good potential to receive an FDA approval in 2013 and could be destined to become the best selling anti-inflammatory in history in a $60+ billion market.