Ever since December 2011, when two negative articles sent shares of Ampio Pharmaceuticals (NASDAQ:AMPE) tumbling from almost $8.00 to $2.54 in only a few months, Ampio has been surrounded in controversy with strong opinions voiced from both the visionary bulls and the disbelieving bears. One minute shares are rising on a company press release that appears to be good news for shareholders and a few minutes later a negative article surfaces disputing the good news and shares quickly tank.
Perhaps it is because Ampio is almost too good to be true and because it has been developing several promising drugs in record time and at record low cost. In less than three short years the company has positioned three potential blockbusters for FDA approval and all three are in the final stages of demonstrating success or failure. Ampio's destiny is about to be revealed in this last few months of 2013.
Ampio's pipeline that accounts for the stocks uptrend over the past year consists of Ampion, Optina, Zertane, Vasaloc, Zertane ED, Oxidation Reduction Potential diagnostic and NCE 001. Additionally, the company owns a treasure chest of over 100 compounds to draw from for future development.
Ampion is a novel anti-inflammatory for a large number of indications, but it's first use is to treat osteoarthritis of the knee. There are close to 27 million Americans suffering from osteoarthritis and there is no effective treatment other than joint replacement. Of the current anti-inflammatories offered to treat osteoarthritis patients, every single one has serious adverse side effects, and not even one is reasonably effective. Ampion is a biologic that has a known safety record of over forty years as Human Serum Albumin. Based on recently announced results of Ampion's Spring Trial of 329 patients, Ampion effectively treated osteoarthritis of the knee and equally important demonstrated no adverse side effects. The final 12 week leg of the Ampion Phase III trial is underway or close to being underway and it would be very surprising if results did not match the same positive results of the Phase II trial and the Phase III Spring trial. If Ampion continues to perform as it has in the past, and if it receives FDA approval, it is clearly destined to become the dominant treatment in the $65 billion anti-inflammatory market. What could that do to a company's share price with only 45 million shares fully diluted.
Prior results from Ampion's Phase II trial were so compelling that the FDA was inspired last year to assemble a large panel of 18 of their leading experts to provide Ampio with guidance for the trials currently underway. Some patients are even calling Ampion a "Miracle Drug". This short Channel 9 News interview of Norm Johnson shows his miraculous recovery from extreme knee pain where he found it very difficult just to walk and almost impossible to go up and down stairs. Norm was in so much pain that he was resigned and ready to schedule knee replacement surgery . . . until he joined a clinical trial and received a single injection of "Ampion" into his knee. Within one hour after receiving the injection, his pain was completely gone and he was able to walk pain free. Six months later he remains pain free and he can be seen climbing up and down a steep ladder. Mr. Johnson cancelled his plans for knee replacement surgery.
The fact that Ampion seems to keep working even after six months from the injections has researchers puzzled so it wouldn't be surprising if even bigger news unfolds soon. Ampio owns the worldwide patents for Ampion. Several announcements relative to Ampion results are expected over the next few months and could be leading to a very exciting 2014.
Diabetic Macular Edema, "DME", and Macular Degeneration, "MD", are serious sight threatening illnesses that are both closely related in that the blood vessels beneath the retina begin leaking causing swelling of the macula, loss of visual acuity and damage to the rods and cone cells responsible for converting the light to electrical signals and sending them to the brain. This condition leads to blindness.
The need for treatment is so great that patients even resort to the treatment of anti-VEGF injections into the eyeball that are unpleasant and risky. They are very expensive at anywhere from $1,000 to $2,000 per injection, and the side effects can cause pain, headaches, blindness, strokes, heart problems and even death. In spite of these adverse side effects, Roche with their drug Lucentis, and Regeneron (NASDAQ:REGN) with Eylea are selling over $3 billion per year of their anti-VEGF injections.
Optina is underway in a Phase IIb trial where if results are positive, it is possible this could be the pivotal trial that leads to FDA approval. Based on the earlier trial in Canada and the mechanism clearly explained in the Scientific Journal, "Retina Today", Optina stands a good chance of succeeding and gaining approval. The fact that Optina is a pill and not an injection could set the stage for Optina dominating the DME and MD markets soon. Prior results from an earlier Optina trial were compelling enough to inspire the FDA to assemble it scarce resources of a panel of 18 leading experts in ophthalmology and provide guidance to Ampio to structure the current ongoing trial. Results are expected to be known in only a few months. If approved, Optina has the potential to be a mega blockbuster because it will be the first treatment that is effective and that has no adverse side effects and even better, it is a pill. Ampio owns the worldwide patents for Optina. An announcement on Optina trial results is expected within the next few months.
Zertane is repurposed Tramadol that has already been proven for safety and efficacy and is used to treat a male sexual dysfunction called premature ejaculation, "PE". About 25% of the male population is estimated to suffer from PE. Ampio owns the worldwide patents for Zertane. Johnson & Johnson (NYSE:JNJ) offers Priligy for PE but it has not been approved in the United States. Ampio achieved an important milestone earlier this year when it announced that the FDA approved its Patient Outcome Questionnaire for PE that is essential for a successful conclusion of the phase III pivotal trials. The company announced it is in negotiations for the licensing of Zertane with Big Pharma companies. A surprise announcement is overdue and could come at any time.
Zertane ED is a super version of Zertane with Viagra or a PE 5 inhibitor blended with it. Zertane ED will provide treatment for Erectile Dysfunction and Premature Ejaculation all in one little pill. Ampio owns the worldwide patents for Zertane ED. With Viagra worldwide patent issues, Zertane ED should be of very high interest to Pfizer (NYSE:PFE).
Vasaloc is repurposed danazol, that is the same drug as Optina except it is used to treat diabetic nephropathy or kidney failure from leaking blood vessels in the kidneys. The mechanism and the results are the same. The numbers for prevalence of diabetic nephropathy are sketchy but very large and growing due to the pandemic increase in diabetes. It is not known if any kidney patients are included in the current Phase IIb trial, but the FDA did recommend including some kidney patients when they provided guidance for the Optina trials in 2012. Results are expected to be announced in the next few months.
Oxidation Reduction Potential, "ORP", is a breakthrough diagnostic expected to save millions of lives and billions of dollars because it can quickly tell if a patient is seriously ill or not as in the case of chest pains at the emergency hospitals. Ampio expects to announce results from the ORP clinical trials in the next few months.
NCE001 is an exciting new class of cancer treatment that is called a phosphatase activator. Kinase Inhibitors such as Pharmacyclics (NASDAQ:PCYC) Ibrutinib are today's current new hopes for effective cancer treatment, but phosphatase activators have demonstrated remarkable results on several different lethal cancers including inflammatory breast cancer, multiforme glioblastoma, and renal cell carcinoma. NCE001 is quietly in development and announcements are expected this year also.
With only 45 million shares fully diluted, and with three potential mega blockbusters and several other promising products, Ampio is poised to rise by magnitudes not seen very often and could easily become Wall Street's Cinderella stock of the decade.
Ampio is a small cap company and as such is riskier than larger and better funded companies enjoying large revenues. Ampio's drugs may fail trials or the company may not be able to raise sufficient capital to remain a viable enterprise.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.