What is Ampion™?
Ampion™ is a small anti-inflammatory molecule made by humans (biologic) in response to injury. Discovered by Dr. David Bar-Or, Ampion™ is being studied as a new drug for the treatment of pain and inflammation in many conditions.
What does Ampion™ treat?
Ampion™ may be useful with degenerative diseases such as osteoarthritis, autoimmune diseases including rheumatoid disease, tissue injury including burns and to reduce pain and swelling after surgery.
What clinical trials are being conducted with Ampion™?
Ampion™ is being tested in patients with osteoarthritis of the knee, in a Phase Ib trial, to demonstrate a reduction of pain and swelling and improved range of motion. In this initial trial, a single injection to the knee is used in conjunction with standard medications.
What is a Phase Ib trial?
A Phase Ib trial is a study designed to assess the safety and efficacy of a drug in a small population of patients. Ampion™ is found in an already approved product, Human Serum Albumin (HSA), which has been given to millions of people for over 40 years. This Phase Ib trial will be the first trial in patients to show that Ampion™ is not only well tolerated but also effective in providing relief. The Company believes that since Ampion is a naturally occurring human biologic, it will have a shorter path to market than a traditional small molecule NME.
What is a New Molecular Entity (NME)?
This is a general term used by many regulatory bodies in different countries to refer to a drug that has never been approved. Regulators need extensive evidence of safety in animals and humans often involving thousands of subjects to allow progression to Phase II.
What is a biologic?
Biologics describe a very broad range of therapies or products that are derived from a biological source and are generally considered safer since they are present in the body. Biologics range from very complex cell therapies to simple blood products. Ampion™ is derived from one such blood product, Human Serum Albumin, and in most countries would be classified as a biologic.
Biologics are usually controlled by a different division of regulatory agencies than for traditional drugs. In the US, the FDA division that regulates biologics is called the Center for Biological Evaluation and Research (CBER) as opposed to the Center for Drug Evaluation and Research (CDER) that evaluates new molecular entities.
Is Ampion™ protected by patents?
Yes, there is an extensive worldwide patent portfolio surrounding Ampion™ and its uses including an issued composition of matter patent on the synthetic form.
What side effects does Ampion™ have?
Ampion™ is made in the body from one of the most common proteins in our blood, HSA. Since it is found in approved HSA preparations in similar concentrations to our clinical trial doses and since albumin has been administered to patients for decades, Ampion™ is very unlikely to have any significant side effects.
Learn More About:
Premature ejaculation is a distressing male sexual dysfunction that is more common than erectile dysfunction (ED) and has a major impact on the quality of life for men and their sexual partners.
A complication of diabetes mellitus that damages the retina in the eyes and leads to blindness
A progressive complication of diabetes mellitus that leads to end-stage renal disease (ESRD) requiring kidney transplantation or chronic dialysis
|AMPE Stock Quote - delayed|
06/07/2013 | Press Release
06/06/2013 | Press Release
06/03/2013 | Press Release