Diseases & Conditions

Acute Otitis Media (AOM)

AOM is the most common indication for which an antibiotic is prescribed to children, with an estimated 15 million prescriptions each year in the U.S. alone. However, treatment of AOM with antibiotics has demonstrated limited therapeutic value, and is associated with the development of drug resistant bacteria. The annual costs of treating AOM in the U.S. is over $5 billion.

In pre-clinical animal studies, administration of P13 has been shown to reduce both middle ear inflammation and fluid accumulation, and to reduce the incidence of severe hearing loss. It has shown efficacy against AOM induced by both Gram-negative and Gram-positive bacteria, and is predicted to be effective against viral infections.

Rheumatoid Arthritis (RA)

RA is a chronic, systemic inflammatory disease that may affect many tissues and organs, but principally attacks the joints producing an inflammation of the synovial membrane that often progresses to destruction of the articular cartilage and stiffness of the joints.

Rheumatoid arthritis can also produce diffuse inflammation in the lungs, pericardium, pleura and sclera, and also nodular lesions, most common in subcutaneous tissue under the skin. Although the cause of rheumatoid arthritis is unknown, autoimmunity plays a pivotal role in its chronicity and progression.

About 1% of the world's population is afflicted by rheumatoid arthritis, women three times more often than men. Onset is most frequent between the ages of 40 and 50, but people of any age can be affected. It can be a disabling and painful condition, which can lead to substantial loss of functioning and mobility. It is diagnosed chiefly on symptoms and signs, but also with blood tests (especially a test called rheumatoid factor) and X-rays.

Pre-clinical in vivo pilot tests of P13 have suggested oral efficacy in reducing inflammation caused by Rheumatoid Arthritis.

Systemic Inflammation (Sepsis)

Sepsis is a serious medical condition that is characterized by a whole-body inflammatory state (called a Systemic Inflammatory Response Syndrome or SIRS) and the presence of a known or suspected infection. The body may develop this inflammatory response to microbes in the blood, urine, lungs, skin, or other tissues.

Sepsis is usually treated in the intensive care unit with intravenous fluids and antibiotics. If fluid replacement is insufficient to maintain blood pressure, specific vasopressor drugs can be used. Artificial ventilation and dialysis may be needed to support the function of the lungs and kidneys, respectively.

P13 treats sepsis by abating the cytokine storm that occurs early in the inflammatory response. It has been shown in pre-clinical in vivo testing to significantly improve survival rates.

Psoriasis

Psoriasis is a chronic non-infectious disease that affects mainly the skin, and is thought to be autoimmune in origin. It commonly causes red, scaly patches to appear on the skin, although some patients have no dermatological symptoms. The scaly patches caused by psoriasis, called psoriatic plaques, are areas of inflammation and excessive skin production. Skin rapidly accumulates at these sites and takes on a silvery-white appearance. Psoriasis is a chronic recurring condition that varies in severity from minor localized patches to complete body coverage. Psoriasis can also cause inflammation of the joints, which is known as psoriatic arthritis and affects ten to fifteen percent of people with psoriasis. Factors that may aggravate psoriasis include stress, withdrawal of systemic corticosteroid, excessive alcohol consumption, and smoking.