Technology

Americans Suffering from OA

Spent Annually Treating OA

Will Suffer From OA by 2030

The Problem

Osteoarthritis (OA) is a crippling disease that is caused by the breakdown of cartilage within joints. While the exact cause of OA remains unknown, post-traumatic injuries (e.g., ACL tear) and age-related wear and tear of the joints significantly increase the incidence of the disease. Over 27 million people are treated for arthritis-related pain in the United States alone, placing a $185B burden on our healthcare system and economy. Missed work, lost productivity, and excessive medical expenditure all result from the lack of an effective treatment. The discovery of a safe, effective therapy for OA would have an enormous impact on the well-being of our nation’s population and significantly impact our economy.

The Solution: A2M

Alpha-2-Macroglobulin (A2M) is a naturally-occurring blood serum protein that plays a small role in the clotting cascade. This protein has been shown to protect against cartilage breakdown in animal models of osteoarthritis. A2M inhibits a class of deleterious enzymes called proteases, which are overabundant in the joints of patients with OA, and degrade the cartilage cushion and cause pain/inflammation. A2M inhibits all the inflammatory mediators of the process, eliminating the burden on the immune system and allowing the body to heal itself efficiently. Unfortunately, the levels of naturally-occurring A2M are insufficient to completely halt the progression of OA, and can only delay the onset of symptoms at best. Cytonics has demonstrated that concentrating A2M within the joint cavity can halt the progression of OA, allowing the body to heal itself and bring about significant relief to the suffering patient.

Osteoarthritis & A2M

A2M Therapy

Arthritic joints make several molecular compounds that destroy the cartilage, which is the essence of osteoarthritis. These molecules, called catabolic proteases, work by degrading cartilage and damaging your joint by breaking down the cells. Alpha-2-Macroglobulin (A2M), found naturally in the blood, captures these destructive proteases and neutralizes their degenerative effect. Injections of concentrated A2M can inhibit all of the molecular causes of cartilage breakdown and thereby prevent cartilage loss, reduce pain, and stop the progression of OA.

A2M Technology

Much has been made of the new field of “regenerative orthopedics” utilizing the capabilities of a patient’s own “autologous” stem cells or platelet-rich plasma. Yet none of these techniques have undergone the rigor and scrutiny of a randomized, controlled FDA study to gain marketing approval. Such approval is the first step to gaining reimbursement that will enable a successful treatment to be offered to all patients, not just those few who will pay cash for unproven, unapproved, unlabeled indications. Cytonics’ Autologous Platelet Integrated Concentration (APIC™) System is the only autologous A2M treatment to submit and win an Investigational New Drug (IND) approval. Based on our in-depth knowledge of the pain cascade and discovery of FAC, we developed the APIC™ treatment with the intent of halting cartilage damage at its source. The APIC™ system utilizes a unique process to concentrate plasma proteins from a patient’s own blood. We initiated a successful Phase 1/ 2 clinical trial with APIC™. Moreover, our recombinant A2M-based drug product, CYT-108, has been shown to slow the progression of osteoarthritis in pre-clinical models by Cytonics and by independent researchers at Brown University (Arthritis Research & Therapy 2017 19:175).

The Cytonics Advantage

Breakthrough technology Is based upon a naturally occurring molecule within the body.

Living Pain-Free

We have developed the Autologous Platelet Integrated Concentration (APIC™) System to purify and concentrate A2M from patients’ own blood, allowing us to inject the concentrate back into the OA-afflicted joint in doses high enough to lend a therapeutic effect. This is the only treatment on the market that selectively concentrates A2M to deliver this molecule in therapeutic doses.

The results of the APIC™ treatment are often observed within hours or days of the procedure and have long-lasting effects of 6 to 12 months. No more than 1 to 2 injections are required per year to stop the progression of OA and significantly reduce joint pain.

Our APIC™ therapy has allowed over 6,000 patients to reclaim their mobility and live their lives pain-free!

State-of-the-Art Innovation

Patents

Cytonics’ technology is on the cutting edge of innovation in the regenerative medicine space. The clinical success of our APIC™ technology resulted in the development of a revolutionary new drug (CYT-108), predicated on the mechanism of action of A2M, which has the potential to eradicate OA.

We are currently pursuing pre-clinical trials for this pharmaceutical “recombinant” version of A2M, CYT-108. This synthetic drug has been engineered to function more effectively than the naturally-occurring A2M, and its superiority has been verified in rodent studies.

CYT-108 has the potential to be the first “off-the-shelf” product to treat OA and other musculoskeletal diseases. It can be manufactured in a lab and produced at an industrial scale. No longer will A2M therapies be reliant upon extracting and processing blood from the patient. CYT-108 will provide a fast and effective option for the treatment of OA.

Our APIC™ technology and CYT-108 are secured by broad international patents that protect our ingenuity and design.

CYT-108 has been proven to be both safe and effective in animals, giving us confidence that we will show similar results in human clinical trials and successfully bring our this revolutionary new drug to market.

Our Pipeline

Our APIC™ system for concentrating the naturally occurring A2M in the patient’s blood has been approved by the FDA and used to treat over 6,000 patients.

We have developed a smaller, less expensive APIC™ system dubbed “APIC™ Mini” to provide physicians with a solution for treating small joints (such as fingers) that do not require as much volume. The APIC™ Mini also has the potential for veterinary applications.

We are currently pursuing pre-clinical studies for our recombinant A2M, CYT-108. We have contracted a research organization, Goodwin Biotechnology, to purify industrial-scale quantities of CYT-108 for pre-clinical experiments and FDA clinical trials.