Critical Limb Ischemia

Is Angiogenesis a Treatment or Potential Cure?

Zhittya Genesis Medicine is developing a drug, Fibroblast Growth Factor 1 (FGF-1), to potentially treat Critical Limb Ischemia (CLI) by stimulating the growth of new blood vessels in ischemic leg tissue. As of May 2022, Zhittya Genesis Medicine has initiated efforts to test FGF-1 in human medical research studies following promising preclinical studies.

CLI, a severe form of peripheral artery disease (PAD), occurs when blood flow to the legs is significantly reduced or blocked, leading to extreme pain, ulcers, and even gangrene. Without effective treatment, CLI can result in amputation and high mortality rates. The current standard treatments, such as surgical bypass or revascularization, are not viable for up to 50% of CLI patients, creating an urgent need for alternative therapies.

FGF-1 has shown remarkable efficacy in preclinical studies, including the successful revascularization of ischemic tissue in animal models. In a rabbit model of CLI, FGF-1 significantly increased blood vessel density and blood flow in ischemic limbs. These promising results support the potential of FGF-1 as a groundbreaking treatment for CLI.

History

For nearly two decades, “therapeutic angiogenesis” (the growth of the new blood vessels to treat disease) has been explored as a treatment for peripheral artery disease (PAD) and critical limb ischemia (CLI). However, Fibroblast Growth Factor 1 (FGF-1), a potent angiogenic growth factor, had not been tested in clinical trials for PAD or CLI until recently.

FGF-1 has demonstrated significant potential in other conditions characterized by ischemia, such as severe coronary artery disease and chronic diabetic foot ulcers. In a US FDA-approved clinical study, FGF-1 stimulated robust angiogenesis in the heart, leading to improved exercise and angina pain scores in patients. In another trial, FGF-1 facilitated the complete closure of diabetic foot ulcers by promoting new blood vessel growth.

Building on these successes, Zhittya Genesis Medicine initiated efforts to develop FGF-1 for the treatment of CLI. CLI is a severe manifestation of peripheral artery disease (PAD), where blood flow to the legs is critically reduced or blocked, leading to severe pain, ulcers, gangrene, and a high risk of amputation and mortality.

Preclinical studies in animal models of PAD and CLI have shown that FGF-1 can safely and effectively stimulate the growth of new, durable arteries in ischemic limbs. These promising results have paved the way for human clinical trials. Zhittya Genesis Medicine is now preparing to conduct FDA-authorized clinical trials and medical research studies to evaluate the safety and efficacy of FGF-1 in patients with CLI. By promoting new blood vessel growth and improving blood flow in ischemic tissues, FGF-1 holds the potential to revolutionize the treatment of this debilitating condition.

Watch as Zhittya Genesis Medicine’s drug is used to grow new blood vessels in the human heart in a US FDA Phase IIA Clinical Trial done at the University of Cincinnati, and reported by ABC Nightly News. Zhittya believes that by growing new blood vessels in the limbs, that the symptoms of Critical Limb Ischemia can be alleviated.

Dr. Jacobs explains how their drug, FGF1, promotes the growth of new blood vessels to improve blood flow and alleviate symptoms. The presentation includes animal study results, clinical trial plans, and details on manufacturing FGF1 using genetic engineering. The webinar emphasizes the drug's potential to treat various vascular diseases safely.

Our Partners

  • University of Nevada, Reno

    Zhittya Genesis Medicine continues to cooperate and work with research and laboratory staff at the University of Nevada, Reno where Zhittya conducts some of its research related to FGF-1, Parkinson’s Disease, and more.

  • Cross Border Medical Tourism

    Zhittya Genesis Medicine’s partner in patient facilitation, patient logistics, and operations based in Los Angeles, California. Cross Border Medical Tourism ensures that all of our patients are cared for throughout our programs.

  • WundHealing Biopharmaceuticals

    Zhittya Genesis Medicine’s marketing partner based in Las Vegas, Nevada, helping Zhittya Genesis Medicine market and distribute our potential treatment following anticipated approval by the US FDA and other regulatory bodies.

News

  • Zhittya finishes additional production of FGF-1

    February 2024:

    Zhittya Genesis Medicine completes the production of additional FGF-1 with its partners. This new batch of FGF-1 will allow for Zhittya Genesis Medicine to continue to conduct studies into the future for Critical Leg Ischemia.

  • March 2024 Update

    Zhittya Genesis Medicine is advancing the treatment of Critical Leg Ischemia (CLI) by leveraging the angiogenic properties of FGF-1 to stimulate new blood vessel growth in ischemic areas. This innovative approach has demonstrated promising results in treating peripheral artery disease (PAD) and diabetic foot ulcers (DFUs), showing potential to reverse CLI by improving blood flow and promoting tissue healing. The successful application of FGF-1 in growing new blood vessels in the heart and other ischemic tissues supports its potential to significantly enhance outcomes for patients suffering from CLI.

  • April 2024 Update

    Zhittya Genesis Medicine is advancing the treatment of Critical Leg Ischemia (CLI) by leveraging the angiogenic properties of FGF-1 to stimulate new blood vessel growth in ischemic legs, aiming to address the root cause of the disease. Preclinical studies in animal models have shown promising results, and preparations are underway to file applications in The Bahamas to begin human trials. This innovative approach aims to improve blood flow, promote tissue healing, and potentially reverse CLI, thereby reducing the risk of amputations and improving patient outcomes.

  • May 2024 Update

    Zhittya Genesis Medicine is actively progressing in the treatment of Critical Leg Ischemia (CLI) by preparing to file applications in The Bahamas, where diabetes and CLI are prevalent. CLI often leads to severe outcomes, including amputations and reduced life expectancy. Zhittya has developed protocols and possesses significant quantities of FGF-1, which has shown promising results in animal studies by stimulating new blood vessel growth and reversing CLI. This therapeutic approach, known as angiogenesis, addresses the core issue of poor blood flow. With plans to start treatments soon, Zhittya aims to bring hope to millions affected by CLI globally.