IMN 3001
Description:IMN
3001 is an oral BCP formulation containing anti-LPS immunoglobulin
(IgG1), insulin growth and other natural βfactor (IGF-1), transmissible
growth factor (TGF) bioactives.
Indication/Need: IMN3001 is a nutritional formulation for cancer patients to help address two very common severe side effects from cancer treatment: chemotherapy-related mucositis and radiation induced enteritis. Mucositis involves painful sores throughout the GI tract, which interfere with nutrition and quality of life, as well as predispose already immuno-compromised patients to infections. Radiation induced enteritis may significantly interfere with swallowing and nutrition.
Target Market
Patients undergoing chemotherapy and radiation treatments. In the USA alone 1 million patients undergo chemotherapy annually, receiving 4 months of treatment each, on average. Five hundred thousand patients undergo radiation treatments annually lasting 2 months each, including time to resolve GI side effects (using lung cancer as the clinical example). Prevalence of mucositis varies across treatments, ranging from a low of 12% in patients receiving adjuvant chemotherapy to 99% in patients subjected to high-dose chemotherapy for bone marrow transplant. Other estimates indicate a range of more than 50% in patients on high-dose chemotherapy or those with leukemia, 21%-31% in patients with solid tumors, and 60%-90% in patients with head and neck cancer receiving standard chemotherapy and radiation therapy.
Background on Mucositis
Radiotherapy and chemotherapy treatments of cancer cause damage to rapidly dividing cells. The epithelia of the whole alimentary tract, including the mouth and intestines may, in particular, may be badly affected, with severe inflammation and ulceration. This is known as alimentary mucositis. Symptoms can include difficulty in swallowing, pain, heartburn, abdominal pain, bloating, vomiting, diarrhoea and constipation (Duncan and Grant 2003). The condition can lead to withdrawing from treatment, decreasing treatment dosage to cope with the side-effect, and may even cause death directly due to the damage and septicaemia. Mucositis is a complex inflammatory process involving all the tissues and cellular elements of the mucosa of the alimentary tract. This process begins within hours of the start of the therapy and thus starts to occur days before any visible overt damage (Keefe 2005) is noted in the mouth. The release of bacterial by-products from the gut plays a major role in the amplification of the primary damage following radiotherapy, chemotherapy and bone marrow transplantation (Hill and Ferrara 2000).
Overview of the Product
Immuron is developing a natural, orally delivered mouthwash/drink, to help prevent and treat oral and gastrointestinal mucositis (together termed alimentary mucositis). The formulation is designed to target several pathways in the pathogenesis of clinical disease. The product would be taken before and following cancer therapy. The product is designed to target two of the key phases in the pathogenesis of mucositis. In particular, the product targets the ‘damage response and signal amplification’ and the ‘healing’ phases.
Link to the clinicaltrials.gove website noting the study initiated at Tel Aviv Medical Center
Indication/Need: IMN3001 is a nutritional formulation for cancer patients to help address two very common severe side effects from cancer treatment: chemotherapy-related mucositis and radiation induced enteritis. Mucositis involves painful sores throughout the GI tract, which interfere with nutrition and quality of life, as well as predispose already immuno-compromised patients to infections. Radiation induced enteritis may significantly interfere with swallowing and nutrition.
Target Market
Patients undergoing chemotherapy and radiation treatments. In the USA alone 1 million patients undergo chemotherapy annually, receiving 4 months of treatment each, on average. Five hundred thousand patients undergo radiation treatments annually lasting 2 months each, including time to resolve GI side effects (using lung cancer as the clinical example). Prevalence of mucositis varies across treatments, ranging from a low of 12% in patients receiving adjuvant chemotherapy to 99% in patients subjected to high-dose chemotherapy for bone marrow transplant. Other estimates indicate a range of more than 50% in patients on high-dose chemotherapy or those with leukemia, 21%-31% in patients with solid tumors, and 60%-90% in patients with head and neck cancer receiving standard chemotherapy and radiation therapy.
Background on Mucositis
Radiotherapy and chemotherapy treatments of cancer cause damage to rapidly dividing cells. The epithelia of the whole alimentary tract, including the mouth and intestines may, in particular, may be badly affected, with severe inflammation and ulceration. This is known as alimentary mucositis. Symptoms can include difficulty in swallowing, pain, heartburn, abdominal pain, bloating, vomiting, diarrhoea and constipation (Duncan and Grant 2003). The condition can lead to withdrawing from treatment, decreasing treatment dosage to cope with the side-effect, and may even cause death directly due to the damage and septicaemia. Mucositis is a complex inflammatory process involving all the tissues and cellular elements of the mucosa of the alimentary tract. This process begins within hours of the start of the therapy and thus starts to occur days before any visible overt damage (Keefe 2005) is noted in the mouth. The release of bacterial by-products from the gut plays a major role in the amplification of the primary damage following radiotherapy, chemotherapy and bone marrow transplantation (Hill and Ferrara 2000).
Overview of the Product
Immuron is developing a natural, orally delivered mouthwash/drink, to help prevent and treat oral and gastrointestinal mucositis (together termed alimentary mucositis). The formulation is designed to target several pathways in the pathogenesis of clinical disease. The product would be taken before and following cancer therapy. The product is designed to target two of the key phases in the pathogenesis of mucositis. In particular, the product targets the ‘damage response and signal amplification’ and the ‘healing’ phases.
Link to the clinicaltrials.gove website noting the study initiated at Tel Aviv Medical Center