The Kalos Lead Program is focused on Human Cancers and their related comorbidities, such as ascites and metastasis. This will provide non-toxic tumor stasis and an improved Quality of Life without chemotherapy or radiation therapy. This program is intended initially to work in conjunction with or following a highly toxic regimen to create an alternative for patients who currently receive no more therapy because of their health or for those who need a nontoxic safe alternative to their previous therapies. This by using KTH-222 as a part of a toxic drug holiday or treatment vacation Kalos expects to help stabilize the patients and allow them time to recover and improve their quality of life while holding their tumors in a sustained state of slowed growth or stasis.
Pancreatic and ovarian cancers are considered Orphan Diseases and unmet clinical needs, which will permit the company to seek rapid review and early approval. Kalos will seek to secure ‘Breakthrough Technology’ designation from the FDA, which will shorten the review and approval process while presenting a new option for patients who are now left to wait out their cancers progression or remission.
Program Two is focused on Animal Health, with its lead animal health drug KTV-111 which leverages the diuretic and therapeutic effects of the Kalos platform of new chemical entities (NCE’s) to replace Lasix (Furosemide) which is being banned as a race day medication in thoroughbred race horses and other fields of competitive horses such as Steeple Chasers, Hunter, Jumper and rodeo type equine athletes. This program will first treat Epistaxis; bleeding known as (EIPH) exercise induced pulmonary hemorrhage. This market is in excess of billion dollars per annum globally and revenue can be realized in the Animal health field in as little as three years based on a shorter path to approval.. Rather than using Animal health as a way to evergreen an expiring drug program, Kalos looks to maximize the revenue opportunity to create options for the company, such as using the near term potential revenue to support R&D activity in the parent company, or to spin out this program and share royalty income while providing a short term return for investors. The animal data gathered from this program will provide useful data and insights that can be utilized in our human therapeutic platform. We in effect will be commercializing a portion of our large animal studies.
Program Three is focused on first in class therapeutic approaches to Retinal Diseases. This treatment is based upon the cell signaling power of our therapeutic, which blocks VEGF signaling in Wet Adult Macular Degeneration (AMD). This program offers an additional effect which triggers what we believe to be immunologic processes which removes the dead cellular debris while ending formation of frail capillaries which lead to blindness. This therapeutic has the potential to impact Orphan Diseases in this space like Diabetic Macular Edema.
R&D programs for each program will require late stage pre-clinical development work undertaken in a collaborative lab services arrangement with one or more institutional research centers.
Successful execution of R&D efforts in each program will enable the company to secure a further financing, and to provide opportunities to negotiate partnership arrangements with appropriate big pharma and biopharma companies.
The Kalos Team is devoted to treating the unmet needs of people living with incurable diseases, while doing so with less toxic and debilitating side effects commonly associated with Chemotherapies. Kalos believes that by leveraging nature and all of the body’s mechanisms we can create new safer approaches to hyperproliferative diseases and diseases that affect the metabolic system as well. Kalos aims to treat dangerous and debilitating diseases and improve the quality of life for the patient and their families.
The mechanism of this peptide has been demonstrated in five laboratories using more than nine different types of cancer cell lines and three different human cancer xenograft models. The Company’s novel peptide has also demonstrated the potential to very effectively treat ascites and edema that lead to pain and even cancer patient death.
KTH-222, our lead drug candidate from the Kalos proprietary platform, regulates cell growth via inhibition of the mitogen-activated protein kinase (MAPK) pathway. As an endogenous peptide acting through a natural mechanism, KT-220 can produce broader anti-cancer activity than small molecules without the associated side effects. ANP peptides are designed by nature to inhibit the MAPK pathway by controlling initiation of the signaling cascade while synthetic drugs block only specific parts of the pathway. Supporting the inherent anti-cancer properties of the naturally occurring peptide and the Kalos platform, is the well-known rarity of primary and metastatic cancers in the heart, where these peptides are at their highest concentrations
The platform of new therapies consists of a novel array of natriuretic peptides produced by the heart that have well-known physiological effects such as salt excretion, diuresis and vasodilation. Because of these antihypertensive effects, they were first used in humans as a treatment for congestive heart failure. These peptides are commonly administered intravenously and have produced no known serious adverse effects.
The predecessor drug to our current lead candidate KTH-222 demonstrated remarkably broad anti-cancer activity, including inhibition of pancreatic, lung, prostate, breast, ovarian, colon, and melanoma cells in culture and of pancreatic, breast, and lung cancer tumors in models of human cancer. This versatility will allow Kalos to develop a complete tailored approach to a multitude of cancers and related comorbidities, as well as a breakthrough approach to treating metastatic disease.
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