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 OTC: CUBT http://CurativeBiotech.com INVESTOR PRESENTATION https://curativebiotech.com/news-and-media/presentations Curative Biotechnology, a development-stage biomedical company, focuses on novel treatments for rare diseases. The company focuses on therapies with potentially accelerated development paths as a result of the disease, the nature of the therapeutic itself, or the stage of clinical development. Its pipeline candidates include CURB906, an antibody-drug conjugate for targeting CD56 positive brain tumors; and IMT504, a novel immune therapy to treat rabies. The company has an agreement with Mid-Atlantic BioTherapeutics, Inc. to develop an adjuvant for the COVID-19 vaccines which enhance antibody response. Current Drug Pipeline https://curativebiotech.com/pipelineTreatments for six (6) Ocular conditions, one (1) Oncology, one (1) Infectious disease and one (1) vaccine adjunct candidate* Metformin eyedrops for treatment of Acute Macular Degeneration (AMD) AMD is a visually threatening condition, most often found in patients over age 60. Early and Intermediate AMD are characterized by enlarged drusen behind the eye’s retina. Close to 10% of the world’s population is over 60, increasing the prevalence of age-related macular degeneration. Dry AMD accounts for 80-90% of AMD cases, while wet AMD is 10-20% of cases. Currently there are no approved drug treatments for Dry AMD or Geographic Atrophy (late stage dry AMD). Wet AMD is caused by blood vessels that leak in the retina. These abnormal blood vessels may leak fluids or blood into the back of the eye. Curative Biotech will reformulate metformin to treat intermediate dry AMD and Geographic Atrophy for the first indications. Development to be led by the lead inventor on the NEI Patents, Dr. Kapil Bharti. Curative is in negotiations with NEI to conduct the first clinical trial. This product may be eligible for 505(b)(2) treatment as a reformulation of an already approved drug. The global age-related macular degeneration (AMD) market is expected to attain a value of $8.9 billion by 2022 Stargardt DiseaseStargardt disease is a type of inherited age-related macular degeneration that causes vision loss in children or young adults.The retina contains light-sensing cells called photoreceptors, which include rods and cones. Rods are in the outer retina and help people when lighting is dim and dark. Cones are in the macula and help people see intricate visual detail and color. Both cones and rods negatively affected in Stargardt disease, cones are more strongly impacted in people who have Stargardt disease. The Global Stargardt Disease Therapeutics Market is estimated to be valued at US$ 213.5 million in 2023 and is expected to exhibit a CAGR of 31.7% during the forecast period (2023 - 2028). Retinitis PigmentosaRetinitis pigmentosa (RP) is a genetic disorder which leads to a gradual loss of sight, causing a deterioration of night vision and peripheral vision. People with RP experience a gradual decline in their vision, because photoreceptors degenerate. Retinitis pigmentosa, is a condition where patients typically loses ability to see at night in young years, side vision in middle age, and focal vision in later in his/her life due to relentless loss of cone photoreceptor cells. Retinitis Pigmentosa (RP), an acquired retinal condition that causes retinal depletion, is an uncommon illness. Its underlying manifestations are decreased night vision along with loss of fringe vision. It slowly causes visual impairment. There is no conclusive remedy for retinitis pigmentosa. Hence medical institutions and various research and development centers are researching to develop a full proof cure for this disease which is boosting the growth of global retinitis pigmentosa market. ChoroideremiaChoroideremia is a hereditary degeneration of the retina in males that causes a gradual loss of vision. It starts in early childhood with night-blindness, then follows with peripheral vision loss and eventually progresses to the loss of central vision. The lack of a functional protein in the retina causes cell death that is followed by the gradual deterioration of the retinal pigment epithelium, photoreceptors, and the choroid. Choroideremia results in progressive loss of vision and is more prominent in males. The first symptom of choroideremia is usually night blindness that occurs at an early stage. Global Choroideremia Treatment market is expected to account for $4.3 Billion by 2028 Late Onset Retinal DegenerationLate-onset retinal degeneration occurs in adulthood and is an inherited retinal dystrophy. It leads to central vision loss. https://www.sciencedaily.com/releases/2021/12/211209133927.htm Diabetic RetinopathyDiabetic retinopathy is the leading cause of blindness in adults. It is a complication of diabetes that causes damage to the blood vessels of the retina. At first, diabetic retinopathy may cause no symptoms or only mild vision problems. Eventually, it can cause blindness. The global diabetic retinopathy market reached a value of US$ 7.64 Billion in 2020. and is expected to register a CAGR of 7.6% over the forecast period. Market growth can be primarily attributed to increased funding by regulatory bodies for researching ocular disorders. REFERENCE LINK: https://curativebiotech.com/pipeline |
From 1990 to 2017, worked at National Cancer Insitute of the NIH. Since 2017 Director of Center for Antibody Therapeutics at University of Pittsburgh. Dr. Dimitrov’s major long-term goal is the development of clinically useful therapeutics and vaccines based on human monoclonal antibodies in different formats including engineered antibody domains, chimeric antigen receptors, bispecific antibodies and antibody drug conjugates. He has authored or coauthored more than 370 articles, several books, and is the inventor or coinventor of more than 100 inventions, patent applications or patents. Dr. Dimitrov is the lead inventor on the Antibody Drug Conjugate patent exclusively licensed to Curative Biotech from the National Cancer Institute to treat glioblastoma.
Currently President of Sohn Health Strategies and Adjunct Professor at the University of California, San Francisco.
Dr. Sohn has deep biopharmaceutical industry knowledge with over thirty (30) years of U.S. and global experience with expertise in the development and introduction of new medicines for patients and diseases with significant unmet needs. Her skill sets include strategic product development, business development and the introduction of new vaccines, pharmaceutical products and consumer healthcare brands.
Dr. Sohn started the U.S. Vaccine Business for SmithKline Beecham and led the launch of its first vaccine in the U.S. and helped shape their global vaccine portfolio pipeline as a member of the International Vaccine Steering Committee. Subsequently, she led the US commercialization of the company’s largest CNS product. Dr. Sohn later became senior vice president, Worldwide Business Development and a member of the global executive committee at GlaxoSmithKline Consumer Healthcare where she led U.S. and global transactions, including the $1.3 billion acquisition and integration of Block Drug and the $566 million acquisition of CNS, Inc.
Boca Raton, FL, Jan. 05, 2023 (GLOBE NEWSWIRE) -- Curative Biotechnology Inc. (OTC: CUBT) ("Curative Biotech" or the "Company"), a development-stage biomedical company focused on novel treatments for rare diseases and conditions, announced today that it has successfully completed its Investigational New Drug (IND) enabling Tolerance and Toxicology Study of Metformin HCL Solution by Topical Instillation (eye drops) in Rabbits.
Paul Michaels, Chairman and President of Curative Biotechnology, said, "We are pleased to announce the successful completion of these important studies, outlined in our Pre IND meeting with the FDA. We are now able to move on to preparing the Company's first IND application to move our Metformin reformulation into a clinical trial to treat Intermediate Dry Age-Related Macular Degeneration (AMD) and Geographical Atrophy (GA) resulting from AMD."
Michaels continued, "Both Dry AMD and GA are currently unmet medical needs with no FDA approved efficacious treatment options. As previously announced, we will be conducting the first in human study under a CRADA (Cooperative Research and Development Agreement) with the National Eye Institute of the National Institutes of Health, in Bethesda Maryland."
About Macular Degeneration (AMD)
Macular Degeneration is a common eye disorder among people over 50 causing blurred or reduced central vision due from the deterioration of the inner layers of the macula. The macula is the part of the retina that gives the eye clear vision in the direct line of sight. Dry AMD accounts for 80-90% of all age-related macular degeneration (AMD cases), while wet AMD represents 10-20% of patient cases. Currently there are no approved drug treatments for Dry AMD or Geographic Atrophy (late-stage dry AMD).
About Curative Biotechnology, Inc. http://curativebiotech.com
Curative Biotechnology, Inc. (Curative Biotech) is a development stage biomedical company focused on novel therapies for rare diseases. The Company is focused on identifying, acquiring and developing disease modifying therapeutic drug candidates with a concentration on rare disease indications. Curative Biotech has ongoing programs in three different therapeutic areas: infectious disease, neuro oncology and degenerative eye disease. The Company's pipeline includes IMT504, CURB906 and Metformin Reformulation. IMT504 is a novel immune therapy to treat rabies and an adjuvant for vaccines. CURB906 is a fully humanized CD56 monoclonal antibody carrying a cytotoxic drug conjugate directly to the tumor cancer site to kill the tumor by inhibiting tumor growth and migration of the tumor. Metformin Reformulation is targeting the treatment of intermediate and late-stage Age-Related Macular Degeneration (AMD) disease.
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Steve Chizzikhttps://www.wsj.com/articles/curative-biotechnology-announces-completion-of-ind-enabling-reformulated-metformin-hcl-eye-drop-study-01672923305
Connectyx (now Curative Botechnology) Announces Grant of Exclusive Worldwide License from National Institutes of Health for Repurposing Metformin to Treat Degenerative Eye Disease
Boca Raton, FL, Feb. 04, 2021 (GLOBE NEWSWIRE) -- Connectyx Technologies Holdings Group, Inc. (OTC: CTYX) (“Connectyx” or the “Company”), a development-stage biomedical company focusing on novel treatments for rare diseases today announced it has entered into an Exclusive Patent License Agreement to practice inventions contained within the patent applications listed below with the National Eye Institute (NEI), of the National Institutes of Health (NIH), including the repurposed use of Metformin to treat Retinal Degeneration (RD).
The license patent rights include U.S. provisional patent application No. 62/899,899 and entitled, “Druggable Targets to Treat Retinal Degeneration” filed September 13, 2019 (E-227-2017-US-01); International Patent Application No.: PCT/US2020/050540 and entitled, “Druggable Targets to Treat Retinal Degeneration” filed September 11, 2020 (E-227-2017-PCT-O2); and U.S. and foreign patent applications claiming priority to the applications. The territory for the exclusive license is worldwide.
The degeneration of the Retinal Pigment Epithelium (RPE) is associated with various types of RD such as Stargardt disease, retinitis pigmentosa, choroideremia, late-onset retinal degeneration (L-ORD), and age-related macular degeneration (AMD). In the United States, 11 million people are affected by some form of AMD.
Research has shown that Metformin, an FDA-approved drug that has been widely used for the treatment of diabetes in the United States since 1995, can activate AMP-activated protein kinase, can reduce vascular endothelial growth factor (VEGF) secretion, and can correct baseline calcium levels in patient RPE cells. The new treatment indications will require reformulating the drug into an eye drop, injectable or other topical delivery method to be able to deliver sufficient drug to the RPE layer to have a therapeutic effect. This reformulated drug should be eligible for a 505(b)(2) accelerated development path. While the field of use covers treating any degenerative eye disease, the Company is targeting Stargardt, a currently untreatable orphan disease that causes vision loss in children, as the first indication for this therapeutic product.
Paul Michaels, Chairman and President of Connectyx, said, “We are pleased to expand our product portfolio with the addition of reformulated and repurposed Metformin, which is the fifth most prescribed drug in the United States. This very promising product adds a second in licensed product from the NIH to our development portfolio. As stated above, we believe our Metformin reformulation may show efficacy in treating a wide range of RD diseases that cause vision loss. We are focused on developing disease modifying therapeutics to meet the unmet needs of patients. The Company anticipates being prepared for human testing of this reformulation by third quarter of 2022.”
About Age-Related Macular Degeneration, Stargardt Disease, Retinitis Pigmentosa and Choroideremia
AMD is the leading cause of vision loss in people ages 60+. It destroys a patient’s sharp, central vision. Stargardt disease is a type of AMD that causes vision loss in children or young adults. Retinitis pigmentosa is a genetic disorder which leads to a gradual loss of sight, causing a deterioration of night vision and peripheral vision. Choroideremia is a hereditary retinal degeneration that causes a gradual loss of vision. It starts in early childhood with night blindness, then follows with peripheral vision loss and eventually progresses to the loss of central vision. Diabetic retinopathy is the leading cause of blindness in adults. Diabetes harms blood vessels inside the eye by weakening them so they leak fluid into the retina, which can damage areas of the retina, causing blurry, distorted vision.
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