PROTERIS BIOTECH AWARDED NEW FEDERAL GRANT TO DEVELOP A BIOLOGIC EYE DROP FOR THE TREATMENT OF DRY EYE
The National Eye Institute of the National Institutes of Health (NIH) has awarded Small Business Innovation Research (SBIR) grant R43-EY037590 to Proteris Biotech, Inc. (PB) to continue preclinical development of an innovative eye drop technology for the treatment of dry eye. The ultimate goal is a new U.S. Food and Drug Administration (FDA)-approved biologic drug.
The National Eye Institute of the National Institutes of Health (NIH) has awarded Small Business Innovation Research (SBIR) grant R43-EY037590 to Proteris Biotech, Inc. (PB) to continue preclinical development of an innovative eye drop technology for the treatment of dry eye. The ultimate goal is a new U.S. Food and Drug Administration (FDA)-approved biologic drug.
Dry eye, characterized by inadequate hydration and lubrication of the ocular surface, is a group of disorders that affects ~5 million people over the age of 50 in the USA today. Dry eye is brought on by many situations, including aging, eye surgery, autoimmune conditions, and environmental exposure. Symptoms include pain, burning, itching, redness, sensitivity to light, and other discomfort. If left untreated, severe cases may result in vision loss due to corneal scarring.
The active ingredient of PB’s eye drop is clusterin, a natural protein found in all bodily fluids, including the tears. Clusterin is a molecular chaperone and a matrix metalloproteinase inhibitor. PB and academic collaborators at the University of Southern California’s Keck School of Medicine in Los Angeles and
Boston University’s Chobanian & Avedisian School of Medicine showed in three preclinical models of dry eye that clusterin reduces inflammation, reverses ocular surface damage (epitheliopathy), restores mucous-secreting goblet cells and regenerates corneal nerves.
“At the present time, two FDA-approved small molecules dominate the dry eye market” observes M. Elizabeth Fini, Ph.D., PB’s Chief Scientific Officer. “These drugs are anti-inflammatory because they target T-cells that regulate the immune response, but they are slow to act and they are not consistently effective in improving epitheliopathy. In contrast, clusterin’s anti-inflammatory activity is at least partially due to its ability to directly target epitheliopathy. Clusterin thus acts quickly to protect, seal and heal.”
“The most innovative action of clusterin, however” said Dr. Fini, “is one we only recently discovered, working with our Boston University collaborators in a Sjögren’s disease model of dry eye. We found that treatment with clusterin ophthalmic solution regenerates corneal nerves lost to dry eye.”
The cornea is the most highly innervated organ in the body. Corneal nerves are necessary for sensation, to maintain health of the corneal epithelium and to control tear production by the lacrimal gland. Loss of corneal nerves exacerbates dry eye and can lead to corneal ulceration. The only drug currently approved by the FDA for corneal nerve regeneration is Nerve Growth Factor, approved for the treatment of neurotrophic keratitis.
The mission of the National Institutes of Health’s (NIH) Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs is to foster scientific excellence and technological innovation through the investment of Federal research funds in critical American priorities to build a strong national economy.
“NIH grant applications are rigorously peer-reviewed in a highly competitive process that focuses on scientific excellence, innovation, and impact”, notes John C. Fini, PB’s Chief Executive Officer. “Award of this third NIH grant to Proteris Biotech provides independent validation of our vision for clusterin as a breakthrough therapeutic.”
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Proteris Biotech, Inc. is a start-up biotechnology company incorporated in Glendale, California, but currently based in Mansfield, Massachusetts. The company platform is therapeutic products that harness the body’s natural response to stress.
Contact: John C. Fini, CEO
Email: johncfini@proterisbiotech.com
Website: www.proterisbiotech.com
This press release was prepared by Proteris Biotech. Its content does not necessarily represent the official views of the National Institutes of Health.
Proteris Biotech awarded second federal grant to develop a biologic eye drop for the treatment of epitheliopathy in dry eye
The National Eye Institute of the National Institutes of Health (NIH) has awarded Small Business Technology Transfer (STTR) grant R41-EY034396 to Proteris Biotech, Inc. (PB) to continue development of an innovative eye drop technology for the treatment of ocular surface damage in dry eye, also called epitheliopathy. The ultimate goal is a new U.S. Food and Drug Administration (FDA)-approved biologic drug. The grant begins September 30, 2023.
The National Eye Institute of the National Institutes of Health (NIH) has awarded Small Business Technology Transfer (STTR) grant R41-EY034396 to Proteris Biotech, Inc. (PB) to continue development of an innovative eye drop technology for the treatment of ocular surface damage in dry eye, also called epitheliopathy. The ultimate goal is a new U.S. Food and Drug Administration (FDA)-approved biologic drug. The grant begins September 30, 2023.
Dry eye, characterized by inadequate hydration and lubrication of the ocular surface, is a group of disorders that affects ~5 million people over the age of 50 in the USA today. Dry eye is brought on by many situations, including aging, eye surgery, autoimmune conditions, and environmental exposure. Symptoms include pain, burning, itching, redness, sensitivity to light, and other discomfort. If left untreated, severe cases may result in vision loss due to corneal scarring.
The active ingredient of PB’s eye drop is clusterin, a natural protein found in all bodily fluids, including the tears. Clusterin is a molecular chaperone and matrix metalloproteinase inhibitor. PB’s collaborators at the University of Southern California’s Keck School of Medicine in Los Angeles, and at Tufts Medical Center and Tufts University School of Medicine in Boston, showed in two preclinical models that clusterin prevents and ameliorates ocular surface epitheliopathy due to dry eye.
“At the present time, there are only two FDA-approved drugs for the treatment of dry eye”, observes PB’s Chief Scientific Officer M. Elizabeth Fini, Ph.D. “These drugs target the inflammatory response. They act very slowly, and neither was consistently effective in improving epitheliopathy in human clinical trials. Clusterin also has anti-inflammatory activity. However the innovation of clusterin is that it works by targeting the ocular surface damage common to all forms of dry eye. Clusterin acts quickly to protect, seal and heal.”
The mission of the NIH STTR program is to support scientific excellence and technological innovation through the investment of Federal research funds in critical American priorities to build a strong national economy. A feature of the STTR program is the requirement for the small business to formally collaborate with an academic institution. PB will subcontract a portion of the work under the new grant to Sharmila Masli, Ph.D. at Boston University School of Medicine. Dr. Masli is an Associate Professor in the Department of Ophthalmology.
“NIH grant applications are rigorously peer-reviewed in a highly competitive process”, notes PB’s Chief Executive Officer John C. Fini. “Award of this second NIH grant provides new independent validation of our vision for clusterin as a breakthrough therapeutic.”
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Proteris Biotech, Inc. is a start-up biotechnology company incorporated in Glendale, California, but currently based in Mansfield, Massachusetts. The company platform is therapeutic products that harness the body’s natural response to stress.
Contact: John C. Fini, CEO
Email: Proterisbiotech@gmail.com
Website: www.proterisbiotech.com
This press release was prepared by Proteris Biotech Inc. Its content does not necessarily represent the official views of the National Institutes of Health.
Proteris Biotech awarded federal grant to develop Protearin for dry eye
The National Eye Institute of the National Institutes of Health (NIH) has awarded a Small Business Technology Transfer (STTR) grant R41-EY025890 to Proteris Biotech, Inc. (PB) to develop innovative technology for the treatment of dry eye. The ultimate goal is a new U.S. Food and Drug Administration (FDA) approved biotherapeutic called Protearin. The grant will begin May 1, 2016.
April 25, 2016
The National Eye Institute of the National Institutes of Health (NIH) has awarded a Small Business Technology Transfer (STTR) grant R41-EY025890 to Proteris Biotech, Inc. (PB) to develop innovative technology for the treatment of dry eye. The ultimate goal is a new U.S. Food and Drug Administration (FDA) approved biotherapeutic called Protearin. The grant will begin May 1, 2016.
Dry eye, characterized by inadequate hydration and lubrication of the ocular surface, is a group of disorders that affects ~5 million people over the age of 50 in the USA today. Dry eye conditions are brought on by aging, eye surgery or environmental exposure. Symptoms include pain, burning, itching, redness, sensitivity to light and other discomfort. If left untreated, severe cases may result in vision loss due to corneal scarring.
Protearin is based on the natural glycoprotein clusterin. PB’s collaborators at the University of Southern California (USC) in Los Angeles showed in a preclinical model that clusterin prevents and ameliorates ocular surface disease by a remarkable sealing mechanism.
“At the present time, only a single FDA-approved drug exists for the treatment of dry eye”, observes PB’s Chief Scientific Officer Dr. M. Elizabeth Fini. “Most drugs currently under development seek to target the inflammatory response that initiates dry eye, but the character of this response may differ in the various disease subtypes. The innovation of Protearin is that it works downstream of inflammation, targeting the ocular surface damage common to all forms of dry eye.”
The mission of the NIH STTR program is to support scientific excellence and technological innovation through the investment of Federal research funds in critical American priorities to build a strong national economy. A feature of the STTR program is the requirement for the small business to formally collaborate with an academic institution. PB will subcontract a portion of the work under the new grant to Shinwu Jeong at the USC Institute for Genetic Medicine. Dr. Jeong is also a USC Eye Institute researcher and an Assistant Professor of Research in the Department of Ophthalmology at USC.
“NIH grant applications are rigorously peer-reviewed in a highly competitive process”, notes PB’s Chief Executive Officer John C. Fini. “Award of this new grant provides independent validation of our vision for Protearin as a breakthrough therapeutic.”
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Proteris Biotech, Inc. is a start-up biotechnology company located in Pasadena, California, USA. The company platform is therapeutic products that harness the body’s natural response to stress.
Contact: John C. Fini; phone: (617) 435-4912; email: Proterisbiotech@gmail.com
Website: www.proterisbiotech.com
This press release was prepared by Proteris Biotech Inc. Its content does not necessarily represent the official views of the National Institutes of Health.
Promising USC study focuses on treatment for dry eyes
A natural protein in tears could help researchers looking at the common affliction.
By Meg Aldrich
Neww research by the Fini Lab at Keck Medicine of USC demonstrates for the first time that a natural protein in tears may be key to treating dry eye syndrome, a common affliction of the eye that affects millions of people.
Published in PLOS ONE, the study suggests a new approach to treating dry eye. Using an experimental mouse model, the researchers found that the natural tear protein known as clusterin seals the ocular surface barrier, while also protecting against further damage.
“It is well known that clusterin protects cells and proteins,” said Shinwu Jeong, assistant professor of research ophthalmology in the Institute for Genetic Medicine at the Keck School of Medicine of USC and the senior author of the study. “A problem in dry eye appears to be that natural clusterin is depleted. We predicted that adding it back would be beneficial. However, the novel mechanism of sealing was unexpected.”
Common symptoms
Dry eye conditions are brought on by aging, eye surgery or environmental exposure. Symptoms include pain, burning, itching, redness, sensitivity to light and other discomfort. If left untreated, severe cases may result in vision loss due to corneal scarring.
“We are the first to report functions for this protein in dry eye and shed some light on its potential use for ophthalmology treatments,” said Aditi Bauskar, a Ph.D. student in USC’s medical biology program and lead author of the study.
The researchers studied the ocular surface barrier rather than upstream effects of tear production, chemistry and inflammation that contribute to dry eye conditions.
“Our pre-clinical results are very promising and make a strong case to use clusterin as a biological drug to prevent or treat not only dry eye but also other corneal disorders involving damage to the ocular surface barrier,” Bauskar noted.
No drugs are currently on the market to address ocular surface barrier disruption.
The research is the basis of several patent applications with the USC Stevens Center for Innovation, one of which has been issued. It was conducted in the lab of M. Elizabeth Fini, director of the USC Institute for Genetic Medicine and professor of cell and neurobiology and ophthalmology at the Keck School.
Other USC co-authors include faculty members Wendy Mack of preventive medicine, Martin Heur of ophthalmology and Janet Moradian-Oldak of the Ostrow School of Dentistry of USC.
SC CTSI-Supported Researchers make important discovery on Ameliorate Dry Eye treatment
Researchers find natural protein seals ocular surface and offers promise to ameliorate dry eye.
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Researchers find natural protein seals ocular surface and offers promise to ameliorate dry eye.”
Note: Researchers Elizabeth Fini, Ph.D, and Aditi Bauskar received support from the SC CTSI Biostatistics program for their study investigating the role of clusterin in protecting the ocular surface barrier.
Millions of people suffer from dry eye conditions brought on by causes such as aging, eye surgery or environmental exposure. Dry eye represents one of the most common conditions seen by eye care practitioners. It significantly impacts patients’ quality of life and if left untreated, more severe cases may result in vision loss due to corneal scarring.
Recent research by Keck Medicine of the University of Southern California (USC) scientists, published in PLOS ONE, suggests a new approach to treating dry eye. Using an experimental mouse model, the researchers demonstrated for the first time that the natural tear protein clusterin seals the ocular surface barrier, while also protecting against further damage.
Findings show that clusterin blocks uptake of fluorescein dye, a clinical test used to diagnose dry eye, according to senior and corresponding author Shinwu Jeong, Ph.D., assistant professor of research ophthalmology in the Institute for Genetic Medicine at the Keck School of Medicine of USC. “It is well known that clusterin protects cells and proteins”, he said. “A problem in dry eye appears to be that natural clusterin is depleted. We predicted that adding it back would be beneficial, however the novel mechanism of sealing was unexpected.”
The researchers studied the ocular surface barrier rather than upstream effects of tear production; tear chemistry and inflammation that contribute to dry eye conditions.
“We are the first to report functions for this protein in dry eye and shed some light on its potential use for ophthalmology treatments,” said Aditi Bauskar, a Ph.D. graduate student in USC’s medical biology program, and lead author on the paper. “Our pre-clinical results are very promising and make a strong case to use clusterin as a biological drug to prevent or treat not only dry eye, but also other corneal disorders involving damage to the ocular surface barrier.”
Currently there are no drugs on the market addressing ocular surface barrier disruption. This work is the basis of several patent applications with USC Stevens Center for Innovation, one that has just issued. Research was conducted in the lab of M. Elizabeth Fini, Ph.D., director of the USC Institute for Genetic Medicine and professor of cell & neurobiology and ophthalmology. Other USC co-authors include faculty members Wendy J. Mack (preventive medicine and SC-CTSI), Martin Heur (ophthalmology) and Janet Moradian-Oldak (Ostrow School of Dentistry).
Funding was provided by the James H. Zumberge Faculty Research & Innovation Fund, National Institutes of Health grants, Research to Prevent Blindness, University of Southern California and the Keck School of Medicine of USC.
Bauskar A, Mack WJ, Mauris J, Argüeso P, Heur M, Nagel BA, Kolar GR, Gleave ME, Nakamura T, Kinoshita S, Moradian-Oldak J, Panjwani N, Pflugfelder SC, Wilson MR, Fini ME, Jeong S (2015) Clusterin Seals the Ocular Surface Barrier in Mouse Dry Eye. PLoS ONE 10(9): e0138958. doi:10.1371/journal.pone.0138958