Makindus Appoints World Renowned Experts on Stargardt Disease to Newly Formed Scientific Advisory Board
- Preparations underway to commence Phase 3 program of MI-100 for the treatment of Stargardt disease-
Jun 24, 2015, 07:55 ET
DOYLESTOWN, Pa., June 24, 2015 /PRNewswire/ -- Makindus, Inc., a specialty pharmaceutical development company focused on ophthalmology, announced today the formation of its Scientific Advisory Board (SAB) with four key appointments: Marco A. Zarbin, M.D., Ph.D., FACS, Adrian Koh Hoch Chuan, M.D., Urlich Kellner, M.D., and Paul S. Bernstein, M.D., Ph.D. This prestigious Board will provide scientific oversight, strategic guidance and work closely with the Makindus management team as it prepares to advance its lead product candidate MI-100 for Stargardt disease into Phase 3 clinical development this year.
Stargardt disease, also known as juvenile macular degeneration, is a genetic disorder that causes progressive vision loss. The estimated prevalence in the U.S. and Europe is approximately 1 in 10,000 individuals. There is currently no cure or treatment. Makindus has received orphan drug designation for MI-100 in both the United States and Europe.
Makindus has assembled a preeminent group of retinal specialists renowned worldwide for their research and experience with Stargardt disease.
- MARCO A. ZARBIN, MD, PhD, FACS, Professor and Chair, Institute of Ophthalmology and Visual Science, Professor of Neurosciences, Rutgers New Jersey Medical School; Chief, Department of Ophthalmology, University Hospital, Newark, New Jersey.
- ADRIAN KOH HOCK CHUAN MD, Director, Retinal Centre International, Vice-President of the International Retinal Foundation; Founding Partner, Senior Consultant, Eye & Retina Surgeons, Camden Medical Centre; Visiting Consultant to the Vitreoretinal Service, Singapore National Eye Centre (SNEC) and Visiting Consultant to the Eye Institute, Tan Tock Seng Hospital.
- ULRICH KELLNER, MD, AugenZentrum Siegburg Professor, Medical Head MVZ ADTC Siegburg GmbH, (Germany). Specializes in rare retinal disorders with over 155 publications as author or co-author in peer-reviewed journals (primarily on the diagnosis and treatment of retinal diseases) and 9 books about retinal diseases and adverse drug reactions.
- PAUL S. BERNSTEIN, MD, PhD, Professor of Ophthalmology and Visual Sciences, Moran Eye Center of the University of Utah; Adjunct Professor, University of Utah Department of Pharmacology and Toxicology. Focuses on both basic science retina research and clinical practice devoted to diseases of the retina and vitreous with special emphasis on macular and retinal degenerations.
"We are thrilled to have attracted some of the world's leading experts in Stargardt diseases to our newly formed Scientific Advisory Board as we prepare to advance MI-100 into a Phase 3 registration program this year," said Manohar Katakam, Ph.D., President and Chief Executive Officer of Makindus. "Their background and experience with retinal diseases will be invaluable to Makindus. Importantly, the formation of our SAB serves as an endorsement of scientific and clinical enthusiasm for MI-100 and more broadly our ophthalmology pipeline."
"The Makindus Scientific Advisory Board will also serve as a Clinical Steering Committee which underscores our commitment to gaining the insights, direction and expertise of the world's leading retinal specialists as we advance MI-100. We expect the upcoming clinical trial of MI-100 will be the largest study ever done for Stargardt disease and are excited about the possibility of providing a solution for these patients where no viable therapy currently exists," said David Eveleth, Ph.D., Clinical Head of Makindus and former Head of Ophthalmology at Pfizer. "The core and heart of our clinical program for MI-100 is to improve vision and quality of life for individuals living with Stargardt disease."
MI-100 is a novel formulation of a legacy compound that has shown promising results in improving visual acuity for Stargardt patients in an investigator-initiated clinical trial. Makindus has developed MI-100 in a new proprietary sterile and more convenient ophthalmic dosage form that allows for a ready-to-use multi-dose eye dropper for easy administration.
Makindus has reviewed the clinical development program for MI-100 with the U.S. Food & Drug Administration (FDA) and plans to file a New Drug Application (NDA) utilizing a streamlined 505(b)(2) regulatory pathway. The Company is in the process of finalizing clinical supplies and preparing for the initiation of the Phase 3 program for MI-100. Makindus in discussions to secure additional funding and collaboration support for the development of MI-100 for Stargardt disease.
About Makindus, Inc.
Makindus is a specialty pharmaceutical development company focused on ophthalmology and rare diseases. The Company's lead asset is MI-100, a novel ophthalmic formulation of a legacy compound being developed for Stargardt disease, a rare form of juvenile macular degeneration that occurs in approximately 1 in 10,000 individuals. Makindus has met with the FDA and is in the final stages of planning a Phase 3 clinical trial program. The Company is seeking partners and additional sources of funding and collaborate for the development program of MI-100 for Stargardt disease.
For more information, visit www.makindus.com.
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SOURCE Makindus, Inc.
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