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CONFIRMED REPEATED NEWS, SAME HAPPENED WITH BNOX YESTERDAY******MARKET WILL DICTATE WAY FORWARD*****TREAD CAREFULLY
HAPPY WEEKEND TO YOU AND YOURS***GREETINGS
okyo 1.99 news
OKYO Pharma Announces OK-101 Successfully Achieved Statistical Significance for Multiple Signs and Symptoms of Dry Eye Disease including Ocular Pain Relief in its First-in-Human Phase 2 Trial of OK-101 $OKYO https://t.co/tgjKEzE3jP
— Health Stocks News (@health_stocks) March 22, 2024
EXIT...LOOKS LIKE DILUTION INTO NEWS
OKYO Pharma Receives FDA Approval of IND for OK-101 in Neuropathic Corneal Pain
OK-101 is the first IND clearance granted by FDA for a drug to begin clinical studies specifically to treat patients suffering with neuropathic corneal pain (NCP), a major unmet medical need
The initial trial of OK-101 to treat NCP is designed as a randomized, placebo-controlled, double-masked Phase 2 clinical trial and is planned to begin in 2Q 2024
NCP is an Orphan disease as listed in the National Organization for Rare Disorders
LONDON and NEW YORK, Feb. 09, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and for neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, announced today that the U.S. Food and Drug Administration (FDA) has cleared OK-101 as its first Investigational New Drug (IND) application for the treatment of NCP.
Notably, the initial IND submission to FDA proposed an open-label design for the clinical trial. Based on positive feedback from FDA, the Phase 2 study is now designed as a double-masked, randomized, 12-week placebo-controlled trial comparing OK-101 to placebo in NCP patients. A total of 54 patients are planned for the study, with NCP disease confirmed via confocal microscopy. The primary endpoint will be measured utilizing VAS pain relief scores. These protocol changes will enable a statistically valid demonstration of a true drug effect of OK-101 on NCP symptoms. OKYO Pharma is scheduling this trial to begin in Q2 2024.
The OK-101 trial, designed as a single-center trial, will be led by Pedram Hamrah, MD, of Tufts Medical Center, as Principal Investigator. Dr. Hamrah is Professor and Vice Chair of Research and Academic Programs, Co-Director of the Cornea Service and Director of the Center for Translational Ocular Immunology at Tufts Medical Center. An ophthalmologist and a clinician-scientist, Dr. Hamrah is a leading expert in NCP and co-inventor on the OK-101 patent. He is also a member of OKYO’s Scientific Advisory Board.
“I am very pleased that we have gained FDA IND clearance for the first drug to be tested for NCP, a debilitating disease,” said Dr. Hamrah. “Receiving the IND clearance in an important and novel indication was not a trivial hurdle to overcome. Now that the path has been opened for drugs to be tested in NCP, I am looking forward to working with the OKYO team to launch this important trial.”
“We are pleased to gain IND clearance for OK-101 to treat NCP as a second important disease target for the Company,” said Dr. Gary S. Jacob, CEO of OKYO. “OK-101 recently demonstrated favorable tolerability in a Phase 2 trial of dry eye patients along with statistically significant improvements in dry eye symptoms such as stinging/burning and blurred vision, which are also hallmarks of NCP. OK-101 was also shown in a cutting-edge mouse model of NCP to significantly reduce ocular neuropathic pain. We are looking forward to advancing OK-101 to potentially treat NCP, a chronically painful ocular disease with no FDA-approved therapy and a major unmet medical need for patients suffering from this condition.”
OKYO Pharma Receives FDA Approval of IND for OK-101 in Neuropathic Corneal Pain
Early still here
..bailed w a profit lol ...
I don't remember what $2 looks like
Really, looks like 2 bucks.
bet the first time that ever happened to you ...lol
..frustrating..Had limit order $3.05..now $2ish, important cure, OKYO$..gl...
Amazing...clinical trial is favorable but pps keeps going down...go figure
Big volume, just needed to take a breathe before we move further up the ladder imo
Got to add down here...could be a $75-100 play before Y/E
..thought it make $3..sell the news, terrible.. OKYO$...
Got some $2.35s...deal
Bought more this morning...luv sales
Looks like we're seeing it $$ been a phenomenal week
OKYO Pharma Announces Positive Safety Data Profile for the ongoing OK-101 Phase 2 Clinical Trial to Treat Dry Eye Disease ("DED")
https://www.globenewswire.com/news-release/2023/10/05/2755253/0/en/OKYO-Pharma-Announces-Positive-Safety-Data-Profile-for-the-ongoing-OK-101-Phase-2-Clinical-Trial-to-Treat-Dry-Eye-Disease-DED.html
$OKYO
$OKYO Video - Corporate Profile on OKYO Pharma Ltd (Nasdaq: OKYO)
Heading to $3
Looks like we're OK-yo!...
OKYO$$ breaking $2.. let's Goooo!!!!!!!!!!
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