Cenegermin

RegeneRx Partner Submits Phase 3 Protocol for Neurotrophic Keratopathy (NK)

Retrieved on: 
Tuesday, September 27, 2022
Dry eye syndrome, Risk, Trial of the century, JV, FDA, Prevalence, OTCQB, Company, Wound healing, Form 10-K, Private Securities Litigation Reform Act, Therapy, DED, Regeneration, Forward-looking statement, Electric Bond and Share Company v. Securities and Exchange Commission, NK, Patient, Clinical trial, Cornea, Cytoprotection, USD, CRO, Goal, HLB, Cenegermin, Degenerative disease, Research, Market share, Security (finance), SEC, Annual report, Pharmaceutical industry

ROCKVILLE, Md., Sept. 27, 2022 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx" or "Company"), a clinical-stage drug development company focused on tissue protection, repair, and regeneration, is reporting today that its U.S. joint venture (JV) partner and licensee, HLB Therapeutics (HLBT), has announced that it submitted a protocol for its second phase 3 clinical trial (SEER-2) to the U.S. FDA on September 26th, evaluating RGN-259 as a treatment for neurotrophic keratopathy (NK).  NK is being developed by ReGenTree, a U.S. joint venture company between RegeneRx Biopharmaceuticals, Inc. and HLB Therapeutics.  The following is the text of HLB's press release with a few edits and modifications for clarification.

Key Points: 
  • NK is being developed by ReGenTree, a U.S. joint venture company between RegeneRx Biopharmaceuticals, Inc. and HLB Therapeutics.
  • The following is the text of HLB's press release with a few edits and modifications for clarification.
  • In the SEER-2 and SEER-3 studies, approximately 70 patients will be recruited in each study to evaluate efficacy, in particular complete healing after 4 weeks treatment.
  • RGN-259 is a sterile, preservative-free, eye drop developed to reduce damage and improve healing for various ophthalmic indications including dry eye syndrome and neurotrophic keratopathy.

RegeneRx Partner Signs LOI with Global Ophthalmology CRO for Two Phase 3 Clinical Trials in Neurotrophic Keratitis

Retrieved on: 
Monday, July 18, 2022
Research, SEC, Neurotrophic keratitis, Patent, Cytoprotection, Letter, Disease, OTCQB, Patient, Security (finance), Risk, U.S. Securities and Exchange Commission, Form 10-K, Time, Annual report, Private Securities Litigation Reform Act, Forward-looking statement, DED, Ophthalmology, Duane syndrome, Wound healing, HLB, Neurotrophic factors, Dry eye syndrome, JV, Company, CRO, Therapy, Regeneration, NK, FDA, SPA, Protocol, Clinical trial, Pharmaceutical industry, EU, Cenegermin

The FDA requires two successful phase 3 trials in most circumstances prior to submitting a new drug or biologics application (NDA/BLA).

Key Points: 
  • The FDA requires two successful phase 3 trials in most circumstances prior to submitting a new drug or biologics application (NDA/BLA).
  • The purpose of conducting simultaneous trials is to reduce the time required to complete phase 3.
  • Unlike dry eye disease, clinical studies for neurotrophic keratitis require a very simple and clear single primary endpoint, such as complete healing," according to HLBT.
  • The CRO, which signed the letter of intent with ReGenTree, a U.S. joint venture between RegeneRx and HLBT, participated in the clinical trial of Oxervate and has clinical experience and expertise in NK clinical trials.

Global Neurotrophic Keratitis Market (2021 to 2029) - by Treatment and Geography - ResearchAndMarkets.com

Retrieved on: 
Wednesday, April 28, 2021
Health, Other Health, Branches of biology, Neurotrophic keratitis, Neurotrophic factors, Keratitis, Clinical medicine, Medical specialties, Cenegermin

The global prevalence rate of neurotrophic keratitis is reported to be 5 per 10,000 individuals.

Key Points: 
  • The global prevalence rate of neurotrophic keratitis is reported to be 5 per 10,000 individuals.
  • The treatment options adopted for neurotrophic keratitis depends upon the severity and stage of the disease.
  • The recent approval of Oxervate by EMA and priority review designation approved by the USFDA will popularize the utilization of recombinant human nerve growth factor for the treatment of neurotrophic keratitis during the forecast period.\nNorth America is presently responsible for 33% market share and is leading the regional segment for neurotrophic keratitis market.
  • The chief contributing factors accountable for its dominance in regional market are rising prevalence of neurotrophic keratitis and affordable reimbursement scenario pertaining to the medication used for its treatment.

Dompé and The Farmamondo Group: Exclusive Agreement to Distribute Oxervate™ in Russia and Other CIS Countries

Retrieved on: 
Thursday, November 26, 2020
Branches of biology, Neurotrophic keratitis, Cenegermin, Keratitis, Clinical medicine, Biology, Neurotrophic factors

MILAN, Nov. 26, 2020 /PRNewswire/ -- Domp farmaceutici Spaand FarmaMondo entered into an exclusive Managed Access Program distribution agreement appointing the FarmaMondo Group as the exclusive partner to make their innovative productOxervate (Cenegermin) available for patients affected by Neurotrophic Keratitis (NK) in Russia and other CIS countries.

Key Points: 
  • MILAN, Nov. 26, 2020 /PRNewswire/ -- Domp farmaceutici Spaand FarmaMondo entered into an exclusive Managed Access Program distribution agreement appointing the FarmaMondo Group as the exclusive partner to make their innovative productOxervate (Cenegermin) available for patients affected by Neurotrophic Keratitis (NK) in Russia and other CIS countries.
  • The agreement appoints FarmaMondo as the exclusive provider of access for those NK patients with unmet need through a Named Patient Managed Access Program.
  • We believe expanding the distribution of Oxervate will dramatically improve the life of many now living with a highly debilitating disease," said Eriona Gjinukaj, Chief Operating Officer of Domp.
  • Oxervate (cenegermin) is a first-in-class treatment for neurotrophic keratitis, with a mechanism of action that targets the root pathology of the disease.

Tanner Pharma Group and Dompé Initiate Distribution Partnership for Oxervate®

Retrieved on: 
Thursday, July 30, 2020
Biotechnology, Pharmaceutical, Optical, Health, Health, Articles, Cenegermin, Pharmaceutical industry, Medication, Pharma, Neurotrophic Keratitis, Oxervate, Dompé, Tanner Pharma Group

Oxervate (cenegermin) is the first application of a human nerve growth factor as drug or treatment and is the first-ever topical biologic medication approved in ophthalmology for a rare disease of the eye.

Key Points: 
  • Oxervate (cenegermin) is the first application of a human nerve growth factor as drug or treatment and is the first-ever topical biologic medication approved in ophthalmology for a rare disease of the eye.
  • Oxervate is approved in Europe and the United States, Switzerland, Israel, Canada and Australia.
  • The agreement allows Tanner Pharma Group to provide access to Oxervate for patients in countries where there is presently no therapeutic alternative.
  • Tanner Pharma Group is a specialist pharmaceutical services provider based in Charlotte, USA with offices in Europe and Latin America.

Dompé receives Industry Innovation Award from the National Organization for Rare Disorders for the Development of Oxervate™ eye drops (cenegermin-bkbj), for neurotrophic keratitis

Retrieved on: 
Wednesday, March 13, 2019
Neurotrophic factors, Branches of biology, Rare diseases, Neurotrophic keratitis, Keratitis, Medicine, Cenegermin, Medical specialties

"We are proud to honor Domp with an Industry Innovation Award and to thank them for the work they are doing on behalf of the rare disease community."

Key Points: 
  • "We are proud to honor Domp with an Industry Innovation Award and to thank them for the work they are doing on behalf of the rare disease community."
  • Domp supports the rare disease community through continued research and development activity in rare diseases, support of NORD's RareCareprogram, and membership on NORD's corporate council.
  • "Domp is extremely proud of the development program that resulted in the FDA approval of Oxervate.
  • 5 Mastropasqua L, Massaro-Giordano G, Nubile M, Sacchetti M. Understanding the Pathogenesis of Neurotrophic Keratitis: The Role of Corneal Nerves.

Dompé receives FDA approval of Oxervate™ eye drops (cenegermin-bkbj ophthalmic solution), first-in-class recombinant human nerve growth factor with potential to completely heal rare neurotrophic keratitis

Retrieved on: 
Thursday, August 23, 2018
Neurotrophic factors, Biology, Cell biology, Cell signaling, Neurochemistry, Developmental neuroscience, Cenegermin, Proteins, Neurotrophic keratitis, Nerve growth factor, Low-affinity nerve growth factor receptor, Neurotrophic factor receptor

"Oxervate represents the first therapy from Domp that will be available in the United States," said Sergio Domp, Chairman of Domp.

Key Points: 
  • "Oxervate represents the first therapy from Domp that will be available in the United States," said Sergio Domp, Chairman of Domp.
  • It contains cenegermin-bkbj, a recombinant form of human nerve growth factor, a protein made by the human body.
  • Nerve growth factor (NGF) acts through specific high-affinity and low-affinity nerve growth factor receptors in the anterior segment of the eye to support corneal innervation and integrity.
  • Phase II Randomized, Double-Masked, Vehicle-Controlled Trial of Recombinant Human Nerve Growth Factor for Neurotrophic Keratitis.

FDA approves first drug for neurotrophic keratitis, a rare eye disease

Retrieved on: 
Wednesday, August 22, 2018
Health, Rare diseases, Neurotrophic keratitis, Medicine, Cenegermin, Keratitis, Orphan drug, Fungal keratitis

"In the past, it has often been necessary to turn to surgical interventions; these treatments are usually only palliative in this disease.

Key Points: 
  • "In the past, it has often been necessary to turn to surgical interventions; these treatments are usually only palliative in this disease.
  • Neurotrophic keratitis is a degenerative disease resulting from a loss of corneal sensation.
  • One group was treated with Oxervate eye drops and the other group was treated with an eye drop without cenegermin.
  • Oxervate also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.