sodium nitrite slow-release oral (JAN101) / TheraVasc, JanOne, Soin Neuroscience - LARVOL DELTA

Effects of Sustained-release Oral Sodium Nitrite on Postoperative Pain and Recovery Following Total Knee Arthroplasty (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: University of Alabama at Birmingham | Trial primary completion date: Jul 2025 ➔ Oct 2025

Trial primary completion date • Orthopedics • Pain • CCL2 • ITGAM • ITGB2 • TNFA

Effects of Sustained-release Oral Sodium Nitrite on Postoperative Pain and Recovery Following Total Knee Arthroplasty (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: University of Alabama at Birmingham | Initiation date: Feb 2024 ➔ May 2024

Trial initiation date • Orthopedics • Pain • CCL2 • ITGAM • ITGB2 • TNFA

JanOne Wins "Best Abstract" Award at the Ohio Society of Interventional Pain Physicians Annual Meeting (PRNewswire) - P2 | N=26 | NCT02412852 | Sponsor: TheraVasc Inc. | "JanOne...has won a prestigious 'Best Abstract' award for reporting that JanOne's treatment for diabetic neuropathy showed both effectiveness against pain and potential to improve nerve function....'Our data showed that Jan101 may not only provide a non-opioid treatment for diabetic neuropathy pain, but also showed statistically significant improvement in nerve conduction velocity. This finding indicates that Jan101 may actually improve nerve function.'"

P2 data • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

JanOne to Present Prior Phase II Data on Diabetic Neuropathy at the Ohio Society of Interventional Pain Physicians Annual Meeting (PRNewswire) - P2 | N=26 | NCT02412852 | Sponsor: TheraVasc Inc. | "JAN101 Showed Statistically Significant Reduction in Pain and Improvement in Nerve Conduction Velocity in Prior Phase II study....JanOne...will present prior data on Jan101's randomized double blind placebo-controlled trial in diabetic neuropathy patients....The Ohio Society of Interventional Pain Physicians annual meeting is a large regional pain management meeting from August 17 – 20th that draws attendance from physicians across the US."

P2 data • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Effects of Sustained-release Oral Sodium Nitrite on Postoperative Pain and Recovery Following Total Knee Arthroplasty (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: University of Alabama at Birmingham

New P1 trial • Orthopedics • Pain • CCL2 • ITGAM • ITGB2 • PTX3 • TNFA

JanOne to Present Data On Its Two Non-Opioid Drug Candidates at The Appalachian Region Spine and Pain Meeting on Drug Development Programs to Treat Pain on April 15, 2023 (PRNewswire) - "JanOne...Dr. Amol Soin, Chief Medical Officer of JanOne, will be presenting at the Appalachian Region Spine and Pain Meeting in Sulfur Springs, West Virginia on Saturday, April 15th on the topic of Innovation in Pain Medicine and will be discussing the drug development programs at JanOne. JanOne is a biotech company that is developing two different late-stage non-opioid drug candidates: JAN 101 is designed to treat peripheral artery disease that was also shown to improve pain in patients with diabetic neuropathy in a phase II study and JAN 123 which is low dose naltrexone to treat Complex Regional Pain Syndrome."

Clinical data • Preclinical • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

JanOne to Present Important Trial Results at Annual Meeting of American Society of Interventional Pain Physicians (PRNewswire) - “JanOne…will present data on two of its investigational pharmaceutical compounds at the American Society of Interventional Pain Physicians (ASIPP) annual meeting in Washington DC in March, 2023. Dr. Amol Soin, Chief Medical Officer of JanOne, will present results from the Phase IIa trial of JAN 101, which treats patients with painful diabetic peripheral neuropathy. He will also report data from in vitro studies of JAN 123, the low-dose naltrexone that treats complex regional pain syndrome and is being readied for late-stage clinical trials to facilitate FDA approval.”

P2a data • Preclinical • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

JanOne Inc. Announces an Improved Formulation of JAN101 (PRNewswire) - "JanOne Inc...announced today that work has been completed by Dr. Maureen Donovan at the University of Iowa that will allow for an improved formulation of JAN101....This new formulation will be used by CoreRx, JanOne's GMP manufacturer, to manufacture clinical supply and validate the JAN101 manufacturing process for the Company's upcoming pivotal clinical trial. JanOne expects to begin the manufacturing and validation process in the near future."

Clinical • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Arterial Disease • Peripheral Neuropathic Pain

"$JAN JanOne Inc. Announces an Improved Formulation of JAN101 https://t.co/Mc9TSbrYCm" (@stock_titan)

JanOne Inc. Announces the Issuance of U.S. Patent Covering a Method of Improving Nerve Function Using JAN101 (PRNewswire) - "JanOne Inc...announced today that a patent was issued that covers a method of improving nerve function using JAN101. JAN101 (formerly known as TV1001SR), is a potential treatment for peripheral artery disease (PAD), a vascular disease that affects more than 8.5 million people in the U.S. and more than 60 million people worldwide....It is the latest United States patent to be issued in connection with JanOne's Inc.'s PAD and pain development program."

Patent • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

"$JAN JanOne Inc. Announces the Issuance of U.S. Patent Covering a Method of Improving Nerve Function Using JAN101 https://t.co/ZXaf9XcyPo #patent" (@stock_titan)

JanOne Sells GeoTraq to SPYR Technologies in a $13.5 Million Transaction (PRNewswire) - "JanOne Inc...announced today that it has sold substantially all of the assets, and none of the liabilities, of GeoTraq Inc...its wholly-owned subsidiary, to SPYR Technologies Inc....'This sale of our subsidiary will help us continue to fund the necessary clinical trials for JAN101.'"

Financing • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

JanOne Successfully Begins Production of JAN101 cGMP Batch for Phase 2b Peripheral Artery Disease (PAD) Trial and Potential Covid-19 Study (PRNewswire) - "JanOne Inc...today announced that the Company has started production of JAN101 under Current Good Manufacturing Practices (cGMP) for the company's anticipated Phase 2b trials to treat Peripheral Artery Disease (PAD) and as a potential treatment for Covid-19 vascular complications....The Phase 2b trial is expected to begin in early 2021."

Clinical • New P2b trial • Infectious Disease • Novel Coronavirus Disease

JanOne Announces Strategic Plan to Divest its Legacy Businesses (PharmiWeb) - "JanOne Inc....provided an update today regarding its initiatives to pursue a strategic alternative process for its legacy businesses first announced in June 2020. The Company has received interest from third parties with respect to the sale of its legacy recycling business and is currently reviewing these opportunities....'We remain highly focused on continued advancement of our clinical candidate, JAN101, to treat peripheral artery disease (PAD) and to find non-addictive alternatives to pain....We believe a successful transaction related to the disposition of our legacy recycling business will enhance shareholder value and enable us to concentrate our efforts on advancing JAN101.'...JanOne will provide further disclosure as appropriate."

Licensing / partnership • CNS Disorders • Neuralgia • Pain

JanOne Inc to ramp up production of its lead therapy JAN101 as a potential coronavirus treatment (Proactiveinvestors) - "JanOne Inc. (NASDAQ:JAN)...Dr Amol Soin tells Proactive the firm is on track to begin GMP production of its lead therapy JAN101 as potential coronavirus treatment and as a treatment for peripheral artery disease (PAD)...Dr Soin say the plan thereafter is to begin in-human trials in Dayton, Ohio. Shortly thereafter, early next year the group plans to run a large pursue a Phase 2b trial to treat PAD."

Media quote

JanOne to Host Telebriefing to Discuss Drug Candidate JAN101 for Treatment of Peripheral Artery Disease (PAD) and Potential Applications for COVID-19 Vascular Complications (BioSpace) - "JanOne Inc. (Nasdaq: JAN), a company focused on developing treatments for conditions that cause severe pain and drugs with non-addictive, pain-relieving properties, today announced that it intends to provide a public business update via teleconference regarding the advancements made through its lead drug candidate JAN101....JanOne's management update will be represented by...Amol Soin, MD..."

Live event

JanOne Completes Stable Formulation of JAN101 in Preparation for Its First GMP Manufacturing Batch to Support Upcoming Clinical Trials (PRNewswire) - "...JAN101 is planned for use to treat COVID-19 vascular complications pending approval of the IND submission, expected to be completed in late August 2020....The company is preparing its IND packages for FDA submission...to extend JAN101 to potentially mitigate severe organ and tissue damage caused by COVID-19. The successful formulation of JAN101 will allow the company to begin its engineering run and GMP manufacturing for multiple trials expected to begin in early 2021."

New indication • Infectious Disease • Novel Coronavirus Disease

JanOne Receives FDA Authorization for Transfer of Investigational New Drug (IND) Application for its Sodium Nitrite Tablets (Yahoo Finance) - "JanOne Inc....has received confirmation from the Federal Food and Drug Administration (FDA) for the investigational new drug (IND) sponsorship transfer covering its sodium nitrite tablets previously held by Soin Neuroscience....Sodium nitrite has demonstrated positive results on vascular conditions, such as PAD, diabetic neuropathy and even vascular decline associated with normal aging....'The transfer of the IND is significant not only for advancing JanOne's clinical research for PAD treatment but other indications as well'...Dr. Soin, in collaboration with Dr. Giordano and JanOne's scientific advisory board chair, Dr. Christopher Kevil, are the nation's leading experts on sodium nitrite."

FDA event • Neuralgia • Pain • Peripheral Neuropathic Pain

JanOne Changes Internal Drug Candidate Name from TV1001SR to JAN101 (PRNewswire) - "JanOne Inc....announces a internal name change for its current drug candidate from TV1001SR to JAN101...The name change will be effective immediately and will be used in all its current and future clinical trials, Indications for a New Drug, clinical and research studies planned to be conducted in the future."

Clinical • Neuralgia • Pain • Peripheral Neuropathic Pain

A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain (clinicaltrials.gov) - P2a; N=26; Completed; Sponsor: TheraVasc Inc.; Active, not recruiting ➔ Completed; Phase classification: P2 ➔ P2a

Clinical • Phase classification • Trial completion • CNS Disorders • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Neuralgia • Pain