Levodopa-induced dyskinesia

Vistagen Receives Notice from European Patent Office of Intention to Grant Patent for AV-101 to Treat Neuropathic Pain

Retrieved on: 
Wednesday, December 27, 2023

The patent, once granted, will not expire until at least 2034 and will become part of Vistagen’s global patent portfolio on therapeutic uses and manufacturing techniques for AV-101.

Key Points: 
  • The patent, once granted, will not expire until at least 2034 and will become part of Vistagen’s global patent portfolio on therapeutic uses and manufacturing techniques for AV-101.
  • In the study, AV-101 prodrug was systematically administered in four rat models of pain to examine its analgesic and behavioral profile.
  • The preclinical study was conducted by Tony L. Yaksh, PhD, Professor of Anesthesiology and Pharmacology at the University of California, San Diego.
  • Vistagen plans to seek potential strategic collaborations to further advance the clinical development and commercialization of AV-101.

PharmaTher Holdings Submits Fast Track Application to FDA for KETARX™ (Ketamine) for the Treatment of Parkinson’s Disease

Retrieved on: 
Tuesday, May 2, 2023

Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.

Key Points: 
  • Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.
  • NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
  • Summary results of the Phase I/II clinical study:
    Enrolled subjects with moderate to advanced Parkinson’s disease with a target infusion rate being 0.30 mg/kg/hr.
  • Parkinson’s disease is a debilitating disorder that affects an estimated 1 million people in the U.S. and 10 million people worldwide.

Sinopia Biosciences Selects Lead Clinical Candidate, Secures Funding to Advance into the Clinic for Parkinson’s Disease

Retrieved on: 
Wednesday, April 19, 2023

Further, Sinopia has been selected to receive $2.0M in funding from The Michael J.

Key Points: 
  • Further, Sinopia has been selected to receive $2.0M in funding from The Michael J.
  • Fox Foundation for Parkinson’s Research (MJFF) to advance SB-0110 into Phase 1 clinical trials.
  • “We are excited to select our lead clinical candidate, SB-0110, and to secure funding from two premier research institutions that are committed to advancing novel therapeutics for Parkinson’s disease,” said Iman Famili, Ph.D., President and Chief Executive Officer of Sinopia Biosciences.
  • We are excited to begin IND-enabling studies and are committed to advance the program to clinical studies,” said Aarash Bordbar, Ph.D., Co-founder and Chief Technology Officer of Sinopia Biosciences.

PharmaTher Holdings Announces Update of Type C Meeting with the FDA for KETARX™ (Ketamine) in Parkinson’s Disease

Retrieved on: 
Wednesday, March 29, 2023

The Company will provide updates to its clinical development initiatives as they arise.

Key Points: 
  • The Company will provide updates to its clinical development initiatives as they arise.
  • Summary results of the Phase I/II clinical study:
    Enrolled subjects with moderate to advanced Parkinson’s disease with a target infusion rate being 0.30 mg/kg/hr.
  • The maximum tolerated infusion rate ranged from 0.20-0.30 mg/kg/hr, which was dependent on either discomfort due to dissociation or hypertension.
  • Parkinson’s disease is a debilitating disorder that affects an estimated 1 million people in the U.S. and 10 million people worldwide.

EQS-News: Newron announces 2022 financial results and provides outlook for 2023

Retrieved on: 
Thursday, March 16, 2023

Milan, Italy, March 14, 2023, 7 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2022, and provided an outlook for 2023.

Key Points: 
  • Milan, Italy, March 14, 2023, 7 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2022, and provided an outlook for 2023.
  • The results showed that the addition of evenamide improved symptoms of psychosis in patients with TRS.
  • Recruitment at treatment centers in Europe, Asia and Latin America is ongoing and results are expected in 2023.
  • ESG focus areas and objectives for 2023 have been defined and Newron’s Annual ESG reporting efforts commence with the Annual Report 2022 published today.

Newron Announces 2022 Financial Results and Provides Outlook For 2023

Retrieved on: 
Tuesday, March 14, 2023

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2022, and provided an outlook for 2023.

Key Points: 
  • Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2022, and provided an outlook for 2023.
  • The results showed that the addition of evenamide improved symptoms of psychosis in patients with TRS.
  • Recruitment at treatment centers in Europe, Asia and Latin America is ongoing and results are expected in 2023.
  • ESG focus areas and objectives for 2023 have been defined and Newron’s Annual ESG reporting efforts commence with the Annual Report 2022 published today.

PharmaTher Holdings Submits FDA Meeting Package to Discuss Phase 3 Program and Fast Track Designation for KETARX™ (Ketamine) in Parkinson’s Disease

Retrieved on: 
Wednesday, February 1, 2023

In addition, the Company has requested guidance from the FDA to obtain Fast Track Designation for KETARX™.

Key Points: 
  • In addition, the Company has requested guidance from the FDA to obtain Fast Track Designation for KETARX™.
  • The goal date for the FDA in providing its written responses is March 20, 2023.
  • Summary results of the study:
    Enrolled subjects with moderate to advanced Parkinson’s disease with a target infusion rate being 0.30 mg/kg/hr.
  • Clinical programs conducted under Fast Track Designation may be eligible for Accelerated Approval and Priority Review of new drug applications if relevant criteria are met.

PharmaTher Holdings Provides Update for KETARX™ (Racemic Ketamine) Development Programs and Expected Milestones for 2023

Retrieved on: 
Wednesday, January 11, 2023

TORONTO, Jan. 11, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, today provided an update for its clinical development programs and milestones for 2023 with KETARX™ (racemic ketamine) as a potential treatment for mental health, neurological and pain disorders.

Key Points: 
  • Of the three forms of ketamine, only racemic ketamine and S-ketamine products have been approved by FDA.
  • The Company recently completed the development of the microneedle patch system for the intradermal delivery of sustained low-dose ketamine.
  • This milestone has enabled progression toward process validation and the manufacturing of cGMP clinical materials to support ongoing clinical development.
  • Upon completion of the study, PharmaTher aims to seek guidance from the FDA to determine the final clinical development plan.

PharmaTher Announces Poster Presentation of Positive Efficacy and Safety Data from Phase 1/2 Clinical Study of Ketamine in the Treatment of Levodopa-Induced Dyskinesia in Parkinson’s Disease at Neuroscience 2022 by the Society for Neuroscience

Retrieved on: 
Monday, November 14, 2022

TORONTO, Nov. 14, 2022 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, today announced that a poster presentation of the Phase 1/2 clinical study of ketamine in the treatment of levodopa-induced dyskinesia in Parkinson’s disease was presented at Neuroscience 2022 by the Society for Neuroscience being held November 12-16, 2022, at the San Diego Convention Center in San Diego, California. In addition, the Company has engaged the FDA to establish the next steps for a planned Phase 3 clinical study to allow for the Company’s proprietary ketamine intravenous product, KETARX™, approval for Parkinson’s disease under the 505(b)(2) regulatory pathway.

Key Points: 
  • A Notice of Allowance is issued after the USPTO makes the determination that a patent should be granted from an application.
  • Parkinsons disease is a debilitating disorder that affects an estimated 1 million people in the U.S. and 10 million people worldwide.
  • The possible therapeutic effect of low-dose ketamine on levodopa-induced dyskinesia was noted in a retrospective analysis of Parkinsons disease patients who received ketamine for pain relief.
  • There is currently no cure for Parkinsons disease, although some drug combinations are used to treat the disease symptoms.

PharmaTher Holdings Announces Grant of U.S. Patent Covering Ketamine for Parkinson’s Disease

Retrieved on: 
Wednesday, October 5, 2022

TORONTO, Oct. 05, 2022 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on developing and commercializing novel uses and delivery forms of ketamine to treat mental health, neurological and pain disorders, is pleased to announce that the United States Patent and Trademark Office (“USPTO”) granted US Patent No: 11,426,366, titled “Compositions and Methods for Treating Motor Disorders,” which includes claims intended to cover ketamine in the potential treatment of Parkinson’s Disease and motor disorders that cause involuntary or uncontrollable movement or actions of the body (the “Patent”).

Key Points: 
  • In August 2020, the Company entered into an exclusive license agreement with the University of Arizona to develop and commercialize the Patent.
  • Parkinsons disease is a debilitating disorder that affects an estimated 1 million people in the U.S. and 10 million people worldwide.
  • The possible therapeutic effect of low-dose ketamine on levodopa-induced dyskinesia was noted in a retrospective analysis of Parkinsons disease patients who received ketamine for pain relief.
  • There is currently no cure for Parkinsons disease, although some drug combinations are used to treat the disease symptoms.